cholecalciferol and Vitamin-D-Deficiency

Although vitamin D deficiency resulting from insufficient sunlight exposure or inadequate dietary vitamin D intake is the most common cause of rickets, mutations in genes involved in vitamin D metabolism can cause genetic forms of rickets termed Vitamin D-Dependent Rickets (VDDR). In 2018, Roizen et al. described a new type of VDDR, named VDDR3, caused by a recurrent missense mutation in the CYP3A4 gene that leads to accelerated inactivation of vitamin D metabolites. Here, we describe the third case of VDDR3 due to the same CYP3A4 mutation in a 2-year-old boy with bone deformities associated with poor growth. As in the previously reported cases, this patient had no family history of rickets. Serial measurements of vitamin D metabolites after a single 150,000 IU dose of cholecalciferol demonstrated an accelerated inactivation of 25(OH)D and 1,25(OH)2D. Significant improvement in growth velocity and healing of bone deformities were achieved after a short period of treatment with 10.000 IU of cholecalciferol daily, showing the importance of early recognition and prompt precision therapy of this condition.

Topics: Child, Preschool; Cholecalciferol; Cytochrome P-450 CYP3A; Humans; Male; Rickets; Vitamin D; Vitamin D Deficiency

The discovery of a fat-soluble nutrient that had antirachitic activity and no vitamin A activity by McCollum has had far reaching health benefits for children and adults. He named this nutrient vitamin D. The goal of this review and personal experiences is to give the reader a broad perspective almost from the beginning of time for how vitamin D evolved to became intimately involved in the evolution of land vertebrates. It was the deficiency of sunlight causing the devastating skeletal disease known as English disease and rickets that provided the first insight as to the relationship of sunlight and the cutaneous production of vitamin D

Topics: Adult; Animals; Anniversaries and Special Events; Child; Cholecalciferol; Humans; Rickets; Sunlight; Vitamin D; Vitamin D Deficiency; Vitamins

In addition to the role of vitamin D in bone mineralization, calcium and phosphate homeostasis, and skeletal health, evidence suggests an association between vitamin D deficiency and a wide range of chronic conditions. This is of clinical concern given the substantial global prevalence of vitamin D deficiency. Vitamin D deficiency has traditionally been treated with vitamin D. By means of targeted literature searches of PubMed, this narrative review overviews the physiological functions and metabolic pathways of vitamin D, examines the differences between calcifediol and vitamin D. For supplemental use in the healthy population, calcifediol can be used at doses of up to 10 µg per day for children ≥ 11 years and adults and up to 5 µg/day in children 3-10 years. For therapeutic use of calcifediol under medical supervision, the dose, frequency and duration of treatment is determined according to serum 25(OH)D concentrations, condition, type of patient and comorbidities. Calcifediol differs pharmacokinetically from vitamin D. Calcifediol is suitable for use in all patients with vitamin D deficiency and may be preferable to vitamin D

Topics: Adult; Calcifediol; Child; Cholecalciferol; Dietary Supplements; Humans; Vitamin D; Vitamin D Deficiency; Vitamins

Children and young adults with HIV infection may exhibit vitamin D deficiency, which is harmful to bone health as well as the endocrine and immune systems.. This study sought to investigate the effect of vitamin D supplementation on children and young adults with HIV infection.. The PubMed, Embase, and Cochrane databases were searched. Randomized controlled trials that have evaluated the effects of vitamin D supplementation (ergocalciferol or cholecalciferol) at any dose or for any duration in children and young adults with HIV infection, aged 0-25 y, were included. A random-effects model was used, and the standardized mean difference (SMD) and 95% CI were calculated.. Ten trials, with 21 publications and 966 participants (mean age: 17.9 y), were included in the meta-analysis. The supplementation dose and the duration of the studies included ranged from 400 to 7000 IU/d and from 6 to 24 mo, respectively. Vitamin D supplementation was associated with a significantly higher serum 25(OH)D concentration at 12 mo (SMD: 1.14; 95% CI: 0.64, 1.65; P < 0.00001) compared with a placebo. No significant difference was observed in spine BMD (SMD: -0.09; 95% CI: -0.47, 0.3; P = 0.65) at 12 mo between these 2 groups. However, participants who received higher doses (1600-4000 IU/d) had significantly higher total BMD (SMD: 0.23; 95% CI: 0.02, 0.44; P = 0.03) and nonsignificantly higher spine BMD (SMD: 0.3; 95% CI: -0.02, 0.61; P = 0.07) at 12 mo compared with those who received standard doses (400-800 IU/d).. Vitamin D supplementation in children and young adults with HIV infection increases the serum 25(OH)D concentration. A relatively high daily dose of vitamin D (1600-4000 IU) improves total BMD at 12 mo and results in sufficient 25(OH)D concentrations.

Topics: Adolescent; Child; Cholecalciferol; Dietary Supplements; HIV Infections; Humans; Randomized Controlled Trials as Topic; Vitamin D; Vitamin D Deficiency; Young Adult

For many years vitamin D3 was known only as a regulator of the calcium-phosphate and water-electrolyte balances. Recent studies have paid special attention to other biological effects of calcitriol (the bioactive form of vitamin D3) with particular emphasis on its influence on immune function. Thus, any alterations, especially deficiencies, in the physiological level of calcitriol have serious health consequences. The aim of the study was to summarise the current state of knowledge concerning the role of vitamin D3 in selected pulmonary diseases.. The review was based on data obtained from articles published in PubMed between 2000-2022. Papers were reviewed for scientific merit and relevance.. In the reviewed literature, much attention was paid to clinical studies focused on the role of vitamin D3 in the pathogenesis of selected respiratory diseases. As revealed in research over the last two decades, vitamin D3 deficiency increases the risk and worsens the course of asthma, cystic fibrosis, chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, as well as COVID-19. Surprisingly, vitamin D supplementation has not always proved to be an effective therapeutic strategy. The review also presents the unique concept of the possibility of using vitamin D3 in the prevention and treatment of pulmonary fibrosis in the course of hypersensitivity pneumonitis.. Due to the multiplicity and variety of factors that affect the metabolism of vitamin D3, effective counteracting, and even more eliminating the negative consequences of disorders in the level and activity of calcitriol in the respiratory tract, seems to be a breakneck action. On the other hand, only a deep understanding of the role of calcitriol in the pathogenesis of lung diseases provides the chance to develop an effective therapy.

Topics: Calcitriol; Cholecalciferol; COVID-19; Humans; Pulmonary Fibrosis; Vitamin D; Vitamin D Deficiency

Hypoparathyroidism (HypoPT) is a rare endocrine disorder characterized by the absence or insufficient parathyroid hormone production resulting in chronic hypocalcemia. Complications of HypoPT include perturbation of several target organs. The conventional treatment consists of the administration of active vitamin D, namely calcitriol. Regarding vitamin D status, few data are available, mostly in HypoPT subjects supplemented with parent vitamin D. In addition, perturbation of vitamin D metabolism has been poorly investigated, as well as the contribution of altered vitamin D status on the clinical expression of the disease. The most recent consensus on the management of chronic HypoPT suggests the baseline evaluation of serum 25-hydroxy-vitamin D [25(OH)D] and supplementation with parent vitamin D with the aim to achieve and maintain serum 25(OH)D levels in the range of 30-50 ng/mL. The rationale for using supplementation with parent vitamin D (either ergocalciferol or cholecalciferol) in HypoPT would be to provide sufficient 25(OH)D substrate to the residual 1-α-hydroxylase activity, thus ensuring its conversion to active vitamin D in renal and extra-renal tissues. More data from experimental and clinical studies are needed for better assessing how these mechanisms may significantly influence metabolic control in HypoPT and eventually skeletal and extra-skeletal manifestation of the disease. Finally, future data will clarify how the currently available parent vitamin D compounds (ergocalciferol, cholecalciferol, calcifediol) would perform in addressing these specific issues.

Topics: Calcifediol; Calcitriol; Cholecalciferol; Ergocalciferols; Humans; Hypoparathyroidism; Parathyroid Hormone; Vitamin D; Vitamin D Deficiency; Vitamins

Low serum 25-hydroxy-vitamin D [25(OH)D] levels are prevalent worldwide. Although the benefits of vitamin D supplementation have focused on skeletal disorders (eg, rickets, osteomalacia, osteoporosis), emerging evidence for nonskeletal health merits further discussion.. The purpose of this review was to critically examine the vitamin D supplementation literature pertaining to nonskeletal health to help guide clinicians.. A scoping review that included observational studies and randomized clinical trials (RCTs) was performed. Evidence from meta-analyses and individual RCTs are discussed, and controversies and future directions are considered.. 25(OH)D deficiency is a ubiquitous condition associated with multiple nonskeletal diseases, including cardiometabolic (heart disease, diabetes, and kidney disease), immune (HIV/AIDS and cancer), lung (from traditional chronic disorders to coronavirus disease 2019), and gut diseases. Vitamin D deficiency also affects health across the life span (children, pregnant, and elderly), mental illness, and reproduction in both men and women. In contrast, vitamin D supplementation does not necessarily improve major medical outcomes, even when low 25(OH)D levels are treated. Screening for 25(OH)D status remains an important practice, primarily for high-risk patients (eg, elderly, women with osteoporosis, people with low exposure to sunlight). It is reasonable to supplement with vitamin D to treat 25(OH)D deficiency, such that if beneficial nonskeletal health occurs, this may be considered as a coadjutant instead of the central tenet of the disease. Furthermore, optimizing dosing regimens is an important clinical consideration.. Although 25(OH)D deficiency is prevalent in nonskeletal diseases, there is no uniform evidence that vitamin D supplementation improves major medical outcomes, even when low 25(OH)D levels are corrected. Findings from RCTs warrant caution due to possible selection bias. Overall, vitamin D supplementation must be guided by circulating levels as a reasonable medical practice to correct 25(OH)D deficiency.

Topics: Aged; Child; Cholecalciferol; COVID-19; Dietary Supplements; Female; Humans; Male; Osteoporosis; Pregnancy; Vitamin D; Vitamin D Deficiency; Vitamins

An undersupply of 25-(OH) vitamin D3 (calcifediol) exists in many countries with moderate sunlight, long winters and only moderate fish consumption. Risk groups for vitamin D3 deficiency are older persons over 65 years, geriatric persons in nursing homes, infants and children/adolescents. Therefore, there are also many situations in Germany which justify vitamin D substitution; however, vitamin D3 is currently praised as a "magic bullet" against everything. But what do the data look like? Where can it help and where can it not help?. Eine Unterversorgung von 25(OH)Vitamin‑D

Topics: Adolescent; Aged; Aged, 80 and over; Animals; Calcifediol; Child; Cholecalciferol; Humans; Infant; Life Style; Vitamin D; Vitamin D Deficiency

In the last decade, an increasing awareness was directed to the role of Vitamin D in non-skeletal and preventive roles for chronic diseases. Vitamin D is an essential hormone in regulating calcium/phosphorous balance and in the pathogenesis of inflammation, insulin resistance, and obesity. The main forms of vitamin D, Cholecalciferol (Vitamin D3) and Ergocalciferol (Vitamin D2) are converted into the active form (1,25-dihydroxyvitamin D) thanks to two hydroxylations in the liver, kidney, pancreas, and immune cells. Some anti-inflammatory cytokines are produced at higher levels by vitamin D, while some pro-inflammatory cytokines are released at lower levels. Toll-Like Receptor (TLR) expression is increased, and a pro-inflammatory state is also linked to low levels of vitamin D. Regardless of how it affects inflammation, various pathways suggest that vitamin D directly improves insulin sensitivity and secretion. The level of vitamin D in the body may change the ratio of pro- to anti-inflammatory cytokines, which would impact insulin action, lipid metabolism, and the development and function of adipose tissue. Many studies have demonstrated an inverse relationship between vitamin D concentrations and pro-inflammatory markers, insulin resistance, glucose intolerance, metabolic syndrome, obesity, and cardiovascular disease. It is interesting to note that several long-term studies also revealed an inverse correlation between vitamin D levels and the occurrence of diabetes mellitus. Vitamin D supplementation in people has controversial effects. While some studies demonstrated improvements in insulin sensitivity, glucose, and lipid metabolism, others revealed no significant effect on glycemic homeostasis and inflammation. This review aims to provide insight into the molecular basis of the relationship between vitamin D, insulin resistance, metabolic syndrome, type 1 and 2 diabetes, gestational diabetes, and cardiovascular diseases.

Topics: Anti-Inflammatory Agents; Cardiovascular Diseases; Cholecalciferol; Cytokines; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Female; Humans; Inflammation; Insulin; Insulin Resistance; Metabolic Syndrome; Obesity; Pregnancy; Vitamin D; Vitamin D Deficiency; Vitamins

People of Black and Asian ethnicities have a higher infection rate and mortality as a result of COVID-19. It has also been reported that vitamin D deficiency may play a role in this, possibly because of the multi-gene regulatory function of the vitamin D receptor. As a result, increased dietary intake and/or supplementation to attain adequate 25-hydroxyvitamin D (25(OH)D) levels could benefit people in these ethnicities. The present study aimed to review the literature examining the changes in 25(OH)D in different types of vitamin D supplementation from randomised controlled trials in this population.. This systematic review was conducted using the PRISMA guidelines. Electronic databases were systematically searched using keywords related to vitamin D supplementation in Black and Asian ethnicities.. Eight studies were included in the review. All the included studies found that supplementation of vitamin D (D. Oral vitamin D supplementation may be more efficacious in increasing 25(OH)D levels than food fortification of Black and Asian ethnicities, with vitamin D

Topics: Cholecalciferol; COVID-19; Dietary Supplements; Humans; Pandemics; Randomized Controlled Trials as Topic; Vitamin D; Vitamin D Deficiency; Vitamins

Topics: Breast Feeding; Cholecalciferol; Dietary Supplements; Female; Humans; Infant; Mothers; Randomized Controlled Trials as Topic; Vitamin D; Vitamin D Deficiency; Vitamins

An increasing number of studies are analyzing the relationship between serum vitamin D levels and the development of sensitization and allergic diseases in genetically predisposed individuals, as well as the impact of vitamin D supplementation. This article reviews the literature on this subject. Clinical trials, meta-analyses and systematic reviews consulted in PubMed, EMBASE, Scopus, Ovid, Wiley Online Library, Springer, Cochrane and manual resources were included, with the keywords: vitamin D, 25 hydroxyvitamin D, cholecalciferol, asthma, rhinitis, allergy, 25-OH-D, 1,25 hydroxyvitamin D, supplementation. The results show a positive linear trend, however, differ. We should keep in mind that in the studies there is heterogeneity of population groups and associated factors, which may modify such studies. It is necessary to increase research to clarify this relationship and to have successful interventions from the patient's approach to the strengthening of pharmacological and immunological treatment of allergic patients with these diseases.. Cada vez son más los trabajos que analizan la relación de los niveles séricos de vitamina D y el desarrollo de sensibilizaciones y enfermedades alérgicas en los individuos con predisposición genética, así como el impacto de su suplementación. El presente artículo efectúa una revisión de la literatura acerca de este tema. Se incluyeron ensayos clínicos, metaanálisis y revisiones sistemáticas consultadas en PubMed, EMBASE, Scopus, Ovid, Wiley Online Library, Springer, Cochrane y recursos manuales, con las palabras clave: vitamina D, 25 hidroxivitamina D, colecalciferol, asma, rinitis, alergia, 25-OH-D, 1,25 hidroxivitamina D, suplementación. Los resultados muestran una tendencia lineal positiva; sin embargo, algunos difieren. Debemos tener en mente que en los estudios existe heterogeneidad de los grupos poblacionales y los factores asociados, lo que puede modificarlos. Es necesario incrementar las investigaciones para clarificar esta relación y tener intervenciones exitosas desde el abordaje del paciente hasta el fortalecimiento del tratamiento farmacológico e inmunológico de los pacientes alérgicos con estas enfermedades.

Topics: Asthma; Cholecalciferol; Humans; Hypersensitivity; Vitamin D; Vitamin D Deficiency; Vitamins

The role of vitamin D on muscle health is debated.. An individual participant metanalysis of 4 randomized placebo-controlled trials, investigating short-term (3-9months) effects of vitamin D3 in moderate (2800 IU) to high (7000 IU) daily oral doses on muscle health and quality of life (QoL). Inclusion criteria were either obesity (n = 52), newly diagnosed primary hyperparathyroidism (n = 41), Graves' disease (n = 86), or secondary hyperparathyroidism (n = 81).. Overall (n = 260) as well as in a subgroup analysis including only vitamin D insufficient [25(OH)D < 50 nmol/L] individuals (n = 176), vitamin D supplementation did not affect measures of muscle health (isometric muscle strength, Timed Up and Go test, chair rising test, body composition, and balance) or QoL. However, a beneficial effect was present on QoL (physical component score) in vitamin D deficient [25(OH)D < 25 nmol/L] individuals (n = 34). Overall, relative changes in 25(OH)D inversely affected maximum muscle strength in a dose-response manner. Stratified into body mass index 30 kg/m2, vitamin D supplementation had divergent effects on isometric muscle strength, with beneficial effects in obese individuals (n = 93) at knee flexion 90° (P = 0.04), and adverse effects in nonobese individuals (n = 167) at handgrip (P = 0.02), knee extension 60° (P = 0.03) and knee flexion 60° (P < 0.01).. Overall, short-term treatment with moderate to high daily doses of vitamin D did not affect muscle health or QoL. A potential beneficial effect was present on muscle strength in severely obese individuals and on QoL in vitamin D deficient individuals. Subgroup analyses, however, suggested negative effects of large relative increases in p-25(OH)D.

Topics: Cholecalciferol; Dietary Supplements; Double-Blind Method; Graves Disease; Hand Strength; Humans; Muscle Strength; Muscles; Obesity; Postural Balance; Quality of Life; Time and Motion Studies; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D deficiency is the main cause of nutritional rickets in children and osteomalacia in adults. There is consensus that nutritional access to vitamin D can be estimated by measuring serum concentrations of 25OHD and vitamin D deficiency can thus be considered as calcifediol deficiency. However, the threshold for vitamin D/calcifediol sufficiency remains a matter of debate. Vitamin D/calcifediol deficiency has been associated with musculoskeletal effects but also multiple adverse extra-skeletal consequences. If these consequences improve or if they can be treated with vitamin D supplementation is still unclear. Observational studies suggest a higher infection risk in people with low calcifediol levels. There is also a consistent association between serum calcifediol and cardiovascular events and deaths, but large-scale, long-term intervention studies did not show any benefit on cardiovascular outcomes from supplementation, at least not in subjects without clear vitamin D deficiency. Cancer risk also did not change with vitamin D treatment, although there are some data that higher serum calcifediol is associated with longer survival in cancer patients. In pregnant women, vitamin D supplementation decreases the risk of pre-eclampsia, gestational diabetes mellitus, and low birth weight. Although preclinical studies showed that the vitamin D endocrine system plays a role in certain neural cells as well as brain structure and function, there is no evidence to support a beneficial effect of vitamin D in neurodegenerative diseases. Vitamin D supplementation may marginally affect overall mortality risk especially in elderly subjects with low serum calcifediol concentrations.

Topics: Aged; Calcifediol; Child; Cholecalciferol; Female; Humans; Pregnancy; Risk Factors; Vitamin D; Vitamin D Deficiency

Vitamin D deficiency has a high worldwide prevalence, but actions to improve this public health problem are challenged by the heterogeneity of nutritional and clinical vitamin D guidelines, with respect to the diagnosis and treatment of vitamin D deficiency. We aimed to address this issue by providing respective recommendations for adults, developed by a European expert panel, using the Delphi method to reach consensus. Increasing the awareness of vitamin D deficiency and efforts to harmonize vitamin D guidelines should be pursued. We argue against a general screening for vitamin D deficiency but suggest 25-hydroxyvitamin D (25(OH)D) testing in certain risk groups. We recommend a vitamin D supplementation dose of 800 to 2000 international units (IU) per day for adults who want to ensure a sufficient vitamin D status. These doses are also recommended for the treatment of vitamin D deficiency, but higher vitamin D doses (e.g., 6000 IU per day) may be used for the first 4 to 12 weeks of treatment if a rapid correction of vitamin D deficiency is clinically indicated before continuing, with a maintenance dose of 800 to 2000 IU per day. Treatment success may be evaluated after at least 6 to 12 weeks in certain risk groups (e.g., patients with malabsorption syndromes) by measurement of serum 25(OH)D, with the aim to target concentrations of 30 to 50 ng/mL (75 to 125 nmol/L).

Topics: Adult; Cholecalciferol; Dietary Supplements; Humans; Prevalence; Risk Factors; Vitamin D; Vitamin D Deficiency; Vitamins

Single nucleotide polymorphisms (SNPs) in vitamin D metabolism pathway genes are associated with circulating 25-hydroxyvitamin D (25(OH)D) in adults. Less is known about the relationships between mother and offspring SNPs and umbilical cord blood 25(OH)D.. (1) To undertake a meta-analysis of the relationships of maternal and offspring SNPs in the vitamin D metabolism pathway and cord blood 25(OH)D in pregnant women including novel data; and (2) to examine these relationships in women who received antenatal cholecalciferol supplementation in a clinical trial.. Novel data analysis from an observational mother-offspring cohort study (Southampton Women's Survey) and the MAVIDOS double-blind, randomized, placebo-controlled trial of 1000 IU/day cholecalciferol supplementation in pregnancy, and an electronic literature search of published studies in PubMed up to 31 July 2021. Studies reporting associations between rs12785878 (DHCR7), rs10741657 (CYP2R1), rs6013897 (CYP24A1), or rs2282679 (GC) and cord blood 25(OH)D. One published study was included in addition to the novel data analysis. Associations between both maternal and offspring SNPs at rs2282679 (GC) and rs12785878 (DHCR7), and cord blood 25(OH)D were identified. When maternal genotype was adjusted for offspring genotype, and vice versa, there was persisting evidence for associations with maternal rs12785878 (β [95% CI] 1.6 nmol/L [0.3, 2.8] per common allele), and offspring rs2282679 (β 3.1 nmol/L ]2.0, 4.4] per common allele). Maternal and offspring SNPs at rs1074657 and rs613897 were not associated with cord blood 25(OH)D.. Associations between both maternal and offspring SNPs at rs2282679 (GC) and rs12785878 (DHCR7), and cord blood 25(OH)D were identified. When maternal genotype was adjusted for offspring genotype, and vice versa, there was persisting evidence for associations with maternal rs12785878 (β [95% CI] 1.6 nmol/L [0.3, 2.8] per common allele), and offspring rs2282679 (β 3.1 nmol/L ]2.0, 4.4] per common allele). Maternal and offspring SNPs at rs1074657 and rs613897 were not associated with cord blood 25(OH)D.. Common genetic variation in the vitamin D metabolism pathway is associated with umbilical cord blood 25(OH)D.

Topics: Adult; Calcifediol; Cholecalciferol; Cohort Studies; Female; Fetal Blood; Humans; Polymorphism, Single Nucleotide; Pregnancy; Randomized Controlled Trials as Topic; Vitamin D; Vitamin D Deficiency

Vitamin D is essential for the normal mineralization of bones during childhood. Although diet and adequate sun exposure should provide enough of this nutrient, there is a high prevalence of vitamin D deficiency rickets worldwide. Children with certain conditions that lead to decreased vitamin D production and/or absorption are at the greatest risk of nutritional rickets. In addition, several rare genetic alterations are also associated with severe forms of vitamin-D-resistant or -dependent rickets. Although vitamin D3 is the threshold nutrient for the vitamin D endocrine system (VDES), direct measurement of circulating vitamin D3 itself is not a good marker of the nutritional status of the system. Calcifediol (or 25(OH)D) serum levels are used to assess VDES status. While there is no clear consensus among the different scientific associations on calcifediol status, many clinical trials have demonstrated the benefit of ensuring normal 25(OH)D serum levels and calcium intake for the prevention or treatment of nutritional rickets in childhood. Therefore, during the first year of life, infants should receive vitamin D treatment with at least 400 IU/day. In addition, a diet should ensure a normal calcium intake. Healthy lifestyle habits to prevent vitamin D deficiency should be encouraged during childhood. In children who develop clinical signs of rickets, adequate treatment with vitamin D and calcium should be guaranteed. Children with additional risk factors for 25(OH)D deficiency and nutritional rickets should be assessed periodically and treated promptly to prevent further bone damage.

Topics: Calcifediol; Calcium; Child; Cholecalciferol; Humans; Infant; Pediatrics; Rickets; Vitamin D; Vitamin D Deficiency; Vitamins

Calcifediol (25-OH-vitamin D3) is the prohormone of the vitamin D endocrine system. It is used to prevent and treat vitamin D deficiency. Calcifediol, as well as cholecalciferol (vitamin D3), is efficient and safe in the general population, although calcifediol has certain advantages over cholecalciferol, such as its rapid onset of action and greater potency. This review analyzed studies comparing the efficacy and safety of both calcifediol and cholecalciferol drugs in the short and long term (>6 months). Calcifediol was found to be more efficacious, with no increase in toxicity. We also assessed the predictability of both molecules. A 25OHD increase depends on the dose and frequency of calcifediol administration. In contrast, after cholecalciferol administration, 25OHD increase depends on more factors than dose and frequency of administration, also phenotypic aspects (such as obesity and malabsorption), and genotypic factors impacts in this increase.

Topics: Calcifediol; Cholecalciferol; Dietary Supplements; Humans; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D is an important human hormone, known primarily to be involved in the intestinal absorption of calcium and phosphate, but it is also involved in various nonskeletal processes (molecular, cellular, immune, and neuronal). One of the main health problems nowadays is the vitamin D deficiency of the human population due to lack of sun exposure, with estimates of one billion people worldwide with vitamin D deficiency, and the consequent need for clinical intervention (i.e., prescription of pharmacological vitamin D supplements). An alternative to reduce vitamin D deficiency is to produce good dietary sources of it, a scenario in which the yeast Saccharomyces cerevisiae seems to be a promising alternative. This review focuses on the potential use of yeast as a biological platform to produce vitamin D, summarizing both the biological aspects of vitamin D (synthesis, ecology and evolution, metabolism, and bioequivalence) and the work done to produce it in yeast (both for vitamin D

Topics: Cholecalciferol; Dietary Supplements; Humans; Saccharomyces cerevisiae; Vitamin D; Vitamin D Deficiency; Vitamins

The importance of vitamin D3 (hydroxycholecalciferol) as one of the liposoluble vitamins is known in the prevention and treatment of metabolic bone diseases (rickets, osteomalacia, osteoporosis). In recent years, however, information has increased on the importance of vitamin D3 in numerous organ systems and in the pathogenesis of various diseases, e. g. ophthalmopathies. The immunological functions of vitamin D3 are the subject of studies dealing with autoimmune optic nerve disorders and their results appear to have a positive effect on demyelinating diseases. It also plays an important role in maintaining the thickness of the retinal nerve fiber layer, but its additional administration has not been successful. Optical neuritis may be the first sign of multiple sclerosis. It appears that sufficient serum vitamin D3 levels may protect patients from deterioration in the form of a further attack of demyelination. The course of diabetic retinopathy is probably also influenced by vitamin D3, inter alia, by correlating the fact that its receptor and the enzymes of its metabolism are expressed on the retina. Low serum levels of vitamin D3 may even trigger age-related macular degeneration. Conversely, higher dietary intake of vitamin D3 may positively affect neovascularization. The optimal level of hydroxycholecalciferol is between 60 and 200 nmol /l, the severe deficit represents a decrease below 25 nmol/l. The body can normally produce up to 10,000 IU of this vitamin after exposure to sunlight. However, the demonstration of its protective character in connection with the mentioned diseases of the retina and optic nerve will require a sufficient number of studies to confirm the facts found so far about this rediscovered vitamin.

Topics: Cholecalciferol; Dietary Supplements; Humans; Hydroxycholecalciferols; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D (calciferol) is a fat-soluble vitamin that has a significant role in phospho-calcium metabolism, maintaining normal calcium levels and bone health development. The most important compounds of vitamin D are cholecalciferol (vitamin D3, or VD3) and ergocalciferol (vitamin D2, or VD2). Besides its major role in maintaining an adequate level of calcium and phosphate concentrations, vitamin D is involved in cell growth and differentiation and immune function. Recently, the association between vitamin D deficiency and the progression of fibrosis in chronic liver disease (CLD) was confirmed, given the hepatic activation process and high prevalence of vitamin D deficiency in these diseases. There are reports of vitamin D deficiency in CLD regardless of the etiology (chronic viral hepatitis, alcoholic cirrhosis, non-alcoholic fatty liver disease, primary biliary cirrhosis, or autoimmune hepatitis). Vitamin D binding protein (VDBP) is synthesized by the liver and has the role of binding and transporting vitamin D and its metabolites to the target organs. VDBP also plays an important role in inflammatory response secondary to tissue damage, being involved in the degradation of actin. As intense research during the last decades revealed the possible role of vitamin D in liver diseases, a deeper understanding of the vitamin D, vitamin D receptors (VDRs), and VDBP involvement in liver inflammation and fibrogenesis could represent the basis for the development of new strategies for diagnosis, prognosis, and treatment of liver diseases. This narrative review presents an overview of the evidence of the role of vitamin D and VDBP in CLD, both at the experimental and clinical levels.

Topics: Actins; Calcium; Cholecalciferol; Ergocalciferols; Humans; Liver Diseases; Non-alcoholic Fatty Liver Disease; Phosphates; Receptors, Calcitriol; Vitamin D; Vitamin D Deficiency; Vitamin D-Binding Protein; Vitamins

Official public health pronouncements about sun exposure and vitamin D can be summarized as follows: First, there is no such thing as a safe tan. Therefore, avoid exposing the skin to sunshine. Second, in the absence of sunshine, a daily intake of 800 IU/day (20 mcg/d) vitamin D or less is sufficient for the health needs of almost all members of the population. However, exposure of the skin to sunlight induces multiple mechanisms that lower blood pressure, while also initiating production of vitamin D, which is needed to produce a hormone that regulates multiple systems including the cellular biology that affects cancer mortality. Disease-prevention relationships point to a beneficial threshold for serum 25-hydroxyvitamin D [25(OH)D; the index of vitamin D nutrition] that is at least 75 nmol/l (30 ng/ml). To ensure the threshold for all adults, an average per-day minimum total input of vitamin D3 from sunshine/UVB exposure, and/or from food (natural food like fish or fortified food like milk), and/or vitamin supplementation of at least 4,000 IU/d (100 mcg/d) is required. Strong, although not Level-1, evidence indicates that the maintenance of that threshold will lower mortality overall, lower mortality from cancer, and lower the risk of certain other diseases such as respiratory infection and COVID-19.

Topics: Cholecalciferol; COVID-19; Dietary Supplements; Hormones; Humans; Neoplasms; Public Health; Sunbathing; Sunlight; Vitamin D; Vitamin D Deficiency; Vitamins

(1) Background: In the present paper we aimed to review the evidence about the potential implication of vitamin D in the pathogenesis and management of systemic sclerosis (SSc); (2) Methods: we performed a review of the literature looking for studies evaluating the potential role of vitamin D and its analogs in SSc. We searched the PubMed, Medline, Embase, and Cochrane libraries using the following strings: (vitamin D OR cholecalciferol) AND (systemic sclerosis OR scleroderma). We included cohort studies, case-control studies, randomized controlled trials, and observational studies. (3) Results: we identified nine pre-clinical and 21 clinical studies. Pre-clinical data suggest that vitamin D and its analogs may suppress fibrogenesis. Clinical data are concordant in reporting a high prevalence of hypovitaminosis D and osteoporosis in SSc patients; data about the association with clinical manifestations and phenotypes of SSc are, conversely, far less consistent; (4) Conclusions: in vitro data suggest that vitamin D may play an antifibrotic role in SSc, but clinical data confirming this finding are currently lacking. Hypovitaminosis D is common among SSc patients and should be treated to reduce the risk of osteoporosis.

Topics: Cholecalciferol; Humans; Osteoporosis; Rickets; Scleroderma, Systemic; Vitamin D; Vitamin D Deficiency; Vitamins

Recent studies have clearly shown that vitamin D

Topics: Animals; Animals, Domestic; Birds; Cholecalciferol; Female; Fishes; Genitalia, Female; Pregnancy; Receptors, Calcitriol; Reproduction; Vitamin D; Vitamin D Deficiency

The 100th anniversary of the discovery of vitamin D3 (VitD3) coincides with significant recent advances in understanding its mechanism of action along with accumulating knowledge concerning its genomic and nongenomic activities. A close relationship between VitD3 and the immune system, including both types of immunity, innate and adaptive, has been newly identified, while low levels of VitD3 have been implicated in the development of autoimmune thyroiditis (AIT). Active 1,25(OH)

Topics: Cholecalciferol; COVID-19; Hashimoto Disease; Humans; Inflammation; Thyroiditis, Autoimmune; Vitamin D; Vitamin D Deficiency; Vitamins

Supplementation with high doses of vitamin D, known as mega-dose or "stoss therapy," refers to administering high doses of vitamin D by oral or intramuscular route in short periods of time. In this sense, conducting a review to organize this knowledge in a single article will generate a helpful instrument for researchers working in this area and for health professionals who use this therapeutic tool.. To carry out a literature review on safety and efficacy (normalization of serum vitamin D level, and changes in the clinical picture) of vitamin D mega-dose use.. This is a systematic review of the literature searching data through the electronic banks of PubMed, Scielo, and LILACS, using the following keywords: "vitamin D," "mega-dose," "stoss therapy," "cholecalciferol," in different combinations. CONSORT questionnaire was used to assess the quality of the included studies.. Of the 59 articles screened for this review, 10 were included in the review, studying patients with rickets, osteoporosis, and critically ill patients. Two studies compared the exact dosage of vitamin D by different routes of administration, and three studies compared different doses by the same route. All others studied vitamin D mega-dose versus placebo. Adverse effects were observed through the presence of hypercalcemia/hypercalciuria. Serum vitamin D levels were normalized between 70 and 100% of patients, and adverse effects ranged between 1.9 and 18.5%.. The study demonstrated that vitamin D mega-dose therapy is effective in normalizing serum vitamin levels, and the toxicity assessed through adverse effects was low, with no expressive clinical significance. Despite this, there is still a need for further studies in the area to confirm the results found.

Topics: Cholecalciferol; Humans; Rickets; Vitamin D; Vitamin D Deficiency; Vitamins

The 4

Topics: Cholecalciferol; COVID-19; Humans; SARS-CoV-2; Vitamin D; Vitamin D Deficiency

After the recognition of the efficacy of cod-liver oil in rickets at the end of the eighteenth century, and the isolation and synthesis of the liposoluble vitamin D in 1931, its mode of actions and functions were deeply explored. Biochemical studies permitted to identify five forms of vitamin D, called D1, D2, D3, D4 and D5, differing in ultrastructural conformation and origin, with vitamin D2 (ergocalciferol) and D3 (cholecalciferol) representing the active forms. In the last decades especially, a constantly increasing bulk of data highlighted how vitamin D could regulate several activities and processes.. The aim of the present paper was to review and comment on the literature on vitamin D, with a focus on its possible role in the pathophysiology of neuropsychiatric disorders.. Available literature indicates that vitamin D regulates a variety of processes in humans and in the central nervous system. Vitamin D deficiency is associated with an enhanced pro-inflammatory state, and formation of Aβ oligomers that might contribute to the cognitive decline typical of the elderly age and, perhaps, dementia. More in general, vitamin D is supposed to play a crucial role in neuroinflammation processes that are currently hypothesized to be involved in the pathophysiology of different psychiatric disorders, such as major depression, bipolar disorders, obsessive-compulsive disorders and psychosis.. It is conceivable that vitamin D supplementation might pave the way towards "natural" treatments of a broad range of neuropsychiatric disorders, or at least be useful to boost response to psychotropic drugs in resistant cases.

Topics: Aged; Cholecalciferol; Dietary Supplements; Hormones; Humans; Psychotropic Drugs; Vitamin D; Vitamin D Deficiency; Vitamins

Topics: Alzheimer Disease; Antigens, Neoplasm; Black or African American; Cholecalciferol; COVID-19; Dementia; Diabetes Mellitus; Dietary Supplements; Female; Health Status Disparities; Humans; Male; Prevalence; Status Asthmaticus; Vitamin D; Vitamin D Deficiency

Vitamin D can be obtained from diet, direct sunlight, or supplementation. The most common form is synthesized in the skin after exposure to ultraviolet B radiation. Nevertheless, the thought is that vitamin D is more of a multifunctional hormone or prohormone. This is because vitamin D plays contributes to many processes in the body. Calcitriol has been shown to have enhancing effects on the immune system, the cardiovascular system, the endocrine system, and other metabolic pathways. There is evidence that vitamin D has also a role in depression, pain, and cancer.

Topics: Antioxidants; Calcitriol; Cholecalciferol; Dietary Supplements; Humans; Neoplasms; Protective Agents; Receptors, Calcitriol; Sunlight; Vitamin D Deficiency

Low serum vitamin D levels have been associated with adverse clinical outcomes; identifying and treating deficiency may improve outcomes.. To review the evidence about screening for vitamin D deficiency in adults.. PubMed, EMBASE, the Cochrane Library, and trial registries through March 12, 2020; bibliographies from retrieved articles, outside experts, and surveillance of the literature through November 30, 2020.. Fair- or good-quality, English-language randomized clinical trials (RCTs) of screening with serum 25-hydroxyvitamin D (25[OH]D) compared with no screening, or treatment with vitamin D (with or without calcium) compared with placebo or no treatment conducted in nonpregnant adults; nonrandomized controlled intervention studies for harms only. Treatment was limited to studies enrolling or analyzing participants with low serum vitamin D levels.. Two reviewers assessed titles/abstracts and full-text articles, extracted data, and assessed study quality; when at least 3 similar studies were available, meta-analyses were conducted.. Mortality, incident fractures, falls, diabetes, cardiovascular events, cancer, depression, physical functioning, and infection.. Forty-six studies (N = 16 205) (77 publications) were included. No studies directly evaluated the health benefits or harms of screening. Among community-dwelling populations, treatment was not significantly associated with mortality (pooled absolute risk difference [ARD], 0.3% [95% CI, -0.6% to 1.1%]; 8 RCTs, n = 2006), any fractures (pooled ARD, -0.3% [95% CI, -2.1% to 1.6%]; 6 RCTs, n = 2186), incidence of diabetes (pooled ARD, 0.1% [95% CI, -1.3% to 1.6%]; 5 RCTs, n = 3356), incidence of cardiovascular disease (2 RCTs; hazard ratio, 1.00 [95% CI, 0.74 to 1.35] and 1.09 [95% CI, 0.68 to 1.76]), incidence of cancer (2 RCTs; hazard ratio, 0.97 [95% CI, 0.68 to 1.39] and 1.01 [95% CI, 0.65 to 1.58], or depression (3 RCTs, various measures reported). The pooled ARD for incidence of participants with 1 or more falls was -4.3% (95% CI, -11.6% to 2.9%; 6 RCTs). The evidence was mixed for the effect of treatment on physical functioning (2 RCTs) and limited for the effect on infection (1 RCT). The incidence of adverse events and kidney stones was similar between treatment and control groups.. No studies evaluated the direct benefits or harms of screening for vitamin D deficiency. Among asymptomatic, community-dwelling populations with low vitamin D levels, the evidence suggests that treatment with vitamin D has no effect on mortality or the incidence of fractures, falls, depression, diabetes, cardiovascular disease, cancer, or adverse events. The evidence is inconclusive about the effect of treatment on physical functioning and infection.

Topics: Accidental Falls; Adult; Asymptomatic Diseases; Cholecalciferol; Fractures, Bone; Humans; Mass Screening; Practice Guidelines as Topic; Vitamin D; Vitamin D Deficiency; Vitamins

The role of vitamin D supplementation as a treatment for COVID-19 has been a subject of considerable discussion. A thorough understanding of the current evidence regarding the effectiveness and safety of vitamin D supplementation for COVID-19 based on randomised controlled trials is required.. To assess whether vitamin D supplementation is effective and safe for the treatment of COVID-19 in comparison to an active comparator, placebo, or standard of care alone, and to maintain the currency of the evidence, using a living systematic review approach.. We searched the Cochrane COVID-19 Study Register, Web of Science and the WHO COVID-19 Global literature on coronavirus disease to identify completed and ongoing studies without language restrictions to 11 March 2021.. We followed standard Cochrane methodology. We included randomised controlled trials (RCTs) evaluating vitamin D supplementation for people with COVID-19, irrespective of disease severity, age, gender or ethnicity. We excluded studies investigating preventive effects, or studies including populations with other coronavirus diseases (severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS)).. We followed standard Cochrane methodology. To assess bias in included studies, we used the Cochrane risk of bias tool (ROB 2) for RCTs. We rated the certainty of evidence using the GRADE approach for the following prioritised outcome categories: individuals with moderate or severe COVID-19: all-cause mortality, clinical status, quality of life, adverse events, serious adverse events, and for individuals with asymptomatic or mild disease: all-cause mortality, development of severe clinical COVID-19 symptoms, quality of life, adverse events, serious adverse events.. We identified three RCTs with 356 participants, of whom 183 received vitamin D. In accordance with the World Health Organization (WHO) clinical progression scale, two studies investigated participants with moderate or severe disease, and one study individuals with mild or asymptomatic disease. The control groups consisted of placebo treatment or standard of care alone. Effectiveness of vitamin D supplementation for people with COVID-19 and moderate to severe disease We included two studies with 313 participants. Due to substantial clinical and methodological diversity of both studies, we were not able to pool data. Vitamin D status was unknown in one study, whereas the other study reported data for vitamin D deficient participants. One study administered multiple doses of oral calcifediol at days 1, 3 and 7,  whereas the other study gave a single high dose of oral cholecalciferol at baseline. We assessed one study with low risk of bias for effectiveness outcomes, and the other with some concerns about randomisation and selective reporting. All-cause mortality at hospital discharge (313 participants) We found two studies reporting data for this outcome. One study reported no deaths when treated with vitamin D out of 50 participants, compared to two deaths out of 26 participants in the control group (Risk ratio (RR) 0.11, 95% confidence interval (CI) 0.01 to 2.13). The other study reported nine deaths out of 119 individuals in the vitamin D group, whereas six participants out of 118 died in the placebo group (RR 1.49, 95% CI 0.55 to 4.04]. We are very uncertain whether vitamin D has an effect on all-cause mortality at hospital discharge (very low-certainty evidence). Clinical status assessed by the need for invasive mechanical ventilation (237 participants) We found one study reporting data for this outcome. Nine out of 119 participants needed invasive mechanical ventilation when treated with vitamin D, compared to 17 out of 118 participants in the placebo group (RR 0.52, 95% CI 0.24 to 1.13). Vitamin D supplementation may decrease need for invasive mechanical ventilation, but the evidence is uncertain (low-certainty evidence). Quality of life We did not find data for quality of life. Safety of vitamin D supplementation for people with COVID-19 and moderate to severe disease We did not include data from one study, because assessment of serious adverse events was not described and we are concerned that data might have been inconsistently measured. This study. There is currently insufficient evidence to determine the benefits and harms of vitamin D supplementation as a treatment of COVID-19. The evidence for the effectiveness of vitamin D supplementation for the treatment of COVID-19 is very uncertain. Moreover, we found only limited safety information, and were concerned about consistency in measurement and recording of these outcomes. There was substantial clinical and methodological heterogeneity of included studies, mainly because of different supplementation strategies, formulations, vitamin D status of participants, and reported outcomes. There is an urgent need for well-designed and adequately powered randomised controlled trials (RCTs) with an appropriate randomisation procedure, comparability of study arms and preferably double-blinding. We identified 21 ongoing and three completed studies without published results, which indicates that these needs will be addressed and that our findings are subject to change in the future. Due to the living approach of this work, we will update the review periodically.

Topics: 25-Hydroxyvitamin D 2; Adrenal Cortex Hormones; Adult; Azithromycin; Bias; Calcifediol; Cause of Death; Ceftriaxone; Cholecalciferol; COVID-19; COVID-19 Drug Treatment; Drug Therapy, Combination; Humans; Hydroxychloroquine; Middle Aged; Quality of Life; Randomized Controlled Trials as Topic; Vitamin D Deficiency; Vitamins

Over the past two decades, many studies reported the benefits of higher 25-hydroxyvitamin D [25(OH)D] concentrations for nonskeletal effects. Researchers found significant benefits in reducing risk of acute respiratory tract infections, many types of cancer, type 2 diabetes mellitus, premature death, and adverse pregnancy and birth outcomes. In addition, 25(OH)D concentrations are low for various reasons in several categories of people, including the obese, those with dark skin living at higher latitudes, the elderly, and those who do not eat much eggs, fish, meat, or vitamin D fortified milk. Measuring 25(OH)D concentrations is one way to both increase the awareness of vitamin D's importance in maintaining good health and to encourage vitamin D supplementation or increased solar ultraviolet-B exposure to sustain well-being throughout life by reducing disease incidence. Although 20 ng/ml seems adequate to reduce risk of skeletal problems and acute respiratory tract infections, concentrations above 30 ng/ml have been associated with reduced risk of cancer, type 2 diabetes mellitus, and adverse pregnancy and birth outcomes. Thus, judicious testing of 25(OH)D concentrations could reduce disease incidence and make treatment expenditures more cost-effective.

Topics: Aged; Animals; Cholecalciferol; Diabetes Mellitus, Type 2; Dietary Supplements; Female; Humans; Pregnancy; Public Health; Vitamin D; Vitamin D Deficiency

Vitamin D is a pleiotropic secosteroid yielding multiple actions in human physiology. Besides the canonical regulatory activity on bone metabolism, several non-classical actions have been described and the ability of vitamin D to partake in the regulation of the immune system is particularly interesting, though far stronger and convincing evidence has been collected in in vitro as compared to in vivo studies. Whether vitamin D is able to regulate at physiological concentrations the human immune system remains unproven to date. Consequently, it is not established if vitamin D status is a factor involved in the pathogenesis of immune-mediated diseases and if cholecalciferol supplementation acts as an adjuvant for autoimmune diseases. The development of autoimmunity is a heterogeneous process, which may involve different organs and systems with a wide range of clinical implications. In the present paper, we reviewed the current evidences regarding vitamin D role in the pathogenesis and management of different autoimmune diseases.

Topics: Autoimmune Diseases; Cholecalciferol; Chronic Disease; Humans; Vitamin D Deficiency

Given the succession of communications in scientific and popular circuits, tending to take for granted a role for vitamin D in the control of the coronavirus pandemic, the authors conducted an analysis of the literature currently available in order to recognize what is supported by opinions personal and what evidence of effectiveness. At the end of the bibliographic survey there is the current absence of evidence of efficacy in favor of vitamin D in the treatment of coronavirus infection in its various expressions. The diffusion of personal opinions as if they were evidence can be a disturbing factor for adequate assistance and for correct research.

Topics: Betacoronavirus; Calcifediol; Cholecalciferol; Coronavirus Infections; COVID-19; Evidence-Based Medicine; Humans; Pandemics; Pneumonia, Viral; Respiratory Tract Diseases; SARS-CoV-2; Vitamin D; Vitamin D Deficiency; Vitamins

Sickle cell disease (SCD) is a genetic chronic haemolytic and pro-inflammatory disorder. With increased catabolism and deficits in energy and nutrient intake, individuals with SCD suffer multiple macro- and micro-nutritional deficiencies, including vitamin D deficiency. This is an update of a previous review.. To investigate the effects of vitamin D supplementation in children and adults with SCD and to compare different dose regimens. To determine the effects of vitamin D supplementation on general health (e.g. growth status and health-related quality of life), on musculoskeletal health (including bone mineral density, pain crises, bone fracture and muscle health), on respiratory health (including lung function, acute chest syndrome, acute exacerbation of asthma and respiratory infections) and the safety of vitamin D supplementation.. We searched the Cochrane Haemoglobinopathies Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. Date of last search: 19 March 2020. We also searched database such as PubMed, clinical trial registries and the reference lists of relevant articles and reviews. Date of last search: 14 January 2020.. Randomised controlled trials (RCTs) and quasi-RCTs comparing oral administration of any form of vitamin D supplementation at any dose and for any duration to another type or dose of vitamin D or placebo or no supplementation in people with SCD, of all ages, gender, and phenotypes.. Two authors independently extracted the data and assessed the risk of bias of the included studies. They used the GRADE guidelines to assess the quality of the evidence.. Vitamin D versus placebo One double-blind RCT (n = 39) compared oral vitamin D3 (cholecalciferol) supplementation (20 participants) to placebo (19 participants) for six weeks. Only 25 participants completed the full six months of follow-up. The study had a high risk of bias due to incomplete outcome data, but a low risk of bias for randomisation, allocation concealment, blinding (of participants, personnel and outcome assessors) and selective outcome reporting; and an unclear risk of other biases. Vitamin D supplementation probably led to higher serum 25(OH)D levels at eight weeks, mean difference (MD) 29.79 (95% confidence interval (CI) 26.63 to 32.95); at 16 weeks, MD 12.67 (95% CI 10.43 to 14.90); and at 24 weeks, MD 15.52 (95% CI 13.50 to 17.54) (moderate-quality evidence). There was little or no difference in adverse events (tingling of lips or hands) between the vitamin D and placebo groups, risk ratio 3.16 (95% CI 0.14 to 72.84) (low-quality evidence). Vitamin D supplementation probably caused fewer pain days compared to the placebo group at eight weeks, MD -10.00 (95% CI -16.47 to -3.53) (low-quality evidence), but probably led to a lower (worse) health-related quality of life score (change from baseline in physical functioning PedsQL scores); at both 16 weeks, MD -12.56 (95% CI -16.44 to -8.69) and 24 weeks, MD -12.59 (95% CI -17.43 to -7.76), although this may not be the case at eight weeks (low-quality evidence). Vitamin D supplementation regimens compared Two double-blind RCTs (83 participants) compared different regimens of vitamin D. One RCT (n = 62) compared oral vitamin D3 7000 IU/day to 4000 IU/day for 12 weeks, while the second RCT (n = 21) compared oral vitamin D3 100,000 IU/month to 12,000 IU/month for 24 months. Both RCTs had low risk of bias for blinding (of participants, personnel and outcome assessors) and incomplete outcome data, but the risk of selective outcome reporting bias was high. The bias from randomisation and allocation concealment was low in one study but not in the second. There was an unclear risk of other biases. When comparing oral vitamin D 100,000 IU/month to 12,000 IU/month, the higher dose may have resulted in higher serum 25(OH)D levels at one year, MD 16.40 (95% CI 12.59 to 20.21) and at two years, MD 18.96 (95% CI 15.20 to 22.72) (low-quality evidence). There was little or no difference in adverse events between doses (low-quality evidence). There were more episodes of acute chest syndrome in the high-dose gr. We included three RCTs of varying quality. We consider that the current evidence presented in this review is not of sufficient quality to guide clinical practice. Until further evidence becomes available, clinicians should consider the relevant existing guidelines for vitamin D supplementation and dietary reference intakes for calcium and vitamin D. Well-designed RCTs of parallel design, are required to determine the effects and the safety of vitamin D supplementation as well as to assess the relative benefits of different doses in children and adults with SCD.

Topics: Administration, Oral; Anemia, Sickle Cell; Bias; Child; Cholecalciferol; Humans; Pain; Quality of Life; Randomized Controlled Trials as Topic; Time Factors; Vitamin D; Vitamin D Deficiency

Both sun exposure and serum vitamin D levels have been associated with lower risks of all-cause mortality and chronic age-related diseases, e.g., cancer, diabetes and cardiovascular disease, in epidemiological studies. These associations have mainly been ascribed to beneficial effects of vitamin D. However, a vast body of randomized controlled trials (RCTs) and Mendelian randomization studies have failed to confirm any major health benefits from vitamin D supplementation. In this review, we present tentative evidence showing that red and near-infrared light, both being present in sunlight, could explain the associations between sunlight exposure and better health status. Body irradiation with red and near-infrared light, usually termed as photobiomodulation (PBM), has demonstrated beneficial effects in animal models of chronic diseases. Beyond this, preliminary evidence from RCTs suggest potential clinical benefit from PBM for chronic diseases. PBM is currently being investigated in many pre-registered clinical trials, results of which will eventually clarify the role of red and near-infrared light in the prevention and treatment of common age-related chronic diseases.

Topics: Aging; Animals; Cardiovascular Diseases; Cholecalciferol; Humans; Infrared Rays; Sunlight; Vitamin D; Vitamin D Deficiency

Vitamin D3 is well-known as a major regulator of calcium and phosphorus homeostasis. A growing body of evidence highlights its crucial role in the regulation of reproductive processes in females. The role of vitamin D3 in the female reproductive tract has been extensively investigated because its receptor is abundant in reproductive organs, including ovary. Importantly, besides expression of vitamin D3 receptor, the ovary is an extrarenal site of vitamin D3 metabolism. The influence of vitamin D3 on follicular development and ovarian steroidogenesis has been investigated. Furthermore, vitamin D3 deficiency has also been associated with polycystic ovary syndrome, premature ovarian failure and ovarian cancer. The objective of this review is to summarize our knowledge about the contribution of vitamin D3 to physiological and pathological processes within the ovary.

Topics: Animals; Calcium; Cholecalciferol; Female; Humans; Ovary; Polycystic Ovary Syndrome; Receptors, Calcitriol; Vitamin D Deficiency

Vitamin D deficiency is a global health problem due to its high prevalence and its negative consequences on musculoskeletal and extra-skeletal health. In our comparative review of the two exogenous vitamin D supplementation options most used in our care setting, we found that cholecalciferol has more scientific evidence with positive results than calcifediol in musculoskeletal diseases and that it is the form of vitamin D of choice in the most accepted and internationally recognized clinical guidelines on the management of osteoporosis. Cholecalciferol, unlike calcifediol, guarantees an exact dosage in IU (International Units) of vitamin D and has pharmacokinetic properties that allow either daily or even weekly, fortnightly, or monthly administration in its equivalent doses, which can facilitate adherence to treatment. Regardless of the pattern of administration, cholecalciferol may be more likely to achieve serum levels of 25(OH)D (25-hydroxy-vitamin D) of 30-50 ng/mL, an interval considered optimal for maximum benefit at the lowest risk. In summary, the form of vitamin D of choice for exogenous supplementation should be cholecalciferol, with calcifediol reserved for patients with liver failure or severe intestinal malabsorption syndromes.

Topics: Animals; Calcifediol; Cholecalciferol; Dietary Supplements; Humans; Musculoskeletal System; Osteoporosis; Vitamin D; Vitamin D Deficiency

Vitamin D metabolites have a pleiotropic role in human physiology, both in static and dynamic conditions, and a lot of vitamin D-related biological effects could influence physical and sport performances in athletes. Probably due to different factors (e.g., drugs, doping, nutrition, ultraviolet B radiation exposure), in athletes a very high prevalence of vitamin D inadequacy (i.e., deficiency or insufficiency) has been observed. Vitamin D inadequacy in athletes could be associated with specific health risks and to alterations of functional capacities, potentially influencing the fine adjustment of physical performances during training and sport competitions. When risk factors for vitamin D inadequacy exist, a preventive vitamin D supplementation is indicated, and if a vitamin D inadequacy is diagnosed, its supplementation is recommended. Unfortunately, on these issues many concerns remain unresolved. Indeed, it is not clear if athletes should be classified as a special population at increased risk for vitamin D inadequacy; moreover, in comparison to the non-athletic population, it is still not clear if athletes should have different reference ranges and different optimal target levels for serum vitamin D, if they have additional health risks, and if they need different type of supplementations (doses) for prevention and/or replacement therapy. Moreover, in athletes also the abuse of vitamin D supplements for ergogenic purposes raise different ethical and safety concerns. In this review, the main physio-pathological, functional and clinical issues that relate vitamin D to the world of athletes are described.

Topics: Athletes; Cholecalciferol; Dietary Supplements; Health; Humans; Nutritional Status; Risk Factors; Sports; Vitamin D; Vitamin D Deficiency

The specific compound that is meant for use in the context of vitamin D supplementation is often ambiguous. The term "supplementation" has been used in the context of cholecalciferol, ergocalciferol, calcidiol, and calcitriol. In nature, by far the major form of vitamin D that nurtures the body is cholecalciferol. In contrast, ergocalciferol is primarily a synthetic and less stable product which is less potent per microgram dose than is cholecalciferol. Calcidol is the major circulating metabolite of cholecalciferol, while calcitriol is the hormone that upregulates the active transport of calcium from the gut, and which suppresses parathyroid hormone secretion. Nutrition policy papers and guidelines leave unstated the obvious fact that calcidiol and calcitriol are not nutrients, and that those metabolites are not pertinent to food fortification or dietary supplementation. Recent evidence shows that ergocalciferol is not stable with storage, and it is far more susceptible to breakdown with cooking and baking than is cholecalciferol. Therefore, it must be concluded that cholecalciferol is the only form of vitamin D that should be considered in the context of the nutritional functions of fortification and supplementation.

Topics: Calcifediol; Calcitriol; Cholecalciferol; Dietary Supplements; Humans; Parathyroid Hormone; Vitamin D; Vitamin D Deficiency

This Research Reflection short review will discuss vitamin D metabolism, its role in nutrition, disease prevention, and welfare of dairy cattle, as well as its toxicity. Vitamin D is an important fat-soluble vitamin. However, some researchers regard it as a hormone due to its function in the organism. Its role is not limited just to Ca homoeostasis and bone metabolism but is also associated with immunity. In dairy cattle it is known for preventing milk fever. Cows can acquire vitamin D in many ways for example through feed, parenteral injections or through UVB irradiation from the sun or artificial lighting. The vitamin D in feed can either be plant-/ fungi- based ergocalciferol or animal-based cholecalciferol. There is currently only one registered feed vitamin D supplement for cattle in the European Union and it is cholecalciferol. Animals can also synthesize their own vitamin D when 7-dihydrocholesterol in the skin is irradiated with UVB light resulting in cholecalciferol production. Despite its importance, many cattle are deficient in vitamin D due to inadequate supplementation or insufficient sun exposure. In a study performed at the Veterinary Faculty in Slovenia 12 high producing Holstein Friesian cows at a commercial dairy farm were blood tested for vitamin D status for three succeeding months and all but one were vitamin D insufficient in all testings. The cows were not exposed to direct sunlight and the content of vitamin D3 in feed was <400 IU/kg dry matter, which is less than half of the NRC (2001) recommendation. Deficiency can also occur due to diseases affecting the gastrointestinal tract, such as paratuberculosis, which lower the absorptive capacity of the gut. Vitamin D can be toxic if cows are over-supplemented or consume large quantities of plants like Trisetum flavescens, which contain an active form of vitamin D-calcitriol or its glycosides, that are activated by digestion in the rumen.

Topics: Animal Feed; Animal Welfare; Animals; Cattle; Cattle Diseases; Cholecalciferol; Dairying; Dietary Supplements; European Union; Female; Health Status; Lactation; Skin; Sunlight; Vitamin D; Vitamin D Deficiency

Vitamin D deficiency has high prevalence worldwide. Vitamin D3, the active form of vitamin D, exhibits array of roles in body, from calcium homeostasis and bone mineralization to cancer, neurological disorders, immunomodulatory action, and cardiac health. Current approaches for supplementing vitamin D3 are restricted to oral and parenteral routes. This review highlights recent research in the field of transdermal delivery of vitamin D, its active form and analogues with the aid of penetration enhancers and novel carrier system as nutritional supplement in case of vitamin D deficiency. The penetration of vitamin D3 is challenging; however, by means of reducing hydrophobicity of the active and encapsulating vitamin D3 in a suitable carrier system, penetration is achieved. The results show that penetration of vitamin D3 through skin is feasible. Further clinical trials could strengthen these results. However, the present research till date shows transdermal vitamin D3 a promising way of supplementation.

Topics: Administration, Cutaneous; Cholecalciferol; Clinical Trials as Topic; Drug Carriers; Drug Compounding; Gels; Humans; Nanospheres; Permeability; Pharmaceutic Aids; Skin; Skin Cream; Tissue Distribution; Transdermal Patch; Treatment Outcome; Vitamin D Deficiency; Vitamins

Diabetes mellitus, a metabolic disorder associated with chronic complications, is traditionally classified into two main subtypes. Type 1 diabetes mellitus (T1DM) results from gradual pancreatic islet β cell autoimmune destruction, extending over months or years. Type 2 diabetes mellitus (T2DM) is a heterogeneous disorder, with both insulin resistance and impairment in insulin secretion contributing to its pathogenesis. Vitamin D is a fat-soluble vitamin with an established role in calcium metabolism. Recently, several studies have provided evidence suggesting a role for it in various non-skeletal metabolic conditions, including both types of diabetes mellitus. Preclinical studies of vitamin D action on insulin secretion, insulin action, inflammatory processes, and immune regulation, along with evidence of an increase of hypovitaminosis D worldwide, have prompted several epidemiological, observational, and supplementation clinical studies investigating a potential biological interaction between hypovitaminosis D and diabetes. This narrative review aims to summarize current knowledge on the effect of vitamin D on T1DM and T2DM pathogenesis, prevention, and treatment, as well as on micro- and macrovascular complications of the disease. Furthermore, on the basis of current existing evidence, we aim to highlight areas for potential future research.

Topics: Calcium-Regulating Hormones and Agents; Cholecalciferol; Diabetes Complications; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Humans; Vitamin D Deficiency

Topics: Aging; Alzheimer Disease; Calcium; Cholecalciferol; Humans; Nerve Degeneration; Neurons; Receptors, Calcitriol; Vitamin D Deficiency

Vitamin D deficiency is an established risk factor for many autoimmune diseases and the anti-inflammatory properties of vitamin D underscore its potential therapeutic value for these diseases. However, results of vitamin D3 supplementation clinical trials have been varied. To understand the clinical heterogeneity, we reviewed the pre-clinical data on vitamin D activity in four common autoimmune diseases: multiple sclerosis (MS), rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and inflammatory bowel disease (IBD), in which patients are commonly maintained on oral vitamin D3 supplementation. In contrast, many pre-clinical studies utilize other methods of manipulation (i.e. genetic, injection). Given the many actions of vitamin D3 and data supporting a vitamin D-independent role of the Vitamin D receptor (VDR), a more detailed mechanistic understanding of vitamin D3 activity is needed to properly translate pre-clinical findings into the clinic. Therefore, we assessed studies based on route of vitamin D3 administration, and identified where discrepancies in results exist and where more research is needed to establish the benefit of vitamin D supplementation.

Topics: Autoimmune Diseases; Cholecalciferol; Humans; Receptors, Calcitriol; Vitamin D Deficiency

To evaluate the effect of vitamin D3 on blood pressure in people with vitamin D deficiency.. Randomized controlled trials (RCTs) were electronically searched databases including CNKI, VIP, WanFang Data, the Cochrane Library, PubMed, and EMbase which were about oral vitamin D3 among people with vitamin D deficiency from inception to December 2017. Two reviewers independently screened literature according to the inclusion and extracted data; meta-analysis was performed using RevMan5.3.. A total of 17 RCTs with 22 arms involving 1687 participants were included. The results of meta-analysis showed that, there were no significant differences between the vitamin D deficiency group and the control group on the level of change in systolic pressure (ΔSBP) [weighted mean difference (WMD) = -1.94, 95% confidence interval (CI) (-3.93,0.04) P = .06] and on the level of change in diastolic pressure (ΔDBP) [WMD = -0.50, 95% CI (-1.17, 0.17) P = .14]. The results of subgroups showed that, there were statistically significant differences in the age of >50 years subgroup on ΔSBP [WMD = -2.32, 95% CI (-4.39, -0.25) P = .03]; there were statistically significant differences in the hypertension subgroup on ΔSBP [WMD = -6.58, 95% CI (-8.72, -4.44) P <.00001]; there were statistically significant differences in the hypertension subgroup on ΔDBP [WMD = -3.07, 95% CI (-4.66, -1.48) P = .0002]; there were statistically significant differences in the body mass index (BMI) >30 subgroup on ΔSBP [WMD = -3.51, 95% CI (-5.96, -1.07) P = .005].. Oral vitamin D3 has no significant effect on blood pressure in people with vitamin D deficiency. It reduces systolic blood pressure in people with vitamin D deficiency that was older than 50 years old or obese. It reduces systolic blood pressure and diastolic pressure in people with both vitamin D deficiency and hypertension.

Topics: Blood Pressure; Cholecalciferol; Humans; Randomized Controlled Trials as Topic; Vitamin D Deficiency

Vitamin D is an essential nutrient whose deficiency has been associated with the risk of various chronic diseases such as osteoporosis, hypertension, cardiovascular disease, diabetes, some types of cancer and even overweight and obesity. Although vitamin D can be synthesized at the skin from exposure to sunlight, this source is not always sufficient to meet the needs. For example, the use of sunscreen or the low exposition to the sunlight limits the syntheses. In fact, studies have found that at least half of the Spanish population has vitamin D deficits. Therefore, the dietary contribution is fundamental. Although there are different foods fortified in this vitamin, few products are natural source of it, as fatty fish and eggs. However, according to different studies carried out in the Spanish population, there is a low consumption of this food group. In this way, it would be advisable to promote egg consumption among the population, since this food, in addition to having many nutrients, contains a high amount of vitamin D, which contributes to avoid the appearance of deficiencies and the consequences health consequences that this implies.. La vitamina D es un nutriente esencial cuya deficiencia se ha asociado con el riesgo de aparición de diversas enfermedades crónicas, como la osteoporosis, la hipertensión arterial, la enfermedad cardiovascular, la diabetes, algunos tipos de cáncer e incluso el padecimiento de sobrepeso y obesidad. A pesar de que la vitamina D puede sintetizarse a nivel cutáneo a partir de la exposición a la luz solar, esta fuente no es siempre suficiente para cubrir las necesidades debido al uso de cremas de protección solar y a la baja exposición que se produce durante el invierno, o, como en el caso de las personas enfermas, que salen poco a la calle o se exponen poco a la luz del sol. De hecho, estudios han constatado que al menos la mitad de la población española presenta déficit de vitamina D. Por ello, el aporte dietético es fundamental. Aunque existen diferentes alimentos fortificados con esta vitamina, son pocos los productos que son una fuente natural, entre los que se encuentran los pescados grasos y los huevos. Sin embargo, de acuerdo con diferentes estudios realizados en la población española, existe un bajo consumo de este último grupo de alimentos. De esta manera, sería recomendable fomentar el consumo de huevo entre la población, ya que este alimento, además de tener numerosos nutrientes, contiene una cantidad elevada de vitamina D, lo que contribuye a evitar la aparición de deficiencias y las consecuencias negativas para la salud que ello implica.

Topics: Cholecalciferol; Eggs; Ergocalciferols; Humans; Nutrition Policy; Spain; Sunlight; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D is recognized to play an essential role in health and disease. In kidney disease, vitamin D analogs have gained recognition for their involvement and potential therapeutic importance. Nephrologists are aware of the use of oral native vitamin D supplementation, however, uncertainty still exists with regard to the use of this treatment option in chronic kidney disease as well as clinical settings related to chronic kidney disease, where vitamin D supplementation may be an appropriate therapeutic choice. Two consecutive meetings were held in Florence in July and November 2016 comprising six experts in kidney disease (N = 3) and bone mineral metabolism (N = 3) to discuss a range of unresolved issues related to the use of cholecalciferol in chronic kidney disease. The panel focused on the following six key areas where issues relating to the use of oral vitamin D remain controversial: (1) vitamin D and parathyroid hormone levels in the general population, (2) cholecalciferol in chronic kidney disease, (3) vitamin D in cardiovascular disease, (4) vitamin D and renal bone disease, (5) vitamin D in rheumatological diseases affecting the kidney, (6) vitamin D and kidney transplantation.

Topics: Cholecalciferol; Humans; Renal Insufficiency, Chronic; Vitamin D Deficiency

The ability to synthesise sufficient vitamin D through sunlight in human subjects can be limited. Thus, diet has become an important contributor to vitamin D intake and status; however, there are only a few foods (e.g. egg yolk, oily fish) naturally rich in vitamin D. Therefore, vitamin D-enriched foods via supplementing the animals' diet with vitamin D or vitamin D fortification of foods have been proposed as strategies to increase vitamin D intake. Evidence that cholecalciferol (vitamin D3) and calcifediol (25(OH)D3) content of eggs, fish and milk increased in response to vitamin D3 supplementation of hens, fish or cows' diets was identified when vitamin D-enrichment studies were reviewed. However, evidence from supplementation studies with hens showed only dietary 25(OH)D3, not vitamin D3 supplementation, resulted in a pronounced increase of 25(OH)D3 in the eggs. Furthermore, evidence from randomised controlled trials indicated that a 25(OH)D3 oral supplement could be absorbed faster and more efficiently raise serum 25(OH)D concentration compared with vitamin D3 supplementation. Moreover, evidence showed the relative effectiveness of increasing vitamin D status using 25(OH)D3 varied between 3·13 and 7·14 times that of vitamin D3, probably due to the different characteristics of the investigated subjects or study design. Therefore, vitamin D-enrichment or fortified foods using 25(OH)D3 would appear to have advantages over vitamin D3. Further well-controlled studies are needed to assess the effects of 25(OH)D3 enriched or fortified foods in the general population and clinical patients.

Topics: Animal Feed; Animals; Calcifediol; Cholecalciferol; Diet; Dietary Supplements; Eggs; Food, Fortified; Humans; Milk; Seafood; Vitamin D; Vitamin D Deficiency; Vitamins

One significant health issue that plagues contemporary society is that of Type 2 diabetes (T2D). This disease is characterised by higher-than-average blood glucose levels as a result of a combination of insulin resistance and insufficient insulin secretions from the β-cells of pancreatic islets of Langerhans. Previous developmental research into the pancreas has identified how early precursor genes of pancreatic β-cells, such as Cpal, Ngn3, NeuroD, Ptf1a, and cMyc, play an essential role in the differentiation of these cells. Furthermore, β-cell molecular characterization has also revealed the specific role of β-cell-markers, such as Glut2, MafA, Ins1, Ins2, and Pdx1 in insulin expression. The expression of these genes appears to be suppressed in the T2D β-cells, along with the reappearance of the early endocrine marker genes. Glucose transporters transport glucose into β-cells, thereby controlling insulin release during hyperglycaemia. This stimulates glycolysis through rises in intracellular calcium (a process enhanced by vitamin D) (Norman et al., 1980), activating 2 of 4 proteinases. The rise in calcium activates half of pancreatic β-cell proinsulinases, thus releasing free insulin from granules. The synthesis of ATP from glucose by glycolysis, Krebs cycle and oxidative phosphorylation plays a role in insulin release. Some studies have found that the β-cells contain high levels of the vitamin D receptor; however, the role that this plays in maintaining the maturity of the β-cells remains unknown. Further research is required to develop a more in-depth understanding of the role VDR plays in β-cell function and the processes by which the beta cell function is preserved.

Topics: Animals; Blood Glucose; Cholecalciferol; Diabetes Mellitus, Type 2; Humans; Insulin-Secreting Cells; Mice; Pancreas; Rats; Receptors, Calcitriol; Risk Factors; Transcription Factors; Vitamin D Deficiency

Studies have indicated that 25-hydroxyvitamin D (25(OH)D) level in obese is lower than normal weight subjects; however, results of studies that investigated relationship between 25(OH)D and fat mass are inconsistent. In addition, several randomized clinical trials (RCTs) have studied the influence of cholecalciferol supplement on percentage fat mass (PFM) but their results are conflicting. The objectives were to investigate the association between vitamin D3 and PFM pooling together observational studies and RCTs. PubMed/MEDLINE, Cochrane, and Scopus were comprehensively searched from inception to September 2016. The Fisher's Z (SE) of correlation coefficient and mean (SD) of changes in PFM from baseline were used to perform meta-analysis in observational studies and RCTs, respectively. To determine potential source of heterogeneity, subgroup and meta-regression analyses were conducted. Pooling correlation coefficients showed an inverse association between PFM (Fisher's Z: - 0.24, 95% CI: - 0.30 to -0 .18) and FM (Fisher's Z: - 0.32, 95% CI: - 0.43 to - 0.22) and 25(OH)D. Subgroup analysis revealed continent but not gender influence on the effect size. Meta-regression analysis indicated that age, latitude, and longitude are not sources of heterogeneity. Combining trials showed vitamin D3 supplementation had a mild but insignificant effect on PFM (- 0.31%, 95% CI: - 1.07 to 0.44). Subgroup analyses indicated that type of cholecalciferol and treatment regimens explain source of heterogeneity. Age, baseline body mass index, dose of cholecalciferol, length of study, female (%), and baseline 25(OH)D are not source of heterogeneity. In conclusion, our results state that 25(OH)D level is inversely correlated with PFM but cholecalciferol supplementation had no effect on PFM.

Topics: Adipose Tissue; Adolescent; Adult; Aged; Aged, 80 and over; Body Composition; Cholecalciferol; Dietary Supplements; Female; Humans; Male; Middle Aged; Obesity; Vitamin D; Vitamin D Deficiency; Young Adult

Understanding of vitamin D physiology is important because about half of the population is being diagnosed with deficiency and treated with supplements. Clinical guidelines were developed based on observational studies showing an association between low serum levels and increased cardiovascular risk. However, new randomized controlled trials have failed to confirm any cardiovascular benefit from supplementation in the general population. A major concern is that excess vitamin D is known to cause calcific vasculopathy and valvulopathy in animal models. For decades, administration of vitamin D has been used in rodents as a reliable experimental model of vascular calcification. Technically, vitamin D is a misnomer. It is not a true vitamin because it can be synthesized endogenously through ultraviolet exposure of the skin. It is a steroid hormone that comes in 3 forms that are sequential metabolites produced by hydroxylases. As a fat-soluble hormone, the vitamin D-hormone metabolites must have special mechanisms for delivery in the aqueous bloodstream. Importantly, endogenously synthesized forms are carried by a binding protein, whereas dietary forms are carried within lipoprotein particles. This may result in distinct biodistributions for sunlight-derived versus supplement-derived vitamin D hormones. Because the cardiovascular effects of vitamin D hormones are not straightforward, both toxic and beneficial effects may result from current recommendations.

Topics: Age Factors; Atherosclerosis; Calcium, Dietary; Cardiovascular Diseases; Cholecalciferol; Confounding Factors, Epidemiologic; Dietary Supplements; Drug Administration Schedule; Food; Guidelines as Topic; Humans; Hydroxylation; Observational Studies as Topic; Precision Medicine; Receptors, LDL; Sunlight; Vascular Calcification; Vitamin D; Vitamin D Deficiency; Vitamins

In the UAE and the Gulf region in general, there are several intricate public health issues in the context of vitamin D deficiency that needs to be addressed. Changes in lifestyle such as diet, lack of exercise, cultural habits, avoiding sun exposure due to excessive heat, and other risk factors predispose those who live in GULF countries, such as Emiratis likely to becoming vitamin D deficient. Consequently, the prevalence of vitamin D deficiency is high, and new guidelines are needed to overcome this major public health issue. Peer-reviewed papers related to guidelines and those vitamin D-related papers relevant to the Middle-Eastern region were extracted from multiple research databases using key words according to the general guidelines from the Preferred Reporting Items for Systematic Analysis. This guideline was prepared focusing on the United Arab Emirate and the Gulf populations, to overcome the high incidence of vitamin D deficiency and to improve overall health. We recommend the following vitamin D supplementations for different groups of people: (A) Breastfed infants supplement with 400 IU/day up to age 6 months, and 400-600 IU/day between 6 and 12 months, depending on daily intake of total vitamin D and sun exposure; (B) for children and adolescents of age 1-18 years supplement with 600-1000 IU/day depending on the body weight; (C) adults greater than 18 years', supplementation with 1000-2000 IU/day is recommended, while, (D) the elderly (over 65 years) should be supplemented with 2000 IU/day, throughout the year; (E) pregnant and breast feed women, 2000 IU/day from the first trimester of pregnancy. (F) Premature infants, supplementation of 400-800 IU/daystart from the first days of life. (G) For obese, individuals and those with metabolic syndrome, supplementation of 2000 IU/day (H) For individuals with dark skin complexions and for night workers, supplementation of 1000-2000 IU/day (25-50μg/day), throughout the year, depending on body weight. The goal of supplementation is to achieve and longer term maintenance of serum 25(OH)D concentration of 30-50ng/mL.

Topics: Adolescent; Adult; Aged; Child; Child, Preschool; Cholecalciferol; Ergocalciferols; Female; Humans; Infant; Infant, Premature; Middle Aged; Pregnancy; United Arab Emirates; Vitamin D; Vitamin D Deficiency

Vitamin D deficiency (<20 ng/mL) and insufficiency (20-29 ng/mL) are common among patients with chronic kidney disease (CKD) or undergoing dialysis. In addition to nutritional and sunlight exposure deficits, factors that affect vitamin D deficiency include race, sex, age, obesity and impaired vitamin D synthesis and metabolism. Serum 1,25(OH)₂D levels also decrease progressively because of 25(OH)D deficiency, together with impaired availability of 25(OH)D by renal proximal tubular cells, high fibroblast growth factor (FGF)-23 and decreased functional renal tissue. As in the general population, this condition is associated with increased morbidity and poor outcomes. Together with the progressive decline of serum calcitriol, vitamin D deficiency leads to secondary hyperparathyroidism (SHPT) and its complications, tertiary hyperparathyroidism and hypercalcemia, which require surgical parathyroidectomy or calcimimetics. Kidney Disease Outcomes Quality Initiative (KDOQI) and Kidney Disease Improving Global Outcomes (KDIGO) experts have recognized that vitamin D insufficiency and deficiency should be avoided in CKD and dialysis patients by using supplementation to prevent SHPT. Many vitamin D supplementation regimens using either ergocalciferol or cholecalciferol daily, weekly or monthly have been reported. The benefit of native vitamin D supplementation remains debatable because observational studies suggest that vitamin D receptor activator (VDRA) use is associated with better outcomes and it is more efficient for decreasing the serum parathormone (PTH) levels. Vitamin D has pleiotropic effects on the immune, cardiovascular and neurological systems and on antineoplastic activity. Extra-renal organs possess the enzymatic capacity to convert 25(OH)D to 1,25(OH)₂D. Despite many unanswered questions, much data support vitamin D use in renal patients. This article emphasizes the role of native vitamin D replacement during all-phases of CKD together with VDRA when SHPT persists.

Topics: Cholecalciferol; Dialysis; Dietary Supplements; Ergocalciferols; Fibroblast Growth Factor-23; Humans; Hypercalcemia; Hyperparathyroidism, Secondary; Parathyroid Hormone; Randomized Controlled Trials as Topic; Renal Insufficiency, Chronic; Vitamin D Deficiency

The role of vitamin D in supporting the growth and maintenance of the skeleton is robust; with recent research also suggesting a beneficial link between vitamin D and other non-skeletal health outcomes, including immune function, cardiovascular health and cancer. Despite this, vitamin D deficiency remains a global public health issue, with a renewed focus in the UK following the publication of Public Health England's new Dietary Vitamin D Requirements. Natural sources of vitamin D (dietary and UVB exposure) are limited, and thus mechanisms are needed to allow individuals to achieve the new dietary recommendations. Mandatory or voluntary vitamin D food fortification may be one of the mechanisms to increase dietary vitamin D intakes and subsequently improve vitamin D status. However, for the food industry and public to make informed decisions, clarity is needed as to whether vitamins D2 and D3 are equally effective at raising total 25-hydroxyvitamin D (25(OH)D) concentrations as the evidence thus far is inconsistent. This review summarises the evidence to date behind the comparative efficacy of vitamins D2 and D3 at raising 25(OH)D concentrations, and the potential role of vitamin D food fortification as a public health policy to support attainment of dietary recommendations in the UK. The comparative efficacy of vitamins D2 and D3 has been investigated in several intervention trials, with most indicating that vitamin D3 is more effective at raising 25(OH)D concentrations. However, flaws in study designs (predominantly under powering) mean there remains a need for a large, robust randomised-controlled trial to provide conclusive evidence, which the future publication of the D2-D3 Study should provide (BBSRC DRINC funded: BB/I006192/1). This review also highlights outstanding questions and gaps in the research that need to be addressed to ensure the most efficacious and safe vitamin D food fortification practices are put in place. This further research, alongside cost, availability and ethical considerations (vitamin D3 is not suitable for vegans), will be instrumental in supporting government, decision-makers, industry and consumers in making informed choices about potential future vitamin D policy and practice.

Topics: Animals; Biomedical Research; Cholecalciferol; Congresses as Topic; Dietetics; Ergocalciferols; Evidence-Based Medicine; Food, Fortified; Global Health; Humans; Nutrition Policy; Nutritional Sciences; Public Health Practice; Societies, Scientific; Vitamin D Deficiency

Conflicting evidence exists concerning the supplementation of vitamin D in knee osteoarthritis condition. This systematic literature review was done to explore the effects of vitamin D supplementation in the management of knee osteoarthritis. Electronic literature search was done in databases like PubMed

Topics: Aged; Cholecalciferol; Dietary Supplements; Ergocalciferols; Female; Humans; Knee Joint; Male; Middle Aged; Osteoarthritis, Knee; Randomized Controlled Trials as Topic; Risk Factors; Treatment Outcome; Vitamin D Deficiency

Vitamin D is a fat-soluble vitamin that is naturally found in very few food sources. It is produced endogenously from ultraviolet light from the sun striking the skin and then triggering vitamin D synthesis and activation. Vitamin D helps promote calcium absorption in the gut, maintains adequate serum calcium and phosphate levels, promotes bone growth, modulates cell growth, and has many other roles. There have been an increasing number of people, especially in older adults, with vitamin D deficiency. This is in part a result of a reduction of sun exposure as people age, increase in use of sunscreen, and other factors. This article highlights the roles of cholecalciferol (vitamin D3) versus ergocalciferol (vitamin D2) supplementation for practicing pharmacists.

Topics: Cholecalciferol; Dietary Supplements; Ergocalciferols; Humans; Vitamin D Deficiency

Traditional methods of depression treatment with the use of pharmacotherapy with antidepressants have limited effectiveness. Biological, psychological and environmental causes of depressive disorders are known, but pathophysiology of depression has not been fully explained. Many factors and mechanisms play role in the pathophysiology of depression, one of which may be vitamin D3 deficiency. Deficiency or border level of vitamin D3 is fairly common in the general population and may occur even in one billion people globally. Epidemiological studies show that vitamin D3 or its metabolites do not reach an optimal level in most adults. Even lower than the optimal level may cause clinical symptoms and be one of the risk factors for depression. In the population of patients suffering from depressive disorders deficiency or insufficiency of vitamin D3 occur more frequently than in the general population. The use of vitamin D3in patients with depression may have antidepressant effect. Continuous supplementation may also reduce the risk of recurrence. This article is a review of literature on the possible impact of vitamin D3 deficiency on the prevalence of depression and antidepressant effect of the supplementation. Selection of articles was made by searching the Medline and PubMed databases using specific keywords: depression, vitamin D3 deficiency. Previous studies on the use of vitamin D3 and its role in prevention and treatment of depressive disorders included too small number of people to clearly assess the effectiveness and safety of supplementation used as adjunctive therapy to antidepressants, as well as and dose range which should be used.

Topics: Cholecalciferol; Depressive Disorder, Major; Dietary Supplements; Female; Humans; Hydroxycholecalciferols; Male; Vitamin D Deficiency

Osteoporotic fractures are common in patients with chronic kidney disease (CKD). Morbidity and mortality are higher in CKD patients with a fracture than in the general population. The assessment of bone mineral density for fracture prediction may be useful at all CKD stages. It should be considered when this influences treatment decisions. Vitamin D deficiency is common in patients with CKD, particularly in patients with proteinuria, due to loss of 25-hydroxyvitamin D and its binding protein. Vitamin D supplementation should be prescribed early in the course of renal disease. For treatment and prevention of vitamin D deficiency in CKD patients cholecalciferol 800 IU/day or the equivalent per month is recommended just as in the general population.

Topics: Bone Density Conservation Agents; Cholecalciferol; Humans; Osteoporosis; Osteoporotic Fractures; Renal Insufficiency, Chronic; Vitamin D; Vitamin D Deficiency

Evidence exists for a role for vitamin D and its active metabolites in modulating immune functions. In animal models, vitamin D deficiency is associated with a higher risk for autoimmunity in genetically predisposed subjects and increases in susceptibility to infections. In addition, high-dose vitamin D can improve immune health, prevent autoimmunity, and improve defense against infections. In humans, evidence exists on associations between vitamin D deficiency and impaired immune function, leading to autoimmunity in genetically predisposed people and increased risk for infections; data on therapeutic immune effects of vitamin D supplementation when vitamin D levels are already sufficient are lacking.

Topics: Animals; Autoimmunity; Cholecalciferol; Dietary Supplements; Humans; Leukocytes; Macrophages; Vitamin D Deficiency

Vitamin D deficiency occurs all over the world, mainly in the Middle East, China, Mongolia, and India. This article focuses on the vitamin D status in adults. Risk groups include older persons, pregnant women, and non-Western immigrants. Adequate vitamin D status, defined as serum 25-hydroxyvitamin D greater than 50 nmol/L, is present in less than 50% of the world population, at least in winter. Preventative strategies, such as increasing fish consumption, fortification of foods, use of vitamin D supplements, and advice for moderate sunlight exposure, are warranted.

Topics: Cholecalciferol; Dietary Supplements; Food, Fortified; Global Health; Humans; Risk Factors; Seasons; Vitamin D Deficiency

Vitamin D deficiency is often reported in people with chronic liver diseases. Therefore, improving vitamin D status could have a beneficial effect on people with chronic liver diseases.. To assess the beneficial and harmful effects of vitamin D supplementation in people with chronic liver diseases.. We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Science Citation Index Expanded, and Conference Proceedings Citation Index - Science. We also searched databases of ongoing trials and the World Health Organization International Clinical Trials Registry Platform. We scanned bibliographies of relevant publications and asked experts and pharmaceutical companies for additional trials. All searches were up to January 2017.. Randomised clinical trials that compared vitamin D at any dose, duration, and route of administration versus placebo or no intervention in adults with chronic liver diseases. Vitamin D could have been administered as supplemental vitamin D (vitamin D. We used standard methodological procedures expected by The Cochrane Collaboration. We contacted authors of the trials to ask for missing information. We conducted random-effects and fixed-effect meta-analyses. For dichotomous outcomes, we calculated risk ratios (RRs), and for continuous outcomes, we calculated mean differences (MD), both with 95% confidence intervals (CI) and Trial Sequential Analyses-adjusted CIs. We calculated Peto odds ratio (OR) for rare events. We considered risk of bias in domains to assess the risk of systematic errors. We conducted Trial Sequential Analyses to control the risk of random errors. We assessed the quality of the evidence with GRADE.. We included 15 randomised clinical trials with 1034 participants randomised. All trials had a parallel group design. Nine trials were conducted in high-income countries and six trials in middle-income countries. All trials were at high risk of bias. Six trials included participants with chronic hepatitis C, four trials included participants with liver cirrhosis, four trials included participants with non-alcoholic fatty liver disease, and one trial included liver transplant recipients. All included trials reported the baseline vitamin D status of participants. Participants in six trials had baseline 25-hydroxyvitamin D levels at or above vitamin D adequacy (20 ng/mL), while participants in the remaining nine trials were vitamin D insufficient (less than 20 ng/mL). All trials administered vitamin D orally. Mean duration of vitamin D supplementation was 0.5 years and follow-up was 0.6 years. Eleven trials (831 participants; 40% women; mean age 52 years) tested vitamin D. We are uncertain as to whether vitamin D supplements in the form of vitamin D

Topics: Administration, Oral; Calcitriol; Cause of Death; Cholecalciferol; Chronic Disease; Ergocalciferols; Female; Hepatitis C, Chronic; Humans; Hydroxycholecalciferols; Liver Cirrhosis; Liver Diseases; Liver Transplantation; Male; Middle Aged; Non-alcoholic Fatty Liver Disease; Randomized Controlled Trials as Topic; Vitamin D; Vitamin D Deficiency; Vitamins

Sickle cell disease is a genetic chronic haemolytic and pro-inflammatory disorder. The clinical manifestations of sickle cell disease result from the presence of mutations on the beta globin genes that generate an abnormal haemoglobin product (called haemoglobin S) within the red blood cell. Sickle cell disease can lead to many complications such as acute chest syndrome, stroke, acute and chronic bone complications (including painful vaso-occlusive crisis, osteomyelitis, osteonecrosis and osteoporosis). With increased catabolism and deficits in energy and nutrient intake, individuals with sickle cell disease suffer multiple macro- and micro-nutritional deficiencies, including vitamin D deficiency. Since vitamin D maintains calcium homeostasis and is essential for bone mineralisation, its deficiency may worsen musculoskeletal health problems encountered in sickle cell disease. Therefore, there is a need to review the effects and the safety of vitamin D supplementation in sickle cell disease.. To investigate the hypothesis that vitamin D supplementation increases serum 25-hydroxyvitamin D level in children and adults with sickle cell disease.To determine the effects of vitamin D supplementation on general health such as growth status and health-related quality of life; on musculoskeletal health including bone mineral density, pain crises, bone fracture and muscle health; on respiratory health which includes lung function tests, acute chest syndrome, acute exacerbation of asthma and respiratory infections; and the safety of vitamin D supplementation in children and adults with sickle cell disease.. We searched the Cochrane Haemoglobinopathies Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched database such as PubMed, clinical trial registries and the reference lists of relevant articles and reviews.Date of last search: 15 December 2016.. Randomised controlled studies and quasi-randomised controlled studies (controlled clinical studies) comparing oral administration of any form of vitamin D supplementation to another type of vitamin D or placebo or no supplementation at any dose and for any duration, in people with sickle cell disease, of all ages, gender, and phenotypes including sickle cell anaemia, haemoglobin sickle cell disease and sickle beta-thalassaemia diseases.. Two authors independently extracted the data and assessed the risk of bias of the included study. They used the GRADE guidelines to assess the quality of the evidence.. One double-blind randomised controlled study including 46 people with sickle cell disease (HbSS, HbSC, HbSβ+thal and HbSβ0thal) was eligible for inclusion in this review. Of the 46 enrolled participants, seven withdrew before randomisation leaving 39 participants who were randomised. Only 25 participants completed the full six months of follow up. Participants were randomised to receive oral vitamin D3 (cholecalciferol) (n = 20) or placebo (n = 19) for six weeks and were followed up to six months. Two participants from the treatment group have missing values of baseline serum 25-hydroxyvitamin D, therefore the number of samples analysed was 37 (vitamin D n = 18, placebo n = 19).The included study had a high risk of bias with regards to incomplete outcome data (high dropout rate in the placebo group), but a low risk of bias for other domains such as random sequence generation, allocation concealment, blinding of participants, personnel and outcome assessors, selective outcome reporting; and an unclear risk of other biases.Compared to the placebo group, the vitamin D group had significantly higher serum 25-hydroxyvitamin D (25(OH)D) levels at eight weeks, mean difference 29.79 (95% confidence interval 26.63 to 32.95); at 16 weeks, mean difference 12.67 (95% confidence interval 10.43 to 14.90); and at 24 weeks, mean difference 15.52 (95% confidence interval 13.50 to 17.54). We determined the quality of the evidence for this outcome to be moderate. There was no significant difference of adverse events (tingling of lips or hands) between the vitamin D and placebo groups, risk ratio 3.16 (95% confidence interval 0.14 to 72.84), but the quality of the evidence was low. Regarding the frequency of pain, the vitamin D group had significantly fewer pain days compared to the placebo group, mean difference -10.00 (95% confidence interval -16.47 to -3.53), but again the quality of the evidence was low. Furthermore, the review included physical functioning PedsQL scores which was reported as absolute change from baseline. The vitamin D group had a lower (worse) health-related quality of life score than the placebo group but this was not significant at eight weeks, mean difference -2.02 (95% confidence interval -6.34 to 2.30). However, the difference was significant at both 16 weeks, mean difference -12.56 (95% confidence interval -16.44 to -8.69) and 24 weeks, mean difference -12.59 (95% confidence interval -17.43 to -7.76). We determined the quality of evidence for thi. We included only one low-quality clinical study which had a high risk of bias with regards to incomplete outcome data. Therefore, we consider that the evidence is not of sufficient quality to guide clinical practice. Until further evidence becomes available, clinicians should consider the relevant existing guidelines for vitamin D supplementation (e.g. the Endocrine Society Clinical Practice Guidelines) and dietary reference intakes for calcium and vitamin D (e.g. from the USA Institute of Medicine). Evidence of vitamin D supplementation in sickle cell disease from high quality studies is needed. Well-designed, randomised, placebo-controlled studies of parallel design, are required to determine the effects and the safety of vitamin D supplementation in children and adults with sickle cell disease.

Topics: Anemia, Sickle Cell; Cholecalciferol; Humans; Pain; Quality of Life; Randomized Controlled Trials as Topic; Time Factors; Vitamin D; Vitamin D Deficiency

Middle East Respiratory Syndrome (MERS) is a novel respiratory illness firstly reported in Saudi Arabia in 2012. It is caused by a new corona virus, called MERS corona virus (MERS-CoV). Most people who have MERS-CoV infection developed severe acute respiratory illness.. This work is done to determine the clinical characteristics and the outcome of intensive care unit (ICU) admitted patients with confirmed MERS-CoV infection.. This study included 32 laboratory confirmed MERS corona virus infected patients who were admitted into ICU. It included 20 (62.50%) males and 12 (37.50%) females. The mean age was 43.99 ± 13.03 years. Diagnosis was done by real-time reverse transcription polymerase chain reaction (rRT-PCR) test for corona virus on throat swab, sputum, tracheal aspirate, or bronchoalveolar lavage specimens. Clinical characteristics, co-morbidities and outcome were reported for all subjects.. Most MERS corona patients present with fever, cough, dyspnea, sore throat, runny nose and sputum. The presence of abdominal symptoms may indicate bad prognosis. Prolonged duration of symptoms before patients' hospitalization, prolonged duration of mechanical ventilation and hospital stay, bilateral radiological pulmonary infiltrates, and hypoxemic respiratory failure were found to be strong predictors of mortality in such patients. Also, old age, current smoking, smoking severity, presence of associated co-morbidities like obesity, diabetes mellitus, chronic heart diseases, COPD, malignancy, renal failure, renal transplantation and liver cirrhosis are associated with a poor outcome of ICU admitted MERS corona virus infected patients.. Plasma HO-1, ferritin, p21, and NQO1 were all elevated at baseline in CKD participants. Plasma HO-1 and urine NQO1 levels each inversely correlated with eGFR (. SnPP can be safely administered and, after its injection, the resulting changes in plasma HO-1, NQO1, ferritin, and p21 concentrations can provide information as to antioxidant gene responsiveness/reserves in subjects with and without kidney disease.. A Study with RBT-1, in Healthy Volunteers and Subjects with Stage 3-4 Chronic Kidney Disease, NCT0363002 and NCT03893799.. HFNC did not significantly modify work of breathing in healthy subjects. However, a significant reduction in the minute volume was achieved, capillary [Formula: see text] remaining constant, which suggests a reduction in dead-space ventilation with flows > 20 L/min. (ClinicalTrials.gov registration NCT02495675).. 3 组患者手术时间、术中显性失血量及术后 1 周血红蛋白下降量比较差异均无统计学意义（. 对于肥胖和超重的膝关节单间室骨关节炎患者，采用 UKA 术后可获满意短中期疗效，远期疗效尚需进一步随访观察。.. Decreased muscle strength was identified at both time points in patients with hEDS/HSD. The evolution of most muscle strength parameters over time did not significantly differ between groups. Future studies should focus on the effectiveness of different types of muscle training strategies in hEDS/HSD patients.. These findings support previous adverse findings of e-cigarette exposure on neurodevelopment in a mouse model and provide substantial evidence of persistent adverse behavioral and neuroimmunological consequences to adult offspring following maternal e-cigarette exposure during pregnancy. https://doi.org/10.1289/EHP6067.. This RCT directly compares a neoadjuvant chemotherapy regimen with a standard CROSS regimen in terms of overall survival for patients with locally advanced ESCC. The results of this RCT will provide an answer for the controversy regarding the survival benefits between the two treatment strategies.. NCT04138212, date of registration: October 24, 2019.. Results of current investigation indicated that milk type and post fermentation cooling patterns had a pronounced effect on antioxidant characteristics, fatty acid profile, lipid oxidation and textural characteristics of yoghurt. Buffalo milk based yoghurt had more fat, protein, higher antioxidant capacity and vitamin content. Antioxidant and sensory characteristics of T. If milk is exposed to excessive amounts of light, Vitamins B. The two concentration of ZnO nanoparticles in the ambient air produced two different outcomes. The lower concentration resulted in significant increases in Zn content of the liver while the higher concentration significantly increased Zn in the lungs (p < 0.05). Additionally, at the lower concentration, Zn content was found to be lower in brain tissue (p < 0.05). Using TEM/EDX we detected ZnO nanoparticles inside the cells in the lungs, kidney and liver. Inhaling ZnO NP at the higher concentration increased the levels of mRNA of the following genes in the lungs: Mt2 (2.56 fold), Slc30a1 (1.52 fold) and Slc30a5 (2.34 fold). At the lower ZnO nanoparticle concentration, only Slc30a7 mRNA levels in the lungs were up (1.74 fold). Thus the two air concentrations of ZnO nanoparticles produced distinct effects on the expression of the Zn-homeostasis related genes.. Until adverse health effects of ZnO nanoparticles deposited in organs such as lungs are further investigated and/or ruled out, the exposure to ZnO nanoparticles in aerosols should be avoided or minimised.

Topics: A549 Cells; Acetylmuramyl-Alanyl-Isoglutamine; Acinetobacter baumannii; Acute Lung Injury; Adaptor Proteins, Signal Transducing; Adenine; Adenocarcinoma; Adipogenesis; Administration, Cutaneous; Administration, Ophthalmic; Adolescent; Adsorption; Adult; Aeromonas hydrophila; Aerosols; Aged; Aged, 80 and over; Aging; Agriculture; Air Pollutants; Air Pollution; Airway Remodeling; Alanine Transaminase; Albuminuria; Aldehyde Dehydrogenase 1 Family; Algorithms; AlkB Homolog 2, Alpha-Ketoglutarate-Dependent Dioxygenase; Alzheimer Disease; Amino Acid Sequence; Ammonia; Ammonium Compounds; Anaerobiosis; Anesthetics, Dissociative; Anesthetics, Inhalation; Animals; Anti-Bacterial Agents; Anti-HIV Agents; Anti-Infective Agents; Anti-Inflammatory Agents; Antibiotics, Antineoplastic; Antibodies, Antineutrophil Cytoplasmic; Antibodies, Monoclonal, Humanized; Antifungal Agents; Antigens, Bacterial; Antigens, CD; Antigens, Differentiation, Myelomonocytic; Antimetabolites, Antineoplastic; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Antioxidants; Antitubercular Agents; Antiviral Agents; Apolipoproteins E; Apoptosis; Arabidopsis; Arabidopsis Proteins; Arsenic; Arthritis, Rheumatoid; Asthma; Atherosclerosis; ATP-Dependent Proteases; Attitude of Health Personnel; Australia; Austria; Autophagy; Axitinib; Bacteria; Bacterial Outer Membrane Proteins; Bacterial Proteins; Bacterial Toxins; Bacterial Typing Techniques; Bariatric Surgery; Base Composition; Bayes Theorem; Benzoxazoles; Benzylamines; beta Catenin; Betacoronavirus; Betula; Binding Sites; Biological Availability; Biological Oxygen Demand Analysis; Biomarkers; Biomarkers, Tumor; Biopsy; Bioreactors; Biosensing Techniques; Birth Weight; Blindness; Blood Chemical Analysis; Blood Gas Analysis; Blood Glucose; Blood Pressure; Blood Pressure Monitoring, Ambulatory; Blood-Brain Barrier; Blotting, Western; Body Mass Index; Body Weight; Bone and Bones; Bone Density; Bone Resorption; Borates; Brain; Brain Infarction; Brain Injuries, Traumatic; Brain Neoplasms; Breakfast; Breast Milk Expression; Breast Neoplasms; Bronchi; Bronchoalveolar Lavage Fluid; Buffaloes; Cadherins; Calcification, Physiologic; Calcium Compounds; Calcium, Dietary; Cannula; Caprolactam; Carbon; Carbon Dioxide; Carboplatin; Carcinogenesis; Carcinoma, Ductal; Carcinoma, Ehrlich Tumor; Carcinoma, Hepatocellular; Carcinoma, Non-Small-Cell Lung; Carcinoma, Pancreatic Ductal; Carcinoma, Renal Cell; Cardiovascular Diseases; Carps; Carrageenan; Case-Control Studies; Catalysis; Catalytic Domain; Cattle; CD8-Positive T-Lymphocytes; Cell Adhesion; Cell Cycle Proteins; Cell Death; Cell Differentiation; Cell Line; Cell Line, Tumor; Cell Movement; Cell Nucleus; Cell Phone Use; Cell Proliferation; Cell Survival; Cell Transformation, Neoplastic; Cell Transformation, Viral; Cells, Cultured; Cellulose; Chemical Phenomena; Chemoradiotherapy; Child; Child Development; Child, Preschool; China; Chitosan; Chlorocebus aethiops; Cholecalciferol; Chromatography, Liquid; Circadian Clocks; Circadian Rhythm; Circular Dichroism; Cisplatin; Citric Acid; Clinical Competence; Clinical Laboratory Techniques; Clinical Trials, Phase I as Topic; Clinical Trials, Phase II as Topic; Clostridioides difficile; Clostridium Infections; Coculture Techniques; Cohort Studies; Cold Temperature; Colitis; Collagen Type I; Collagen Type I, alpha 1 Chain; Collagen Type XI; Color; Connective Tissue Diseases; Copper; Coronary Angiography; Coronavirus 3C Proteases; Coronavirus Infections; Cost of Illness; Counselors; COVID-19; COVID-19 Testing; Creatine Kinase; Creatinine; Cross-Over Studies; Cross-Sectional Studies; Cryoelectron Microscopy; Cryosurgery; Crystallography, X-Ray; Cues; Cultural Competency; Cultural Diversity; Curriculum; Cyclic AMP Response Element-Binding Protein; Cyclin-Dependent Kinase Inhibitor p21; Cycloparaffins; Cysteine Endopeptidases; Cytokines; Cytoplasm; Cytoprotection; Databases, Factual; Denitrification; Deoxycytidine; Diabetes Complications; Diabetes Mellitus; Diabetes Mellitus, Experimental; 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Forced Expiratory Volume; Forests; Fractures, Bone; Fruit and Vegetable Juices; Fusobacteria; G1 Phase Cell Cycle Checkpoints; G2 Phase Cell Cycle Checkpoints; Gamma Rays; Gastrectomy; Gastrointestinal Microbiome; Gastrointestinal Stromal Tumors; Gefitinib; Gels; Gemcitabine; Gene Amplification; Gene Expression; Gene Expression Regulation; Gene Expression Regulation, Bacterial; Gene Expression Regulation, Neoplastic; Gene Expression Regulation, Plant; Gene Knockdown Techniques; Gene-Environment Interaction; Genotype; Germany; Glioma; Glomerular Filtration Rate; Glucagon; Glucocorticoids; Glycemic Control; Glycerol; Glycogen Synthase Kinase 3 beta; Glycolipids; Glycolysis; Goblet Cells; Gram-Negative Bacterial Infections; Granulocyte Colony-Stimulating Factor; Graphite; Greenhouse Effect; Guanidines; Haemophilus influenzae; HCT116 Cells; Health Knowledge, Attitudes, Practice; Health Personnel; Health Services Accessibility; Health Services Needs and Demand; Health Status Disparities; Healthy Volunteers; 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YAP-Signaling Proteins; Yogurt; Young Adult; Zebrafish; Zebrafish Proteins; Ziziphus

Traditionally classified as a vitamin, vitamin D represents a group of fat-soluble secosteroids with D2 (ergocalciferol) and D3 (cholecalciferol) being the most relevant of the group. The importance of this prohormone exceeds its known ability to maintain intra- and extracellular calcium and phosphate concentrations, thereby preserving essential metabolic functions such as the promotion of mineralization and maintenance and remodeling of the bone. Current observational research recognizes the potential antiproliferative, prodifferentiative, and immunomodulatory effects of vitamin D and its metabolites in the human body. The purposes of this paper are to: (1) review how vitamin D interacts in the body, its deficiency at the population level, and how it relates to oral health in children; and (2) assess proposed biological mechanisms by which vitamin D may play a preventive role in the development of dental caries.

Topics: Child; Cholecalciferol; Dental Caries; Diet; Drug Interactions; Humans; Nutritional Status; Oral Health; Salivary Proteins and Peptides; Tooth, Deciduous; United States; Vitamin D; Vitamin D Deficiency

Vitamin D deficiency occurs frequently in patients with cystic fibrosis (CF). Vitamin D is important for optimal mineralization of bone and may be important for other comorbidities commonly occurring in patients with CF. Vitamin D deficiency in patients with CF can arise from various causes including pancreatic exocrine insufficiency, lack of outdoor activity, and alterations of vitamin D metabolism. Due to fat malabsorption stemming from pancreatic insufficiency, higher oral doses of vitamin D are necessary to correct and maintain optimal vitamin D status in patients with CF. Recent studies have demonstrated that higher vitamin D status is associated with better lung function and that vitamin D therapy may help recovery from pulmonary exacerbations of CF. The mechanisms by which vitamin D may exert its beneficial actions in CF are unclear but likely related to the role vitamin D has in modulating the adaptive and innate immune response. Large randomized clinical studies to evaluate the potential role of vitamin D as adjunctive therapy in CF that goes beyond bone are necessary.

Topics: Bone Diseases; Cholecalciferol; Clinical Trials as Topic; Comorbidity; Cystic Fibrosis; Ergocalciferols; Humans; Inflammation; Lung; Randomized Controlled Trials as Topic; Respiratory Function Tests; Vitamin D; Vitamin D Deficiency

The steroid hormone metabolite of vitamin D3, 1α,25-dihydroxyvitamin D3 (1,25D3), promotes osteogenic activity and regulates calcium and phosphate metabolism, which are actions regarded as classical vitamin D-regulated functions. Besides its role in these processes, 1,25D3 also seems implicated in the host defense against microbial/pro-inflammatory attacks. Low serum levels of vitamin D3 (vitamin D deficiency) are associated with osteoporosis and increased risk of fractures but also inflammatory diseases and their disease progression, presumably via mechanisms associated with 1,25D3-evoked modulation of the innate immune system. 1,25D3 has been reported to modulate many inflammatory responses, suggesting that it regulates multiple transcriptional targets within the inflammatory system.. Experimental studies in various experimental systems show that 1,25D3 differentially regulates the production of pro-inflammatory cytokines and chemokines depending on cell type. Importantly, many reports show that 1,25D3 up-regulates expression of the human antimicrobial peptide hCAP-18/LL-37 gene. The hCAP-18/LL-37 gene seems indeed to be an important transcriptional target for 1,25D3. However, only limited evidence is presented showing that 1,25D3 consistently increases the amount of biologically active LL-37 peptide.. In the present review, we discuss 1,25D3-induced down-regulation of cytokine/chemokine production and stimulation of hCAP-18/LL-37 gene expression which represent two very important pathways for 1,25D3-evoked regulation of the innate immune response.

Topics: Animals; Antimicrobial Cationic Peptides; Cathelicidins; Cholecalciferol; Cytokines; Gene Expression; Humans; Immunity, Innate; Vitamin D Deficiency

Vitamin D is best known for its influence on skeletal health. There is growing recognition, however, that vitamin D has nonskeletal actions, which could have important implications for understanding the consequences of vitamin D deficiency. In epidemiologic studies, vitamin D deficiency has been consistently associated with an increased risk for cardiovascular disease and hypertension. Disruption of vitamin D signaling in animal models promotes hypertension, cardiac hypertrophy, and atherosclerosis. This evidence has led to the initiation of prospective randomized trials of vitamin D supplementation in individuals at risk for cardiovascular disease. The results of these trials should help to guide strategies for screening and management of vitamin D deficiency in the clinic and at the population level.

Topics: Animals; Cardiovascular Diseases; Cholecalciferol; Dietary Supplements; Humans; Randomized Controlled Trials as Topic; Renin-Angiotensin System; Risk Factors; Vitamin D; Vitamin D Deficiency

Obesity induced low-grade chronic inflammation disrupts proper immune and metabolic function. Vitamin D deficiency increases inflammation, which is associated with cardiometabolic risk. This systematic review examines the association between oral vitamin D (VD) supplementation and circulating inflammatory biomarkers and glycemic outcomes from randomized controlled trials (RCTs) of overweight and/or obese adults.. MEDLINE OVID, EMBASE and the Cochrane Central Register of Controlled Trials were searched according to a predefined protocol. Eligible RCTs included adults randomized to receive either oral VD or placebo. Two reviewers independently assessed RCTs for inclusion. Bias was assessed using the Cochrane Collaboration risk of bias tool. Mean differences were calculated comparing end-of-study sample means between the independent VD and placebo groups.. Eleven unique RCTs met inclusion criteria from a total of 3,383 identified citations, including 79 screened articles and 14 full text data extractions. Inflammatory and glycemic measures were reported in 7 and 10 RCTs, respectively. Most trial findings were non-significant with considerable heterogeneity in design, participants and outcomes. All but one trial was rated as either high or unclear risk of bias. Two RCTs reported significant changes in inflammatory biomarkers; however, the mean difference between groups was not statistically significant: C-reactive protein 0.19 mg/L (p = 0.88); Tumor Necrosis Factor -0.54 pg/ml (p = 0.20). Two other trials found significant mean differences in fasting plasma glucose -0.32 mmol/L (p = 0.03), Hemoglobin A1c -0.13% (p = 0.04), and Homeostatic Model Assessment -0.86 (p = 0.02) following VD supplementation.. Overall, there is no clear established benefit of VD supplementation on inflammatory biomarkers among overweight/obese adults. Baseline serum VD possibly influences the effect of VD repletion on inflammatory markers. Risk of bias was present in most studies, thus supporting the need for higher quality studies in this area to more conclusively understand the role VD supplementation has on inflammatory pathways.

Topics: Adult; Blood Glucose; C-Reactive Protein; Cholecalciferol; Humans; Inflammation; Obesity; Overweight; Randomized Controlled Trials as Topic; Tumor Necrosis Factor-alpha; Vitamin D Deficiency; Vitamins

Previous randomized clinical trials (RCTs) of the effects of vitamin D3 supplementation (VD3S) on blood pressure have generated inconsistent results. We evaluated the effect of VD3S on systolic blood pressure (SBP) and diastolic blood pressure (DBP) in a meta-analysis.. Literature searches of PubMed, Scopus, Ovid, and Google scholar for publications in English were conducted up to April 2015. RCTs that assessed the effect of VD3S on SBP and DBP were selected.. A total of 30 RCTs with 41 arms including 4744 participants were included. The mean duration of the studies was 5.6 ± 4.0 months, and doses of VD3S varied between 200 and 12,000 IU/day. VD3S had no effect on SBP (-0.68 mmHg, 95%CI: -2.19 to 0.84), and DBP (-0.57 mmHg, 95%CI: -1.36 to 0.22). Subgroup analysis revealed that daily vitamin D3 therapy at a dose of >800 IU/day for <6 months in subjects ≥50 years old reduced both SBP and DBP (p < 0.001). In addition, VD3S showed hypotensive effects in healthy subjects and hypertensive patients, but a hypertensive effect in overweight and obese subjects. However, after excluding overweight and obese subjects, VD3S significantly reduced SBP and DBP. VD3S in combination with calcium supplementation significantly elevated SBP (3.64 mmHg, 95%CI: 3.15-4.13) and DBP (1.71 mmHg, 95%CI: 1.25-2.18). No evidence of publication bias was found. The effects of VD3S on blood pressure depend on dose of supplementation, treatment regimens, trial duration, and population subgroup. Supplementation may be beneficial at daily doses >800 IU/day for <6 months in subjects ≥50 years old.

Topics: Blood Pressure; Calcium; Cholecalciferol; Dietary Supplements; Dose-Response Relationship, Drug; Female; Humans; Hypertension; Male; Middle Aged; Randomized Controlled Trials as Topic; Risk Factors; Time Factors; Treatment Outcome; Vitamin D Deficiency

The existing guidelines on screening and treatment are confusing because different guidelines target different populations. The IOM and AAP guidelines target generally healthy populations, whereas the Endocrine Society and other subspecialty guidelines target individuals with specific medical conditions associated with increased bone fragility. These distinctions have not always been well articulated. For healthy adolescents, the AAP does not recommend universal screening or screening of obese or dark-skinned individuals. Increased dietary intake of vitamin D is recommended, and vitamin D supplementation can be considered if the RDA cannot be met. For adolescents with chronic medical illnesses associated with increased fracture risk, screening for vitamin D deficiency should be performed by obtaining a serum 25-OHD level. Those found to be deficient (25-OHD level < 20 ng/mL) should be treated with doses of vitamin D2 or vitamin D3 higher than the daily requirement (as discussed in the section on vitamin D and chronic disease), followed by a maintenance dose. A repeat 25-OHD level should be obtained after the therapeutic course is completed. Some experts advocate for achievement of 25-OHD levels greater than 30 ng/mL in conditions associated with increased bone fragility, and several pediatric subspecialty organizations have made recommendations specific to the diseases they treat. In such instances, the recommendations of the pediatric subspecialty organizations should take precedence over the AAP recommendations for adolescents with chronic illnesses associated with increased bone fragility because the AAP recommendations were primarily targeted at a healthy population.

Topics: Adolescent; Celiac Disease; Cholecalciferol; Comorbidity; Cystic Fibrosis; Ergocalciferols; Feeding and Eating Disorders; Humans; Inflammatory Bowel Diseases; Mass Screening; Practice Guidelines as Topic; Rheumatic Diseases; Vitamin D; Vitamin D Deficiency; Vitamins

Falls are a major health problem in elderly individuals. Although intensive physical therapy and management of hazards in the home can reduce falls by 25%, long-term practicality limits their use. Interest in vitamin D as a medical therapy has led to many trials; however, results using daily oral doses of vitamin D have been inconsistent. In the past 5 years, studies on the effect of bolus doses of vitamin D have produced surprising results. Bolus doses of vitamin D, given annually (at a dose of 300,000 IU or 500,000 IU) or monthly (at a dose of 24,000 IU or 60,000 IU) - equivalent to approximate daily doses of 800 IU, 1400 IU and 2,000 IU - result in a significant increase in the number of falls and fractures associated with serum levels of 25-hydroxyvitamin D greater than 40-45 ng/ml (equivalent to 100-112 nmol/l). These unexpected results show increased falls and fractures are adverse events related to vitamin D administration. Until further safety data is available, bolus dosing or daily doses should not exceed 3,000 IU and serum levels of 25-hydroxyvitamin D should not exceed 40-45 ng/ml (equivalent to 100-112 nmol/l) in elderly individuals.

Topics: Accidental Falls; Cholecalciferol; Ergocalciferols; Fractures, Bone; Humans; Physical Therapy Modalities; Vitamin D; Vitamin D Deficiency; Vitamins

Recent findings suggest that vitamin D is a marker for outcomes in critical illness. The purpose of this review is to summarize current biological, observational and interventional evidence in the critically ill.. Both biological and observational studies support the role of vitamin D deficiency in adverse critical illness outcomes. Interventional trials of critically ill patients show that to improve vitamin D status, high-dose vitamin D3 is required. Critically ill patients have a relatively blunted response to vitamin D supplementation compared to the general outpatient population. Toxicity from high-dose vitamin D in trials in the critically ill has been limited to mild hypercalcemia. Recent evidence suggests that treatment of severely vitamin D-deficient critically ill patients with high-dose vitamin D early in the ICU course may improve mortality.. Vitamin D deficiency is a potentially modifiable marker for adverse outcomes in critical illness and critical illness survivors. Vitamin D supplementation is inexpensive and appears safe in critical illness trials. A well powered interventional trial is required to determine the definitive answer regarding the role of vitamin D supplementation in the improvement of critical care outcomes. Until such data are available, a cautious approach to correction of vitamin D status in the ICU is warranted.

Topics: Biomarkers; Cholecalciferol; Critical Illness; Dietary Supplements; Humans; Intensive Care Units; Nutrition Therapy; Treatment Outcome; Vitamin D; Vitamin D Deficiency; Vitamins

There is controversy surrounding the designation of vitamin D adequacy as defined by circulating levels of the metabolite 25-hydroxyvitamin D (25(OH)D). Depending on the cutoff level chosen, dietary intakes of vitamin D may or may not provide sufficient impact upon vitamin D status measured as improvement in serum levels of 25(OH)D. We sought to examine whether modest daily doses (5-20 μg) as found in fortified foods or multivitamin supplements had a measureable impact on vitamin D status, defined as moving from below to above 50 nmol/L, or from less than 30 nmol/L to above 30 nmol/L. Published literature was searched for relevant articles describing randomized controlled trials. Exclusion criteria were: studies not involving humans; review articles; studies lacking blood level data pre- and post-treatment; no control group; bolus treatments (weekly, monthly, yearly); vitamin D < 5 μg or > 20 μg; baseline 25(OH)D ≥ 75 nmol/L; subjects not defined as healthy; studies < 8 weeks; and age < 19 years. Of the 127 studies retrieved, 18 publications with 25 separate comparisons met criteria. The mean rate constant, defined as change in 25(OH)D in nmol/L per μg vitamin D administered, was calculated as 2.19 ± 0.97 nmol/L per μg. There was a significant negative correlation (r = -0.65, p = 0.0004) between rate constant and administered dose. To determine impact of the dose reflecting the Estimated Average Requirement (EAR) of 10 μg administered in nine studies (10 comparisons), in every case mean 25(OH)D status rose either from "insufficient" (30-50 nmol/L) to "sufficient" (> 50 nmol/L) or from "deficient" (< 30 nmol/L) to "insufficient" (> 30 but < 50 nmol/L). Our study shows that when baseline levels of groups were < 75 nmol/L, for every microgram of vitamin D provided, 25(OH)D levels can be raised by 2 nmol/L; and further, when groups were deficient or insufficient in vitamin D, there was significant value in providing additional 10 μg per day of vitamin D.

Topics: Cholecalciferol; Dietary Supplements; Dose-Response Relationship, Drug; Food, Fortified; Humans; Randomized Controlled Trials as Topic; Vitamin D; Vitamin D Deficiency

The prevalence of vitamin D deficiency in hemodialysis patients is high. While most hemodialysis patients are treated with activated vitamin D (1,25[OH]2D) to prevent renal osteodystrophy, clinical practices of the screening and treatment of 25(OH)2D deficiency are highly variable. It is unclear if nutritional vitamin D supplementation with D2 or D3 provides an additional clinical benefit beyond that provided by activated vitamin D treatment in this population.. We will conduct a systematic review of nutritional vitamin D (D2/D3) supplementation and health-related outcomes in hemodialysis patients according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The primary objective is to assess the impact of nutritional vitamin D supplementation on clinical outcomes relevant in hemodialysis patients, such as mortality, cardiovascular events, infections, and fractures. Secondary outcomes will include anemia, hyperparathyroidism, medication use (erythrocyte-stimulating agents, activated vitamin D), and quality of life. We will search MEDLINE, Scopus, Web of Science, and ClinicalTrials.gov for randomized, controlled trials of nutritional vitamin D supplementation (ergocalciferol/D2 or cholecalciferol/D3) in chronic hemodialysis patients. The Cochrane Risk Assessment Tool will be used to assess the quality of eligible studies. We will perform meta-analyses using standard techniques for the outcomes listed above if pooling is deemed appropriate/sufficient. The results of this systematic review may highlight gaps in our knowledge of the relevance of nutritional vitamin D in end-stage renal disease, allowing for the informed design of clinical trials assessing the impact of nutritional vitamin D therapy in the hemodialysis population in the future.. PROSPERO CRD42014013931.

Topics: Cardiovascular Diseases; Cholecalciferol; Chronic Kidney Disease-Mineral and Bone Disorder; Clinical Protocols; Dietary Supplements; Ergocalciferols; Fractures, Bone; Humans; Infections; Renal Dialysis; Renal Insufficiency, Chronic; Research Design; Systematic Reviews as Topic; Vitamin D Deficiency; Vitamins

This comprehensive review addresses the issue of Vitamin D deficiency and its management in adults. Briefly describing the history of Vitamin D development and its role in human physiology, it discusses D deficiency in adults. Pragmatic suggestion for diagnosis, choice of therapy, and monitoring are presented from a patient-centred viewpoint, keeping socioeconomic realities in perspective. The review adds to current medical literature by collating evidence in a format that will be useful to practicing clinicians.

Topics: Cholecalciferol; Humans; Patient Preference; Patient-Centered Care; Vitamin D Deficiency; Vitamins

Calcium and phosphorus represent building material for bones. The supplier of these bone minerals is the hormone calcitriol, which originates from vitamin D, itself made by sunshine in human skin. Requirement for bone minerals is highest during phases of rapid growth, and no one grows faster than the foetus and the infant, making them particularly vulnerable. Deprivation of calcium, whether through low calcium intake or low vitamin D, leads to serious health consequences throughout life, such as hypocalcaemic seizures, dilated cardiomyopathy, skeletal myopathy, congenital and infantile rickets, and osteomalacia. These 5 conditions are often summarised as 'symptomatic vitamin D deficiency', are fully reversible but also fully preventable. However, the increasing prevalence of rickets and osteomalacia, and the deaths from hypocalcaemic cardiomyopathy, demand action from global health care providers. Clarification of medical and parental responsibilities is a prerequisite to deliver successful prevention programmes. The foetus and infant have the human right to be protected against harm, and vitamin D supplementation has the same public health priority as vaccinations.

Topics: Calcitriol; Calcium; Calcium, Dietary; Cardiomyopathy, Dilated; Cholecalciferol; Ergocalciferols; Female; Fetal Diseases; Humans; Infant; Infant, Newborn; Osteomalacia; Pregnancy; Pregnancy Complications; Rickets; Seizures; Vitamin D Deficiency; Vitamins

To provide a detailed summary of current scientific knowledge on uterine fibroids (leiomyomas) in vitro and in in vivo animal models, as well as to postulate the potential role of vitamin D3 as an effective, inexpensive, safe, long-term treatment option for uterine fibroids.. PubMed search articles were used to identify the most relevant studies on uterine fibroids, as well as effects of vitamin D3 on uterine fibroid cells and fibroid tumor growth in in vivo animal models.. University research laboratory.. Not applicable.. None.. Despite numerous publications available on uterine fibroids, information about the role that vitamin D3 plays in the regulation of uterine fibroids is limited. Most of the recent vitamin D3-related studies on uterine fibroids were published from our group. Recent studies have demonstrated that vitamin D deficiency plays a significant role in the development of uterine fibroids. Our recent studies have demonstrated that vitamin D3 reduces leiomyoma cell proliferation in vitro and leiomyoma tumor growth in in vivo animal models. These results postulate the potential role of vitamin D3 for an effective, safe, nonsurgical medical treatment option for uterine fibroids.. This article reviews human and animal studies and uncovers new possibilities for understanding the vitamin D-based therapeutic option for an effective, safe, long-term treatment of uterine fibroids. On the basis of these results, a clinical trial with vitamin D3 or a hypocalcemic analog, paricalcitol, may be warranted for nonsurgical medical treatment of uterine fibroids.

Topics: Animals; Antineoplastic Agents; Black or African American; Cholecalciferol; Dietary Supplements; Ergocalciferols; Female; Humans; Leiomyoma; Risk Factors; Signal Transduction; Treatment Outcome; Uterine Neoplasms; Vitamin D; Vitamin D Deficiency

Vitamin D, also known as cholecalciferol, is the precursor to the active steroid hormone 1, 25-dihydroxyvitamin D3 (calcitriol; 1, 25(OH)2D3). The main physiological role for 1, 25(OH)2D3 is to regulate calcium and inorganic phosphate homeostasis for bone health. More recently, vitamin D has been investigated for its effects in the prevention and treatment of a variety of diseases such as cancer, autoimmune disorders, and cardiovascular disease. Preclinical data strongly support a role for vitamin D in the prevention of cancer through its anti-proliferative, pro-apoptotic, and anti-angiogenic effects on cells. Epidemiologic and clinical studies have shown mixed data on the correlation between serum vitamin D levels and cancer risk. This report seeks to outline results from the most recent preclinical and clinical studies investigating the potential role of vitamin D in cancer prevention.

Topics: Calcitriol; Cholecalciferol; Humans; Neoplasms; Vitamin D; Vitamin D Deficiency

Topics: Adult; Algorithms; Calcifediol; Calcitriol; Child; Cholecalciferol; Diabetes Mellitus; Disease Management; Female; Humans; Infant, Newborn; Kidney Diseases; Male; Obesity; Osteoporosis; Pregnancy; Recommended Dietary Allowances; Risk; Vitamin D Deficiency

There is considerable variation in incremental circulating 25-hydroxyvitamin D (25OHD) levels on vitamin D supplements, even when similar age groups and identical vitamin D doses are compared. We therefore aimed to investigate the importance of body weight for the dose-response relation in circulating 25OHD.. We performed a systematic review of randomized placebo-controlled vitamin D supplementation trials in all age groups ≥10 years to clarify the influence of body weight and other parameters on incremental circulating 25OHD levels (difference between baseline and in-study values) in vitamin D-deficient and non-deficient individuals.. We included 144 cohorts from 94 independent studies, published from 1990 to November 2012, in our systematic review. There was a logarithmic association between vitamin D dose per kg body weight per day and increment in circulating 25OHD. In multivariable regression analysis, vitamin D dose per kg body weight per day could explain 34.5% of variation in circulating 25OHD. Additional significant predictors were type of supplement (vitamin D2 or vitamin D3), age, concomitant intake of calcium supplements and baseline 25OHD, explaining 9.8, 3.7, 2.4 and 1.9%, respectively, of the variation in circulating 25OHD.. This systematic review demonstrates that body weight is an important predictor of variation in circulating 25OHD in cohorts on vitamin D supplements. Our model provides an estimate of the daily vitamin D dose that is necessary for achieving adequate circulating 25OHD levels in vitamin D-insufficient or vitamin D-deficient individuals/cohorts with different body weights and ages.

Topics: Adolescent; Adult; Age Factors; Aged; Aged, 80 and over; Body Weight; Calcium; Child; Cholecalciferol; Dietary Supplements; Ergocalciferols; Female; Humans; Male; Middle Aged; Vitamin D; Vitamin D Deficiency

Vitamin D is not really a vitamin but the precursor to the potent steroid hormone calcitriol, which has widespread actions throughout the body. Calcitriol regulates numerous cellular pathways that could have a role in determining cancer risk and prognosis. Although epidemiological and early clinical trials are inconsistent, and randomized control trials in humans do not yet exist to conclusively support a beneficial role for vitamin D, accumulating results from preclinical and some clinical studies strongly suggest that vitamin D deficiency increases the risk of developing cancer and that avoiding deficiency and adding vitamin D supplements might be an economical and safe way to reduce cancer incidence and improve cancer prognosis and outcome.

Topics: 25-Hydroxyvitamin D3 1-alpha-Hydroxylase; Breast Neoplasms; Calcitriol; Cholecalciferol; Colonic Neoplasms; Disease Progression; Endocrine System; Female; Humans; Male; Neoplasms; Neoplastic Stem Cells; Polymorphism, Genetic; Prognosis; Prostatic Neoplasms; Randomized Controlled Trials as Topic; Risk; Signal Transduction; Steroid Hydroxylases; Vitamin D; Vitamin D Deficiency; Vitamin D3 24-Hydroxylase

In recent years there has been increasing interest in the non-skeletal effects of vitamin D. It has been suggested that vitamin D deficiency may influence the development of diabetes, cardiovascular dysfunction and autoimmune diseases. This review focuses on the current knowledge of the effects of vitamin D and its deficiency on cardiovascular function, glucose homeostasis and immune function, with a particular focus on children. Although, there is good evidence to show that there is an association between vitamin D deficiency and an abnormality of the above systems, there is little evidence to show that vitamin D supplementation leads to an improvement in function, especially in childhood.

Topics: Adaptive Immunity; Adolescent; Animals; Cardiovascular Physiological Phenomena; Cardiovascular System; Child; Child, Preschool; Cholecalciferol; Ergocalciferols; Female; Glucose; Homeostasis; Humans; Immunity; Immunity, Innate; Infant; Male; Risk Factors; Vitamin D; Vitamin D Deficiency

The aim of this study was to review factors that influence serum 25(OH)D when patients are given vitamin D supplements.. From a comprehensive search of all randomized controlled clinical trials with vitamin D3 supplementation available on PubMed up to November 2011, we selected 33 with 43 treatment arms that included at least 30 adult participants. The achieved pooled mean difference (PMD) and 95% confidence intervals (CIs) were calculated using the random-effects models. Meta-regression and subgroup analyses were performed for prespecified factors, including dose, duration, baseline serum 25(OH)D, and age.. With a mean baseline serum 25(OH)D of 50.4 nmol/L, PMD was 37 nmol/L (95% CI, 33-41) with significant heterogeneity among studies. Dose (slope: 0.006; P < 0.001), trial duration (slope: 0.21; P < 0.001), baseline serum 25(OH)D (slope: -0.19; P < 0.001), and age (slope: 0.42; P < 0.001) independently influenced vitamin D response. Similar results were found in studies with a mean baseline serum 25(OH)D <50 nmol/L. In subgroup analyses, the PMD was higher with doses ≥800 IU/d (39.3 nmol/L) after 6 to 12 mo (41.7 nmol/L), with baseline 25(OH)D <50 nmol/L (39.6 nmol/L), and in adults aged >80 y (40.5 nmol/L).. This meta regression indicates that a higher increase in serum levels of 25(OH)D in adults is found with a dose of ≥800 IU/d, after at least 6 to 12 mo, and even when baseline 25(OH)D is low and in adults >80 y.

Topics: Cholecalciferol; Dietary Supplements; Humans; Vitamin D; Vitamin D Deficiency

Vitamin D is the sunshine vitamin for good reason. During exposure to sunlight, the UV B photons enter the skin and photolyze 7-dehydrocholesterol to previtamin D3 which in turn is isomerized by the body's temperature to vitamin D3. Most humans have depended on sun for their vitamin D requirement. Skin pigment, sunscreen use, aging, time of day, season and latitude dramatically affect previtamin 13 synthesis. Vitamin D deficiency was thought to have been conquered, but it is now recognized that more than 50% of the world's population is at risk for vitamin D deficiency. This deficiency is in part due to the inadequate fortification of foods with vitamin D and the misconception that a healthy diet contains an adequate amount of vitamin D. Vitamin D deficiency causes growth retardation and rickets in children and will precipitate and exacerbate osteopenia, osteoporosis and increase risk of fracture in adults. The vitamin D deficiency has been associated pandemic with other serious consequences including increased risk of common cancers, autoimmune diseases, infectious diseases and cardiovascular disease. There needs to be a renewed appreciation of the beneficial effect of moderate sunlight for providing all humans with their vitamin D requirement for health.

Topics: Aging; Bone Diseases, Metabolic; Cholecalciferol; Dehydrocholesterols; Humans; Osteoporosis; Photolysis; Rickets; Skin; Skin Neoplasms; Skin Pigmentation; Sunlight; Sunscreening Agents; Ultraviolet Rays; Vitamin D; Vitamin D Deficiency

Vitamin D is a compound responsible for maintaining mineral homeostasis. It protects against calcium and phosphate deficiency through the effects on the intestine, kidney, parathyroid gland and bone. All mechanisms that help maintain mineral homeostasis of the body are regulated by the vitamin D hormonal form - calcitriol. Synthesis of vitamin D starts in the skin as a non-enzymatic process, which begins during exposure to sunlight, when the absorption of ultraviolet B (UVB) radiation results in convertion of 7-dehydrocholesterol, a metabolite of cholesterol that is stored in the skin, to precholecalciferol (previtamin-D₃) that is immediately converted into cholecalciferol (vitamin D₃). After the skin synthesis cholecalciferol is transported to the liver where it undergoes hydroxylation, what results in formation of calcidiol (25(OH)D₃). The second metabolic process takes place in the kidney, where calcidiol undergoes hydroxylation at the C-1 position to the hormonal, the most active metabolite - 1,25-dihydroxyvitamin D (calcitriol). Vitamin D deficiency may result in bone diseases, such as rickets in children and osteomalacia and osteoporosis in adults. Symptoms of osteomalacia affect mainly the skeletal system and are similar to that observed in rickets. It concerns thoracic kyphosis, pelvis deformities and also the varus knee. Osteoporosis is another condition that is related to abnormalities of mineral homeostasis. It is characterized by the progressive loss of bone mass, impaired bone microarchitecture, and consequently increased fragility and susceptibility to fracture. For the last several years other, non-classic actions of vitamin D₃ have been discussed. It was engendered by the discovery of vitamin D3 receptor (VDR) in the most of body tissues and cells. Hence, there are many hypotheses which suggest the inverse relationship between vitamin D status and various diseases, such as cancer, autoimmune diseases, diabetes mellitus and others.

Topics: Adult; Aged; Child; Cholecalciferol; Humans; Photosynthesis; Skin; Sunlight; Ultraviolet Rays; Vitamin D; Vitamin D Deficiency

Topics: Administration, Oral; Cholecalciferol; Drug Administration Schedule; Humans; Injections, Intramuscular; Practice Guidelines as Topic; Vitamin D Deficiency; Vitamins

The magnitude of vitamin D inputs in individuals not taking supplements is unknown; however, there is a great deal of information on quantitative response to varying supplement doses. We reanalyzed individual 25-hydroxyvitamin D [25(OH)D] concentration data from 8 studies involving cholecalciferol supplementation (total sample size = 3000). We extrapolated individual study dose-response curves to zero concentration values for serum 25(OH)D by using both linear and curvilinear approaches and measured seasonal oscillation in the serum 25(OH)D concentration. The total basal input (food plus solar) was calculated to range from a low of 778 iu/d in patients with end-stage renal disease to a high of 2667 iu/d in healthy Caucasian adults. Consistent with expectations, obese individuals had lower baseline, unsupplemented 25(OH)D concentrations and a smaller response to supplements. Similarly, African Americans had both lower baseline concentrations and lower calculated basal, all-source inputs. Seasonal oscillation in 4 studies ranged from 5.20 to 11.4 nmol/L, reflecting a mean cutaneous synthesis of cholecalciferol ranging from 209 to 651 iu/d at the summer peak. We conclude that: 1) all-source, basal vitamin D inputs are approximately an order of magnitude higher than can be explained by traditional food sources; 2) cutaneous, solar input in these cohorts accounts for only 10-25% of unsupplemented input at the summer peak; and 3) the remainder must come from undocumented food sources, possibly in part as preformed 25(OH)D.

Topics: Adult; Aged; Black or African American; Cholecalciferol; Diet; Dietary Supplements; Dose-Response Relationship, Drug; Female; Humans; Kidney Failure, Chronic; Male; Middle Aged; Obesity; Reference Values; Seasons; Skin; Sunlight; Vitamin D; Vitamin D Deficiency; White People

Our understanding of the mechanism of action of vitamin D has been broadened by the discovery of the extrarenal 1α-hydroxylase (CYP27B1) in various vitamin D target tissues around the body and the implications of this for the putative paracrine actions of 1α,25-dihydroxyvitamin D₃. This review updates our current knowledge of the cytochrome P450-mediated steps of vitamin D activation (CYP2R1, CYP27B1) and inactivation (CYP24A1, CYP3A4) and the newest physiological roles of vitamin D. The review goes on to examine how well exogenously supplied vitamin D compounds, whether dietary vitamin D₂ supplements or prescribed vitamin D analogs, substitute for their natural counterparts; how in some cases vitamin D can be used in conjunction with vitamin D analogs; and the overall impact of these supplements and drugs on the components of the vitamin D signal transduction machinery.

Topics: 25-Hydroxyvitamin D3 1-alpha-Hydroxylase; Animals; Cholecalciferol; Diet; Dietary Supplements; Ergocalciferols; Humans; Signal Transduction; Vitamin D; Vitamin D Deficiency

Nonalcoholic fatty liver disease (NAFLD) and vitamin D3 deficiency are two highly prevalent pathologic conditions worldwide that share several cardiometabolic risk factors. In addition to its traditional calcium-related effects on the skeleton, vitamin D3 deficiency has now been recognized to exert nonskeletal adverse effects on several other organ systems. Accumulating epidemiological evidence suggests that low levels of serum 25-hydroxyvitamin D3 are associated with the presence and severity of NAFLD, independently of several potential confounders, including features of the metabolic syndrome. The molecular mechanisms of this association remain incompletely understood. A variety of biologically plausible mechanisms may mediate a hepato-protective role for the active metabolite of vitamin D3. 1α,25-dihydroxyvitamin D3 modulates the insulin signaling pathway/insulin resistance, suppresses fibroblast proliferation and collagen production, exerts anticoagulant and profibrinolytic effects, and modulates macrophage activity and inflammatory cytokine generation. Overall, the high prevalence of vitamin D3 deficiency and the plausible biological mechanisms linking this to NAFLD suggest that treatment of vitamin D3 deficiency to prevent and/or treat NAFLD is a promising field to explore. Large placebo-controlled randomized clinical trials are urgently needed to determine whether vitamin D3 supplementation could have any potential benefit in reducing the development and progression of NAFLD.

Topics: Adipose Tissue; Bile; Bile Acids and Salts; Cholecalciferol; Fatty Liver; Humans; Immunologic Factors; Insulin Resistance; Intestinal Mucosa; Models, Biological; Non-alcoholic Fatty Liver Disease; Risk Factors; Signal Transduction; Vitamin D Deficiency

Humans derive most vitamin D from the action of sunlight in their skin. However, in view of the current Western lifestyle with most daily activities taking place indoors, sun exposure is often not sufficient for adequate vitamin D production. For this reason, dietary intake is also of great importance. Animal foodstuffs (e.g., fish, meat, offal, egg, dairy) are the main sources for naturally occurring cholecalciferol (vitamin D-3). This paper therefore aims to provide an up-to-date overview of vitamin D-3 content in various animal foods. The focus lies on the natural vitamin D-3 content because there are many countries in which foods are not regularly fortified with vitamin D. The published data show that the highest values of vitamin D are found in fish and especially in fish liver, but offal also provides considerable amounts of vitamin D. The content in muscle meat is generally much lower. Vitamin D concentrations in egg yolks range between the values for meat and offal. If milk and dairy products are not fortified, they are normally low in vitamin D, with the exception of butter because of its high fat content. However, as recommendations for vitamin D intake have recently been increased considerably, it is difficult to cover the requirements solely by foodstuffs.

Topics: Animals; Biological Availability; Cholecalciferol; Dairy Products; Diet; Eggs; Fishes; Food Analysis; Food Handling; Food, Fortified; Hot Temperature; Humans; Meat; Milk; Nutritional Requirements; Vitamin D; Vitamin D Deficiency

Traditionally the main recognized function of vitamin D has been calcium and phosphate homeostasis. Nevertheless, recent evidences have highlighted the importance of vitamin D3 as a protective agent against various cancers. The association between CRC and vitamin D3 was first suggested in ecologic studies, but further was confirmed by observational studies in humans and experimental studies in both animal models and cellular lines. The protective role of vitamin D3 against cancer has been attributed to its influence of on cell proliferation, differentiation, apoptosis, DNA repair mechanisms, inflammation and immune function. In its active (calcitriol) form (1,25-dihydroxyvitamin D3[1α,25-(OH)2D3]) vitamin D3 and the nuclear vitamin D receptor (VDR) regulate hundreds of genes including those coding for proteins involved in cell differentiation and cell proliferation. The current review addresses some of the key mechanisms that influence the biological actions of vitamin D and its metabolites. The insights derived from these mechanisms may aid in designing new uses for this hormone and its non-hypercalcemic derivatives in the treatment and/or prevention of CRC.

Topics: 25-Hydroxyvitamin D3 1-alpha-Hydroxylase; Animals; Antineoplastic Agents; Cadherins; Cholecalciferol; Colon; Colorectal Neoplasms; Disease Progression; Epigenesis, Genetic; Gene Expression Regulation, Neoplastic; Humans; Intercellular Signaling Peptides and Proteins; Multigene Family; Osteopontin; Receptors, Calcitriol; Steroid Hydroxylases; Vitamin D Deficiency; Vitamin D3 24-Hydroxylase

Results of recent studies suggest that circulating levels of vitamin D may play an important role in cancer-specific outcomes. The present systematic review was undertaken to determine the prevalence of vitamin D deficiency (<25 nmol/L) and insufficiency (25-50 nmol/L) in cancer patients and to evaluate the association between circulating calcidiol (the indicator of vitamin D status) and clinical outcomes. A systematic search of original, peer-reviewed studies on calcidiol at cancer diagnosis, and throughout treatment and survival, was conducted yielding 4,706 studies. A total of 37 studies met the inclusion criteria for this review. Reported mean blood calcidiol levels ranged from 24.7 to 87.4 nmol/L, with up to 31% of patients identified as deficient and 67% as insufficient. The efficacy of cholecalciferol supplementation for raising the concentration of circulating calcidiol is unclear; standard supplement regimens of <1,000 IU D₃ /day may not be sufficient to maintain adequate concentrations or prevent decreasing calcidiol. Dose-response studies linking vitamin D status to musculoskeletal and survival outcomes in cancer patients are lacking.

Topics: Calcifediol; Cholecalciferol; Dietary Supplements; Dose-Response Relationship, Drug; Humans; Neoplasms; Treatment Outcome; Vitamin D; Vitamin D Deficiency

There is evidence of aberrations in the vitamin D-endocrine system in subjects with respiratory diseases. Vitamin D deficiency is highly prevalent in patients with respiratory diseases, and patients who receive vitamin D have significantly larger improvements in inspiratory muscle strength and maximal oxygen uptake. Studies have provided an opportunity to determine which proteins link vitamin D to respiratory pathology, including the major histocompatibility complex class II molecules, vitamin D receptor, vitamin D-binding protein, chromosome P450, Toll-like receptors, poly(ADP-ribose) polymerase-1, and the reduced form of nicotinamide adenine dinucleotide phosphate. Vitamin D also exerts its effect on respiratory diseases through cell signaling mechanisms, including matrix metalloproteinases, mitogen-activated protein kinase pathways, the Wnt/β-catenin signaling pathway, prostaglandins, reactive oxygen species, and nitric oxide synthase. In conclusion, vitamin D plays a significant role in respiratory diseases. The best form of vitamin D for use in the treatment of respiratory diseases is calcitriol because it is the active metabolite of vitamin D3 and modulates inflammatory cytokine expression. Further investigation of calcitriol in respiratory diseases is needed.

Topics: Animals; Calcitriol; Cholecalciferol; Cytokines; Humans; Muscle Strength; Oxygen Consumption; Prevalence; Respiratory Tract Diseases; Signal Transduction; Vitamin D; Vitamin D Deficiency

Vitamin D insufficiency and deficiency are widespread in many countries. We review the evidence pertaining to its prevention and treatment. Deficiency may be adequately treated with many different therapeutic regimens of either cholecalciferol or ergocalciferol, owing to the high therapeutic index of both compounds. Nevertheless, the current evidence suggests that regular dosing with oral cholecalciferol (e.g., 60,000 IU weekly) may have slight advantages over other regimens when replenishing vitamin D stores following deficiency. For long-term supplementation, smaller regular doses, such as cholecalciferol 1,000 IU daily, or 10,000 IU weekly, are suitable. Giving reliable and specific advice about appropriate sunlight exposure remains difficult because of differing interindividual skin pigmentation and variable sunlight UVB content at different latitudes, at different times of year, and in different terrestrial environments.

Topics: Cholecalciferol; Ergocalciferols; Humans; Vitamin D Deficiency; Vitamins

Vitamin D promotes the differentiation of prostate cancer cells, raising the possibility that vitamin D deficiency over time may contribute to the progression from subclinical prostate cancer to clinical disease. Since low-risk prostate cancers are monitored over time in an effort to determine which progress into clinically important, more aggressive cancers, they provide an excellent model in which to study, over an extended period of time, the effects of enhancing vitamin D status and related changes in tumor progression. This is particularly relevant to African-American men, who exhibit a high prevalence of vitamin D deficiency as well as higher incidence of prostate cancer and higher mortality rates from prostate cancer than Caucasians. Our research team has recently completed an open-label clinical trial aimed at assessing the safety and potential efficacy of vitamin D3 supplementation at 4000 international units (IU) per day for one year in subjects diagnosed with early stage, low-risk prostate cancer. The results of this clinical study suggest that supplementation with vitamin D3 at 4000IU per day may benefit patients with early stage, low-risk prostate cancer on active surveillance, because of the improved outcome (a decreased number of positive cores at repeat biopsy) in more than half of the subjects enrolled in the trial. We also observed that, after one year of supplementation, there was no difference in circulating levels of vitamin D between African-American and Caucasian subjects who completed the study. These clinical results also suggest that robust and sustained vitamin D3 supplementation can reduce prostate cancer-related health disparities in African-American men and that these health disparities are at least in part the result of widespread hypovitaminosis D within the African-American population. This article is part of a Special Issue entitled 'Vitamin D Workshop'.

Topics: Black or African American; Cholecalciferol; Clinical Trials as Topic; Dietary Supplements; Healthcare Disparities; Humans; Male; Prostatic Neoplasms; Risk; Vitamin D; Vitamin D Deficiency

To study the relationship of 25(OH)D(3) level with disease activity, vascular risk factors and atherosclerosis in SLE.. Consecutive patients who fulfilled four or more ACR criteria for SLE were recruited for assay of 25(OH)D(3) level. Disease activity was assessed by the SLEDAI and physicians' global assessment (PGA). Patients with vascular risk factors were screened for atherosclerosis at the coronary or carotid arteries. Correlation between 25(OH)D(3) levels and SLEDAI scores was studied by linear regression. The link between vascular risk factors, atherosclerosis and vitamin D deficiency was also examined.. A total of 290 SLE patients were studied [94% women; mean (s.d.) age 38.9 (13.1) years; disease duration 7.7 (6.7) years; 78% patients had clinical or serological lupus activity]. Two hundred and seventy-seven (96%) patients had vitamin D insufficiency [25(OH)D(3) < 30 ng/ml] and 77 (27%) patients had vitamin D deficiency (<15 ng/ml). Levels of 25(OH)D(3) correlated inversely with PGA (β -0.20; P = 0.003), total SLEDAI scores (β -0.19; P = 0.003) and subscores due to active renal, musculoskeletal and haematological disease. Subjects with vitamin D deficiency had significantly higher total/high-density lipoprotein (HDL) cholesterol ratio [3.96 (2.94) vs 3.07 (0.80); P = 0.02] and prevalence of aPLs (57 vs 39%; P = 0.007). Of 132 patients, 58 (44%) with vascular risk factors screened were positive for subclinical atherosclerosis. No association could be demonstrated between 25(OH)D(3) level and atherosclerosis, which was mainly associated with increasing age, menopause, obesity and hyper-triglyceridaemia.. In this large cross-sectional study of SLE patients, 25(OH)D(3) level correlates inversely with disease activity. Vitamin D deficiency is associated with dyslipidaemia. In patients with vascular risk factors, subclinical atherosclerosis is not associated with hypovitaminosis D.

Topics: Adult; Atherosclerosis; Cholecalciferol; Cross-Sectional Studies; Female; Humans; Lipids; Lupus Erythematosus, Systemic; Male; Middle Aged; Risk Factors; Severity of Illness Index; Vitamin D Deficiency

To summarize recommendations from the 2011 US Institute of Medicine report (on vitamin D) and the new guideline from the US Endocrine Society with emphasis on treating and preventing vitamin D deficiency, including patients with inflammatory bowel disease and prior gastric bypass.. The US Institute of Medicine Recommended Dietary Allowance of vitamin D is 400 IU per day for children younger than 1 year of age, 600 IU per day for children at least 1 year of age and adults up to 70 years, and 800 IU per day for older adults. The US Institute of Medicine concluded that serum 25-hydroxyvitamin D [25(OH)D] of 20 ng/ml or more will cover the requirements of 97.5% of the population. The US Endocrine Society's Clinical Practice Guideline suggested that 400-1000 IU per day may be needed for children aged less than 1 year, 600-1000 IU per day for children aged 1 year or more, and 1500-2000 IU per day for adults aged 19 years or more to maintain 25(OH)D above the optimal level of 30 ng/ml. Patients with inflammatory bowel disease even in a quiescent state and those with gastric bypass malabsorb vitamin D and need more vitamin D to sustain their vitamin D status.. Difference in the recommendations from the US Institute of Medicine and the US Endocrine Society's Practice Guideline reflects different goals and views on current evidence. Significant gaps remain in the literature, and studies of vitamin D treatment assessing changes in outcomes at different 25(OH)D levels are needed.

Topics: Asymptomatic Diseases; Bone Diseases; Cholecalciferol; Dietary Supplements; Ergocalciferols; Humans; Nutrition Policy; Practice Guidelines as Topic; Vitamin D; Vitamin D Deficiency; Vitamins

Frailty is an extremely common and serious health problem in the elderly. Frailty has been described as "a biologic syndrome of decreased reserve and resistance to stressors, resulting from cumulative declines across multiple physiologic systems and causing vulnerability to adverse health outcomes" by Fried and colleagues. Frailty is associated with incident falls, functional limitation, disability, and mortality. There are many reports that vitamin D deficiency may play roles in diabetes mellitus, cancers, multiple sclerosis, and other autoimmune diseases, and was associated with poorer physical performance, falls and fractures, and a greater risk of nursing home admission. Recently, researches suggest that vitamin D may provide treatment and prevention from these diseases lead to frailty. Vitamin D is expected to be a treatment for frailty in an aging society.

Topics: Accidental Falls; Aged; Aged, 80 and over; Cholecalciferol; Frail Elderly; Humans; Osteoporosis; Osteoporotic Fractures; Vitamin D Deficiency

Vitamin D3 shows a multitude of possible preventive effects in various diseases. Calcitriol, the biologically active form of vitamin D3, affects not only bone metabolism but also acts on the renal renin secretion, the pancreatic insulin production in the beta cells, growth and proliferation of smooth and cardiac muscle cells and the function of lymphocytes and macrophages. Although the human body can synthesise vitamin D3 itself, vitamin D deficiency is common in the German population. Numerous trials studied the association between vitamin D deficiency and different diseases. It is known that even mild forms of vitamin D deficiency increase the risk for cardiovascular diseases or diabetes mellitus. Furthermore, an association with cancer such as pancreatic or colorectal cancer was observed. This is attributed to the influence of vitamin D on cell differentiation, angiogenesis, DNA repair mechanisms and the transcription of numerous genes. In addition, effects of vitamin D deficiency in diseases such as Parkinson's disease, multiple sclerosis and autoimmune diseases are discussed. However, up to now the level of evidence of all these observations is low. There are missing confirmatory randomized controlled trials. Noting the possible preventive effects of vitamin D, a moderate exposure to sunlight to increase vitamin D synthesis can be recommended. Even a controlled supplementation of vitamin D in patients with vitamin D deficiency is considered as reasonable. However, an uncritical substitution of high-dose vitamin D should be avoided because of the risk of hypercalcaemia.

Topics: Calcitriol; Cholecalciferol; Dose-Response Relationship, Drug; Health Promotion; Hypercalcemia; Primary Prevention; Sunlight; Vitamin D; Vitamin D Deficiency

Vitamin D deficiency is widespread in both the pediatric and adult chronic kidney disease (CKD) population. CKD is characterized by dysregulation of vitamin D and mineral metabolism. Secondary hyperparathyroidism and its management puts patients with CKD at increased cardiovascular risk. Emergence of experimental and some clinical data suggesting beneficial effects of vitamin D on proteinuria, blood pressure, inflammation and cardiovascular outcomes has pushed it to the center stage of CKD research. Pediatric data on vitamin D dysregulation and its consequences are still in its infancy. Ongoing prospective studies such as Chronic Kidney disease in Children (CKiD) and the Cardiovascular Comorbidity in Children with CKD (4 C) should help to delineate the evolution of disturbances in mineral metabolism and its adverse effects on growth, CKD progression and cardiovascular outcomes.

Topics: Child; Cholecalciferol; Dietary Supplements; Ergocalciferols; Growth Disorders; Humans; Hyperparathyroidism, Secondary; Kidney; Renal Insufficiency, Chronic; Vitamin D; Vitamin D Deficiency; Vitamins

Currently, there is a lack of clarity in the literature as to whether there is a definitive difference between the effects of vitamins D2 and D3 in the raising of serum 25-hydroxyvitamin D [25(OH)D].. The objective of this article was to report a systematic review and meta-analysis of randomized controlled trials (RCTs) that have directly compared the effects of vitamin D2 and vitamin D3 on serum 25(OH)D concentrations in humans.. The ISI Web of Knowledge (January 1966 to July 2011) database was searched electronically for all relevant studies in adults that directly compared vitamin D3 with vitamin D2. The Cochrane Clinical Trials Registry, International Standard Randomized Controlled Trials Number register, and clinicaltrials.gov were also searched for any unpublished trials.. A meta-analysis of RCTs indicated that supplementation with vitamin D3 had a significant and positive effect in the raising of serum 25(OH)D concentrations compared with the effect of vitamin D2 (P = 0.001). When the frequency of dosage administration was compared, there was a significant response for vitamin D3 when given as a bolus dose (P = 0.0002) compared with administration of vitamin D2, but the effect was lost with daily supplementation.. This meta-analysis indicates that vitamin D3 is more efficacious at raising serum 25(OH)D concentrations than is vitamin D2, and thus vitamin D3) could potentially become the preferred choice for supplementation. However, additional research is required to examine the metabolic pathways involved in oral and intramuscular administration of vitamin D and the effects across age, sex, and ethnicity, which this review was unable to verify.

Topics: Cholecalciferol; Dietary Supplements; Drug Administration Schedule; Ergocalciferols; Humans; Vitamin D; Vitamin D Deficiency; Vitamins

The development of chronic kidney disease (CKD) is accompanied by a progressive decrease in the ability to produce 1,25-dihydroxyvitamin D. Pharmacological replacement with active vitamin D therefore has been a cornerstone of secondary hyperparathyroidism therapy in the end-stage renal disease population treated by long-term dialysis. Recent evidence suggests that extrarenal conversion of 25-hydroxyvitamin D to 1,25-dihydroxyvitamin D may have significant biological roles beyond those traditionally ascribed to vitamin D. Furthermore, low 25-hydroxyvitamin D levels are common in patients with all stages of CKD. This article focuses on the role of nutritional vitamin D replacement in CKD and aims to review vitamin D biology and summarize the existing literature regarding nutritional vitamin D replacement in these populations. Based on the current state of the evidence, we provide suggestions for clinical practice and address areas of uncertainty that need further research.

Topics: Aged; Calcifediol; Cholecalciferol; Ergocalciferols; Female; Humans; Male; Middle Aged; Renal Dialysis; Renal Insufficiency, Chronic; Vitamin D; Vitamin D Deficiency

Vitamin D deficiency is prevalent among patients with end-stage organ failure awaiting transplant. Low serum 25-hydroxyvitamin D (25-OHD) levels in these patients may be related to many disease-specific factors, as well as decreased sunlight exposure and limited intake of foods containing vitamin D. Low serum 25-OHD levels are also extremely common following solid organ transplantation, both during the immediate postoperative period and in long-term graft recipients. Demographic and lifestyle factors are important in determining D status in transplant recipients. Worse vitamin D status is associated with poorer general health, lower albumin, and even decreased survival among these patients. Although several studies have demonstrated that active forms of vitamin D and its analogues prevent bone loss following transplantation, the data do not show consistent benefit. These therapies may have particular utility after renal transplantation. However, given the narrow therapeutic window with respect to hypercalcemia and hypercalciuria, and the demonstrated efficacy of bisphosphonates to prevent post-transplantation bone loss, we regard these agents as adjunctive rather than primary therapy for transplantation osteoporosis. The effects of 1,25(OH)(2)D on the immune system, which are still being elucidated, may have potential for reducing infections and preventing allograft rejection after transplantation.

Topics: Bone Density Conservation Agents; Bone Resorption; Cholecalciferol; Clinical Trials as Topic; Ergocalciferols; Heart Transplantation; Humans; Kidney Transplantation; Liver Transplantation; Lung Transplantation; Organ Transplantation; Vitamin D; Vitamin D Deficiency

Prostate cancer (PCa) is the second most common cancer in men worldwide. Epidemiological, molecular, and cellular studies have implicated vitamin D deficiency as a risk factor for the development and/or progression of PCa. Studies using cell culture systems and animal models suggest that vitamin D acts to reduce the growth of PCa through regulation of cellular proliferation and differentiation. However, although preclinical studies provide a strong indication for anti-cancer activity, proof of therapeutic benefits in men is still lacking. The anti-proliferative and pro-differentiating properties of vitamin D have been attributed to calcitriol [1,25(OH)(2)D(3)], the hormonally active form of vitamin D, acting through the vitamin D receptor (VDR). Metabolism of vitamin D in target tissues is mediated by two key enzymes: 1α-hydroxylase (CYP27B1), which catalyzes the synthesis of calcitriol from 25(OH)D and 24-hydroxylase (CYP24), which catalyzes the initial step in the conversion of calcitriol to less active metabolites. Many factors affect the balance of calcitriol synthesis and catabolism and several maneuvers, like combination therapy of calcitriol with other drugs, have been explored to treat PCa and reduce its risk. The current paper is an overview addressing some of the key factors that influence the biological actions of vitamin D and its metabolites in the treatment and/or prevention of PCa.

Topics: 25-Hydroxyvitamin D3 1-alpha-Hydroxylase; Animals; Anti-Inflammatory Agents, Non-Steroidal; Calcitriol; Cholecalciferol; Clinical Trials as Topic; Drug Therapy, Combination; Humans; Isoflavones; Male; Mice; Prostatic Neoplasms; Receptors, Calcitriol; Risk Factors; Steroid Hydroxylases; Vitamin D; Vitamin D Deficiency; Vitamin D3 24-Hydroxylase

A nationwide 'vitamin D prophylaxis augmentation programme' initiated in 2005 in Turkey reduced the prevalence of rickets from 6% in 1998 to 0.1% in 2008 in children under 3 years of age. The programme included free distribution of vitamin D drops to all newborns and infants (0-12 months) visiting primary health stations throughout the country. Free disposal of vitamin D to infants is an effective strategy for preventing vitamin D-deficient rickets.

Topics: Cholecalciferol; Humans; Prevalence; Rickets; Turkey; Vitamin D Deficiency

Vitamin D is obtained from cutaneous production when 7-dehydrocholesterol is converted to vitamin D(3) (cholecalciferol) by ultraviolet B radiation or by oral intake of vitamin D. Rickets appeared to have been conquered with vitamin D intake, and many health care professionals thought the major health problems resulting from vitamin D deficiency had been resolved. However, rickets can be considered the tip of the vitamin D deficiency iceberg. In fact, vitamin D deficiency remains common in children and adults. An individual's vitamin D status is best evaluated by measuring the circulating 25-hydroxyvitamin D (25(OH)D3) concentration. There is increasing agreement that the optimal circulating 25(OH)D3 level should be approximately 30 ng/mL or above. Using this definition, it has been estimated that approximately three-quarters of all adults have low levels. In utero and during childhood, vitamin D deficiency can cause growth retardation and skeletal deformities and may increase the risk of hip fracture later in life. Vitamin D deficiency in adults can exacerbate osteopenia and osteoporosis, cause osteomalacia and muscle weakness, and increase the risk of fracture. More recently, associations between low vitamin D status and increased risk for various non-skeletal morbidities have been recognized; whether all of these associations are causally related to low vitamin D status remains to be determined. The discovery that most tissues and cells in the body have vitamin D receptors and that several possess the enzymatic machinery to convert the 25-hydroxyvitamin D3, to the active form, 1,25-dihydroxyvitamin D3, has provided new insights into the function of this vitamin. Of great interest is its role in decreasing the risk of many chronic illnesses, including common cancers, autoimmune diseases, infectious diseases, and cardiovascular disease. In this review I consider the nature of vitamin D deficiency, discuss its role in skeletal and non-skeletal health, and suggest strategies for prevention and treatment.

Topics: Asthma; Biomarkers; Bone Density Conservation Agents; Bone Diseases, Metabolic; Cholecalciferol; Dietary Supplements; Ergocalciferols; Humans; Metabolic Syndrome; Nervous System Diseases; Parathyroid Hormone; Rickets; Risk Factors; Sunlight; Vitamin D; Vitamin D Deficiency

Interactions between drugs and vitamin D have received only little or no attention in the medical and pharmaceutical world in the past. Since more and more drugs are used for the treatment of patients, this topic is increasingly relevant. As such interactions impact the health of the patient and the action and side effects of the drug, physicians and pharmacists should pay more attention to such interactions in the future. A number of drugs can interfere with the vitamin D and bone metabolism. The drug-induced activation of the pregnane X receptor (PXR) is likely to enhance CYP24 expression and the catabolism of 25(OH)D, leading to vitamin D deficiency. PXR-ligands include a wide variety of pharmaceutical agents, such as antiepileptic drugs, taxol, rifampicin, and human immunodeficiency virus protease inhibitors such as ritonavir and saquinavir. Beside this, the medication oriented supplementation of vitamin D can also ameliorate the pharmacologic action of many drugs, such as bisphosphonates, statins and cytostatic drugs.

Topics: Bone and Bones; Cholecalciferol; Drug Interactions; Drug-Related Side Effects and Adverse Reactions; Humans; Pregnane X Receptor; Receptors, Steroid; Vitamin D Deficiency

Several vitamin D replacement regimens are effective. Cumulative dosing may be more important than frequency of dosing (strength of recommendation [SOR]: C, inconsistent results from randomized controlled trials [RCTs] of disease-oriented outcomes).Vitamin D3 (cholecalciferol) may increase serum 25-hydroxy vitamin D (25[OH]D) concentrations more effectively than vitamin D2 (ergocalciferol) (SOR: C, a single RCT of disease-oriented outcomes).

Topics: Cholecalciferol; Dose-Response Relationship, Drug; Drug Administration Schedule; Ergocalciferols; Humans; Vitamin D Deficiency; Vitamins

Topics: Accidental Falls; Aged; Cholecalciferol; Depressive Disorder; Dose-Response Relationship, Drug; Ergocalciferols; Humans; Neurodegenerative Diseases; Nutritional Requirements; Osteoporotic Fractures; Risk Factors; Vitamin D; Vitamin D Deficiency

Ischemic heart disease and cerebrovascular ischemia are leading causes of mortality in industrialized countries. The pathogenesis of these diseases involves the formation of atherosclerotic plaques with eventual rupture and superimposed thrombosis. This process is inhibited by high-density lipoprotein (HDL), the main protein component of which is apolipoprotein A-I (apo A-I). Vitamin D3 is a hormone produced by sun-exposed skin but is acquired also in the diet. The Framingham Offspring Study and the Third National Health and Nutritional Examination Survey showed a link between vitamin D3 intake and cardiovascular risk factors. The link between 25-hydroxyvitamin D3 and HDL cholesterol (HDLc) and apo A-I is not as clear. Studies in vitamin D receptor knockout mice demonstrated higher HDLc and hepatic apo A-I messenger RNA expression relative to wild type. Experiments in cultured hepatocytes supported these observations. Human studies evaluating the relationship between vitamin D3 and apo A-I and HDLc have yielded conflicting results, but most suggest a positive link between increasing vitamin D3 levels and plasma apo A-I and HDLc. The purpose of this review is to examine the evidence linking vitamin D status and cardiovascular disease, to determine if there is a relationship between vitamin D levels and development of an atherogenic lipid profile. Our objectives are to determine if plasma vitamin D levels correlate with plasma HDLc and apo A-I and, if so, offer speculation as to how apo A-I in the context of high vitamin D levels provides enhanced atheroprotection.

Topics: Adolescent; Adult; Aged; Animals; Apolipoprotein A-I; Atherosclerosis; Calcifediol; Cardiovascular Diseases; Child; Child, Preschool; Cholecalciferol; Cholesterol, HDL; Diet; Female; Humans; Male; Mice; Mice, Knockout; Middle Aged; Randomized Controlled Trials as Topic; Receptors, Calcitriol; Risk Factors; Vitamin D; Vitamin D Deficiency

Vitamin D3 deficiency and insufficiency are common in women of child-bearing age. This may be cause for concern because vitamin D3 is a well known regulator of immune function and epidemiological evidence has suggested that immune disorders, including autoimmune diseases, could have developmental origins. However, it is not known whether a developmental deficiency in vitamin D3 could lead to persistent changes in the immune system in adult offspring. Given the prominence of receptors for vitamin D3 within immune cells we hypothesised that the developmental absence of vitamin D3 may alter thymic development and thus produce associated functional changes in T cells. We have developed a model of developmental vitamin D3 (DVD) deficiency in Sprague-Dawley rats, in which the vitamin D3 deficiency is transient and restricted to gestation. First we demonstrate that DVD deficiency induced an increase in central but not peripheral immune organ size. Second when stimulated, lymphocytes from DVD-deficient rats exhibit a pro-inflammatory phenotype. This is the first study to show that a transient vitamin D3 deficiency restricted to gestation can persistently alter aspects of immune phenotype and function in the adult offspring. Given an increased incidence of vitamin D3 deficiency in women of child-bearing age these findings may be highly relevant for autoimmune disorders with a developmental basis.

Topics: Animals; Autoimmune Diseases; Cholecalciferol; Cytokines; Disease Models, Animal; Female; Immune System; Immunophenotyping; Leukocytes, Mononuclear; Lymphocytes; Models, Biological; Organ Size; Rats; Rats, Sprague-Dawley; Th1 Cells; Vitamin D Deficiency

Calcitriol-mediated hypercalcemia resulting from elevated extrarenal 25-hydroxyvitamin D-1alpha-hydroxylase (1alpha-hydroxylase) activity has not previously been described in giant cell polymyositis.. We report an unusual case of hypercalcemia due to disseminated granulomatous disease in a 62-yr-old woman with profound proximal muscle weakness and weight loss. She was initially diagnosed with vitamin D deficiency myopathy with a low serum 25-hydroxyvitamin D; serum calcium at this time was low-normal. Vitamin D(3) 3000 IU daily was prescribed. One month later, blood work showed new hypercalcemia and hypercalciuria with normalized 25-hydroxyvitamin D. 1,25-dihydroxyvitamin D was high-normal, despite a suppressed PTH, undetectable PTHrP, and essentially normal renal function. Her hypercalcemia resolved, and her strength improved only after prednisone was added to bisphosphonate therapy. Two weeks later, she died from acute congestive heart failure.. Autopsy revealed a disseminated giant cell myositis affecting skeletal, cardiac, and gastrointestinal smooth muscle. Immunohistochemistry localized 1alpha-hydroxylase to the inflammatory infiltrates in skeletal and cardiac muscle.. A review of English publications in Medline and Embase, including a reference search of retrieved articles, revealed that calcitriol-mediated hypercalcemia has been described in over 30 conditions, most of which are granulomatous in nature, ranging from inflammatory conditions and foreign body exposures to infections and neoplasms.. Hypercalcemia resulting from autonomous 1alpha-hydroxylase activity may be unmasked by low-dose vitamin D supplementation and should not be excluded from the differential diagnosis of nonparathyroid causes if the serum calcitriol is inappropriately normal, rather than frankly elevated.

Topics: Calcitriol; Cholecalciferol; Fatal Outcome; Female; Heart Failure; Humans; Hypercalcemia; Middle Aged; Neurologic Examination; Polymyositis; Vitamin D Deficiency

We conducted an examination of recent studies to determine whether older adults (>or=65 years) need higher levels of supplementary vitamin D than young adults when attempting to replete vitamin D status in deficient subjects, i.e. those with levels of 25-hydroxyvitamin D less than 75 nmol/L. As data on repletion with vitamin D(2) have recently been published, we restricted our discussion to the use of vitamin D(3) from dietary supplements, prescriptions for large oral doses, and bolus dosing or injections. Most published dosing regimens failed to achieve 75 nmol/L in most all subjects, whether young adults (<65 years) or older adults (>or=65 years). Whether as daily or bolus oral supplementation, elderly subjects appeared to need more vitamin D3 compared with younger adults, however, baseline levels, endpoints, study duration, compliance, and other factors were different among studies. To ensure most subjects are replete in vitamin D, a daily dose of more than 50 microg (2000 IU) in younger and 125 microg (5000 IU) is required. Other strategies including bolus and loading doses are described. No study reported adverse effects of using oral intakes about the current upper level of 50 microg (2000 IU).

Topics: 25-Hydroxyvitamin D 2; Adult; Aged; Aged, 80 and over; Aging; Calcifediol; Cholecalciferol; Dietary Supplements; Humans; Middle Aged; Models, Biological; Nutritional Requirements; Nutritional Status; Vitamin D Deficiency; Young Adult

The biologically active metabolite of vitamin D, 1,25(OH)(2)D(3), affects mineral homeostasis and has numerous other diverse physiologic functions including effects on growth of cancer cells and protection against certain immune disorders. This article reviews the role of vitamin D hydroxylases in providing a tightly regulated supply of 1,25(OH)(2)D(3). The role of extrarenal 1alpha(OH)ase in placenta and macrophages is also discussed, as well as regulation of vitamin D hydroxylases in aging and chronic kidney disease. Understanding specific factors involved in regulating the hydroxylases may lead to the design of drugs that can selectively modulate the hydroxylases. The ability to alter levels of these enzymes would have therapeutic potential for the treatment of various diseases, including bone loss disorders and certain immune diseases.

Topics: Animals; Cholecalciferol; Cholestanetriol 26-Monooxygenase; Chronic Disease; Cytochrome P450 Family 2; Female; Humans; Kidney; Kidney Diseases; Liver; Macrophages; Mice; Placenta; Pregnancy; Steroid Hydroxylases; Vitamin D; Vitamin D Deficiency; Vitamin D-Binding Protein

The importance of vitamin D to normal physiologic function is well established. With deficiency becoming increasingly frequent, the potential for preventing and treating diseases through vitamin D supplementation is gaining in appreciation. Deficiency is particularly common in the geriatric population based on both behavioral and biologic factors, and has been associated with increased risk of musculoskeletal, neuropsychiatric, cardiovascular, endocrine and oncologic disease. Although some experts recommend empiric supplementation for all elderly persons, a strategy of routine screening and documented adequacy of replacement in deficient patients appears superior.

Topics: Adult; Age Factors; Aged; Cardiovascular Diseases; Cholecalciferol; Diabetes Mellitus, Type 2; Ergocalciferols; Female; Humans; Male; Mass Screening; Middle Aged; Prevalence; Risk Factors; Sex Factors; Vitamin D; Vitamin D Deficiency

Vitamin D has historically been considered to play a role solely in bone and calcium metabolism. Human disease associations and basic physiological studies suggest that vitamin D deficiency is plausibly implicated in adverse health outcomes including mortality, malignancy, cardiovascular disease, immune functioning and glucose metabolism. There is considerable evidence that low maternal levels of 25 hydroxyvitamin D are associated with adverse outcomes for both mother and fetus in pregnancy as well as the neonate and child. Vitamin D deficiency during pregnancy has been linked with a number of maternal problems including infertility, preeclampsia, gestational diabetes and an increased rate of caesarean section. Likewise, for the child, there is an association with small size, impaired growth and skeletal problems in infancy, neonatal hypocalcaemia and seizures, and an increased risk of HIV transmission. Other childhood disease associations include type 1 diabetes and effects on immune tolerance. The optimal concentration of 25 hydroxyvitamin D is unknown and compounded by difficulties in defining the normal range. Whilst there is suggestive physiological evidence to support a causal role for many of the associations, whether vitamin D deficiency is a marker of poor health or the underlying aetiological problem is unclear. Randomised controlled trials of vitamin D supplementation with an appropriate assessment of a variety of health outcomes are required.

Topics: Cholecalciferol; Diabetes Mellitus; Diabetes, Gestational; Female; Humans; Infant, Newborn; Infant, Newborn, Diseases; Lactation; Muscle, Skeletal; Parathyroid Hormone; Pre-Eclampsia; Pregnancy; Pregnancy Complications; Reference Values; Skin; Vitamin D Deficiency

There is a recent renewed interest in vitamin D metabolism and pathophysiology, due to its recent description as a hormone with a positive impact on global health rather than a strictly bone hormone: vitamin D could be a protective factor against infection, autoimmunity, cardiovascular morbidity, and cancer. By contrast, vitamin D deficiency appears to be increasingly frequent worldwide. We propose a review of these new aspects of vitamin D metabolism, with a focus on vitamin D status in a local pediatric cohort. There is an urgent need for revisiting current guidelines on vitamin D supplementation and for closely monitoring serum vitamin D in children with chronic diseases, i.e., at greater risk of cardiovascular impairment, bone morbidity, infectious disease, and acute inflammation.

Topics: Autoimmune Diseases; Bacterial Infections; Bone and Bones; Bone Density Conservation Agents; Bone Diseases; Cardiovascular Diseases; Child; Cholecalciferol; Evidence-Based Medicine; France; Global Health; Humans; Inflammation; Meta-Analysis as Topic; Neoplasms; Prevalence; Risk Factors; Virus Diseases; Vitamin D; Vitamin D Deficiency

Vitamin D, is a secosteroid which, in its active form 1,25-(OH)2-Vitamin D3, has hormone activities. Most cells and tissues in the human body have vitamin D receptors that stimulate the nuclear transcription of various genes to alter cellular function. Vitamin D, appears to have an effect on numerous disease states and disorders, including osteoporosis, chronic musculoskeletal pain, diabetes (types 1 and 2), multiple sclerosis, cardiovascular disease, and cancers of the breast, prostate, and colon. According to many researchers there is currently a worldwide vitamin D deficiency in various populations, including infants, pregnant and lactating women, and the elderly. The prevalence of vitamin D, insufficiency in the general German population is high. Vitamin D in the food supply is limited and most often inadequate to prevent deficiencies. Supplemental vitamin D is likely necessary to avoid deficiency, especially in winter months. The estimated cost saving effect of improving vitamin D status in Germany might be up to 37.5 billion euros annually.

Topics: Aged; Aging; Cholecalciferol; Diabetes Mellitus; Female; Germany; Humans; Infant; Male; Multiple Sclerosis; Neoplasms; Nutritional Status; Pregnancy; Receptors, Calcitriol; Vitamin D Deficiency; Vitamins

Vitamins D and K are lipid-phase nutrients that are pleiotropic - endowed with versatile homeostatic capacities at the organ, tissue, and cellular levels. Their metabolic and physiologic roles overlap considerably, as evidenced in the bone and cardiovascular systems. Vitamin D₃ (cholecalciferol, D₃) is the prehormone for the vitamin D endocrine system. Vitamin D₃ undergoes initial enzymatic conversion to 25-hydroxyvitamin D (25D, calcidiol), then to the seco-steroid hormone 1alpha, 25-dihydroxyvitamin D (1,25D, calcitriol). Beyond its endocrine roles in calcium homeostasis, 1,25D likely has autocrine, paracrine, and intracrine effects. At least 17 tissues likely synthesize 1,25D, and 35 carry the vitamin D receptor (VDR). Vitamin D functional deficiency is widespread in human populations. Vitamin K₁ (phylloquinone) is more abundant in foods but less bioactive than the vitamin K₂ menaquinones (especially MK-4, menatetrenone). Menadione (vitamin K₃) has minimal K activity. Vitamin K compounds undergo oxidation-reduction cycling within the endoplasmic reticulum membrane, donating electrons to activate specific proteins via enzymatic gamma-carboxylation of glutamate groups before being enzymatically re-reduced. Warfarin inhibits this vitamin K reduction, necessitating K supplementation during anticoagulation therapy. Along with coagulation factors (II, VII, IX, X, and prothrombin), protein C and protein S, osteocalcin (OC), matrix Gla protein (MGP), periostin, Gas6, and other vitamin K-dependent (VKD) proteins support calcium homeostasis, facilitate bone mineralization, inhibit vessel wall calcification, support endothelial integrity, are involved in cell growth control and tissue renewal, and have numerous other effects. This review updates vitamin D and K skeletal and cardiovascular benefits and evidence for their synergy of action.

Topics: Bone and Bones; Bone Density; Bone Diseases; Calcification, Physiologic; Cardiovascular Diseases; Cardiovascular System; Cholecalciferol; Fractures, Bone; Humans; Nutritional Physiological Phenomena; Osteoblasts; Osteocytes; Vitamin D Deficiency; Vitamin K; Vitamin K 1; Vitamin K 2; Vitamin K 3; Vitamin K Deficiency

This review mainly describes on childhood vitamin D deficiency and x-linked hypophosphatemic rickets. Though nutritional state has improved dramatically, 25 (OH) D level, which is a good indicator of vitamin D status, is marginal especially in winter, and vitamin D deficiency is not rare in Japan. The PTH/Vitamin D axis does not account for the entire picture of x-linked hypophosphatemic rickets, and a new bone (osteocyte) -renal metabolic milieu has emerged and loss of PHEX, mostly expressed in osteocytes, is proposed to result in inappropriate processing of MEPE and consequent reduction in bone mineralization and an increase in circulating FGF23 to give rise to phosphaturia and hypophosphatemia.

Topics: Animals; Calcitriol; Child; Cholecalciferol; Extracellular Matrix Proteins; Familial Hypophosphatemic Rickets; Fibroblast Growth Factor-23; Fibroblast Growth Factors; Genetic Diseases, X-Linked; Glycoproteins; Humans; Osteocytes; PHEX Phosphate Regulating Neutral Endopeptidase; Phosphoproteins; Phosphorus; Vitamin D Deficiency

This is a mini-review of vitamin D(3), its active metabolites and their functioning in the central nervous system (CNS), especially in relation to nervous system pathologies and aging. The vitamin D(3) endocrine system consists of 3 active calcipherol hormones: calcidiol (25OHD(3)), 1alpha-calcitriol (1alpha,25(OH)2D(3)) and 24-calcitriol (24,25(OH)2D(3)). The impact of the calcipherol hormone system on aging, health and disease is discussed. Low serum calcidiol concentrations are associated with an increased risk of several chronic diseases including osteoporosis, cancer, diabetes, autoimmune disorders, hypertension, atherosclerosis and muscle weakness all of which can be considered aging-related diseases. The relationship of many of these diseases and aging-related changes in physiology show a U-shaped response curve to serum calcidiol concentrations. Clinical data suggest that vitamin D(3) insufficiency is associated with an increased risk of several CNS diseases, including multiple sclerosis, Alzheimer's and Parkinson's disease, seasonal affective disorder and schizophrenia. In line with this, recent animal and human studies suggest that vitamin D insufficiency is associated with abnormal development and functioning of the CNS. Overall, imbalances in the calcipherol system appear to cause abnormal function, including premature aging, of the CNS.

Topics: Aging; Aging, Premature; Animals; Calcifediol; Central Nervous System; Cholecalciferol; Chronic Disease; Ergocalciferols; Humans; Risk Factors; Vitamin D; Vitamin D Deficiency

Cholecalciferol was qualified by FDA (Food and Drug Administration) into the A category if administered in recommended doses and to the D category if the doses exceed RDA (Recommended Dietary Allowance). There are very divergent opinions among researchers concerning the optimal daily dose of vitamin D-according to some of them, the optimal dose of vitamin D should exceed 400 Ul/24h. On the other hand, there is no data to estimate the optimal dose and to formulate recommendations. It is necessary to conduct research on animal models to fully comprehend the symptoms and syndromes caused by excess or deficiency of cholecalciferol. However, the conclusions of the research done on animals should not be over-generalized. Moreover, some data concerning the influence of vitamin D administered during the pregnancy on fetal development are often ambiguous. All these facts are the reason why recommendations of vitamin D supplementation in pregnancy still remain uncertain and need thorough investigation.

Topics: Animals; Cholecalciferol; Dietary Supplements; Dose-Response Relationship, Drug; Female; Fetal Development; Humans; Maternal Nutritional Physiological Phenomena; Pregnancy; Pregnancy Complications; Sunlight; Vitamin D Deficiency

New knowledge of the biological and clinical importance of the steroid hormone 1alpha,25-dihydroxyvitamin D(3) [1alpha,25(OH)(2)D(3)] and its receptor, the vitamin D receptor (VDR), has resulted in significant contributions to good bone health. However, worldwide reports have highlighted a variety of vitamin D insufficiency and deficiency diseases. Despite many publications and scientific meetings reporting advances in vitamin D science, a disturbing realization is growing that the newer scientific and clinical knowledge is not being translated into better human health. Over the past several decades, the biological sphere of influence of vitamin D(3), as defined by the tissue distribution of the VDR, has broadened at least 9-fold from the target organs required for calcium homeostasis (intestine, bone, kidney, and parathyroid). Now, research has shown that the pluripotent steroid hormone 1alpha,25(OH)(2)D(3) initiates the physiologic responses of >/=36 cell types that possess the VDR. In addition to the kidney's endocrine production of circulating 1alpha,25(OH)(2)D(3,) researchers have found a paracrine production of this steroid hormone in >/=10 extrarenal organs. This article identifies the fundamentals of the vitamin D endocrine system, including its potential for contributions to good health in 5 physiologic arenas in which investigators have clearly documented new biological actions of 1alpha,25(OH)(2)D(3) through the VDR. As a consequence, the nutritional guidelines for vitamin D(3) intake (defined by serum hydroxyvitamin D(3) concentrations) should be reevaluated, taking into account the contributions to good health that all 36 VDR target organs can provide.

Topics: 24,25-Dihydroxyvitamin D 3; Cholecalciferol; Humans; Nutrition Policy; Organ Specificity; Receptors, Calcitriol; Signal Transduction; Tissue Distribution; Vitamin D; Vitamin D Deficiency

The high prevalence of vitamin D deficiency and insufficiency in the human population results from its inadequate cutaneous production and low dietary intake. Vitamin D status in the organism is determined by circulating levels of 25-hydroxycholecalciferol [25(OH)D3]. 25(OH)D3 is metabolized by a renal 25-hydroxyvitamin D-1alpha-hydroxylase (CYP27B1) into the vitamin D hormone 1,25 dihydroxycholecalciferol (calcitriol), which generates a wide range of biological responses via both the regulation of gene transcription and nongenomic pathways. Most of the circulating metabolite originates from cholecalciferol, which is synthesized in the skin upon exposure to the UVB spectrum of sunlight. The dietary source of vitamin D is extraordinarily low (10%) compared with endogenous production (90%). Recent epidemiological data demonstrated a strong association between poor vitamin D status (i.e. serum 25(OH)D3 levels below 50 nmol/l) and increased risk for chronic illnesses of various etiology. It is now recognized that maintaining a serum 25(OH)D3 level of 80 nmol/l (32 ng/ml) or greater is beneficial in the prevention of osteoporosis, cardiovascular diseases, certain autoimmune diseases, and some forms of cancer. It seems that sensible sun exposure and the use of supplements are the most effective ways of preventing vitamin D deficiency. The aim of the present article is to review new developments related to vitamin D deficiency and insufficiency and their consequences.

Topics: Autoimmune Diseases; Calcium; Calcium, Dietary; Causality; Cholecalciferol; Comorbidity; Dietary Supplements; Humans; Kidney; Neoplasms; Osteoporosis; Sunlight; Vitamin D; Vitamin D Deficiency

Interest in all aspects of vitamin D seems to be surging due to perhaps the increased number of diverse positive studies suggesting it could prevent a variety of chronic diseases. However, before patients and health care professionals are educated on the preventive aspects of this vitamin that acts more like a hormone, a basic rapid review of vitamin D is needed. There are multiple reasons for the high rate of vitamin D deficiency around the world, including an aging population, obesity, protective skin care measures, skin pigmentation, increased awareness, more utilized diagnostic assays, and perhaps even the lack of natural and fortified food and beverage sources. Various benefits and limitations of vitamin D2 and vitamin D3 supplementation are discussed. The proper use of the vitamin D blood test, also known as "25-OH vitamin D," is important, and changing the normal range of this test may allow for a slightly higher cutoff value based on parathyroid hormone reductions and experience from clinical trials of osteoporosis prevention. The vitamin D doses needed to adequately increase blood levels are provided. Finally, increasing the recommended daily allowance of this vitamin to 800 to 1,000 IU per day may be beneficial for most age groups.

Topics: 25-Hydroxyvitamin D 2; Calcium; Cholecalciferol; Dietary Supplements; Energy Intake; Ergocalciferols; Global Health; Humans; Mass Screening; Nutrition Assessment; Nutrition Policy; Nutritive Value; Reference Values; Reproducibility of Results; Risk Factors; Vitamin D; Vitamin D Deficiency; Vitamins

The recent discovery--from a meta-analysis of 18 randomized controlled trials--that supplemental cholecalciferol (vitamin D) significantly reduces all-cause mortality emphasizes the medical, ethical, and legal implications of promptly diagnosing and adequately treating vitamin D deficiency. Not only are such deficiencies common, and probably the rule, vitamin D deficiency is implicated in most of the diseases of civilization. Vitamin D's final metabolic product is a potent, pleiotropic, repair and maintenance, seco-steroid hormone that targets more than 200 human genes in a wide variety of tissues, meaning it has as many mechanisms of action as genes it targets. One of the most important genes vitamin D up-regulates is for cathelicidin, a naturally occurring broad-spectrum antibiotic. Natural vitamin D levels, those found in humans living in a sun-rich environment, are between 40-70 ng per ml, levels obtained by few modern humans. Assessing serum 25-hydroxy-vitamin D (25(OH)D) is the only way to make the diagnosis and to assure treatment is adequate and safe. Three treatment modalities exist for vitamin D deficiency: sunlight, artificial ultraviolet B (UVB) radiation, and vitamin D3 supplementation. Treatment of vitamin D deficiency in otherwise healthy patients with 2,000-7,000 IU vitamin D per day should be sufficient to maintain year-round 25(OH)D levels between 40-70 ng per mL. In those with serious illnesses associated with vitamin D deficiency, such as cancer, heart disease, multiple sclerosis, diabetes, autism, and a host of other illnesses, doses should be sufficient to maintain year-round 25(OH)D levels between 55 -70 ng per mL. Vitamin D-deficient patients with serious illness should not only be supplemented more aggressively than the well, they should have more frequent monitoring of serum 25(OH)D and serum calcium. Vitamin D should always be adjuvant treatment in patients with serious illnesses and never replace standard treatment. Theoretically, pharmacological doses of vitamin D (2,000 IU per kg per day for three days) may produce enough of the naturally occurring antibiotic cathelicidin to cure common viral respiratory infections, such as influenza and the common cold, but such a theory awaits further science.

Topics: Calcifediol; Cholecalciferol; Humans; Mortality; Sunlight; Vitamin D; Vitamin D Deficiency; Vitamins

We evaluated the effect of supplementation with vitamin D(3) (excluding the potential effect of calcium supplementation) on the risk of fall and fracture, primarily in postmenopausal women, using a systematic literature review of MEDLINE, EMBASE, BIOSIS and the Cochrane Database of Systematic Reviews for the period January 1985 to June 2005. Studies examining the effect of vitamin D versus placebo on the risk of fall or fracture in postmenopausal females were of particular interest. Studies of vitamin D in combination with calcium were also included where the control group was treated with calcium alone. Studies of men and women where results for men and women were not presented separately were included. Nine studies met the inclusion criteria. Our primary meta-analyses examined the effect of vitamin D(3) on the risk of fall or fracture; additional analyses examined baseline and difference between baseline and final levels of several serum and urinary biochemical markers. The pooled relative risk (RR) for vitamin D(3) preventing falls was 0.88 (95%CI 0.78-1.00). For fractures, the pooled RR for vitamin D(3) preventing non-vertebral fractures was 0.96 (95%CI 0.84-1.09) and the pooled RR for vitamin D(3) preventing vertebral fractures was 1.22 (95%CI 0.64-2.31). In a subgroup analysis of post-menopausal women, the pooled RR for vitamin D(3) preventing falls was 0.92 (95%CI 0.75-1.12) and in preventing non-vertebral fractures the pooled RR was 0.81 (95%CI 0.48-1.34). There is a trend towards a reduction in the risk of fall among patients treated with vitamin D(3) alone compared with placebo, suggesting that vitamin D(3) should be an integral part of effective osteoporosis management.

Topics: Accidental Falls; Aged; Aged, 80 and over; Bone Density Conservation Agents; Cholecalciferol; Dietary Supplements; Female; Hip Fractures; Humans; Male; Middle Aged; Osteoporosis; Postmenopause; Risk Factors; Spinal Fractures; Treatment Outcome; Vitamin D Deficiency

Individuals are capable of producing vitamin D with proper exposure to sunlight. However, several factors can interfere with the effectiveness of this process. Most sunscreens filter out UVB light, thus inhibiting vitamin D production. Individuals with more darkly pigmented skin have greater difficulty producing vitamin D because melanin acts as an effective natural sunscreen, requiring longer sun exposure to produce an adequate daily allotment of vitamin D. Additionally, solely breastfed infants whose mothers suffered from vitamin D deficiency or insufficiency when pregnant have smaller reserves of the nutrient and are at greater risk of developing nutritional rickets. Vitamin D deficiency leads to rickets, osteomalacia, and osteoporosis. Long-term vitamin D insufficiency can lead to paracrine effects such as type 1 diabetes, cancer, and multiple sclerosis. This article reviews the current literature on vitamin D deficiency and insufficiency and their relation to different disease states. Potential areas for research are discussed.

Topics: Child, Preschool; Cholecalciferol; Endocrine System Diseases; Ergocalciferols; Female; Humans; Infant; Infant, Newborn; Nutritive Value; Paracrine Communication; Pregnancy; Vitamin D Deficiency

The sun is our most important source of vitamin D. Exposure to solaria, in sub-erythemogenic doses, also gives large amounts of this vitamin. The ultraviolet radiation in these sources converts 7-dihydrocholesterol to previtamin D3 in the skin. Furthermore, heat isomerization to vitamin D3 takes place, then transport to the liver and hydroxylation to calcidiol, which is transported to the kidneys and hydroxylated to the active hormone calcitriol. The vitamin D3 status of the body is supposed to be reliably imaged by calcidiol measurements. Calcidiol levels above 12.5 nmol/l prevent rickets and osteomalacia, but optimal levels are probably higher, in the range 100-250 nmol/l. A daily food intake of 100-200 microg vitamin D3 (50-100 g cod-liver oil), or a weekly exposure to two minimal erythemal doses of ultraviolet radiation (20 to 40 minutes whole body exposure to midday midsummer sun in Oslo, Norway), will give this level. An adequate supply of vitamin D3 seems to reduce the incidence rates or improve the prognosis of several cancer forms, including prostate, breast and colon cancer, as well as of lymphomas. Several other diseases are related to a low vitamin D3 status: heart diseases, multiple sclerosis, diabetes, and arthritis. The action mechanisms of vitamin D are thought to be mainly related to its known cell-differentiating and immuno-modulating effects. Even though most of the 250 annual death cases from skin cancer in Norway are caused by sun exposure, we should, in view of the health effects of ultraviolet radiation, consider modifying our restrictive attitude towards sun exposure and use of solaria.

Topics: Calcifediol; Cholecalciferol; Female; Humans; Liver; Male; Photosynthesis; Risk Factors; Skin; Sunlight; Ultraviolet Rays; Vitamin D; Vitamin D Deficiency

Topics: Cholecalciferol; Diagnosis, Differential; Humans; Hypophosphatemia; Orthopedic Procedures; Osteomalacia; Prognosis; Receptors, Calcitriol; Sunlight; Vitamin D Deficiency

Topics: Cholecalciferol; Diagnosis, Differential; Fractures, Spontaneous; Humans; Hypophosphatemia; Osteomalacia; Phosphates; Prognosis; Rickets; Syndrome; Vitamin D Deficiency

Vitamin D is well known as a hormone involved in mineral metabolism and bone growth. Conversion into the active metabolite 1,25-dihydroxyvitamin D3 (1,25(OH)2D3) from the precursor is effected by cytochrome P450 enzymes in the liver (CYP27A1 and CYP2R1) and the kidney (CYP27B1). CYP27A1 has been shown to be transcriptionally regulated by nuclear receptors (PPARalpha, gamma, HNF-4alpha and SHP) which are ligand-dependent transcription factors. CYP27B1 is tightly regulated by the plasma levels of calcium, phosphate, parathyroid hormone (PTH) and 1,25(OH)2D3 itself. In vitamin D target organs, inactivation of vitamin D is attributed to CYP24A1 which is transcriptionally induced by 1,25(OH)2D3 whose action is mediated by binding to its cognate nuclear receptor, the vitamin D receptor (VDR). Diseases associated to Vitamin D deficiency (rickets in children, and osteomalacia or osteoporosis in adults) and autosomal recessive forms of inherited rickets illustrate the key role of vitamin D in calcium homeostasis and bone metabolism. Recently, discovery of 1,25(OH)2D3 new biological actions that include antiproliferative, prodifferentiating effect on many cell types and immunoregulatory properties creates a growing interest for this vitamin. In this way, a best understanding of various actors implicated in vitamin D metabolism and its regulation is of a major importance to optimise the use of vitamin D in disease prevention.

Topics: Cholecalciferol; Homeostasis; Humans; Kidney; Liver; Models, Biological; Vitamin D; Vitamin D Deficiency

Topics: Adult; Age Factors; Bone Density Conservation Agents; Calcium; Cholecalciferol; Diagnosis, Differential; Female; Humans; Osteomalacia; Radiography; Sunlight; Vitamin D Deficiency

It has been shown that epidermal keratinocytes have the capacity for the UVB-induced photochemical conversion of 7-dehydrocholesterol to vitamin D3, and also for the enzymatically controlled hydroxylation of the photolysis product. This metabolic loop results in the formation of the biologically active final product 1alpha,25-dihydroxyvitamin D3 (1alpha,25(OH)2D3, calcitriol). The epidermal synthesis of calcitriol is of fundamental relevance because calcitriol regulates important cellular functions in keratinocytes and immunocompetent cells. Because of their anti-proliferative and prodifferentiating effects, calcitriol and other vitamin D analogs are highly efficient in the treatment of psoriasis vulgaris. In addition, the known therapeutic effect of UVB light therapy in the treatment of psoriasis may, at least in part, be mediated via UVB-induced synthesis of calcitriol. Increasing evidence now indicates that cutaneous vitamin D synthesis is of great importance for the prevention of a broad variety of diseases, including various malignancies. It has been postulated that cancer mortality could be reduced via careful UV exposure or, more safely, via oral substitution with vitamin D. These new findings must be taken into account when establishing new sun protection guidelines for the prevention of skin cancer. In addition, better understanding of the metabolism of vitamin D in the skin has opened up new perspectives for the therapeutic application of vitamin D analogs, e.g. in inflammatory skin diseases.

Topics: Calcitriol; Cholecalciferol; Humans; Skin; Sunlight; Vitamin D; Vitamin D Deficiency

Supplementation of vitamin D in food is available in Japan, therefore, vitamin D deficiency is not likely to occur in our country. But, in the case of nephrotic syndrome and strict dietary protein restriction, low serum 25(OH)D level might develop in chronic kidney disease (CKD)patients. Guideline issued by National Kidney Foundation as DOQI recommend the use of vitamin D2 (ergocalciferol) when serum 25(OH)D level in CKD patients become less than 30 ng/mL. In addition, for the CKD patients with stage 5, the use of active vitamin D3 is recommended because a conversion to 1,25(OH)2D3, which is the most potent vitamin D, might be impossible in these patients. However, vitamin D2 product as a supplementary medicine is not available in Japan unfortunately. In this context, I try to explain the background of the recommendation of vitamin D2 for CKD patients.

Topics: Biomarkers; Cholecalciferol; Diet, Protein-Restricted; Ergocalciferols; Humans; Kidney Failure, Chronic; Nephrotic Syndrome; Practice Guidelines as Topic; Vitamin D; Vitamin D Deficiency

Vitamin D3 is a prohormone produced in skin through ultraviolet irradiation of 7-dehydrocholesterol. It is biologically inert and must be metabolized to 25-hydroxyvitamin D3 in the liver and then to 1alpha,25-dihydroxyvitamin D3 in the kidney before function. The hormonal form of vitamin D3, ie, 1alpha,25-dihydroxyvitamin D3, acts through a nuclear receptor to carry out its many functions, including calcium absorption, phosphate absorption in the intestine, calcium mobilization in bone, and calcium reabsorption in the kidney. It also has several noncalcemic functions in the body. This overview provides a brief description of the physiologic, endocrinologic, and molecular biologic characteristics of vitamin D. It also provides information on new selective analogs of 1alpha,25-dihydroyvitamin D3 for therapy.

Topics: Bone and Bones; Calcitriol; Calcium; Cholecalciferol; Humans; Intestinal Absorption; Kidney; Phosphates; Vitamin D; Vitamin D Deficiency

Human prostate cells contain receptors for 1alpha,25-dihydroxyvitamin D, the active form of vitamin D. Prostate cancer cells respond to vitamin D(3) with increases in differentiation and apoptosis, and decreases in proliferation, invasiveness and metastasis. These findings strongly support the use of vitamin D-based therapies for prostate cancer and/or as a second-line therapy if androgen deprivation fails. The association between either decreased sun exposure or vitamin D deficiency and the increased risk of prostate cancer at an earlier age, and with a more aggressive progression, indicates that adequate vitamin D nutrition should be a priority for men of all ages. Here we summarize recent advances in epidemiological and biochemical studies of the endocrine and autocrine systems associated with vitamin D and their implications for prostate cancer and in the evaluation of vitamin D(3) and its analogs in preventing and/or treating prostate cancer.

Topics: Cholecalciferol; Comorbidity; Humans; Male; Prostatic Neoplasms; Receptors, Calcitriol; Steroid Hydroxylases; Ultraviolet Rays; United States; Vitamin D; Vitamin D Deficiency

Topics: Age Factors; Bone Density; Calcitriol; Calcium; Calcium Channel Blockers; Cholecalciferol; Dietary Supplements; Drug Therapy, Combination; Estrogen Replacement Therapy; Female; Fractures, Bone; Humans; Osteoporosis; Osteoporosis, Postmenopausal; Randomized Controlled Trials as Topic; Selective Estrogen Receptor Modulators; Vitamin D Deficiency

The Health Council of the Netherlands has issued a report on the recommended use of calcium, vitamin D and a number of other vitamins. The recommendations for calcium and vitamin D have been adjusted (upward) in view of recent evidence that these nutrients affect the occurrence of osteoporosis and bone fractures in all stages of life.

Topics: Adult; Age Factors; Aged; Calcifediol; Calcitriol; Calcium Channel Agonists; Calcium, Dietary; Child; Cholecalciferol; Dietary Supplements; Ergocalciferols; Fractures, Bone; Humans; Netherlands; Nutrition Policy; Osteoporosis; Vitamin D; Vitamin D Deficiency

Topics: Aged; Aged, 80 and over; Aging; Calcitriol; Cholecalciferol; Female; Humans; Hydroxycholecalciferols; Osteoporosis; Vitamin D; Vitamin D Deficiency

Topics: 24,25-Dihydroxyvitamin D 3; Animals; Bone Resorption; Calcifediol; Calcitriol; Cholecalciferol; Chronic Kidney Disease-Mineral and Bone Disorder; Dihydroxycholecalciferols; Humans; Intestinal Absorption; Rickets; Vitamin D; Vitamin D Deficiency

It is now accepted that vitamin D is an integral part of a complex endocrine system, one with far-reaching implications in mineral metabolism. Reviews of the sources, functions and metabolism of vitamin D, as currently understood, are presented as a prelude to discussions of the role of vitamin D in calcium and phosphorous homeostatis and possible specific roles for vitamin D in mineralized tissues. Data describing a possible regulatory function for vitamin D in bone and bone protein metabolism are presented. Some of the controversy which presently exists regarding the biochemical mechanism of the action of this vitamin is discussed. Finally, the possible relationship of vitamin D and disorders of skeletal tissues is described.

Topics: Animals; Bone and Bones; Bone Resorption; Calcium; Cell Nucleus; Chemical Phenomena; Chemistry; Cholecalciferol; Chronic Kidney Disease-Mineral and Bone Disorder; Glucocorticoids; Humans; Hydroxylation; Intestinal Mucosa; Kidney; Osteogenesis; Osteoporosis; Parathyroid Hormone; Proteins; Rats; Vitamin D; Vitamin D Deficiency; Vitamin D-Binding Protein

Vitamin D deficiency is common in the elderly, especially in patients with hip fracture. Elderly people infrequently stay outside in the sunshine, and nutrition is deficient in vitamin D. In addition, the hydroxylation of vitamin D into active metabolites decreases with age. Vitamin D deficiency ultimately leads to osteomalacia, but in an earlier stage it causes secondary hyperparathyroidism, which is accompanied by increased bone turnover and cortical bone loss. Along these pathways vitamin D deficiency may contribute to the pathogenesis of hip fractures. In a survey in Amsterdam vitamin D deficiency was observed in more than 60% of the patients with hip fracture. Transilial bone biopsy showed signs of high turnover and cortical bone loss in more than 20% of patients. The elderly which are institutionalized carry an increased risk. Prevention or vitamin D deficiency is possible by adequate exposure to ultraviolet light. Primarily, the elderly should be encouraged to go out into the sunshine regularly. Advice on nutrition may be given additionally. When sunshine exposure is negligible, as in many disabled and institutionalized elderly, a daily supplement of vitamin D3 400 IU should be given. Preventive measures have to be evaluated prospectively. Vitamin D deficiency is not the most important risk factors for hip fractures, but the easiest to correct.

Topics: Adult; Aged; Aging; Cholecalciferol; Hip Fractures; Humans; Hydroxylation; Hyperparathyroidism; Middle Aged; Nutritional Requirements; Osteomalacia; Sunlight; Vitamin D; Vitamin D Deficiency

Topics: Animals; Arsenic; Bone and Bones; Boron; Bromine; Cadmium; Cholecalciferol; Connective Tissue; Fertility; Fluorine; Growth; Hematopoiesis; Humans; Lead; Lithium; Metalloproteins; Nickel; Nutritional Requirements; Silicon; Sleep; Tin; Trace Elements; Vanadium; Vitamin D Deficiency

Synthesis of 1,25(OH)2D3 is controlled by numerous factors. The major ones, however, are the circulating amounts of parathyroid hormone (the secretion of which is stimulated by low serum calcium), serum or extracellular fluid phosphorus concentrations, circulating levels of 1,25(OH)2D3 itself, and perhaps serum calcium directly. Many of the other factors noted have effects in vitro only or effects that are observed inconsistently or in one species only. Thus, in low-calcium states, 1,25(OH)2D3 synthesis increases because of increased parathyroid hormone activity. Parathyroid hormone may stimulate 1,25(OH)2D3 synthesis directly or via alterations (a decrease) in serum phosphorus or both. Low serum phosphorus will stimulate 1,25(OH)2D3 synthesis independent of parathyroid hormone levels. Low serum calcium may directly stimulate 25(OH)D3 1 alpha-hydroxylase activity independently of parathyroid hormone. In general terms the vitamin D-endocrine system tends to correct abnormalities in calcium and phosphorus homeostasis. The further metabolism of 1,25(OH)2D3 to other metabolites appears to be mainly a degradative or excretory process. Currently there is no evidence that 1,25(OH)2D3 must itself be altered to other metabolites prior to inducing intestinal calcium transport or bone mobilization. The processes involved in the excretion of 1,25(OH)2D3, such as side-chain oxidation and biliary excretion, are not regulated by serum calcium, phosphorus, or 1,25(OH)2D3 levels. The biliary excretion pathway is also unsaturable over a very wide range and not regulated by calcium, phosphorus, or vitamin D3. Therefore these processes, which account for a large part of the metabolism of 1,25(OH)2D3, are largely unregulated by factors that control the synthesis of 1,25(OH)2D3 and regulate the formation of other calcium-controlling hormones. Other processes involved in the metabolism of 1,25(OH)2D3, such as 24-hydroxylation and 26-hydroxylation, occur in normocalcemic and normophosphatemic states. 24-Hydroxylation is also induced by 1,25(OH)2D3, which benefits the organism, because excessive 1,25(OH)2D3 in various tissues can be altered to a less active metabolite, 1,24,25(OH)3D3. Although there is still no evidence concerning the regulation of C-24 oxidation by dietary calcium and phosphorus levels, the fact that this process is induced by 1,25(OH)2D3 suggests that the metabolic pathway functions in much the same manner as the 24-hydroxylation pathway. The formation of 1,25(

Topics: Animals; Bile; Bone and Bones; Calcitriol; Chickens; Cholecalciferol; Half-Life; Humans; Hydroxylation; Intestinal Mucosa; Liver; Oxidation-Reduction; Rats; Vitamin D Deficiency

Our perception of vitamin D has evolved since the early part of this century. As an active, dihydroxylated metabolite vitamin D is acknowledged today not as an essential dietary factor but rather as a major calciotropic hormone. This paper summarizes current understanding of the formation and action of vitamin D in health and disease. The importance of laboratory assessment of serum vitamin D metabolites in the diagnosis and management of disorders of calcium and phosphorus metabolism is discussed.

Topics: Adult; Animals; Calcium; Chemical Phenomena; Chemistry; Child; Cholecalciferol; Dogs; Female; Humans; Infant; Infant, Newborn; Male; Middle Aged; Osteomalacia; Parathyroid Glands; Pregnancy; Rats; Receptors, Cell Surface; Rickets; S100 Calcium Binding Protein G; Vitamin D; Vitamin D Deficiency

Diagnostic and therapeutical uses of vitamin D3 and its metabolites are reviewed. Special emphasis is dedicated to the fetomaternal relationships of 1,25 (OH)2 D3 and 25-OH-D3 at term. The serum levels of 1,25 (OH)2 D3 have been found to be higher in the maternal serum then in the corresponding fetus (85.3 pg/ml and 50.9 pg/ml, respectively). The highest serum levels of 1,25 (OH)2 D3 were found in October and the lowest ones in January showing that there is a dependence on the ultraviolet light. It has been found that there is a correlation between the fetomaternal serum levels of 1,25 (OH)2 D3 and 25-OHD. However, there is no correlation between the serum levels of 1,25 (OH)2 D3 and 25-OHD3, neither in the fetus nor in the mother.

Topics: Adult; Calcifediol; Calcitriol; Child; Cholecalciferol; Female; Fetal Blood; Fetus; Humans; Hypophosphatemia, Familial; Infant; Infant, Newborn; Nutritional Requirements; Pregnancy; Rickets; Seasons; Ultraviolet Rays; Vitamin D Deficiency

Topics: Aged; Aging; Calcium; Cholecalciferol; Color; Humans; Hypocalcemia; Light; Lighting; Osteoporosis; Sunlight; Ultraviolet Rays; Vision, Ocular; Vitamin D; Vitamin D Deficiency

Topics: Adult; Aged; Animals; Calcifediol; Calcitriol; Child; Cholecalciferol; Dehydrocholesterols; Dihydroxycholecalciferols; Ergocalciferols; Female; Humans; Hydroxycholecalciferols; Infant, Newborn; Liver; Nutritional Requirements; Pregnancy; Skin; Species Specificity; Ultraviolet Rays; Vitamin D; Vitamin D Deficiency

Topics: Cholecalciferol; Endocrine System Diseases; Humans; Infant, Newborn; Kidney Diseases; Vitamin D; Vitamin D Deficiency

A rapidly growing understanding of the biochemical and physiological processes that underlie the metabolism of vitamin D has provided new insights into the pathogenesis of oestomalacia. Many of the vitamin D--resistant osteomalacia syndromes can now be explained on the basis of defects in the metabolic conversion of vitamin D to the biologically active dihydroxylated metabolite 1,25(OH)2D and perhaps, in some instances, to impairement of the actions of 1,25(OH)2D on target tissues. The availability of this new information has made possible the synthesis of 1-hydroxylated forms of the vitamin for therapeutic use in states of vitamin D resistance. Although many questions regarding the pathogenesis and most effective approaches in the management of osteomalacia remain unanswered, considerable progress has been made in this direction as a result of continued research on the subject.

Topics: Bone Neoplasms; Chemical Phenomena; Chemistry; Cholecalciferol; Dihydroxycholecalciferols; Ergocalciferols; Giant Cell Tumors; Humans; Hydroxycholecalciferols; Hypoparathyroidism; Hypophosphatemia, Familial; Kidney Failure, Chronic; Metabolism, Inborn Errors; Nephrectomy; Osteomalacia; Phosphates; Pseudohypoparathyroidism; Vitamin D; Vitamin D Deficiency

Topics: Animals; Calcium; Cholecalciferol; Humans; Intestinal Absorption; Kidney Failure, Chronic; Rats; Renal Dialysis; Vitamin D; Vitamin D Deficiency

Topics: 25-Hydroxyvitamin D3 1-alpha-Hydroxylase; Androgens; Animals; Bone and Bones; Calcium; Carrier Proteins; Cholecalciferol; Cytochrome P-450 Enzyme System; Ergocalciferols; Estrogens; Female; Ferredoxins; Humans; Hydroxycholecalciferols; Intestine, Small; Kidney; Male; Osteoporosis; Parathyroid Glands; Parathyroid Hormone; Phosphorus; Vitamin D; Vitamin D Deficiency

Topics: Adolescent; Adult; Animals; Binding, Competitive; Child; Child, Preschool; Cholecalciferol; Chromatography; Female; Humans; Infant; Infant, Newborn; Kidney Failure, Chronic; Maternal-Fetal Exchange; Methods; Middle Aged; Pregnancy; Protein Binding; Rats; Rickets; Vitamin D; Vitamin D Deficiency

Vitamin D3 gives rise to at least one hormone in which the kidney is utilized as an endocrine system. This hormone arises from 25-OH-D3 which in turn is synthesized in the liver from vitamin D3. The production of this calcium and phosphorus mobilizing hormone, namely 1,25-(OH)2D3, is strongly regulated by the need for calcium and phosphorus. The regulation of its production can occur only after initial 1,25-(OH)2D3 is made and brings about the appearance of 25-OH-D3-24hydroxylase. The need for calcium brings about a stimulation of parathyroid hormone secretion. The parathyroid hormone suppresses the 24-hydroxylase and stimulates the 1-hydroxylase. Alternatively, the need for phosphorus directly stimulates the 1-hydroxylase and suppresses the 24-hydroxylase. The 24-hydroxylation appears to be the initial reaction leading to the inactivation and excretion of vitamin D whereas the 1-hydroxylation is the reaction bringing about the activation of the molecule to 1,25-(OH)2D3. The 1,25-(OH)2D3, the 25-OH-D3 and an analog of 1,25-(OH)2D3, namely 1alpha-OH-D3, are potentially extremely useful in the treatment of metabolic bone diseases such as renal osteodystrophy, hepatically related disorders of calcium and bone metabolism, hypoparathyroidism, and vitamin D dependency disease. The 1alpha-OH-D3 is effective by virtue of its conversion to 1,25-(OH)2D3. The 25-hydroxylation of both 1alpha-OH-D3 and vitamin D3 itself occurs predominantly in the liver. Finally, it is not entirely settled whether 1,25-(OH)2D3 is active directly in all of the functions of viramin D or whether it must be further converted metabolically. A new metabolic pathway for vitamin D has been discovered in which 1,25-(OH)2D3 loses its 26 and 27 carbons to carbon dioxide, producing an unknown metabolite. It is not certain whether this pathway represents degradation of the 1,25-(OH)2D3 or its further activation.

Topics: 25-Hydroxyvitamin D3 1-alpha-Hydroxylase; Animals; Bone Development; Calcium; Cholecalciferol; Chronic Kidney Disease-Mineral and Bone Disorder; Dihydroxycholecalciferols; Humans; Hydroxycholecalciferols; Intestinal Mucosa; Kidney; Liver; Muscles; Parathyroid Glands; Phosphorus; Steroid Hydroxylases; Structure-Activity Relationship; Vitamin D; Vitamin D Deficiency

Topics: Cholecalciferol; Drug Resistance; Humans; Infant; Renal Aminoacidurias; Rickets; Vitamin D; Vitamin D Deficiency

Topics: Adolescent; Adult; Aged; Alkaline Phosphatase; Anticonvulsants; Bone Diseases; Child; Child, Preschool; Cholecalciferol; Diagnosis, Differential; Epilepsy; Female; Humans; Hypocalcemia; Infant; Male; Middle Aged; Osteomalacia; Phosphates; Rickets; Time Factors; Vitamin D; Vitamin D Deficiency

Topics: Adolescent; Adult; Aged; Calcium; Child; Cholecalciferol; Diet; Diet Therapy; Female; Humans; Hydroxycholecalciferols; Liver; Male; Phosphorus; Phytic Acid; Rickets; Seasons; Skin; Ultraviolet Therapy; Vitamin D; Vitamin D Deficiency

Topics: Alpha-Globulins; Animals; Biological Assay; Chickens; Cholecalciferol; Humans; Hydroxycholecalciferols; In Vitro Techniques; Kidney; Kidney Failure, Chronic; Liver; Mucous Membrane; Osteomalacia; Osteopathic Medicine; Protein Binding; Rats; Tritium; Vitamin D Deficiency

Topics: Adrenal Cortex Hormones; Animals; Anticonvulsants; Bone and Bones; Calcium; Carrier Proteins; Cholecalciferol; Dihydroxycholecalciferols; Humans; Hydroxycholecalciferols; Hypocalcemia; Hypoparathyroidism; Hypophosphatemia, Familial; Intestinal Absorption; Kidney; Kidney Failure, Chronic; Kidney Tubules; Liver; Mixed Function Oxygenases; Parathyroid Hormone; Phosphorus; Vitamin D; Vitamin D Deficiency

Topics: Bone and Bones; Calcification, Physiologic; Calcitonin; Calcium; Calcium Carbonate; Cholecalciferol; Cyclic AMP; Dihydroxycholecalciferols; Feedback; Homeostasis; Humans; Hydroxycholecalciferols; Hyperparathyroidism; Osteoclasts; Osteocytes; Parathyroid Hormone; Vitamin D; Vitamin D Deficiency

Topics: Bone Diseases; Calcium; Carcinoma; Cholecalciferol; Chromatin; Dihydroxycholecalciferols; Ergocalciferols; Homeostasis; Humans; Hydroxycholecalciferols; Intestinal Diseases; Intestinal Mucosa; Kidney; Kidney Diseases; Liver; Liver Diseases; Parathyroid Diseases; Receptors, Drug; Skin Diseases; Thyroid Neoplasms; Vitamin D Deficiency

Topics: Animals; Biological Transport; Calcium; Cholecalciferol; Dactinomycin; Dihydroxycholecalciferols; Ethane; Homeostasis; Hydroxycholecalciferols; Hydroxylation; Hypercalcemia; Hypocalcemia; Intestinal Mucosa; Kidney; Mitochondria; Mitochondrial Swelling; Mixed Function Oxygenases; Organophosphonates; Parathyroid Hormone; Phosphorus; Vitamin D; Vitamin D Deficiency

Extensive experimental evidence has established a significant role of calciferol in the maintenance of normal calcium homeostasis. Present knowledge indicates that vitamin D(3) must first be converted to 25-OH-D(3) and then to 1,25(OH)(2)D(3), the most active known form of the steroid. Many of the factors regulating the rate of production of this last steroid from its precurser have been evaluated, and the concept that vitamin D functions as a steroid hormone seems to be well established. Deranged action of calciferol, caused by impaired metabolism of the steroid or through altered sensitivity of target tissues, may be involved in the pathophysiology of several disease states with abnormal calcium metabolism. It is noted that liver disease, osteomalacia due to anticonvulsant therapy, chronic renal failure, hypophosphatemic rickets, hypoparathyroidism, hyperparathyroidism, sarcoidosis and idiopathic hypercalciuria have possible relation to alterations in metabolism or action of vitamin D. The future clinical availability of 1,25(OH)(2)D(3) and other analogs of this steroid may offer potential therapeutic benefit in the treatment of certain of the disease entities discussed.

Topics: Animals; Biological Transport, Active; Bone Resorption; Calcium; Calcium Metabolism Disorders; Cholecalciferol; Collagen; Homeostasis; Humans; Hydroxycholecalciferols; Hyperparathyroidism; Hypoparathyroidism; Hypophosphatemia, Familial; Intestinal Absorption; Kidney; Kidney Diseases; Liver; Liver Diseases; Sarcoidosis; Skin; Ultraviolet Rays; Vitamin D; Vitamin D Deficiency

Topics: Animals; Cholecalciferol; Chronic Kidney Disease-Mineral and Bone Disorder; Dihydrotachysterol; Dihydroxycholecalciferols; Humans; Hydroxycholecalciferols; Hypophosphatemia, Familial; Rats; Rickets; Vitamin D; Vitamin D Deficiency

Topics: Animal Feed; Animal Nutritional Physiological Phenomena; Animals; Biological Transport; Bone and Bones; Calcium; Calcium Radioisotopes; Cattle; Chemical Phenomena; Chemistry; Cholecalciferol; Female; Intestinal Absorption; Lactation; Nutritional Requirements; Phosphorus; Pregnancy; Rats; Vitamin D; Vitamin D Deficiency

Topics: Biological Assay; Bone and Bones; Bone Diseases; Chemical Phenomena; Chemistry; Chemistry, Physical; Cholecalciferol; Chronic Disease; Humans; Kidney Diseases; Osteomalacia; Protein Binding; Radioimmunoassay; Research; Rickets; Vitamin D; Vitamin D Deficiency

Topics: Aortic Valve Stenosis; Calcium; Calcium Metabolism Disorders; Cholecalciferol; Ergocalciferols; Female; Humans; Hydroxycholecalciferols; Hypercalcemia; Hypophosphatemia, Familial; Infant; Kidney; Nutritional Requirements; Pregnancy; Skin; Vitamin D; Vitamin D Deficiency

Topics: Animals; Calcium; Chickens; Cholecalciferol; Dihydroxycholecalciferols; Humans; Hydroxycholecalciferols; Kidney; Liver; Mixed Function Oxygenases; Parathyroid Hormone; Vitamin D; Vitamin D Deficiency

Topics: Animals; Biological Transport; Calcium; Chickens; Cholecalciferol; Intestinal Absorption; Intestinal Mucosa; Intestine, Small; Phosphates; Phosphorus Radioisotopes; Protein Binding; Vitamin D Deficiency

Topics: Adolescent; Animals; Anticonvulsants; Biliary Tract; Bone Diseases; Calcium; Child; Cholecalciferol; Enzyme Induction; Epilepsy; Humans; Intestinal Absorption; Kidney; Liver; Metabolic Diseases; Phenobarbital; Phenytoin; Tritium; Vitamin D; Vitamin D Deficiency

Topics: Animals; Bone and Bones; Calcium; Cholecalciferol; Dactinomycin; Humans; Kidney; Liver; Nephrectomy; Osteomalacia; Rats; Rickets; Skin; Vitamin D; Vitamin D Deficiency

Topics: Animals; Biological Assay; Calcium; Calcium Isotopes; Chickens; Cholecalciferol; Chromatography; Dactinomycin; Intestinal Absorption; Isomerism; Kidney; Orotic Acid; Protein Biosynthesis; Rats; RNA; Tritium; Vitamin D; Vitamin D Deficiency

Topics: Animals; Biological Transport; Bone Development; Bone Diseases; Calcification, Physiologic; Calcium; Cholecalciferol; Fanconi Syndrome; Humans; Hypoparathyroidism; Intestinal Absorption; Kidney; Liver; Rats; Rickets; Uremia; Vitamin D; Vitamin D Deficiency

Topics: Animals; Calcium; Chickens; Cholecalciferol; Chromosomes; DNA; Intestinal Absorption; Protein Binding; Proteins; Rats; Rickets; RNA; Templates, Genetic; Vitamin D; Vitamin D Deficiency

Topics: Adenosine Triphosphate; Alkaline Phosphatase; Animals; Calcitonin; Calcium; Cholecalciferol; Citrates; Humans; Kidney; Osteomalacia; Parathyroid Hormone; Phosphates; Rats; Rickets; Vitamin D; Vitamin D Deficiency

Topics: Animals; Biological Transport; Bone and Bones; Calcification, Physiologic; Calcium; Calcium Isotopes; Chickens; Cholecalciferol; Ergocalciferols; Intestinal Absorption; Rats; Rickets; Vitamin D; Vitamin D Deficiency

Despite substantial evidence that vitamin D deficiency is highly prevalent among infants born extremely preterm (≤28 weeks' of gestation), several consensus statements do not recommend vitamin D doses >400 IU/day for these infants. Safety remains a concern.. The study aim was to determine safety and efficacy profiles of enteral vitamin D in Black and White infants randomized to three different vitamin D doses soon after birth.. Ancillary study of a masked randomized clinical trial.. Seventy-three infants born extremely preterm between 2012 and 2015 at a southern US academic neonatal unit (33' latitude) who had >90% compliance with the assigned intervention were included.. Infants were randomized to receive placebo (placebo group), 200 IU/day vitamin D (200 IU group), or 800 IU/day vitamin D (800 IU group) during the first 28 days after birth.. Safety outcomes included serum 25-hydroxy vitamin D (25[OH]D) and calcium concentrations. Efficacy outcomes included the predictive risk of bronchopulmonary dysplasia.. Per-protocol analysis using unadjusted, repeated-measures mixed models.. Mean birth weight was 815 ± 199 g. Half were male and 56% were Black. Of 58 infants with 25(OH)D measurements at birth, 40 (69%) had vitamin D deficiency (<20 ng/mL). The mean difference in 25(OH)D in nanograms per milliliter between Postnatal Day 28 and Postnatal Day 1 was +9 in the placebo group, +23 in the 200 IU group, and +62 in the 800 IU group (P < 0.0001). The increase observed in 25(OH)D was more significant among Black infants. The predictive risk of severe bronchopulmonary dysplasia in the 200 IU and 800 IU groups was lower, but this difference did not reach statistical significance. No vitamin D or calcium toxicity was observed.. A vitamin D dose of 800 IU/day safely corrected vitamin D deficiency by Postnatal Day 14.

Topics: Bronchopulmonary Dysplasia; Calcium; Cholecalciferol; Critical Illness; Dietary Supplements; Double-Blind Method; Female; Humans; Infant; Infant, Extremely Premature; Infant, Newborn; Male; Vitamin D Deficiency; Vitamins

Topics: Adult; Alkaline Phosphatase; Calcium; Cholecalciferol; Dietary Supplements; Humans; Parathyroid Hormone; Vitamin D; Vitamin D Deficiency

The aim of the study is to evaluate the effect of vitamin D supplementation alone on the adipokine profile of postmenopausal women.. In this randomized clinical trial, 160 women were randomized to 2 groups: oral supplementation with 1,000 IU cholecalciferol/d (vitamin D, n = 80) or placebo (PL, n = 80). Women with amenorrhea 12 months or more and aged 50 to 65 years were included. Women with established cardiovascular disease, insulin-dependent diabetes, renal failure, liver diseases, and previous use of menopausal hormone therapy and vitamin D were excluded. The intervention lasted 9 months and serum adiponectin, resistin, and adipsin levels were determined at the start and end of treatment. Intention to treat was adopted as the statistical method using a repeated measures design, followed by Wald's multiple comparison test adjusted for group × time interaction.. After 9 months, 25-hydroxyvitamin D concentrations increased from 15.0 ± 7.5 to 27.5 ± 10.4 ng/mL (+45.4%) in the vitamin D group and decreased from 16.9 ± 6. to 13.8 ± 6.0 ng/mL (-18.5%) in the PL group ( P < 0.001). In the vitamin D group, there was an increase in adiponectin (+18.6%) and a decrease in resistin (-32.4%, P < 0.05). At the end point, a difference was observed between the PL and vitamin D groups in mean adiponectin and resistin levels (11.5 ± 5.5 vs 18.5 ± 21.8 ng/mL, P = 0.047, and 16.5 ± 3.5 vs 11.7 ± 3.3 ng/mL, P = 0.027, respectively). There were no significant intervention effects on serum adipsin levels.. Daily supplementation with 1,000 IU of vitamin D alone was associated with an increase in adiponectin and a decrease in resistin, suggesting a beneficial effect on the adipokine profile of postmenopausal women with vitamin D deficiency.

Topics: Adipokines; Adiponectin; Cholecalciferol; Complement Factor D; Dietary Supplements; Double-Blind Method; Female; Humans; Postmenopause; Resistin; Vitamin D; Vitamin D Deficiency; Vitamins

The effect of different dosing regimens of cholecalciferol supplementation on bone biomarkers has not been studied in children with chronic kidney disease (CKD).. This is a post hoc analysis of a multi-center randomized controlled trial which included children with CKD stages 2-4 with vitamin D deficiency (25-hydroxy vitamin D (25OHD) < 30 ng/ml) randomized 1:1:1 to receive an equivalent dose of oral cholecalciferol as daily, weekly or monthly treatment. Markers of bone formation (bone alkaline phosphatase (BAP), procollagen I N terminal peptide (PINP)), bone resorption (tartarate-resistant acid phosphatase 5b (TRAP), C terminal telopeptide (CTX)), and osteocyte markers (intact fibroblast growth factor 23 (iFGF23), sclerostin) and soluble klotho were measured at baseline and after 3 months of intensive replacement therapy. The change in biomarkers and ratio of markers of bone formation to resorption were compared between treatment arms. BAP and TRAP were expressed as age- and sex-specific z-scores.. 25OHD levels increased with cholecalciferol supplementation, with 85% achieving normal levels. There was a significant increase in the BAP/TRAP ratio (p = 0.04), iFGF23 (p = 0.004), and klotho (p = 0.002) with cholecalciferol therapy, but this was comparable across all three therapy arms. The BAPz was significantly higher in the weekly arm (p = 0.01). The change in 25OHD (Δ25OHD) inversely correlated with ΔPTH (r =  - 0.4, p < 0.001).. Although cholecalciferol supplementation was associated with a significant increase in bone formation, the three dosing regimens of cholecalciferol supplementation have a comparable effect on the bone biomarker profile, suggesting that they can be used interchangeably to suit the patient's needs and optimize adherence to therapy. A higher resolution version of the Graphical abstract is available as Supplementary information.

Topics: Alkaline Phosphatase; Biomarkers; Child; Cholecalciferol; Dietary Supplements; Female; Humans; Male; Renal Insufficiency, Chronic; Vitamin D Deficiency

Vitamin D deficiency (defined as 25-hydroxyvitamin D [25(OH)D] <20 ng/mL) is prevalent among children living in temperate climates and has been reported to associate independently with stunting, obesity, and early activation of the hypothalamic-pituitary-gonadal axis. Phase 3 randomized clinical trials to investigate the influence of long-term vitamin D replacement on growth, body composition, and pubertal development of school-aged children with vitamin D deficiency are lacking.. To determine whether weekly oral vitamin D supplementation influences linear growth, body composition, or pubertal development in school-aged children living in a setting where vitamin D deficiency is highly prevalent.. This secondary analysis of a double-blind, placebo-controlled randomized clinical trial was conducted from June 2016 to June 2019 at 18 grade schools in Ulaanbaatar, Mongolia. School-aged children (6 to 13 years at baseline) attending participating schools were included. Exclusion criteria included a positive QuantiFERON-TB Gold in-tube assay result, conditions or medications associated with altered vitamin D metabolism, use of vitamin D supplements, signs of rickets, or intention to move from Ulaanbaatar within 4 years. Of 11 475 children invited to participate in the study, 9814 underwent QFT testing, and 8851 with negative results were included in the study. All but 1 participant in the placebo group completed follow-up and were included in the present analysis. Data were analyzed from November 2021 to February 2022.. Weekly oral doses of vitamin D3, 14 000 IU, (n = 4418), or placebo (n = 4433) for 3 years.. Mean z scores for height for age, body mass index for age, and waist-to-height ratio; mean percentage body fat, fat mass, and fat-free mass; and mean Tanner scores for pubertal development.. Of 8851 participants, 4366 (49.3%) were female, and 8165 (92.2%) were of Khalkh ethnicity; the mean (SD) age was 9.4 (1.6) years. A total of 8453 participants (95.5%) were vitamin D deficient at baseline, and mean end-of-study 25(OH)D concentrations among participants randomized to vitamin D vs placebo were 31.0 vs 10.7 ng/mL (mean difference, 20.3; 95% CI; 19.9-20.6). However, vitamin D supplementation did not influence mean height for age, body mass index for age, waist-to-height ratio, percentage body fat, fat mass, fat-free mass, or Tanner scores, either overall or within subgroups defined by baseline 25(OH)D concentration less than 10 ng/mL vs 10 ng/mL or greater, estimated calcium intake less than 500 mg/d vs 500 mg/d or greater, or male vs female sex.. In school-aged children in this study with low baseline vitamin D status, oral vitamin D3 supplementation at a dose of 14 000 IU per week for 3 years was effective in elevating 25(OH)D concentrations but did not influence growth, body composition, or pubertal development.. ClinicalTrials.gov Identifier: NCT02276755.

Topics: Body Composition; Child; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Male; Prevalence; Vitamin D; Vitamin D Deficiency; Vitamins

The present randomized clinical trial (RCT) was conducted on Jordanian participants with vitamin D deficiency (VDD) with no other medical conditions, to evaluate the combined effect of 1,25-dihydroxy vitamin D 3 (Vit.D 3 ) and omega-3 fatty acid (n-3FA) supplements (D+) on oxidized low-density lipoprotein (Ox-LDL) and non-high-density lipoprotein cholesterol (non-HDL-C) levels as common predictors of cardiovascular diseases (CVDs). Participants were randomized into 4 groups as follows: a control group (C) that received no supplementations, a Vit.D 3 group that received 50,000 IU of Vit.D 3 every week, an n-3FA group that received 300 mg of omega-3 fatty acid every day, and a D+ group that received a combination of both supplements, with the same dosage administered by the previous groups but with a 4-6-hour time interval between Vit.D 3 and n-3FA administration to avoid any possible interaction. All supplementations were administered orally for 8 weeks. Forty-seven participants were allocated to each group. Twenty-six in the control group, 37 participants in the Vit.D 3 group, 37 participants in the n-3FA group, and 46 participants in the D+ group completed the study to the end. The D+ supplementations significantly increased non-HDL-C (118.99 ± 60.98 to 155.26 ± 43.36 mg/dL, P << 0.05) but decreased Ox-LDL-C levels (69.29 ± 37.69 to 52.81 ± 17.30 pg/mL, P = 0.03). The stepwise regression showed that the serum LDL-C level was the main independent variable involved in the elevation of non-HDL levels (R 2 = 0.837) observed at the end of the trial in the D+ group. The groups that were supplemented with either Vit.D 3 alone or n-3FA alone had an insignificant decrease in the level of Ox-LDL-C. In conclusion, despite the observed hyperlipidemic effect, the combination treatment is recommended by the research team because the decrease in Ox-LDL may offset the hyperlipidemic effect.

Topics: Cholecalciferol; Cholesterol; Fatty Acids, Omega-3; Humans; Lipoproteins, LDL; Vitamin D Deficiency

High-dose vitamin D supplementation can increase total osteocalcin concentrations that may reduce insulin resistance in individuals at risk for prediabetes or diabetes mellitus. Magnesium is a cofactor in vitamin D metabolism and activation. The purpose of this study was to determine the combined effect of vitamin D and magnesium supplementation on total osteocalcin concentrations, glycemic indices, and other bone turnover markers after a 12-week intervention in individuals who were overweight and obese, but otherwise healthy. We hypothesized that combined supplementation would improve serum total osteocalcin concentrations and glycemic indices more than vitamin D supplementation alone or a placebo. A total of 78 women and men completed this intervention in 3 groups: a vitamin D and magnesium group (1000 IU vitamin D

Topics: Bone Remodeling; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Insulin Resistance; Magnesium; Male; Obesity; Osteocalcin; Overweight; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D plays a major role in bone health and probably also in multiple extraskeletal acute and chronic diseases. Although supplementation with calcifediol, a vitamin D metabolite, has demonstrated efficacy and safety in short-term clinical trials, its effects after long-term monthly administration have been studied less extensively. This report describes the results of a 1-year, phase III-IV, double-blind, randomized, controlled, parallel, multicenter superiority clinical trial to assess the efficacy and safety of monthly calcifediol 0.266 mg versus cholecalciferol 25,000 IU (0.625 mg) in postmenopausal women with vitamin D deficiency (25(OH)D < 20 ng/mL). A total of 303 women were randomized and 298 evaluated. Patients were randomized 1:1:1 to calcifediol 0.266 mg/month for 12 months (Group A1), calcifediol 0.266 mg/month for 4 months followed by placebo for 8 months (Group A2), and cholecalciferol 25,000 IU/month (0.625 mg/month) for 12 months (Group B). By month 4, stable 25(OH)D levels were documented with both calcifediol and cholecalciferol (intention-to-treat population): 26.8 ± 8.5 ng/mL (Group A1) and 23.1 ± 5.4 ng/mL (Group B). By month 12, 25(OH)D levels were 23.9 ± 8.0 ng/mL (Group A1) and 22.4 ± 5.5 ng/mL (Group B). When calcifediol treatment was withdrawn in Group A2, 25(OH)D levels decreased to baseline levels (28.5 ± 8.7 ng/mL at month 4 versus 14.4 ± 6.0 ng/mL at month 12). No relevant treatment-related safety issues were reported in any of the groups. The results confirm that long-term treatment with monthly calcifediol in vitamin D-deficient patients is effective and safe. The withdrawal of treatment leads to a pronounced decrease of 25(OH)D levels. Calcifediol presented a faster onset of action compared to monthly cholecalciferol. Long-term treatment produces stable and sustained 25(OH)D concentrations with no associated safety concerns. © 2023 Faes Farma SA. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).

Topics: Calcifediol; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Postmenopause; Vitamin D; Vitamin D Deficiency

Vitamin D sufficiency is associated with a reduced risk of fractures, diabetes mellitus, cardiovascular events, and cancers, which are frequent complications after renal transplantation. The VITALE (VITamin D supplementation in renAL transplant recipients) study is a multicenter double-blind randomized trial, including nondiabetic adult renal transplant recipients with serum 25-hydroxy vitamin D (25(OH) vitamin D) levels of <30 ng/mL, which is randomized 12 to 48 months after transplantation to receive high (100 000 IU) or low doses (12 000 IU) of cholecalciferol every 2 weeks for 2 months and then monthly for 22 months. The primary outcome was a composite endpoint, including diabetes mellitus, major cardiovascular events, cancer, and death. Of 536 inclusions (50.8 [13.7] years, 335 men), 269 and 267 inclusions were in the high-dose and low-dose groups, respectively. The serum 25(OH) vitamin D levels increased by 23 versus 6 ng/mL in the high-dose and low-dose groups, respectively (P < .0001). In the intent-to-treat analysis, 15% versus 16% of the patients in the high-dose and low-dose groups, respectively, experienced a first event of the composite endpoint (hazard ratio, 0.94 [0.60-1.48]; P = .78), whereas 1% and 4% of patients in the high-dose and low-dose groups, respectively, experienced an incident symptomatic fracture (odds ratio, 0.24 [0.07-0.86], P = .03). The incidence of adverse events was similar between the groups. After renal transplantation, high doses of cholecalciferol are safe but do not reduce extraskeletal complications (trial registration: ClinicalTrials.gov; identifier: NCT01431430).

Topics: Adult; Cardiovascular Diseases; Cholecalciferol; Dietary Supplements; Double-Blind Method; Humans; Kidney Transplantation; Male; Vitamin D; Vitamin D Deficiency; Vitamins

Hepcidin is considered to play a central role in the pathophysiology of renal anemia. Recent studies in healthy individuals have demonstrated a suppressive effect of vitamin D (VD) on the expression of hepcidin. In this post-hoc analysis based on a randomized controlled study, we evaluated the effect of supplementing chronic kidney disease (CKD) patients (stage G3-G4) with a high daily dose of native VD on serum levels of hepcidin-25, the hepcidin/ferritin ratio, as well as on markers of erythropoiesis.. Patients with CKD stage G3-G4 included in a double blind, randomized, placebo (PBO) controlled study with available hepcidin measurements were analyzed. Study subjects received either 8000 international units (IU) of cholecalciferol daily or PBO for 12 weeks. We evaluated the change in markers of hepcidin expression, erythropoiesis, and iron status from baseline to week 12 and compared the change between the groups.. Eighty five patients completed the study. Calcitriol, but not 25-hydroxyvitamin D (25(OH) D), was inversely correlated with serum levels of hepcidin-25 (rho = -0,38; p =  < 0, 01 and rho = -0,02; p = 0, 89, respectively) at baseline. Supplementation with VD significantly raised the serum concentration of serum 25(OH)D in the treatment group (from 54 (39-71) to 156 (120-190) nmol/L; p =  < 0, 01)) but had no effect on any of the markers of hepcidin, erythropoiesis, or iron status in the entire cohort. However, we did observe an increase in hemoglobin (HB) levels and transferrin saturation (TSAT) as compared to the PBO group in a subgroup of patients with low baseline 25(OH)D levels (< 56 nmol/L). In contrast, in patients with high baseline 25(OH)D values (≥ 56 nmol/L), VD supplementation associated with a decrease in HB levels and TSAT (p = 0,056) within the VD group in addition to a decrease in hepcidin levels as compared to the PBO group.. High-dose VD supplementation had no discernible effect on markers of hepcidin or erythropoiesis in the entire study cohort. However, in patients with low baseline 25(OH)D levels, high-dose VD supplementation associated with beneficial effects on erythropoiesis and iron availability. In contrast, in patients with elevated baseline 25(OH)D levels, high-dose VD supplementation resulted in a decrease in hepcidin levels, most likely due to a deterioration in iron status.

Topics: Cholecalciferol; Dietary Supplements; Erythropoiesis; Hepcidins; Humans; Iron; Renal Insufficiency, Chronic; Vitamin D; Vitamin D Deficiency; Vitamins

The dose of supplemental vitamin D needed in infants born with serum 25-hydroxyvitamin D (25[OH]D) concentrations less than 50 nmol/L (ie, 20 ng/mL) is unclear.. To determine whether a higher dose (1000 IU vs 400 IU per day) is required in infants born with 25(OH)D concentrations less than 50 nmol/L for bone mineral accretion across infancy.. In this prespecified secondary analysis of a double-blinded randomized clinical trial, conducted from March 2016 to March 2019 in a single center in Greater Montreal, Quebec, Canada, a consecutive sample of 139 healthy term singletons were recruited from 866 infants screened for vitamin D status at birth. Data were analyzed from June 2021 to November 2022.. Capillary blood was collected 24 to 36 hours after birth to measure serum total 25(OH)D concentrations. Infants with 25(OH)D concentrations less than 50 nmol/L were randomized to receive either 1000 IU or 400 IU per day of oral vitamin D3 supplementation from age 1 to 12 months. Infants with 25(OH)D concentrations of 50 nmol/L or greater formed a reference group.. Measures at age 1, 3, 6, and 12 months were preplanned and included whole-body bone mineral content, lumbar spine bone mineral content, and bone mineral density using dual-energy x-ray absorptiometry, and serum 25(OH)D3 using liquid chromatography tandem mass spectrometry.. Of 139 included infants, 81 (58.3%) were male, and the median (IQR) gestational age at birth was 39.6 (38.9-40.6) weeks. A total of 49 infants were included in the 1000 IU per day group, 49 infants in the 400 IU per day group, and 41 in the reference group. Mean (SD) whole-body bone mineral content was not different between trial groups over time (1000 IU per day, 173.09 [2.36] g; 400 IU per day, 165.94 [66.08] g). Similarly, no differences were observed in lumbar spine bone mineral content or density. Mean (SD) serum 25(OH)D3 concentrations were significantly higher in the 1000 IU per day group from age 3 to 12 months (3 months, 115.2 [35.3] nmol/L; 6 months, 121.6 [34.4] nmol/L; 12 months, 99.6 [28.8] nmol/L) compared with the 400 IU per day trial group (3 months, 77.4 [23.3] nmol/L; 6 months, 85.1 [18.6] nmol/L; 12 months, 82.3 [14.3] nmol/L).. In this study, a higher dose of vitamin D supplementation in infants born with 25(OH)D concentrations less than 50 nmol/L did not present advantages to bone mass in infancy. This study supports a standard dose of 400 IU per day of vitamin D supplementation for breastfed infants in Montreal.. ClinicalTrials.gov Identifier: NCT02563015.

Topics: Absorptiometry, Photon; Bone Density; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Infant; Infant, Newborn; Male; Vitamin D; Vitamin D Deficiency

To assess whether vitamin D

Topics: Aged; Aged, 80 and over; Cholecalciferol; Dietary Supplements; Double-Blind Method; Exercise; Humans; Vitamin D; Vitamin D Deficiency; Vitamins

Food fortification improves vitamin D intakes but is not yet mandated in many countries. Combining vitamin D with different dietary lipids altered vitamin D absorption in

Topics: Aged; Biomarkers; Calcifediol; Cholecalciferol; Coconut Oil; Dietary Supplements; Humans; Middle Aged; Vitamin D; Vitamin D Deficiency; Vitamins

Immune levels were observed by giving vitamin D supplements to vitamin D deficient women who received the COVID-19 vaccine.. In the research, there were volunteer women who had received two doses of the COVID-19 vaccine who participated for a mean of more than 65 days. Group D (n=14 Pfizer-BioNTech, 2 Sinovac) received 150,000 IU of vitamin D supplementation, but group C (n=14 Pfizer-BioNTech), 3 Sinovac) no support was provided.. When the consumption of vitamin D ends (D group), serum 25-Hydroxy Vitamin D levels were found to increase regularly in the (W3) last measurements (p=0.001). There was no significant difference in immunoglobulin M levels between groups D and C (Control group) (p=0.063). It was observed that the immunoglobulin G levels reached the peak level between the W1 and W2 measurements of the D group (P<0.001) and there were significant differences between the three sizes. Also, no correlation was found between the D group's initial serum immunoglobulin G and 25-Hydroxy Vitamin D levels. However, when the final measurements were examined, a significant positive correlation was found between immunoglobulin G and 25-Hydroxy Vitamin D levels (r=0.558, p=0.031).. It was determined that serum IgG levels increased significantly depending on the duration between those who used vitamin D and those who did not and it was above the initial level for a long time. A positive and significant relationship was found between the last measured immunoglobulin G and 25(OH) D levels while vitamin D supplementation continued.. This study registered under ClinicalTrials.gov (Identifier no. NCT05447065).

Topics: Cholecalciferol; COVID-19; COVID-19 Vaccines; Dietary Supplements; Double-Blind Method; Female; Humans; Immunoglobulin G; Vitamin D; Vitamin D Deficiency

The efficacy of cholecalciferol (vitamin D3) food fortification in low- and middle-income countries near the Equator is unknown.. We examined the effects of providing cholecalciferol-fortified skim milk to adolescents and their mothers on serum total 25(OH)D, free 25(OH)D, and vitamin D-binding protein (DBP) concentrations in a randomized controlled trial.. We randomly assigned 80 Colombian families each with a child aged 12-14.5 y and their mother 1 L of skim milk daily, either fortified with 2400 IU (60 μg) cholecalciferol or unfortified, for 6 wk. We prescribed 500 mL of milk daily to adolescents; mothers consumed the remainder ad libitum. We estimated intent-to-treat effects as the between-arm difference in the change in serum total and free 25(OH)D and DBP concentrations from baseline to the end of follow-up. Secondary analyses included stratification by baseline characteristics and per-protocol comparisons.. Among adolescents, fortification effects (95% CI) on serum total 25(OH)D, free 25(OH)D, and DBP concentrations were 5.4 nmol/L (2.1, 8.8 nmol/L), 0.6 pmol/L (-0.2, 1.4 pmol/L), and -416 nmol/L (-944, 112 nmol/L), respectively. Effects on total 25(OH)D were stronger in adolescents with lower DBP concentrations, darker skin, less sunlight exposure, and higher compliance than in their respective counterparts. Fortification increased free 25(OH)D concentrations in high compliers. Among mothers, the effects (95% CI) on total 25(OH)D and DBP concentrations were 4.0 nmol/L (0.6, 7.5 nmol/L) and -128 nmol/L (-637, 381 nmol/L), respectively. There were no adverse events.. Provision of cholecalciferol-fortified skim milk increases serum total 25(OH)D concentrations in Colombian adolescents and adult women.

Topics: Adolescent; Adult; Animals; Calcifediol; Child; Cholecalciferol; Colombia; Dietary Supplements; Double-Blind Method; Female; Food, Fortified; Humans; Milk; Vitamin D; Vitamin D Deficiency

A Prospective Study to Evaluate the Possible Role of Cholecalciferol Supplementation on Autoimmunity in Hashimoto's Thyroiditis Biva Bhakat1 , Jyotirmoy Pal2 , Sukdeb Das3 , Sumit Kr Charaborty4 1,3Nil Ratan Sircar Medical College, Kolkata, 2 RG Kar Medical College and Hospital, 4 North Bengal Medical College, Siliguri Introduction: Hashimoto thyroiditis (HT) is an autoimmune disease that destroys thyroid cells by antibody and call-mediated immune processes. Hashimoto thyroiditis is the commonest cause of goitre in iodine-sufficient regions.[1] The aetiology of Hashimoto disease is very poorly understood. Most patients develop antibodies to a variety of thyroid antigens, the most common of which is anti-thyroid peroxidase (anti-TPO). Many also form antithyroglobulin (anti-Tg) and TSH receptor blocking antibodies (TBII). These antibodies attack the thyroid tissue, eventually leading to inadequate production of thyroid hormone. There is a small subset of the population, around 10-15% with the clinically evident disease, that are serum antibody-negative.[2][3] The mechanisms underlying the assumption that vitamin D is linked with autoimmunity are not clear but probably are associated with its anti-inflammatory and immunomodulatory functions. The dendritic cells are antigen-presenting cells originating from bone marrow and also a primary target for the immunomodulatory activity of vitamin D. 1,25[OH]2D has direct immunomodulatory effects at the level of the T cell vitamin D receptor. Together, these immunomodulatory effects can lead to the protection of target tissues, such as thyroid cells in autoimmune diseases. Considering that in HT, a disorder of T cell-mediated immunity, immunologic attack is triggered when thyrocytes express MHC class II surface HLA-DR antigens, a process induced by the production of Th1 type inflammatory cytokines (especially IFN-γ). Moreover, at another stage, after being activated by T cells, B cells' ongoing proliferation might be inhibited and apoptosis might be induced by 1,25[OH]2D. Thus, 1,25[OH]2D might decrease antibodies that react with thyroid antigens. The exact levels of vitamin D that are sufficient to improve the immune regulatory function and lead to an effective immune response, should be investigated. Several clinical studies have reported a low vitamin D status in AITD or HT, indicating an association between vitamin D deficiency and thyroid autoimmunity. If supplementation of the Vitamin D decreased thyroid an. Most studies have shown an association between low vitamin D status and pathogenesis of AITD, especially HT. However, there are only few preliminary interventional studies for HT. whether vitamin D supplementation is beneficial for AITD or HT, should be evaluated. Treatment of HT mainly based on thyroid hormone supplementation, so if a beneficial role of vitamin D supplementation is identified/ confirmed, it will be helpful in the treatment of patients with HT and may be a part of treatment of HT patients.. Evaluating the role of vitamin D on an excessive thyroid immune response.. Study area: N.R.S. Medical college and hospital, Kolkata (Department of General Medicine).. 1 year (January,2019 to December,2019 Sample size: 100 patients both male and female. Sample Design: Patients attending outpatient dept in N.R.S medical college.. Prospective, hospital based, single centre study.. Newly diagnosed patients (age >18 years and of both sexes) with HT and vitamin D deficiency.. Patients suffering from: Other autoimmune diseases. Chronic illnesses like diabetes mellitus, chronic kidney disease, chronic liver disease, malignancy. Pregnancy Study tools: Estimation from serum: TSH. Free thyroxine (FT4) 25 hydroxy vitamin D Anti-thyroid peroxidase (anti-TPO) antibody' Study techniques: This is a prospective study conducted in N.R.S Medical college, Kolkata, India. Total 100 adult patients of both sexes diagnosed with HT and vitamin D deficiency (vit D<30 ng/ml)12, having none of the exclusion criteria and getting treatment on out-patient department basis, who gave informed consent were included in our study. Blood samples drawn for anti TPO antibody and 25hydroxy vitamin D from all the participants. The correlations between serum Vit D and anti TPO antibody were measured and presented by correlation coef ficient (r2). Study participants are randomly assigned into two groups by random permuted block. Cholecalciferol supplement given in the dose of 60,000 IU weekly for 8 weeks in one group (n = 50). Another group (n = 50) were given placebo (empty soft gelatine capsule). At the onset of the study, patients were requested to keep their habitual diet and routine level of physical activity throughout the study period and not to take any medication that might affect their reproductive physiology. Compliance to the consumption of supplement and placebo was examined by empty blister packets. However, 2 patients from cholecalciferol group and 1 patient from control group lost to follow up. After 8 weeks blood anti TPO antibody level measured in both the groups (n = 48 & 49 in 2 group). The change in the mean value of anti TPO antibody measured and statistical significance of the change checked. Results considered significant or non-significant when P> or < 0.05, respectively. TSH, T4 measurement Performed with chemiluminescence using ADVIA Centaur XP Immunoassay System. Work plan: Study was done over 12 months. Data collected and compilation done and then statistical analysis done by standard statistical method.. For statistical analysis data were entered into a Microsoft excel spreadsheet and then analyzed by SPSS (version 27.0; SPSS Inc., Chicago, IL, USA) and GraphPad Prism version 5. p-value ≤ 0.05 was considered for statistically significant. The Negative Correlation was found between Serum 25 hydroxy vitamin D (ng/ml) vs Serum TSH (mU/L) which was statistically significant. Distribution of mean serum anti-TPO antibody level (IU/ml) [mean±SD] in both groups before and after intervention Reduction of serum anti-TPO antibody level in cholecalciferol group is 30.5% and reduction of serum anti-TPO antibody level in placebo group is 16.5%.. This study is carried out with the total no. of 100 outdoor based patients of diagnosed Hashimoto's Thyroiditis (elevated Anti-thyroid peroxidase antibody) and vitamin D deficiency (vit D < 30 ng/mL)12 in Nil Ratan Sircar medical college and hospital within the mentioned study period. The study focussed on evaluating the role of vitamin D on an excessive thyroid immune response i.e. the effect of vitamin D supplementation on thyroid autoimmunity and that low vitamin D levels and the risk of HT are closely associated and the potential application of vitamin D in the treatment of AITD. The result demonstrates a negative Correlation between Serum 25 hydroxy vitamin D (ng/mL) vs anti TPO antibody (IU/ml) which was statistically significant. Pearson Correlation Coefficient (r)= -0.775, p value = 0.0001. Goswami et al. conducted a community-based survey on 642 adults to investigate the relationship between serum vitamin D concentrations and thyroid autoimmunity. Their results highlighted a significant inverse association between 25(OH)D3 and TPO Ab levels [40]. This inverse correlation was substantiated in the following studies.[5-8] As regards thyroid function in the context of HT, Mackawy and co-workers demonstrated a strong negative association between serum vitamin D concentrations and TSH levels, leading to speculate that vitamin D deficiency in HT patients could be associated with a progression towards hypothyroidism (TSH > 5.0 m UI/L) [45]. Our study also demonstrates negative Correlation between Serum 25 hydroxy vitamin D (ng/mL) vs Serum TSH (mU/L) and the result was statistically significant. Pearson Correlation Coefficient (r) = -0.301, p value = 0.003. So, the results indicate that vitamin D deficiency is a risk factor of Hashimoto's thyroiditis. Mean (mean± s.d.) Serum anti TPO antibody (IU/ml) before intervention was 545.06± 230.82 and after cholecalciferol supplementation the mean value decreased to 378.6± 160.49. So, there is a 30.5% reduction in the mean value of anti TPO antibody level. Difference of mean Serum anti TPO antibody (IU/mL) was statistically significant (p < 0.0001). In the placebo group the mean Serum anti TPO antibody (IU/ml) (mean ± s.d.) of patients was 686.97± 290.19 and after 8 weeks of placebo the mean value was 573.1 ± 254.09. So, in the placebo group the reduction is only 16.5%. Difference of mean Serum anti TPO antibody (IU/ml) was statistically significant (p < 0.0001). Therefore, in line with the hypothesis. The 8 weeks randomized; double-blind, placebo-controlled clinical trial demonstrates a negative correlation between Serum 25 hydroxy vitamin D vs anti TPO antibody level. Treatment with 60,000 IU cholecalciferol weekly for 8 weeks, is associated with significant decrease in antithyroid antibody titers. It also improved serum TSH level compared with the placebo, i.e. supplementary treatment with cholecalciferol seems to have beneficial effects on AITD. However, large multicentre studies are needed to investigate the impact of vitamin D supplementary treatment on meaningful long-term clinical end points in AITD. References Dana L. Mincer; Ishwarlal Jialal. StatPearls [Internet]. Hashimoto Thyroiditis. Treasure Island (FL): StatPearls Publishing; 2020 Jan. Leung AKC, Leung AAC. Evaluation and management of the child with hypothyroidism. World J Pediatr 2019;15(2):124-134. Yuan J, Sun C, Jiang S, et al. The pevalence of thyroid disorders in patients with vitiligo: a systematic review and meta-analysis. Front Endocrinol (Lausanne) 2018;. Front Endocrinol (Lausanne). 2018; 9:803. Yoo WS, Chung HK. Recent advances in autoimmune thyroid diseases. Endocrinol Metab (Seoul) 2016;31(3):379-385. Ke W, Sun T, Zhang Y, et al. 25-Hydroxyvitamin D serum level in Hashimoto's thyroiditis, but not Graves' disease is relatively deficient. Endocr J 2017;64(6):581-587. Shin D, Kim KJ, Kim D, et al. Low serum vitamin D is associated with anti-thyroid peroxidase antibody in autoimmune thyroiditis. Yonsei Med J 2014; 55:476-481. ElRawi HA, Ghanem NS, ElSayed, N.M.; et al. Study of vitamin D level and vitamin D receptor polymorphism in hypothyroid egyptian patients. J Thyroid Res 2019. Kim CY, Lee YJ, Choi J, et al. The association between low vitamin d status and autoimmune thyroid disease in korean premenopausal women: the 6th korea national health and nutrition examination survey, 2013-2014. Korean J Fam Med 2019;40:323-328. Chaudhary S, Dutta D, Kumar M, et al. Vitamin D supplementation reduces thyroid peroxidase antibody levels in patients with autoimmune thyroid disease: An open-labelled randomized controlled trial. Indian J Endocrinol Metab 2016;20:391-398. Krysiak R, Szkróbka W, Okopie´n, B. The effect of vitamin D on thyroid autoimmunity in levothyroxine-treated women with Hashimoto's thyroiditis and normal vitamin D Status. Exp. Clin. Endocrinol. Diabetes 2017;125:229-233. Krysiak R, Kowalcze K, Okopie´n B. Selenomethionine potentiates the impact of vitamin D on thyroid a

Topics: Adult; Autoimmunity; Cholecalciferol; Dietary Supplements; Female; Graves Disease; Hashimoto Disease; Humans; Hypothyroidism; Male; Nutrition Surveys; Prospective Studies; Randomized Controlled Trials as Topic; Receptors, Calcitriol; Thyroid Hormones; Thyroiditis, Autoimmune; Thyrotropin; Thyroxine; Vitamin D; Vitamin D Deficiency; Young Adult

Compare the efficacy and safety of daily vs. monthly oral vitamin D. Both regimens led to a statistically significant increase in Ca and P levels and fall in ALP and PTH levels from baseline to 4 and 12 weeks of therapy, with no inter-group difference. Infants in group D had statistically significant higher mean 25(OH)D levels as compared to group B at 4 weeks (group D 130.89 ± 43.43 nmol/L, group B - 108.25 ± 32.40 nmol/L; p - 0.012) and 12 weeks (group D - 193.69 ± 32.47 nmol/L, group B - 153.85 ± 33.60 nmol/L; p<0.001). Eight infants [group D - 6/41 (14.6 %); group B - 2/37 (5.4 %), p=0.268] developed mild asymptomatic hypercalcemia without hypercalciuria at 12 weeks that corrected spontaneously within a week.. Both daily and monthly oral vitamin D

Topics: Alkaline Phosphatase; Calcifediol; Calcium; Cholecalciferol; Dietary Supplements; Humans; Infant; Parathyroid Hormone; Vitamin D; Vitamin D Deficiency

Inflammatory processes are increasingly attributed to macrophage polarization. Proinflammatory macrophages promote T helper (Th) 1 response, tissue repair, and Th2 responses. Detection of macrophages in tissue sections is facilitated by CD68. Our study is focused on the expression of CD68 and the estimation of proinflammatory cytokines in children's patients with chronic tonsillitis secondary to vitamin D supplementation. This hospital-based Randomized prospective case-control study was conducted on 80 children with chronic tonsillitis associated with vitamin D deficiency where (40 received vitamin D 50,000 IU weekly for 3-6 months and 40 received 5 ml distilled water as placebo). The serum 25-hydroxyvitamin D [25(OH)D] was measured using an Enzyme-linked immunosorbent assay on all included children. Different histological and immunohistochemical studies for the detection of CD68 were done. There was a significantly lower serum level of 25(OH)D in the placebo group versus the vitamin D group (P < 0.001). The levels of pro-inflammatory cytokines, TNFα, and IL-2 significantly increased in the placebo group as compared to the vitamin D group (P < 0.001). The increased level of IL-4 and IL-10 in the placebo group as compared to the vitamin D group was insignificant (P = 0.32, 0.82) respectively. Vitamin D supplementation alleviated the deleterious effect of chronic tonsillitis on the histological structure of the tonsil. Tonsillar tissues of the children in the control and vitamin D groups demonstrated a highly statistically significantly lower number of CD68 immunoexpressing cells compared with those in the placebo group (P < 0.001). Low vitamin D may play a role in chronic tonsillitis. Vitamin D supplementation could help reduce the occurrence of chronic tonsillitis in susceptible children.

Topics: Case-Control Studies; Child; Cholecalciferol; Cytokines; Dietary Supplements; Humans; Tonsillitis; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D is associated with neurodevelopment, but causality, critical windows, and potentials for modification remain unknown.. To determine the impact of high-dose (1200 IU) vs standard-dose (400 IU) vitamin D3 supplementation during the first 2 years on psychiatric symptoms at ages 6 to 8 years and whether the impact is different in children with lower vs higher maternal vitamin D3 levels; lower vs higher levels were defined as 25-hydroxyvitamin D (25[OH]D) less than 30 ng/mL vs 30 ng/mL or greater.. This study was a long-term follow-up of the double-blind randomized clinical trial (RCT) Vitamin D Intervention in Infants (VIDI) conducted at a single center in Helsinki, Finland, at 60 degrees north latitude. Recruitment for VIDI took place in 2013 to 2014. Follow-up data for secondary data analysis were collected 2020 to 2021. VIDI originally included 987 term-born infants; 546 of these individuals participated in the follow-up at ages 6 to 8 years, among whom 346 individuals had data on parent-reported psychiatric symptoms. Data were analyzed from June 2022 to March 2023.. There were 169 infants randomized to receive 400-IU and 177 infants randomized to receive 1200-IU oral vitamin D3 supplementation daily from ages 2 weeks to 24 months.. Primary outcomes were internalizing, externalizing, and total problems scores, with clinically significant problems defined as T scores of 64 or greater in the Child Behavior Checklist questionnaire.. Among 346 participants (164 females [47.4%]; mean [SD] age, 7.1 [0.4] years), the vitamin D3 dose was 400 IU for 169 participants and 1200 IU for 177 participants. Clinically significant internalizing problems occurred in 10 participants in the 1200-IU group (5.6% prevalence) compared with 20 participants (11.8%) in the 400-IU group (odds ratio, 0.40; 95% CI, 0.17-0.94; P = .04) after adjustment for sex, birth season, maternal depressive symptoms at birth, and parental single status at follow-up. In a post hoc subgroup analysis, 48 children in the 400-IU group with maternal 25(OH)D concentrations less than 30 ng/mL had higher internalizing problems scores compared with children in the 1200-IU group, including 44 children with maternal 25(OH)D concentrations below 30 ng/mL (adjusted mean difference, 0.49; 95% CI, 0.09-0.89; P = .02) and 91 children with maternal concentrations above 30 ng/mL (adjusted mean difference, 0.37; 95% CI, 0.03-0.72; P = .04). Groups did not differ in externalizing or total problems.. This randomized clinical trial found that higher-than-standard vitamin D3 supplementation in the first 2 years decreased risk of internalizing problems at ages 6 to 8 years.. ClinicalTrials.gov Identifiers: NCT01723852 (VIDI) and NCT04302987 (VIDI2).

Topics: Child; Cholecalciferol; Dietary Supplements; Female; Humans; Infant; Infant, Newborn; Vitamin D; Vitamin D Deficiency; Vitamins

The aim of this study was to examine the effect of vitamin D (VitD) supplementation on serum heat-shock proteins (HSP) in postmenopausal women (PW).. In this double-blind, placebo-controlled trial, 160 PW aged 45 to 65 years with amenorrhea 12 months or more were randomized into two groups: 80 PW in VitD group (oral supplementation with 1,000 IU VitD 3 /d) or 80 PW in placebo group. The PW were assessed at baseline and after 10 months of intervention. Plasma concentrations of 25-hydroxyVitD (25[OH]D) were measured by high-performance liquid chromatography. HSP27/pS78/pS82, HSP27/total, HSP60, HSP70/72, and HSP90α levels were assessed in serum using a multiplexed bead immunoassay.. HSP27 (pS78/pS82 [ P < 0.035] and total [ P < 0.001]) levels increased in the supplemented group when compared with the control group. There was no effect of VitD supplementation on HSP60, HSP70/72, and HSP90α levels.. Vitamin D supplementation increases serum HSP27 level in PW.

Topics: Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Heat-Shock Proteins; HSP27 Heat-Shock Proteins; Humans; Postmenopause; Vitamin D; Vitamin D Deficiency

To evaluate the effects of two vitamin D repletion therapies (cholecalciferol) on serum levels of 25-hydroxyvitamin D (25(OH)D) and 24-h urine calcium in patients with recurrent calcium kidney stones and vitamin D deficiency (VDD).. A parallel-group randomized controlled clinical trial on patients who referred to Labbafinejad kidney stone prevention clinic, Tehran, Iran. From 88 recurrent calcium stone formers, 62 patients completed the study. The age of participants was 18-70 years who had serum 25(OH)D levels of 10-20 ng/ml.. Participants received oral cholecalciferol 2000 IU daily for 12 weeks or 50,000 IU weekly for 8 weeks.. Study variables including 24-h urine calcium, supersaturations of calcium oxalate and calcium phosphate, serum 25(OH)D and parathyroid hormone were measured at the beginning of the study and after 12 weeks.. The 24-h urine calcium significantly increased in both groups (β = 69.70, p < 0.001), with no significant difference between treatments. Both groups showed no significant change in the supersaturation levels of calcium oxalate and calcium phosphate. Serum levels of 25(OH)D increased significantly (β = 12.53, p < 0.001), with more increase in the 50,000 IU group (β = 3.46, p = 0.003). Serum parathyroid hormone decreased in both groups (p < 0.001).. Although both treatment protocols increased 24-h urine calcium, they did not increase the supersaturation state of calcium oxalate or calcium phosphate. Trial registration IRCT20160206026406N4, 13/08/2019.

Topics: Adolescent; Adult; Aged; Calcium; Calcium Oxalate; Calcium Phosphates; Cholecalciferol; Humans; Iran; Kidney Calculi; Middle Aged; Parathyroid Hormone; Vitamin D; Vitamin D Deficiency; Vitamins; Young Adult

Vitamin D deficiency (VDD) is highly prevalent in the pediatric intensive care unit (ICU) and associated with worse clinical course. Trials in adult ICU demonstrate rapid restoration of vitamin D status using an enteral loading dose is safe and may improve outcomes. There have been no published trials of rapid normalization of VDD in the pediatric ICU.. We conducted a multicenter placebo-controlled phase II pilot feasibility randomized clinical trial from 2016 to 2017. We randomized 67 critically ill children with VDD from ICUs in Canada, Chile and Austria using a 2:1 randomization ratio to receive a loading dose of enteral cholecalciferol (10,000 IU/kg, maximum of 400,000 IU) or placebo. Participants, care givers, and outcomes assessors were blinded. The primary objective was to determine whether the loading dose normalized vitamin D status (25(OH)D > 75 nmol/L). Secondary objectives were to evaluate for adverse events and assess the feasibility of a phase III trial.. Of 67 randomized participants, one was withdrawn and seven received more than one dose of cholecalciferol before the protocol was amended to a single loading dose, leaving 59 participants in the primary analyses (40 treatment, 19 placebo). Thirty-one/38 (81.6%) participants in the treatment arm achieved a plasma 25(OH)D concentration > 75 nmol/L versus 1/18 (5.6%) the placebo arm. The mean 25(OH)D concentration in the treatment arm was 125.9 nmol/L (SD 63.4). There was no evidence of vitamin D toxicity and no major drug or safety protocol violations. The accrual rate was 3.4 patients/month, supporting feasibility of a larger trial. A day 7 blood sample was collected for 84% of patients. A survey administered to 40 participating families showed that health-related quality of life (HRQL) was the most important outcome for families for the main trial (30, 75%).. A single 10,000 IU/kg dose can rapidly and safely normalize plasma 25(OH)D concentrations in critically ill children with VDD, but with significant variability in 25(OH)D concentrations. We established that a phase III multicentre trial is feasible. Using an outcome collected after hospital discharge (HRQL) will require strategies to minimize loss-to-follow-up.. gov NCT02452762 Registered 25/05/2015.

Topics: Adult; Child; Cholecalciferol; Critical Illness; Dietary Supplements; Double-Blind Method; Feasibility Studies; Humans; Intensive Care Units, Pediatric; Quality of Life; Vitamin D; Vitamin D Deficiency; Vitamins

Platelet hyperactivity is one of the key factors implicated in the development and progression of diabetic vascular complications. Activated platelets mediate leukocyte recruitment that further enhances inflammatory responses in vascular wall ultimately resulting in atherosclerotic complications. Since vitamin D insufficiency is highly prevalent in diabetics, we aimed to evaluate the effect of three dosage forms of vitamin D supplementation on lipid profile, NF-κB, platelet aggregation, and platelet calcium content in type 2 diabetic patients. Type 2 diabetic patients were randomized to receive daily (4000 IU/day) or weekly (50 000 IU/week) oral vitamin D3 for 3 months. Another group received a single parenteral dose (300 000 IU) of vitamin D3, whereas the control group received their antidiabetic drug(s) alone. Serum 25(OH)D, total cholesterol, triglycerides, high- and low-density lipoprotein cholesterol, NF-κB, and platelet aggregation were measured at the beginning and 3 months after vitamin D supplementation. Platelet calcium content was evaluated by measuring the fluorescence intensity of Rhod-2-stained platelets by confocal fluorescence microscopy. Results showed that serum 25(OH)D3 levels significantly increased in all vitamin D3-treated groups. However, the mean level for parenteral treated group was significantly lower than oral-treated groups. Oral and parenteral treatment were also able to decrease NF-κB level, platelet aggregation, and platelet calcium content. However, both oral doses of vitamin D3 were superior to the single parenteral dose. In conclusion, restoring normal levels of vitamin D is an important determinant to maintain normal platelet function and reduce inflammation. Nevertheless, further long-term studies are still needed.

Topics: Calcium; Cholecalciferol; Cholesterol; Diabetes Mellitus, Type 2; Dietary Supplements; Humans; NF-kappa B; Platelet Aggregation; Vitamin D; Vitamin D Deficiency

Although vitamin D is one of the essential nutrients associated with musculoskeletal system function, there is no standard treatment method for vitamin D deficiency. This study aimed to investigate the effects of vitamin D supplementation on the improvement in symptoms, functional recovery of the spine, and changes in the quality of life in patients with spinal stenosis.. In this prospective study, patients with spinal stenosis and serum 25-hydroxy vitamin D levels < 10 ng/mL were randomly assigned to a supplementation group (Group S) and a non-supplementation group (Group NS): 26 participants in Group S (16 females and 10 males) and 25 in Group NS (15 females and 10 males). The degree of lower back pain in both groups was assessed using the visual analog scale; spine function was assessed using the Oswestry disability index and Roland-Morris disability questionnaire; and patient quality of life was assessed using the 36-item short form health survey. We compared and analyzed the values that were measured at baseline, between 4 and 6 weeks (V1), 10 and 12 weeks (V2), and 22 and 26 weeks (V3).. No statistically significant difference was observed in lower back pain, spine function, or quality of life between both groups at baseline. In terms of lower back pain in V1, Group S scored 4.15 ± 3.12, while Group NS scored 5.64 ± 1.85 (P = .045). In V2, Group S scored 3.15 ± 2.38, while Group NS scored 4.52 ± 1.87 (P = .027). Moreover, in V3, Group S scored 3.58 ± 1.65, while Group NS scored 4.60 ± 1.68 (P = .033), indicating a statistically significant improvement in each period.. If a vitamin D deficiency that does not require surgical treatment exists in patients with lumbar spinal stenosis, high-dose vitamin D injections can improve lower back pain, which is the main symptom of lumbar spinal stenosis, as well as the functional outcomes of the spine and quality of life.

Topics: Cholecalciferol; Dietary Supplements; Female; Humans; Low Back Pain; Lumbar Vertebrae; Male; Pilot Projects; Prospective Studies; Quality of Life; Spinal Stenosis; Treatment Outcome; Vitamin D Deficiency

We conducted a follow up of the children in Mongolia whose mothers received one of the three doses of vitamin D (600, 2000, or 4000 IU daily) during pregnancy as part of the randomized, double-blind, clinical trial of vitamin D supplementation to determine their impact on child health to two years. In the parental trial, 119 pregnant women were assigned to 600 IU/day, 121 were assigned 2000 IU/day, and 120 were assigned 4000 IU/day starting at 12-16 weeks' gestation and continuing throughout pregnancy. At baseline, maternal serum 25(OH)D concentrations were similar across arms; 91 % were 50 nmol/l. As expected, there was a dose-response association between the amount of vitamin D consumed (600, 2000, or 4000 IU daily) and maternal 25(OH)D levels at the end of the intervention. Total 311 children of 311 mothers were followed for 2 years to evaluate health outcomes. We determined the child's health outcomes (rickets, respiratory disease [pneumonia, asthma], and diarrhea/vomiting) using a questionnaire and physical examination (3, 6, and 24 months of age). Low levels of mothers' serum 25(OH)D during pregnancy increased the risk of developing rickets, respiratory illness, and other diseases in children during the early childhood period. Rickets was diagnosed in 15.6 % of children of women who received 600 IU of vitamin D during pregnancy, which was higher than in other vitamin D groups. Children in the group whose mothers received low doses of vitamin D (600 IU/day) had a greater probability of developing respiratory diseases compared to the other groups: pneumonia was diagnosed in n = 36 (35.0 %) which was significantly higher than the group receiving vitamin D 4000 IU/day (n = 34 (31.5 %) p = 0.048). In the group whose pregnant mother consumed 600 IU/day of vitamin D, the risk of child pneumonia was ∼ 2 times higher than in the group who consumed 4000 IU/day (OR=1.99, 95 % CI: 1.01-3.90). The incidence of diarrhea and vomiting in children was 12.1 % lower in the 2000 IU/day group and 13.1 % lower in the 4000 IU/day group compared with the 600 IU/day group (p = 0.051). The offspring of pregnant women who regularly used vitamin D at doses above 600 IU/day had lower respiratory disease, rickets, and diarrheal risks at 2 years.

Topics: Child; Child Health; Child, Preschool; Cholecalciferol; Diarrhea; Dietary Supplements; Double-Blind Method; Female; Humans; Outcome Assessment, Health Care; Pneumonia; Pregnancy; Rickets; Vitamin D; Vitamin D Deficiency; Vitamins; Vomiting

Allogeneic hematopoietic stem cell transplant (aHSCT) patients are well known to be at high risk of vitamin D (vit D) deficiency. This study assessed whether a loading dose (100,000 IU) of vitamin D3 pre-aHSCT could effectively achieve and maintain sufficient post-transplant vit D levels (serum total 25 hydroxy vitamin D (25(OH)D) ≥ 75nmol/L). Dual-energy X-ray absorptiometry (DXA) was also conducted for bone health evaluation. 74 patients were enrolled and randomly assigned, in a 1:1 ratio, either to the high vit D group (single loading dose (100,000 IU) plus 2,000 IU vit D3 daily) or the control group (2,000 IU vit D3 daily). Vit D levels were measured at three time points (baseline, day 30 and day 100 post-aHSCT). At baseline, fewer than 50% patients had a sufficient 25(OH)D (control: 42.9%; high vit D: 43.6%). The proportion of patients with sufficient 25(OH)D (nmol/L) was increased at day 30 and day 100, with a trend of higher proportion in the high vit D group at day 30 (high vit D vs. control: 89.7% vs. 74.3%, p = 0.08). The increased 25(OH)D was significantly higher in the high vit D group at day 30 (high vit D vs. control: 29±25.2 vs. 14 ±21.9, p = 0.01). Insufficient vit D level before transplant (baseline) was an independent risk factor for vit D insufficiency (serum 25(OH)D < 75nmol/L) post-aHSCT (OR = 4.16, p = 0.03). DXA suggested significant bone loss for total hip in both groups, and in the femoral neck for the control group only. In conclusion, single loading dose vitamin D3 significantly increased total 25(OH)D levels at day 30 post-transplant, and the intervention was especially beneficial for patients with baseline vit D insufficiency. We acknowledge that the primary outcome at day 100 post-aHSCT indicating superiority of loading dose versus daily dose supplementation was not met.

Topics: Adult; Cholecalciferol; Dietary Supplements; Hematopoietic Stem Cell Transplantation; Humans; Vitamin D; Vitamin D Deficiency; Vitamins

Topics: Athletes; Cholecalciferol; Dietary Supplements; Humans; Vitamin D; Vitamin D Deficiency; Vitamins

This study was performed to evaluate the efficacy of cholecalciferol in improving renal and vascular functions in vitamin D-deficient patients with type 2 diabetes mellitus (T2DM) along with chronic kidney disease (CKD). One hundred patients (18 - 65 years), having T2DM along with CKD (stage IIIA and IIIB) and hypovitaminosis D were randomized (1:1) to receive either oral cholecalciferol 60,000 IU (Group A) or placebo (Group B) weekly for 8 weeks along with standard background treatment. They were followed up for another 24 weeks. Various parameters of renal and vascular functions were compared. Except for serum calcium and phosphate levels which were significantly higher in Group A (

Topics: Cholecalciferol; Diabetes Mellitus, Type 2; Dietary Supplements; Double-Blind Method; Humans; Pulse Wave Analysis; Renal Insufficiency, Chronic; Vitamin D; Vitamin D Deficiency

Vitamin D regulates glucose homeostasis pathways, but effects of vitamin D supplementation on β-cell function remain unclear.. To investigate the effects of vitamin D3 supplementation on insulin sensitivity and β-cell function.. This is a prespecified secondary analysis of the Vitamin D and Type 2 Diabetes study. Overweight/obese adults at high risk for type 2 diabetes (prediabetes) were randomly treated with vitamin D3 4000 IU or matching placebo daily for 24 months.. Disposition index (DI), as an estimate of β-cell function, was calculated as the product of Homeostasis Model Assessment 2 indices derived from C-peptide values (HOMA2%Scpep) and C-peptide response during the first 30 minutes of a 75-g oral glucose tolerance test (OGTT).. Mean age was 60.5 ± 9.8 years and body mass index was 31.9 ± 4.4 kg/m2. Mean serum 25(OH)D level increased from 27.9 ± 10.3 ng/mL at baseline to 54.9 ng/mL at 2 years in the vitamin D group and was unchanged (28.5 ± 10.0 ng/mL) in the placebo group. The baseline DI predicted incident diabetes independent of the intervention. In the entire cohort, there were no significant differences in changes in DI, HOMA2%Scpep, or C-peptide response between the 2 groups. Among participants with baseline 25(OH)D level <12 ng/mL, the mean percent differences for DI between the vitamin D and placebo groups was 8.5 (95% CI, 0.2-16.8).. Supplementation with vitamin D3 for 24 months did not improve an OGTT-derived index of β-cell function in people with prediabetes not selected based on baseline vitamin D status; however, there was benefit among those with very low baseline vitamin D status.

Topics: Aged; Blood Glucose; Cholecalciferol; Diabetes Mellitus, Type 2; Dietary Supplements; Female; Follow-Up Studies; Glucose Tolerance Test; Humans; Incidence; Insulin; Insulin Resistance; Insulin-Secreting Cells; Male; Middle Aged; Overweight; Prediabetic State; Treatment Outcome; Vitamin D; Vitamin D Deficiency

Vitamin D has been linked with glucose and lipid metabolism. Men with impaired gonadal function have a higher risk of metabolic syndrome and mortality, and vitamin D status may be a reversible modulator.. This work aimed to determine the effect of daily vitamin D and calcium supplementation for 150 days on glucose and lipid homeostasis in infertile men.. A single-center, double-blinded, randomized clinical trial (NCT01304927) was conducted. A total of 307 infertile men were randomly assigned (1:1) to a single dose of 300 000 IU cholecalciferol followed by 1400 IU cholecalciferol + 500 mg of calcium daily (n = 151) or placebo (n = 156) for 150 days. Reported metabolic parameters including fasting plasma glucose, glycated hemoglobin A1c, fasting serum insulin, homeostatic model assessment of insulin resistance (HOMA-IR), fasting plasma cholesterols, and triglycerides were secondary end points. The primary end point semen quality has previously been reported.. Men receiving vitamin D supplementation improved their vitamin D status, whereas vitamin D status was aggravated in the placebo group characterized by higher serum parathyroid hormone. At the end of the trial, men receiving vitamin D supplementation had 13% lower fasting serum insulin concentrations compared with the placebo-treated group (65 vs 74 pmol/L, P = .018) and 19% lower HOMA-IR (2.2 vs 2.7, P = .025). Moreover, men in the vitamin D group had higher high-density lipoprotein (HDL) cholesterol levels (1.38 vs 1.32 mmol/L, P = .008) compared with the placebo group.. High-dose vitamin D supplementation has beneficial effects on glucose homeostasis and HDL cholesterol levels in infertile men.

Topics: Adult; Blood Glucose; Calcium; Cholecalciferol; Cholesterol, HDL; Dietary Supplements; Fasting; Glycated Hemoglobin; Humans; Infertility, Male; Insulin; Insulin Resistance; Male; Semen Analysis; Treatment Outcome; Triglycerides; Vitamin D; Vitamin D Deficiency

The effect of daily vitamin D supplementation on the serum concentration of vitamin D (the parent compound) may offer insight into vitamin D disposition.. To assess the total serum vitamin D response to vitamin D3 supplementation and whether it varies according to participant characteristics. To compare results with corresponding results for total serum 25-hydroxyvitamin D [25(OH)D], which is used clinically and measured in supplementation trials.. Exploratory study within a randomized trial.. 2000 International Units of vitamin D3 per day (or matching placebo).. Community-based.. 161 adults (mean ± SD age 70 ± 6 years; 66% males) with type 2 diabetes.. Changes in total serum vitamin D and total serum 25(OH)D concentrations from baseline to year 2.. At baseline, there was a positive, nonlinear relation between total serum vitamin D and total serum 25(OH)D concentrations. Adjusted effects of supplementation were a 29.2 (95% CI: 24.3, 34.1) nmol/L increase in serum vitamin D and a 33.4 (95% CI: 27.7, 39.2) nmol/L increase in serum 25(OH)D. Among those with baseline 25(OH)D < 50 compared with ≥ 50 nmol/L, the serum vitamin D response to supplementation was attenuated (15.7 vs 31.2 nmol/L; interaction P-value = 0.02), whereas the serum 25(OH)D response was augmented (47.9 vs 30.7 nmol/L; interaction P-value = 0.05).. Vitamin D3 supplementation increases total serum vitamin D and 25(OH)D concentrations with variation according to baseline 25(OH)D, which suggests that 25-hydroxylation of vitamin D3 is more efficient when serum 25(OH)D concentration is low.

Topics: Aged; Cholecalciferol; Diabetes Mellitus, Type 2; Diabetic Nephropathies; Dietary Supplements; Fatty Acids, Omega-3; Female; Humans; Male; Middle Aged; Treatment Outcome; Vitamin D; Vitamin D Deficiency

There remains a lack of evidence demonstrating a potential relationship between vitamin D and cardiometabolic risk among children.. We examined the effect of 3 different dosages of vitamin D on cardiometabolic risk factors among children at risk of deficiency.. Racially diverse schoolchildren aged 8-15 y were randomly assigned in a double-blind fashion to supplementation with 600, 1000, or 2000 IU vitamin D3/d for 6 mo. Changes in HDL cholesterol, triglycerides, LDL cholesterol, total cholesterol, and blood glucose over 6 mo and at 12 mo (6 mo post-supplementation) were assessed. Subgroup analyses were also performed by weight status and race.. Among 604 children, 40.9% were vitamin D-inadequate at baseline (<20 ng/mL; mean ± SD: 22.0 ± 6.8 ng/mL), 46.4% were overweight/obese, and 60.9% had ≥1 suboptimal blood lipids or glucose. Over 6 mo, serum 25-hydroxyvitamin D increased in all 3 dosage groups from baseline (mean ± SE change: 4.4 ± 0.6 ng/mL, 5.7 ± 0.7 ng/mL, and 10.7 ± 0.6 ng/mL for 600, 1000, and 2000 IU/d, respectively; P < 0.001). Whereas HDL cholesterol and triglycerides increased in the 600 IU group (P = 0.002 and P = 0.02, respectively), LDL cholesterol and total cholesterol decreased across dosage groups. At 6 mo post-supplementation, HDL cholesterol remained elevated in the 600 and 1000 IU groups ( P < 0.001 and P = 0.02, respectively) whereas triglycerides remained elevated in the 1000 and 2000 IU groups (P = 0.04 and P = 0.006, respectively). The suppression of LDL cholesterol and total cholesterol persisted in the 2000 IU group only (P = 0.04 and P < 0.001, respectively). There were no significant changes in blood glucose and similar responses were observed overall by weight status and racial groups across dosages.. Vitamin D supplementation demonstrated generally positive effects on HDL cholesterol, LDL cholesterol, and total cholesterol, especially at the lower dosage of 600 IU/d, with several significant changes persisting during the post-supplementation period. Increases in triglycerides across dosage groups may be due to natural changes during adolescence warranting further study.This trial was registered at clinicaltrials.gov as NCT01537809.

Topics: Adolescent; Blood Glucose; Cardiometabolic Risk Factors; Child; Child Nutritional Physiological Phenomena; Cholecalciferol; Cholesterol; Cholesterol, HDL; Cholesterol, LDL; Dietary Supplements; Double-Blind Method; Female; Humans; Male; Pediatric Obesity; Triglycerides; Vitamin D; Vitamin D Deficiency

Hypervolemia and vitamin D deficiency occur frequently in patients receiving peritoneal dialysis and may contribute to left ventricular (LV) hypertrophy. The effect of bioelectrical impedance analysis (BIA)-guided volume management or vitamin D supplementation on LV mass among those receiving peritoneal dialysis is uncertain.. Two-by-two factorial randomized controlled trial.. Sixty-five patients receiving maintenance peritoneal dialysis.. BIA-guided volume management versus usual care and oral cholecalciferol 50,000 U weekly for 8 weeks followed by 10,000 U weekly for 44 weeks or matching placebo.. Change in LV mass at 1 year measured by cardiac magnetic resonance imaging.. Total body water decreased by 0.9 + 2.4 (SD) L in the BIA group compared with a 1.5 ± 3.4 L increase in the usual care group (adjusted between-group difference: -2.4 [95% CI, -4.1 to -0.68] L, P = 0.01). LV mass increased by 1.3 ± 14.3 g in the BIA group and decreased by 2.4 ± 37.7 g in the usual care group (between-group difference: +2.2 [95% CI, -13.9 to 18.3] g, P = 0.8). Serum 25-hydroxyvitamin D concentration increased by a mean of 17.2 ± 30.8 nmol/L in the cholecalciferol group and declined by 8.2 ± 24.3 nmol/L in the placebo group (between-group difference: 28.3 [95% CI, 17.2-39.4] nmol/L, P < 0.001). LV mass decreased by 3.0 ± 28.1 g in the cholecalciferol group and increased by 2.0 ± 31.2 g in the placebo group (between-group difference: -4.5 [95% CI, -20.4 to 11.5] g, P = 0.6).. Relatively small sample size with larger than expected variation in change in LV mass.. BIA-guided volume management had a modest impact on volume status with no effect on the change in LV mass. Vitamin D supplementation increased serum vitamin D concentration but had no effect on LV mass.. Unrestricted Baxter International extramural grant and the Kidney Foundation of Canada.. Registered at ClinicalTrials.gov with study number NCT01045980.

Topics: Cholecalciferol; Dietary Supplements; Double-Blind Method; Electric Impedance; Humans; Hypertrophy, Left Ventricular; Peritoneal Dialysis; Vitamin D; Vitamin D Deficiency

Topics: Bone Density; Cholecalciferol; Dietary Supplements; Humans; Kidney Transplantation; Osteoporosis; Parathyroid Hormone; Vitamin D; Vitamin D Deficiency

Different 25-hydroxyvitamin D [25(OH)D] thresholds for treatment with vitamin D supplementation have been suggested and are derived almost exclusively from observational studies. Whether other characteristics, including race/ethnicity, BMI, and estimated glomerular filtration rate (eGFR), should also influence the threshold for treatment is unknown.. The aim was to identify clinical and biomarker characteristics that modify the response to vitamin D supplementation.. A total of 666 older adults in the Multi-Ethnic Study of Atherosclerosis (MESA) were randomly assigned to 16 wk of oral vitamin D3 (2000 IU/d; n = 499) or placebo (n = 167). Primary outcomes were changes in serum parathyroid hormone (PTH) and 1,25-dihydroxyvitamin D [1,25(OH)2D] concentrations from baseline to 16 wk.. Among 666 participants randomly assigned (mean age: 72 y; 53% female; 66% racial/ethnic minority), 611 (92%) completed the study. The mean (SD) change in PTH was -3 (16) pg/mL with vitamin D3 compared with 2 (18) pg/mL with placebo (estimated mean difference: -5; 95% CI: -8, -2 pg/mL). Within the vitamin D3 group, lower baseline 25-hydroxyvitamin D [25(OH)D] was associated with a larger decline in PTH in a nonlinear fashion. With baseline 25(OH)D ≥30 ng/mL as the reference, 25(OH)D <20 ng/mL was associated with a larger decline in PTH with vitamin D3 supplementation (-10; 95% CI: -15, -6 pg/mL), whereas 25(OH)D of 20-30 ng/mL was not (-2; 95% CI: -6, 1 pg/mL). A segmented threshold model identified a baseline 25(OH)D concentration of 21 (95% CI: 13, 31) ng/mL as an inflection point for difference in change in PTH. Race/ethnicity, BMI, and eGFR did not modify vitamin D treatment response. There was no significant change in 1,25(OH)2D in either treatment group.. Of characteristics most commonly associated with vitamin D metabolism, only baseline 25(OH)D <20 ng/mL modified the PTH response to vitamin D supplementation, providing support from a clinical trial to use this threshold to define insufficiency. This trial was registered at clinicaltrials.gov as NCT02925195.

Topics: Aged; Atherosclerosis; Biomarkers; Calcifediol; Cholecalciferol; Dietary Supplements; Ethnicity; Female; Humans; Male; Minority Groups; Parathyroid Hormone; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D insufficiency is associated with risks of cardiovascular diseases (CVD) and cancer in observational studies, but evidence for benefits with vitamin D supplementation is limited.. To investigate the effects of vitamin D3 supplementation on CVD and cancer incidences.. The study was a 5-year, randomized, placebo-controlled trial among 2495 male participants ≥60 years and post-menopausal female participants ≥65 years from a general Finnish population who were free of prior CVD or cancer. The study had 3 arms: placebo, 1600 IU/day, or 3200 IU/day vitamin D3. Follow-up was by annual study questionnaires and national registry data. A representative subcohort of 551 participants had more detailed in-person investigations. The primary endpoints were incident major CVD and invasive cancer. Secondary endpoints included the individual components of the primary CVD endpoint (myocardial infarction, stroke, and CVD mortality), site-specific cancers, and cancer death.. During the follow-up, there were 41 (4.9%), 42 (5.0%), and 36 (4.3%) major CVD events in the placebo, 1600 IU/d (compared with placebo: HR: 0.97; 95% CI: 0.63-1.49; P = 0.89), and 3200 IU/d (HR: 0.84; 95% CI: 0.54-1.31; P = 0.44) arms, respectively. Invasive cancer was diagnosed in 41 (4.9%), 48 (5.8%), and 40 (4.8%) participants in the placebo, 1600 IU/d (HR: 1.14; 95% CI: 0.75-1.72; P = 0.55), and 3200 IU/d (HR: 0.95; 95% CI: 0.61-1.47; P = 0.81) arms, respectively. There were no significant differences in the secondary endpoints or total mortality. In the subcohort, the mean baseline serum 25-hydroxyvitamin D concentration was 75 nmol/L (SD, 18 nmol/L). After 12 months, the concentrations were 73 nmol/L (SD, 18 nmol/L), 100 nmol/L (SD, 21 nmol/L), and 120 nmol/L (SD, 22 nmol/L) in the placebo, 1600 IU/d, and 3200 IU/d arms, respectively.. Vitamin D3 supplementation did not lower the incidences of major CVD events or invasive cancer among older adults, possibly due to sufficient vitamin D status in most participants at baseline.

Topics: Aged; Cardiovascular Diseases; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Finland; Humans; Male; Neoplasms; Vitamin D; Vitamin D Deficiency; Vitamins

Increasing evidence suggests that prevention of lifestyle diseases should begin early. Dairy protein and vitamin D can affect body composition and cardiometabolic markers, yet evidence among well-nourished children is sparse.. We investigated combined and separate effects of high dairy protein intake and vitamin D on body composition and cardiometabolic markers in children.. In a 2 × 2-factorial, randomized trial, 200 white, Danish, 6-8-y-old children substituted 260 g/d dairy in their diet with high-protein (HP; 10 g protein/100 g) or normal-protein (NP; 3.5 g protein/100 g) yogurt and received blinded tablets with 20 µg/d vitamin D3 or placebo for 24 wk during winter. We measured body composition (by DXA), blood pressure, and fasting blood glucose, insulin, C-peptide, and lipids.. In total, 184 children (92%) completed the study. Baseline median (25th-75th percentile) dairy protein intake was median: 3.7 (25th-75th percentile: 2.5-5.1) energy percentage (E%) and increased to median: 7.2 (25th-75th percentile: 4.7-8.8) E% and median: 4.2 (25th-75th percentile: 3.1-5.3) E% with HP and NP. Mean ± SD serum 25-hydroxyvitamin D concentration changed from 81 ± 17 to 89 ± 18 nmol/L and 48 ± 13 nmol/L with vitamin D and placebo, respectively. There were no combined effects of dairy protein and vitamin D, except for plasma glucose, with the largest increase in the NP-vitamin D group (Pinteraction = 0.005). There were smaller increases in fat mass index (P = 0.04) with HP than with NP, and the same pattern was seen for insulin, HOMA-IR, and C-peptide (all P = 0.06). LDL cholesterol was reduced with vitamin D compared with placebo (P < 0.05). Fat-free mass and blood pressure were unaffected.. High compared with normal dairy protein intake hampered an increase in fat mass index. Vitamin D supplementation counteracted the winter decline in 25-hydroxyvitamin D and the increase in LDL cholesterol observed with placebo. This study adds to the sparse evidence on dairy protein in well-nourished children and supports a vitamin D intake of ∼20 µg/d during winter. This trial was registered at clinicaltrials.gov as NCT03956732.

Topics: Blood Glucose; Body Composition; Cardiovascular Diseases; Child; Cholecalciferol; Dietary Supplements; Double-Blind Method; Humans; Vitamin D; Vitamin D Deficiency

Exclusively breastfed infants are at a high risk of vitamin D deficiency. Few studies have evaluated the effects of vitamin D supplementation. Hence, we conducted a prospective randomized controlled trial investigating the effects of oral vitamin D3 400 IU/d supplementation in exclusively breastfed newborns. Serum 25-hydroxy-vitamin D (25[OH]D) levels in pregnant women and their newborns were evaluated. Breastfed newborns were randomized to one of two regimens at age 10 days. One group received vitamin D3 supplementation at a dose of 400 IU/d (vD-400 group), whereas the placebo group received a liquid product without vitamin D3. Outcomes were assessed at 4 months of age. A total of 92 pregnant women and their infants were enrolled, and the data of 72 infants (37 in the vD-400 group and 35 in the placebo group) who completed the study at 4 months of age were assessed. The results showed severe vitamin D deficiency in 15.2% of mothers before delivery, while 54.3% had vitamin D deficiency. Moreover, 15.2% of newborns presented with severe vitamin D deficiency at birth, while 52.2% had vitamin D deficiency. Maternal vitamin D levels were significantly correlated with infant vitamin D levels at birth (r = 0.816, p < 0.001). At 4 months of age, weight, head circumference, serum 25(OH)D, phosphorus, and intact parathyroid hormone levels significantly differed between the vD-400 and placebo groups. However, the body length and bone mineral density of the two groups did not differ significantly. Regardless of vitamin D supplementation, participants with severe vitamin D deficiency had significantly higher intact parathyroid hormone levels and lower bone mineral content. In conclusion, among exclusively breastfed infants, oral supplementation with vitamin D3 at a dose of 400 IU/d from age 10 days increased 25(OH)D concentrations at 4 months of age, but it did not affect bone mineralization. © 2022 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).

Topics: Breast Feeding; Child; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Infant; Infant, Newborn; Parathyroid Hormone; Pregnancy; Prospective Studies; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D deficiency is a common health concern during winter. Eggs are one of the few rich dietary sources of vitamin D, containing cholecalciferol (vitamin D-3) and 25-hydroxyvitamin D-3 [25(OH)D3], with the latter reported to be 5 times more potent at increasing serum 25(OH)D concentrations, the major circulating form of vitamin D. However, whether there is an optimal dose of eggs to increase or maintain 25(OH)D concentrations during wintertime is not known.. To evaluate the dose-response effect of consuming 2, 7, or 12 commercially available eggs per week on serum 25(OH)D concentrations during the autumn-winter months in young adults. Secondary aims were to investigate changes in serum lipids, and the feasibility (adherence) and acceptability to consuming the eggs.. In a 12-wk randomized controlled trial, 51 adults aged 25-40 y were randomly assigned to consume 2 eggs/wk (control, n = 17), 7 eggs/wk (n = 17), or 12 eggs/wk (n = 17). Change in serum 25(OH)D was the primary outcome as assessed by LC/MS/MS. Serum lipids were assessed using standard techniques, and acceptability to consuming the eggs was assessed via a questionnaire.. Forty-two (82%) participants completed the study. Mean adherence to the eggs was 83% for controls, 86% for 7 eggs/wk, and 83% for 12 eggs/wk. Mean serum 25(OH)D concentrations did not change significantly in either the 7-eggs/wk (-8.3 nmol/L; 95% CI: -17.0, 0.4 nmol/L) or 12-eggs/wk (-7.2 nmol/L; 95% CI: -18.6, 4.3 nmol/L) groups, but decreased by 28.6 nmol/L (95% CI: -38.1, -18.9 nmol/L) in controls, which led to a significant (P = 0.003) between-group difference for the change after 12 wk. Serum lipids did not differ between the groups, and acceptability profiles to consuming the eggs were positive and similar for all 3 groups.. Consuming 7 commercially available eggs per week for 12 wk was effective for attenuating the wintertime decline in circulating vitamin D concentrations in young Australian adults, with 12 eggs/wk not providing any additional benefits.

Topics: Australia; Calcifediol; Cholecalciferol; Dietary Supplements; Double-Blind Method; Humans; Tandem Mass Spectrometry; Vitamin D; Vitamin D Deficiency; Vitamins; Young Adult

This study investigated whether UVB-exposed wheat germ oil (WGO) is capable to improving the vitamin D status in healthy volunteers.. Participants who received the UVB-exposed WGO were characterized by an increase of circulating 25(OH)D. UVB-exposed WGO containing 23.7 µg vitamin D can increase 25(OH)D. ClinicalTrials.gov: NCT03499327 (registered, April 13, 2018).

Topics: 25-Hydroxyvitamin D 2; Calcifediol; Cholecalciferol; Chromatography, Liquid; Ergocalciferols; Female; Humans; Male; Plant Oils; Tandem Mass Spectrometry; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D deficiency is frequently found in patients with chronic obstructive pulmonary disease (COPD). Vitamin D has antimicrobial, anti-inflammatory, and immunomodulatory effects. Therefore, supplementation may prevent COPD exacerbations, particularly in deficient patients.. We aimed to assess the effect of vitamin D supplementation on exacerbation rate in vitamin D-deficient patients with COPD.. We performed a multicenter, double-blind, randomized controlled trial. COPD patients with ≥1 exacerbations in the preceding year and a vitamin D deficiency (15-50 nmol/L) were randomly allocated in a 1:1 ratio to receive either 16,800 International Units (IU) vitamin D3 or placebo once a week during 1 y. Primary outcome of the study was exacerbation rate. Secondary outcomes included time to first and second exacerbations, time to first and second hospitalizations, use of antibiotics and corticosteroids, pulmonary function, maximal respiratory mouth pressure, physical performance, skeletal muscle strength, systemic inflammatory markers, nasal microbiota composition, and quality of life.. The intention-to-treat population consisted of 155 participants. Mean ± SD serum 25-hydroxyvitamin D [25(OH)D] concentration after 1 y was 112 ± 34 nmol/L in the vitamin D group, compared with 42 ± 17 nmol/L in the placebo group. Vitamin D supplementation did not affect exacerbation rate [incidence rate ratio (IRR): 0.90; 95% CI: 0.67, 1.21]. In a prespecified subgroup analysis in participants with 25(OH)D concentrations of 15-25 nmol/L (n = 31), no effect of vitamin D supplementation was found (IRR: 0.91; 95% CI: 0.43, 1.93). No relevant differences were found between the intervention and placebo groups in terms of secondary outcomes.. Vitamin D supplementation did not reduce exacerbation rate in COPD patients with a vitamin D deficiency.This trial was registered at clinicaltrials.gov as NCT02122627.

Topics: Cholecalciferol; Dietary Supplements; Double-Blind Method; Humans; Pulmonary Disease, Chronic Obstructive; Quality of Life; Vitamin D; Vitamin D Deficiency

Accumulating evidence suggests that potential cardiovascular benefits of vitamin D supplementation may be restricted to individuals with very low 25-hydroxyvitamin D (25(OH)D) concentrations; the effect of vitamin D on blood pressure (BP) remains unclear. We addressed this issue in a post hoc analysis of the double-blind, randomized, placebo-controlled Styrian Vitamin D Hypertension Trial (2011−2014) with 200 hypertensive patients with 25(OH)D levels <30 ng/mL. We evaluated whether 2800 IU of vitamin D3/day or placebo (1:1) for 8 weeks affects 24-hour systolic ambulatory BP in patients with 25(OH)D concentrations <20 ng/mL, <16 ng/mL, and <12 ng/mL and whether achieved 25(OH)D concentrations were associated with BP measures. Taking into account correction for multiple testing, p values < 0.0026 were considered significant. No significant treatment effects on 24-hour BP were observed when different baseline 25(OH)D thresholds were used (all p-values > 0.30). However, there was a marginally significant trend towards an inverse association between the achieved 25(OH)D level with 24-hour systolic BP (−0.196 per ng/mL 25(OH)D, 95% CI (−0.325 to −0.067); p = 0.003). In conclusion, we could not document the antihypertensive effects of vitamin D in vitamin D-deficient individuals, but the association between achieved 25(OH)D concentrations and BP warrants further investigations on cardiovascular benefits of vitamin D in severe vitamin D deficiency.

Topics: Blood Pressure; Calcifediol; Cholecalciferol; Dietary Supplements; Double-Blind Method; Humans; Hypertension; Vitamin D; Vitamin D Deficiency; Vitamins

Obese children are at high risk of developing vitamin D deficiency. Omega-3 polyunsaturated fatty acids and their derivatives might have a beneficial effect on vitamin D status of obese children, due to their anti-inflammatory action, and increasing its absorption. This multicenter, randomized, double-blind controlled study aims to investigate the effect of vitamin D and docosahexaenoic acid (DHA) co-supplementation for six months on vitamin D status, body composition, and metabolic markers of obese children with vitamin D deficiency. A total of 108 children were enrolled and 73 children completed the study: 33 were supplemented with an oral dose of 500 mg of DHA and 1200 IU/day of vitamin D3 and 41 were supplemented with 1200 IU/day of vitamin D3 + wheat germ oil. At the end of the study, more than 50% of the subjects improved their vitamin D status. However, co-supplementation was not more effective than vitamin D plus wheat germ oil. Fat mass percentage was significantly reduced, and body mass index improved in both groups, even if all the subjects were still obese at the end of the study. Children receiving both vitamin D and DHA presented a higher increase of DHA levels that could be relevant to prevent inflammatory-associated complications of obesity, but they had no effect on vitamin D levels.

Topics: Body Composition; Child; Cholecalciferol; Dietary Supplements; Docosahexaenoic Acids; Double-Blind Method; Humans; Pediatric Obesity; Vitamin D; Vitamin D Deficiency; Vitamins

Observational studies suggest that vitamin D deficiency among people living with HIV is associated with a greater risk of disease progression and death. Low levels of vitamin D in pregnancy are also associated with poor fetal and infant growth. Therefore, vitamin D supplementation may improve clinical outcomes for pregnant women living with HIV and improve fetal and postnatal growth for their infants.. We conducted a randomized, triple-blind, placebo-controlled trial of vitamin D3 supplementation among pregnant and lactating women living with HIV in Dar es Salaam, Tanzania (ClinicalTrials.gov NCT02305927). Participants were randomized with 1:1 allocation stratified by study clinic to receive either daily 3,000 IU vitamin D3 supplements or matching placebo supplements from the second trimester of pregnancy (12-27 weeks) until 1 year postpartum. The primary outcomes were (i) maternal HIV progression or death, (ii) small-for-gestational-age (SGA) live births (<10th percentile), and (iii) infant stunting at 1 year of age (length-for-age z-score < -2). We also examined the effect of vitamin D3 supplementation on secondary maternal and infant health outcomes, maternal and infant serum 25-hydroxyvitamin D (25[OH]D) concentrations, and maternal hypercalcemia. An intent-to-treat analysis was used as the primary analytic approach. We enrolled 2,300 pregnant women between June 15, 2015, and April 17, 2018, and follow-up of mothers and infants was completed on October 20, 2019. There were 1,148 pregnant women randomly assigned to the vitamin D3 group, and 1,152 to the placebo group. The proportion of mothers lost to follow-up at 1 year postpartum was 6.6% in the vitamin D3 group (83 of 1,148) and 6.6% in the placebo group (76 of 1,152). The proportion of children lost to follow-up at 1 year of age was 5.5% in the vitamin D3 group (59 of 1,074 live births) and 5.2% in the placebo group (57 of 1,093 live births). There was no difference in the risk of maternal HIV progression or death, with 166 events during 1,461 person-years of follow-up in the vitamin D3 group and 141 events during 1,469 person-years of follow-up in the placebo group (hazard ratio 1.21, 95% CI 0.97 to 1.52, p = 0.09). There was no difference in the risk of SGA birth between the vitamin D3 (229 SGA births among 1,070 live births) and placebo groups (236 SGA births among 1,091 live births) (relative risk 1.03, 95% CI 0.87 to 1.22, p = 0.70). There was also no difference in the risk of infant stunting at 1 year of age between the vitamin D3 (407 events among 867 infants) and placebo groups (413 events among 873 infants) (relative risk 1.00, 95% CI 0.92 to 1.10, p = 0.95). In terms of adverse events, no cases of maternal hypercalcemia were identified. One hypersensitivity reaction to the trial supplements occurred for a pregnant woman in the placebo group. A limitation of our study is that our finding. The trial findings do not support routine vitamin D supplementation for pregnant and lactating women living with HIV in Tanzania.. ClinicalTrials.gov Identifier: NCT02305927.

Topics: Child; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Growth Disorders; HIV Infections; Humans; Hypercalcemia; Infant; Lactation; Pregnancy; Tanzania; Vitamin D; Vitamin D Deficiency

Type 2 diabetes (T2D) is an epidemic public health concern with considerable morbidity and mortality. Previous research has shown the association between T2D and vitamin D deficiency. This vitamin significantly affects insulin function, which plays a critical role in T2D development.. A prospective double-blinded randomized controlled trial was conducted to test the hypothesis that vitamin D3 (VD3) supplementation can correct VD deficiency without the risk of hypervitaminosis.. The participants of this study included 62 patients with T2D and hypovitaminosis D3. Of these patients, 30 received cholecalciferol (50,000 IU weekly for 8 weeks), and 32 received identical placebo tablets for 8 weeks. Before and after the intervention, patients were subjected to VD3 level assessment through fasting blood samples.. After 8 weeks of intervention, the mean changes in serum VD3 levels in the VD3 group were significant compared to the placebo group (i.e., 21.9 ± 10 vs. 1.2 ± 7 ng/ml, P < 0.001). Also, comparing serum D3 levels of the endpoint with the baseline revealed statistically significant changes in the VD3 group (40 ± 10 vs. 18.1 ± 6 ng/ml, P < 0.001) but no significant change in the placebo group (18.9 ± 7 vs. 20.1 ± 7, P = 0.37).. The results showed that administering a weekly dose of VD3 supplement could improve serum levels above 30 ng/ml in patients with T2D and compensate for vitamin deficiency without the risk of hypervitaminosis, which occurs at the levels above 100 ng/ml of 25(OH)D. However, further large-scale studies are needed to determine if these findings are applicable.

Topics: Cholecalciferol; Diabetes Mellitus, Type 2; Dietary Supplements; Double-Blind Method; Humans; Prospective Studies; Vitamin D; Vitamin D Deficiency; Vitamins

Although vitamin D deficiency is highly prevalent in the Middle East, very few studies have attempted to measure its health impact.. We aimed to assess whether vitamin D3 and calcium, either alone or in combination, have health benefit.. In a 2 × 2 factorial design double-blind, placebo-controlled trial, Community free living adults living in the city of Al Ain, UAE were randomly assigned to receive daily 2000 IU oral vitamin D3 alone, 600 mg calcium alone, oral vitamin D3 (2000 IU per day) combined with 600 mg calcium, or a placebo for 6 months. Primary outcomes were self-rated health and bone turnover markers.. Of the 545 randomized, 277 subjects completed 6 months follow up. 25(OH)D levels marginally increased in the two groups received vitamin D3 alone or combined with calcium compared to the decline seen in those who received calcium supplement alone or a placebo. Sub-group analysis revealed that parathyroid hormone (PTH) concentration decreased and Calcium/creatinine ratio increased significantly in the combined vitamin D and Calcium group compared to the vitamin D alone or Calcium alone in contrast to the increase seen in the placebo group [p < 0.05 for between group difference at 6 months]. There were no statistically significant differences between the supplement and placebo groups at the 6 months follow-up in body weight, body mass index (BMI), blood pressure, body pains and general health.. PTH concentration decreased and calcium/creatinine ratio increased in subjects who received vitamin D and Calcium together compared to those who received vitamin D alone.. NCT02662491 , First registered on 25 January 2016 ( https://register.. gov/prs/app/action/SelectProtocol?sid=S00060CE&selectaction=Edit&uid=U0001M6P&ts=3&cx=scu4cb , Last update: 05 August 2019.

Topics: Adult; Calcium; Calcium, Dietary; Cholecalciferol; Creatinine; Dietary Supplements; Humans; Independent Living; Parathyroid Hormone; Vitamin D; Vitamin D Deficiency; Vitamins

To investigate separate and combined effects of vitamin D supplementation during the extended winter and increased dairy protein intake on muscle strength and physical function in children, and furthermore to explore potential sex differences.. Overall, vitamin D and dairy protein supplementation during the extended winter did not affect muscle strength or physical function in healthy children. Potential sex differences of vitamin D supplementation should be investigated further. REGISTERED AT CLINICALTRIALS.GOV: NCT0395673.

Topics: Child; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Hand Strength; Humans; Male; Milk Proteins; Muscle Strength; Sex Factors; Vitamin D Deficiency

Vitamin D plays an important role in proliferation and differentiation of cells and deficiency of vitamin D disturbs angiogenic balance. Previous studies in animal models have reported an association between serum levels of vitamin D and balance between pro- and anti-angiogenic factors. There is insufficient evidence about the effect of vitamin D on mediators of angiogenesis in patients with CKD. We investigated the effect of cholecalciferol supplementation on serum levels of angiogenic markers in non-diabetic patients with CKD stage 3-4. In this secondary analysis on stored samples of our previously published randomized, double-blind, placebo-controlled trial, stable patients of either sex, aged 18-70 years, with non-diabetic CKD stage 3-4 and vitamin D deficiency (serum 25-hydroxyvitamin D ≤20 ng/ml) were randomized to receive either two directly observed oral doses of cholecalciferol (300,000 IU) or matching placebo at baseline and 8 weeks. The primary outcome was change in brachial artery flow-mediated dilatation at 16 weeks. Changes in levels of serum angiogenesis markers (angiopoietin-1, angiopoietin-2, VEGF-A, VEGEF-R, and Tie-2) between groups over 16 weeks were compared. A total 120 patients were enrolled. Supplementation with cholecalciferol led to significant improvement in FMD. Serum 25(OH)D levels were similar in both groups at baseline (13.21±4.78 ng/ml and 13.40±4.42 ng/ml; p = 0.888). At 16 weeks, the serum 25(OH)D levels increased in the cholecalciferol group but not in the placebo group (between-group difference in mean change:23.40 ng/ml; 95% CI, 19.76 to 27.06; p<0.001). Serum levels of angiogenic markers were similar at baseline. At 16 weeks, angiopoietin-2 level decreased in cholecalciferol group (mean difference:-0.73 ng/ml, 95%CI, -1.25 to -0.20, p = 0.002) but not in placebo group (mean difference -0.46 ng/ml, 95%CI, -1.09 to 0.17, p = 0.154), however there was no between-group difference at 16 weeks (between-group difference in mean change: -0.27 ng/ml, 95%CI, -1.09 to 0.55, p = 0.624). Serum angiopoietin-1 level increased [mean change: 5.63 (0.51 to 10.75), p = 0.018] and VEGF-R level decreased [mean change: -87.16 (-131.89 to -42.44), p<0.001] in placebo group but did not show any change in cholecalciferol group. Our data shows the changes in Ang-1, Ang-2 and Ang-1/Ang-2 ratio after high dose oral cholecalciferol supplementation in patients with non-diabetic G3-4 CKD. The data suggests changes in circulating levels of angiogeni

Topics: Angiopoietin-1; Angiopoietin-2; Biomarkers; Cholecalciferol; Dietary Supplements; Double-Blind Method; Humans; Renal Insufficiency, Chronic; Vitamin D; Vitamin D Deficiency; Vitamins

Current therapeutic strategies for. Twenty subjects were enrolled in this prospective randomized controlled study. One subject dropped out due to lack of contact with the guardian after discharge and one subject dropped out due to withdrawal of consent. Thus, 18 patients with CDI and vitamin D insufficiency (vitamin D level < 17 ng/mL) were divided into two groups: CDI with vitamin D supplementation (n = 8) and CDI without vitamin D supplementation (control: n = 10). Subjects with vitamin D insufficiency were randomized to receive 200,000 IU intramuscular cholecalciferol whereas patients in the control group received only oral vancomycin. Stool samples were obtained twice before vancomycin was administered and eight weeks after treatment; the V3-V4 16S rRNA metagenomic sequencing was performed using EzBioCloud.. The alpha diversity of the gut microbiota in the recovery state was significantly higher than that in the CDI state. Analysis of bacterial relative abundance showed significantly lower. Our study confirmed that the increase in the abundance of beneficial bacteria such as

Topics: Bacteria; Cholecalciferol; Clostridioides difficile; Clostridium Infections; Dietary Supplements; Gastrointestinal Microbiome; Humans; Prospective Studies; RNA, Ribosomal, 16S; Vancomycin; Vitamin D; Vitamin D Deficiency

Recent studies showed that a low 25-hydroxyvitamin D (25(OH)D) level was associated with a higher risk of morbidity and severe course of COVID-19. Our study aimed to evaluate the effects of cholecalciferol supplementation on the clinical features and inflammatory markers in patients with COVID-19. A serum 25(OH)D level was determined in 311 COVID-19 patients. Among them, 129 patients were then randomized into two groups with similar concomitant medication. Group I (n = 56) received a bolus of cholecalciferol at a dose of 50,000 IU on the first and the eighth days of hospitalization. Patients from Group II (n = 54) did not receive the supplementation. We found significant differences between groups with the preferential increase in serum 25(OH)D level and Δ 25(OH)D in Group I on the ninth day of hospitalization (p < 0.001). The serum 25(OH)D level on the ninth day was negatively associated with the number of bed days (r = −0.23, p = 0.006); we did not observe other clinical benefits in patients receiving an oral bolus of cholecalciferol. Moreover, in Group I, neutrophil and lymphocyte counts were significantly higher (p = 0.04; p = 0.02), while the C-reactive protein level was significantly lower on the ninth day of hospitalization (p = 0.02). Patients with supplementation of 100,000 IU of cholecalciferol, compared to those without supplementation, showed a decrease in the frequencies of CD38++CD27 transitional and CD27−CD38+ mature naive B cells (p = 0.006 and p = 0.02) and an increase in the level of CD27−CD38− DN B cells (p = 0.02). Thus, the rise in serum 25(OH)D level caused by vitamin D supplementation in vitamin D insufficient and deficient patients may positively affect immune status and hence the course of COVID-19.

Topics: Biomarkers; Cholecalciferol; COVID-19 Drug Treatment; Dietary Supplements; Humans; Vitamin D; Vitamin D Deficiency

The vitamin D and microRNA (miR) systems may play a role in the pathogenesis of cardiometabolic disorders, including hypertension. The HYPODD study was a double-blind placebo-controlled trial aiming to assess the effects of cholecalciferol treatment in patients with well-controlled hypertension and hypovitaminosis D (25OHD levels < 50 nmol/L). In addition to this clinical trial, we also evaluated the effects of cholecalciferol and calcitriol treatment on miR-21 expression in vivo and in vitro, respectively. Changes in the cardiovascular risk profiles were evaluated in HYPODD patients treated with cholecalciferol (C-cohort) or with placebo (P-cohort). The miR-21circulating levels were measured in four C-cohort patients and five P-cohort patients. In vitro, the miR-21 levels were measured in HEK-293 cells treated with calcitriol or with ethanol vehicle control. Cholecalciferol treatment increased 25OHD levels and reduced parathormone, total cholesterol, and low-density lipoprotein cholesterol levels in C-cohort patients, whereas no significant changes in these parameters were observed in P-cohort patients. The miR-21 circulating levels did not change in the C- or the P-cohort patients upon treatment. Calcitriol treatment did not affect miR-21 levels in HEK-293 cells. In conclusion, hypovitaminosis D correction ameliorated the cardiovascular risk profiles in hypertensive patients treated with cholecalciferol but did not influence the miR-21 expression.

Topics: Calcitriol; Cardiovascular Diseases; Cholecalciferol; Cholesterol; Dietary Supplements; Double-Blind Method; Heart Disease Risk Factors; HEK293 Cells; Humans; Hypertension; MicroRNAs; Risk Factors; Vitamin D; Vitamin D Deficiency; Vitamins

Randomized controlled trials (RCTs) of vitamin D (VitD) supplementation for depression have yielded inconsistent results. We conducted the first RCT of VitD supplementation with multipoint serum 25(OH)D assessments in major depressive disorder (MDD) patients with concurrent severe VitD deficiency.. We randomized antidepressant-free depressed adults with mean baseline 25(OH)D of 11.5 ng/ml to VitD (60,000 IU every 5 days; n = 31) or placebo (n = 28) for 12 weeks. All patients also received escitalopram (10-20 mg/day). Patients were rated at baseline and at the end of weeks 4, 8, and 12. Serum 25(OH)D was estimated at baseline, week 8, and week 12.. In an intent-to-treat analysis, mean Hamilton Depression Scale scores dropped from 25.7 to 5.7 and from 25.8 to 5.0 in VitD and placebo groups, respectively (primary outcome; P = 0.92). VitD and placebo groups did not differ on other objective and subjective ratings of depression, or on global ratings. Similar findings characterized completer analyses. No significant correlations were observed between 25(OH)D levels and depression ratings across the course of the study. Importantly, endpoint escitalopram doses were 4 mg/day higher in placebo than in VitD patients, and 4 mg/day higher in VitD deficient than in VitD sufficient patients.. A ceiling effect with escitalopram may have prevented the discovery of benefits with VitD supplementation.. VitD supplementation does not improve antidepressant outcomes with flexibly dosed escitalopram. VitD deficient depressed patients may require higher antidepressant doses to experience benefits similar to those whose deficiency is corrected by VitD supplementation.

Topics: Adult; Cholecalciferol; Depressive Disorder, Major; Dietary Supplements; Double-Blind Method; Humans; Vitamin D; Vitamin D Deficiency; Vitamins

Low 25-hydroxyvitamin D (25OHD) levels are common in patients with chronic heart failure (HF) and are associated with increased mortality risk. This study aimed to establish the safety and efficacy of oral vitamin D3 (cholecalciferol) supplementation and its effect on endothelial and ventricular function in patients with stable HF.. This study was an investigator-initiated, multicenter, prospective, randomized, placebo-controlled trial. Seventy-three HF patients with 25OHD levels < 75 nmol/L (30 ng/mL) were randomized to receive 4000 IU vitamin D daily or a placebo for 6 months. The primary endpoint was a change in endothelial function between the baseline and after 6 months as assessed using EndoPAT. Secondary endpoints included changes in echocardiographic parameters and differences in quality of life (6-min walking test and New York Heart Association functional status) at 6 months.. There were no adverse events in either group during the study period. Vitamin D supplementation did not improve endothelial dysfunction (EndoPAT: baseline, 1.19 ± 0.4 vs 6 months later, 1.22 ± 0.3, P = .65). However, patients' blood pressure, 6-min walking distance, and EQ-5D questionnaire scores improved after vitamin D treatment. In addition, a significant reduction in the left atrial diameter was observed.. A daily vitamin D dose of 4000 IU for chronic HF appears to be safe. This dosage did not improve endothelial function but did improve the 6-min walk distance, symptoms, and left atrial diameter at 6 months.

Topics: Cholecalciferol; Dietary Supplements; Double-Blind Method; Heart Failure; Humans; Prospective Studies; Quality of Life; Ventricular Function; Vitamin D; Vitamin D Deficiency; Vitamins

There has been a growing interest in the role of vitamin D for the well-being and physical performance of humans under heavy training such as conscripts in military service; however, there is a lack of long-term supplementation studies performed on members of this type of young, physically active, male population. The hypothesis of the study was that vitamin D supplementation during wintertime will decrease the prevalence of critically low vitamin D blood serum levels and increase hand grip strength during the winter season among young male conscripts.. Longitudinal, triple-blinded, randomized, placebo-controlled trial.. Fifty-three male conscripts from the Estonian Army were randomized into two groups: 27 to an intervention group and 26 to a placebo group. The groups were comparable in terms of their demographics. The intervention group received 1200 IU (30 µg) capsules of vitamin D3, and the control group received placebo oil capsules once per day. The length of the follow-up was 7 months, from October 2016 until April 2017. Blood serum vitamin D (25(OH)D), parathyroid hormone (PTH), calcium (Ca), ionized calcium (Ca-i), testosterone and cortisol values, and hand grip strength were measured four times during the study period.. The mean 25(OH)D level decreased significantly in the control group to a critically low level during the study, with the lowest mean value of 22 nmol/l found in March 2017. At that time point, 65% in the control group vs 15% in the intervention group had 25(OH)D values of less than 25 nmol/l (p < 0.001). In the intervention group, the levels of 25(OH)D did not change significantly during the study period. All other blood tests revealed no significant differences at any time point. The corresponding result was found for hand grip strength at all time points.. Long-term vitamin D supplementation during wintertime results in fewer conscripts in the Estonian Army with critically low serum vitamin D (25(OH)D) levels during the winter season. However, this did not influence their physical performance in the form of the hand grip strength test.

Topics: Calcium; Calcium, Dietary; Cholecalciferol; Dietary Supplements; Hand Strength; Humans; Male; Vitamin D; Vitamin D Deficiency; Vitamins

University students are a high-risk group for stress, consumption of junk food and significant weight gain over a short period. Inadequate vitamin D intake has been linked to many health issues, including chronic headache, apathy, aggression and depression. Furthermore, vitamin D deficiency led to dysbiosis of the gut microbiota. The purpose of our study was to estimate the effect of 90-days healthy lifestyle programs along with gut microbiota modulation in university students with vitamin D3 deficiency.. In this randomized controlled trial, 130 students (18-25 years old) with vitamin D deficiency were recruited. Both the standard care group (N.=65) and the intervention group (N.=65) received a 3-months course of individually selected nutrition program and physical activity (8000-10,000 steps daily). The intervention group received an additional treatment with synbiotic Acidolac and vitamin D3 for 3 months. The psycho-emotional status of the participants was assessed by a validated questionnaire that examined situational anxiety. In all students, blood pressure, anthropometric variables, as well as laboratory metabolic parameters, were recorded.. In both groups, vitamin D3 deficiency was associated with instability and lability of mental processes, mood swings, bad sleep, high rates of stuck and agitation for any problem. Combined therapy (diet, physical activity and synbiotic) induced a significant improvement in the psycho-emotional state of students. The 90-days therapy vitamin D3 increased the level of vitamin D3 in serum in the intervention group. Lastly, we observed a decrease in the body weight, body mass index, waist circumference and fatty mass, only in students included in the interventional group.. Nutrition program, physical activity, vitamin D3 intake and gut microbiota modulation led to both the improvement in vitamin D levels in serum and emotional harmonization.

Topics: Adolescent; Adult; Cholecalciferol; Exercise; Gastrointestinal Microbiome; Healthy Lifestyle; Humans; Students; Vitamin D; Vitamin D Deficiency; Vitamins; Young Adult

Vitamin D supplements are widely recommended for bone health in the general population, but data on whether they prevent fractures have been inconsistent.. In an ancillary study of the Vitamin D and Omega-3 Trial (VITAL), we tested whether supplemental vitamin D. Among 25,871 participants (50.6% women [13,085 of 25,871] and 20.2% Black [5106 of 25,304]), we confirmed 1991 incident fractures in 1551 participants over a median follow-up of 5.3 years. Supplemental vitamin D. Vitamin D

Topics: Aged; Cholecalciferol; Dietary Supplements; Double-Blind Method; Fatty Acids, Omega-3; Female; Fractures, Bone; Hip Fractures; Humans; Male; Middle Aged; Osteoporosis; Vitamin D Deficiency

Background: 25-hydroxy vitamin D (Vit D)-deficiency is common among patients with chronic kidney disease (CKD) and contributes to cardiovascular disease (CVD). African Americans (AAs) suffer disproportionately from CKD and CVD, and 80% of AAs are Vit D-deficient. The impact of Vit D repletion on cardio-renal biomarkers in AAs is unknown. We examined Vit D repletion on full-length osteopontin (flOPN), c-terminal fibroblast growth factor-23 (FGF-23), and plasminogen activator inhibitor-1 (PAI-1), which are implicated in vascular and kidney pathology. Methods: We performed a randomized, placebo-controlled study of high-risk AAs with Vit D deficiency, treated with 100,000 IU Vit D3 (cholecalciferol; n = 65) or placebo (n = 65) every 4 weeks for 12 weeks. We measured kidney function (CKD-EPI eGFR), protein-to-creatinine ratio, vascular function (pulse wave velocity; PWV), augmentation index, waist circumference, sitting, and 24-h-ambulatory blood pressure (BP), intact parathyroid hormone (iPTH) and serum calcium at baseline and study end, and compared Vit D levels with laboratory variables. We quantified plasma FGF-23, PAI-1, and flOPN by enzyme-linked immunosorbent assay. Multiple regression analyzed the relationship between log flOPN, FGF-23, and PAI-1 with vascular and renal risk factors. Results: Compared to placebo, Vit D3 repletion increased Vit D3 2-fold (p < 0.0001), decreased iPTH by 12% (p < 0.01) and was significantly correlated with PWV (p < 0.009). Log flOPN decreased (p = 0.03), log FGF-23 increased (p = 0.04), but log PAI-1 did not change. Multiple regression indicated association between log flOPN and PWV (p = 0.04) and diastolic BP (p = 0.02), while log FGF-23 was associated with diastolic BP (p = 0.05), and a trend with eGFR (p = 0.06). Conclusion: Vit D3 repletion may reduce flOPN and improve vascular function in high risk AAs with Vit D deficiency.

Topics: Biomarkers; Black or African American; Blood Pressure Monitoring, Ambulatory; Cardiovascular Diseases; Cholecalciferol; Fibroblast Growth Factors; Humans; Parathyroid Hormone; Plasminogen Activator Inhibitor 1; Pulse Wave Analysis; Renal Insufficiency, Chronic; Vitamin D Deficiency; Vitamins

Vitamin D insufficiency is common in patients suffering from end-stage renal disease (ESRD). In contrast, vitamin D supplementation could improve the status of ESRD patients (ESRDP). However, this effect's molecular mechanism is not fully understood. Therefore, this study aimed to assess vitamin D supplementation's impact on inflammation and oxidative signaling pathways in ESRDP. 104 ESRDP were divided into placebo (53) and vitamin D (51) groups. They were also categorized into four subgroups based on the severity of vitamin D deficiency. The dose of vitamin D3 (0.25-0.5mg/day) supplementation was determined based on plasma levels of calcium and parathyroid hormone (PTH). Vitamin D supplementation was performed for eight weeks. Serum levels of calcium, phosphorus, PTH, albumin, creatinine, ALP, and glomerular filtration along with antioxidant enzymes, malondialdehyde, and pro-inflammatory factors were measured. Moreover, the Nrf2 and NF-ĸB expression was evaluated in whole blood. According to the results, vitamin D supplementation improved the status of patients with ESRD significantly as compared with the placebo group (p<0.05). In addition, the expression of NF-ĸB and the serum levels of pro-inflammatory factors and malondialdehyde were significantly reduced. Finally, the expression of Nrf-2 and the serum of antioxidant enzymes were raised in the vitamin D group as compared with the placebo group (p<0.05). Vitamin D reduces clinical and metabolic symptoms in ESRDP by modulating gene expression (in oxidative stress and inflammation).

Topics: Antioxidants; Biomarkers; Calcium; Cholecalciferol; Dietary Supplements; Humans; Inflammation; Kidney Failure, Chronic; Malondialdehyde; NF-kappa B; Oxidative Stress; Parathyroid Hormone; Vitamin D; Vitamin D Deficiency; Vitamins

Nuclear Factor-κB (NF-κB) is an important member of the basic cellular inflammatory pathway that regulates inflammation and apoptosis in fetal membranes. Vitamin D (VD) exerts its anti-inflammatory and immunomodulatory effects via the NF-κB pathway. This study was designed to investigate amniotic fluid NF-κB levels in pregnant women undergoing VD replacement therapy.. Sixty patients who received antenatal vitamin D supplementation from the 14th week of pregnancy until delivery were included in the study. Participants were selected among those whose serum vitamin D levels were compatible with insufficiency (20-30 ng/mL), according to the Endocrine Society proposal. Participants were divided into three groups with 20 patients in each group and one of the cholecalciferol or placebo treatments was given. Patients in Group 1 were given 500 IU/day of cholecalciferol, while patients in Group 2 were given 1000 IU/day of cholecalciferol. Patients in group 3 were not given cholecalciferol treatment (placebo). Patients in all groups underwent elective cesarean section. Amniotic fluid samples were collected after the fetal membranes were cut and before the fetal parts were manually removed.. The amniotic fluid NF-κB level of the control group who did not receive VD replacement was 9.33±2.02 ng/mL. The amniotic fluid NF-κB level of the 500 IU/day VD replacement group was found to be 6.12±1.23 ng/mL. Compared to the control group, NF-κB levels of pregnant women given 500 IU/day VD replacement were significantly lower (9.33±2.02 ng/mL vs. 6.12±1.23 ng/mL, p<0.03). The amniotic fluid NF-κB level of the 1000 IU/day VD replacement group was found to be 3.09±0.44 ng/mL. Compared to the control group, amniotic fluid NF-κB levels of pregnant women given 1000 IU/day VD replacement were significantly lower (9.33±2.02 ng/mL vs. 3.09±0.44 ng/mL, p<0.01). When the VD replacement groups were compared among themselves, the amniotic fluid NF-κB level decreased approximately twice as much in the 1000 IU/day replacement group compared to the 500 IU/day replacement group (3.09±0.44 ng/mL vs. 6.12±1.23 ng/mL, p<0.01). A negative correlation was found between amniotic fluid NF-κB level and VD dose (r=-0.789, p<0.04).. The present study showed for the first time that amniotic fluid NF-κB levels decreased in pregnant women who underwent VD replacement dose dependent manner.

Topics: Amniotic Fluid; Cesarean Section; Cholecalciferol; Dietary Supplements; Extraembryonic Membranes; Female; Humans; NF-kappa B; Pregnancy; Vitamin D; Vitamin D Deficiency; Vitamins

A way to maintain an adequate vitamin D status is through supplementation. Demonstration of blood-metabolome rhythmicity of vitamin D3 post-dosing effects is lacking in the pharmaco-metabonomics area. Thus, the overall aim of this study was to investigate the diurnal changes in the blood metabolome and how these are affected by vitamin D3 supplementation. The study was conducted as a crossover study, and the treatment included 200 µg (8000 IU) of vitamin D3 as compared with placebo with a washout period of at least 10 days. The participants were postmenopausal women aged 60−80 years (N = 29) with vitamin D insufficiency (serum 25-hydroxyvitamin D < 50 nmol/L) but otherwise healthy. During the intervention day, blood samples were taken at 0 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, and 24 h, and plasma was analysed by proton nuclear magnetic resonance (NMR) spectroscopy as a metabolomics approach. In general, diurnal effects were identified for the majority of the 20 quantified metabolites, and hierarchical cluster analysis revealed a change in the overall plasma metabolome around 12 AM (6 h after intervention), suggesting that the diurnal rhythm is reflected in two diurnal plasma metabolomes; a morning metabolome (8−12 AM) and an afternoon/evening metabolome (2−8 PM). Overall, the effect of vitamin D supplementation on the blood metabolome was minor, with no effect on the diurnal rhythm. However, a significant effect of the vitamin D supplementation on plasma acetone levels was identified. Collectively, our findings reveal an influence of diurnal rhythm on the plasma metabolome, while vitamin D supplementation appears to have minor influence on fluctuations in the plasma metabolome.

Topics: Cholecalciferol; Cross-Over Studies; Dietary Supplements; Double-Blind Method; Female; Humans; Metabolome; Postmenopause; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D deficiency is a common finding in overweight/obese pregnant women and is associated with increased risk for adverse pregnancy outcome. Both maternal vitamin D deficiency and maternal obesity contribute to metabolic derangements in pregnancy. We aimed to assess the effects of vitamin D3 supplementation in pregnancy versus placebo on maternal and fetal lipids. Main inclusion criteria were: women <20 weeks’ gestation, BMI ≥ 29 kg/m2. Eligible women (n = 154) were randomized to receive vitamin D3 (1600 IU/day) or placebo. Assessments were performed <20, 24−28 and 35−37 weeks and at birth. Linear regression models were used to assess effects of vitamin D on maternal and cord blood lipids. In the vitamin D group significantly higher total 25-OHD and 25-OHD3 levels were found in maternal and cord blood compared with placebo. Adjusted regression models did not reveal any differences in triglycerides, LDL-C, HDL-C, free fatty acids, ketone bodies or leptin between groups. Neonatal sum of skinfolds was comparable between the two groups, but correlated positively with cord blood 25-OH-D3 (r = 0.34, p = 0.012). Vitamin D supplementation in pregnancy increases maternal and cord blood vitamin D significantly resulting in high rates of vitamin D sufficiency. Maternal and cord blood lipid parameters were unaffected by Vitamin D3 supplementation.

Topics: Body Fat Distribution; Cholecalciferol; Cholesterol, LDL; Diabetes, Gestational; Dietary Supplements; Fatty Acids, Nonesterified; Female; Humans; Infant, Newborn; Ketone Bodies; Leptin; Life Style; Obesity; Overweight; Pregnancy; Pregnancy Outcome; Pregnant Women; Triglycerides; Vitamin D; Vitamin D Deficiency; Vitamins

To compare the efficacy of sunlight exposure and oral vitamin D3 supplementation to achieve vitamin D sufficiency in infants at 6 months of age.. Open-label randomized controlled trial.. Public hospital in Northern India (28.7°N).. Breastfed infants at 6-8 weeks of age.. Randomized to receive sunlight exposure (40% body surface area for a minimum of 30 minutes/week) or oral vitamin D3 supplementation (400 IU/day) till 6 months of age.. Primary - proportion of infants having vitamin D sufficiency (>20 ng/mL). Secondary - proportion of infants developing vitamin D deficiency (<12ng/mL) and rickets in both the groups at 6 months of age.. Eighty (40 in each group) infants with mean (SD) age 47.8 (4.5) days were enrolled. The proportion of infants with vitamin D sufficiency increased after intervention in the vitamin D group from 10.8% to 35.1% (P=0.01) but remained the same in sunlight group (13.9%) and was significant on comparison between both groups (P=0.037). The mean (SD) compliance rate was 72.9 (3.4) % and 59.7 (23.6) % in the vitamin D and sunlight group, respectively (P=0.01). The geometric mean (95% CI) serum 25(OH) D levels in the vitamin D and sunlight group were 16.23 (13.58-19.40) and 11.89 (9.93-14.23) ng/mL, respectively; (P=0.02), after adjusting baseline serum 25(OH)D with a geometric mean ratio of 1.36 (1.06-1.76). Two infants in sunlight group developed rickets.. Oral vitamin D3 supplementation is more efficacious than sunlight in achieving vitamin D sufficiency in breastfed infants during the first 6 months of life due to better compliance.

Topics: Cholecalciferol; Dietary Supplements; Female; Humans; Infant; Middle Aged; Rickets; Sunlight; Vitamin D; Vitamin D Deficiency; Vitamins

Increase in the prevalence and survival rates has led to the assessment of disease activity and quality of life of SLE patients as targets in treatment. Cholecalciferol was considered as having a role in reducing disease activity and improving quality of life.. A double blind, randomized, controlled trial was conducted on female  outpatients aged 18-60 years with SLE, consecutively recruited from September to December 2021 at Cipto Mangunkusumo Hospital. Sixty subjects who met the research criteria were randomized and equally assigned into the cholecalciferol and placebo groups. The study outcomes were measured at baseline and after 12 weeks of intervention.. Out of 60 subjects, 27 subjects in cholecalciferol group and 25 subjects in placebo group completed the intervention. There was a significant improvement on the level of vitamin D (ng/ml) after intervention in the cholecalciferol group, from an average of 15,69 ng/ml (8.1-28.2) to 49,90 ng/ml (26-72.1), and for the placebo group from 15,0 ng/ml (8.1-25,0) to 17.35 ng/ml (8.1-48.3) (p<0,000). Results of the MEX-SLEDAI score showed significant differences in both groups after the intervention, with a significant decrease in the cholecalciferol group from 2,67 (0-11) to 1,37 (0-6), compared to the placebo group from 2,6 (0-6) to  2,48 (0-6) (p<0,001). There were no significant differences on the quality of life in both groups.. Supplementation of cholecalciferol 5000 IU/day for 12 weeks was statistically significant in increasing vitamin D levels and improving disease activity, but did not significantly improve the quality of life of SLE patients.

Topics: Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Lupus Erythematosus, Systemic; Quality of Life; Vitamin D; Vitamin D Deficiency; Vitamins

To analyze the concentration-time curves of single-dose oral 25(OH)D. Individual concentration-time curves revealed that vitamin D. Pharmacokinetics of 25(OH)D

Topics: Adult; Body Mass Index; Calcifediol; Cholecalciferol; Dietary Supplements; Double-Blind Method; Humans; Vitamin D; Vitamin D Deficiency

Ethiopian women have been reported to have low plasma 25-hydroxy-cholecalciferol (25(OH)D) concentrations despite an abundance of sunshine. Low dietary vitamin D intake, limited skin exposure to sun, and genetics are among factors suggested to affect vitamin D status in this population. In this study (Clinical Trial NCT02210884), we hypothesized that polymorphisms in the vitamin D binding protein (VDBP) gene (rs7041, rs4588) are associated with reduced plasma 25(OH)D concentrations in Ethiopian women. Lactating Ethiopian women (n = 110) were randomly assigned to weekly administration of vitamin D3 (15,000 IU) or a placebo. Plasma 25(OH)D was measured at baseline (within 2 weeks of delivery, before supplementation) and at 3, 6, and 12 months after delivery. Associations between VDBP polymorphism status for rs7041 and rs4588 and plasma 25(OH)D were determined by analysis of variance and multiple linear and logistic regressions. Multiple linear regression with maternal age as a covariate revealed that rs7041 is associated with reduced plasma 25(OH)D (P = .021) and more risk alleles at rs7041 and rs4588 are associated with reduced plasma 25(OH)D (P = .017). Logistic regression models for vitamin D insufficiency showed that additional risk alleles for rs7041 and rs4588 are associated with increased odds ratios (OR = 1.66; 95% CI, 1.10-2.62; P = .019) for plasma 25(OH)D below 40 nmol/L. Supplementation increased plasma 25(OH)D at 3 months in women with fewer risk alleles and across all genotypes at 6 and 12 months. VDBP polymorphisms may contribute to vitamin D insufficiency in Ethiopian lactating women. Furthermore, VDBP polymorphisms may blunt short-term responses to vitamin D supplementation and require longer periods of intervention.

Topics: Calcifediol; Cholecalciferol; Ethiopia; Female; Humans; Lactation; Polymorphism, Single Nucleotide; Vitamin D; Vitamin D Deficiency; Vitamin D-Binding Protein

To determine the effect of population level implementation of a test-and-treat approach to correction of suboptimal vitamin D status (25-hydroxyvitamin D (25(OH)D) <75 nmol/L) on risk of all cause acute respiratory tract infection and covid 19.. Phase 3 open label randomised controlled trial.. United Kingdom.. 6200 people aged ≥16 years who were not taking vitamin D supplements at baseline.. Offer of a postal finger prick test of blood 25(OH)D concentration with provision of a six month supply of lower dose vitamin D (800 IU/day, n=1550) or higher dose vitamin D (3200 IU/day, n=1550) to those with blood 25(OH)D concentration <75 nmol/L, compared with no offer of testing or supplementation (n=3100). Follow-up was for six months.. The primary outcome was the proportion of participants with at least one swab test or doctor confirmed acute respiratory tract infection of any cause. A secondary outcome was the proportion of participants with swab test confirmed covid-19. Logistic regression was used to calculate odds ratios and associated 95% confidence intervals. The primary analysis was conducted by intention to treat.. Of 3100 participants offered a vitamin D test, 2958 (95.4%) accepted and 2674 (86.3%) had 25(OH)D concentrations <75 nmol/L and received vitamin D supplements (n=1328 lower dose, n=1346 higher dose). Compared with 136/2949 (4.6%) participants in the no offer group, at least one acute respiratory tract infection of any cause occurred in 87/1515 (5.7%) in the lower dose group (odds ratio 1.26, 95% confidence interval 0.96 to 1.66) and 76/1515 (5.0%) in the higher dose group (1.09, 0.82 to 1.46). Compared with 78/2949 (2.6%) participants in the no offer group, 55/1515 (3.6%) developed covid-19 in the lower dose group (1.39, 0.98 to 1.97) and 45/1515 (3.0%) in the higher dose group (1.13, 0.78 to 1.63).. Among people aged 16 years and older with a high baseline prevalence of suboptimal vitamin D status, implementation of a population level test-and-treat approach to vitamin D supplementation was not associated with a reduction in risk of all cause acute respiratory tract infection or covid-19.. ClinicalTrials.gov NCT04579640.

Topics: Cholecalciferol; COVID-19; Dietary Supplements; Double-Blind Method; Humans; Respiratory Tract Infections; Vitamin D; Vitamin D Deficiency; Vitamins

Background: Vitamin D is considered to modulate T-cell function, which has been implicated in the treatment of inflammatory conditions. However, there is limited knowledge on the effects of vitamin D and its influences on circulating T-cell profiles in humans, particularly in overweight Black individuals who are more likely to be vitamin D insufficient (serum 25(OH)D concentrations of ≤20 ng/mL). Thus, this study tested the hypothesis that vitamin D supplementation modulates T-cell composition, which is in a dose-dependent manner. Methods: A 16-week randomized, double-blinded, placebo-controlled trial of vitamin D3 supplementation was undertaken in 70 overweight/obese Black people (mean age = 26 years, 82% female) with 25 hydroxyvitamin D ≤ 20 ng/mL at baseline. Subjects were randomly assigned a supervised monthly oral vitamin D3 equivalent to approximately 600 IU/day (n = 17), 2000 IU/day (n = 18), 4000 IU/day (n = 18), or a placebo (n = 17). Fresh peripheral whole blood was collected and CD3+, CD4+ and CD8+ cell counts and percentages were determined by flow cytometry at baseline and at 16 weeks, among 56 subjects who were included in the analyses. Results: A statistically significant increase in CD3+% in the 2000 IU/day vitamin D3 supplementation group, and increases in CD4+% in the 2000 IU/day and 4000 IU/day vitamin D3 supplementation groups were observed (p-values < 0.05) from the changes in baseline to 16 weeks. Further adjustments for age, sex and BMI showed that 2000 IU/day vitamin D3 supplementation increased in CD3+ count, CD3%, CD4 count, and CD4%, as compared to the placebo group (p-values < 0.05). Moreover, the highest serum 25(OH)D quantile group had the highest CD3% and CD4%. Conclusions: Sixteen-week vitamin D3 supplementation increases peripheral blood T-cell numbers and percentages in overweight/obese Black patients with vitamin D insufficiency. This resulting shift in circulating T-cell composition, particularly the increase in T helper cells (CD4+ cells), suggests that vitamin D supplementation may improve immune function in Black individuals.

Topics: Adult; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Male; Obesity; Overweight; Vitamin D; Vitamin D Deficiency; Vitamins

While vitamin D inadequacy occurs worldwide, there is a lack of consensus internationally on the optimum plasma levels of 25(OH)D to maximally suppress the level of parathyroid hormone toward reducing bone loss. This study aimed to investigate the response of intact parathyroid hormone (iPTH) to vitamin D3 supplementation among Malaysian women of reproductive age in a randomised double-blind placebo-control trial [NMRR-15-479-25680]. A total of 106 women who fulfilled the study inclusion criteria were randomly assigned to receive daily one of these three supplement doses (i) 600 IU vitamin D3 + 500 mg calcium; (ii) 1200 IU vitamin D3 + 500 mg calcium; or (iii) 4000 IU vitamin D3 + 500 mg calcium. The placebo group received daily 500 mg calcium. The outcome examined was change in plasma iPTH concentration in response to daily vitamin D3 supplementation for 16 weeks. Fasting blood sample was obtained at baseline and post-supplementation. A total of 78 subjects (73.6%) completed the intervention. None of the supplementation groups brought about any detectable suppression of iPTH concentration post-supplementation. Vitamin D3 supplementation resulted in overall increase in plasma 25(OH)D levels, but only the 4000 IU/day group showed a significant dose effect post-supplementation (mean 49.7 ± 26.5 nmol/L) compared to placebo (29.3 ± 13.3 nmol/L). The lack of iPTH suppression is attributed to high prevalence of vitamin D insufficiency at baseline and the supplementation regimen was inadequate to raise the 25(OH)D level to cause PTH suppression. Inadequate calcium intake of the participants was also a likely contributing factor to the result. As prolonged vitamin D insufficiency and hypocalcaemia could lead to a compensatory rise in PTH resulting in accelerated bone loss, as well as posing increasing risks of non-skeletal morbidities, further clinical trials with an adequately powered sample size should be undertaken over an appropriate study duration to verify the results obtained in this study.

Topics: Calcium; Calcium, Dietary; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Parathyroid Hormone; Vitamin D; Vitamin D Deficiency; Vitamins

A personalized vitamin D3 loading dose has not yet been tested in cancer patients. This interim analysis of the randomized, placebo-controlled VICTORIA trial analyzed the first recruited 74 German adults with nonmetastatic colorectal cancer, a tumor surgery within the past year, and 25-hydroxyvitamin D levels (25(OH)D) < 50 nmol/L. Study participants received a loading dose tailored for a baseline 25(OH)D level and BMI in the first 11 days, followed by a maintenance dose of 2000 IU of vitamin D3 daily until end of trial week 12. The mean 25(OH)D levels were 27.6, 31.0, and 34.1 nmol/L in the placebo group and 25.9, 63.1, and 75.5 nmol/L in the verum group during screening, visit 1 (end of loading dose), and visit 2 (end of maintenance dose), respectively. The prevalence of 25(OH)D) ≥ 50 nmol/L at visits 1 and 2 was 3.5% and 17.4% in the placebo group and 80.0% and 100% in the verum group. No events of 25(OH)D > 150 nmol/L or hypercalcemia were observed. Hypercalciuria events at visit 1 (n = 5 in verum and n = 1 in the placebo group; p = 0.209) receded after discontinuation of the study medication. The personalized loading dose effectively and safely increased the 25(OH)D levels, and 2000 IU of vitamin D3 daily sustained the achieved levels.

Topics: Adult; Cholecalciferol; Colorectal Neoplasms; Dietary Supplements; Double-Blind Method; Humans; Vitamin D; Vitamin D Deficiency; Vitamins

The study objectives were to ascertain the efficacy of vitamin D supplementation in rapidly increasing serum vitamin D and of implementation of a hybrid (virtual and in-person) trial.. Thirty-four (19 intervention, 15 control) subjects were randomized, with 28 (41%) virtual visits. After 44.78 ± 11.00 days from baseline, a significant adjusted group difference of 44.2 (34.7, 53.8) nmol/L was observed in the Δ 25(OH)D (95% CI) in favor of supplementation; 77.8% of intervention, and 13.3% of control, patients were vitamin D sufficient (OR:6.11, 95% CI:1.6, 22.9). The adherence to intervention was 94.7% in the intervention and 100% in the control groups. Irrespective of visit type, high adherence was observed in sampling procedures and completion of fortnightly online questionnaire. No adverse events attributable to vitamin D were reported.. The vitamin D supplementation rapidly and safely raised 25(OH)D levels to sufficient levels for a biological effect. Similarly high adherence to study procedures was observed with virtual and in-person participation.. This trial was registered at https://clinicaltrials.gov on July 23, 2020 (# NCT04483635 ).

Topics: Calcifediol; Cholecalciferol; Dietary Supplements; Double-Blind Method; Humans; Patient Care Team; Vitamin D; Vitamin D Deficiency; Vitamins

Data on the effect of vitamin D (Vit-D) supplementation on cardiorespiratory fitness (VO2max) are conflicting. A possible source of discrepancies in the literature is the heterogeneity in baseline Vit-D status among participants in previous studies. The main objectives of the present study were to assess the impact of Vit-D supplementation on VO2max and inflammatory status in Vit-D deficient young healthy men. Participants (n = 39, baseline serum Vit-D level < 50 nmol/L) were quasi-randomly assigned to one of the two groups, which, in a double-blind manner, supplemented their diet daily with either Vit-D (8000 IU; VD) or placebo (PLC) and concomitantly performed a 12-week supervised resistance training program. During the 12-week intervention, serum Vit-D concentrations increased 3.9-fold (p < 0.001) in the VD group while no changes occurred in the PLC group. Baseline VO2max did not differ in the two groups and remained unchanged during the intervention. Serum interleukin-10/tumour necrosis factor alpha ratio increased significantly (30%, p = 0.007; effect size 0.399) in VD but not in PLC group. In conclusion, 12-week Vit-D supplementation increases serum 25(OH)D levels and improves inflammatory status, but has no impact on VO2max in Vit-D deficient young men engaged in resistance training.

Topics: Cardiorespiratory Fitness; Cholecalciferol; Dietary Supplements; Double-Blind Method; Ergocalciferols; Humans; Male; Resistance Training; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D status and requirements of infants of women with gestational diabetes mellitus (GDM) are unclear.. The objectives were to assess vitamin D status in infants of mothers with GDM and compare vitamin D status in response to 400 vs. 1000 IU/d vitamin D supplementation in infants born with serum 25-hydroxyvitamin D [25(OH)D] <50 nmol/L.. Women with GDM delivering full-term infants (n = 98; March 2017-2019, Montreal, Canada) were surveyed for demographic and lifestyle factors. Pregnancy history was obtained from medical records. Newborn serum 25(OH)D was measured (immunoassay) and categorized as <30 (deficient) or ≥40 nmol/L (adequate). Breastfed neonates (n = 16) with serum 25(OH)D <50 nmol/L at birth were randomly assigned to 400 or 1000 IU/d of supplemental cholecalciferol (vitamin D. Mean newborn serum 25(OH)D was 46.4 (95% CI: 43.9, 49.9) nmol/L, with 15.3% (95% CI: 8.2%, 22.4%) <30 nmol/L and 61.2% (95% CI: 51.6%, 70.9%) ≥40 nmol/L. During the trial, most infants were breastfed to 3 mo (400 IU/d: 87.5%; 1000 IU/d: 75.0%). Mean (± SEM) infant serum 25(OH)D was higher in the 1000-IU/d group at 3 mo (79.9 ± 5.9 vs. 111.5 ± 15.2 nmol/L; P = 0.0263), and although not different at 6-12 mo, was maintained at >50 nmol/L.. Most infants of women with GDM had adequate vitamin D status in this study. In those born with serum 25(OH)D <50 nmol/L, vitamin D status was corrected by 3 mo of age in response to 400 or 1000 IU/d of supplemental vitamin D. Dietary guidance should continue to recommend that all women who could become pregnant take a multivitamin supplement and that breastfed infants receive 400 IU/d of supplemental vitamin D. This study and ancillary trial were registered at clinicaltrials.gov (https://www.. gov/ct2/show/NCT02563015) as NCT02563015.

Topics: Cholecalciferol; Diabetes, Gestational; Dietary Supplements; Female; Humans; Infant; Infant, Newborn; Pregnancy; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D has an immunomodulatory role but the effect of therapeutic vitamin D supplementation in SARS-CoV-2 infection is not known.. Effect of high dose, oral cholecalciferol supplementation on SARS-CoV-2 viral clearance.. Randomised, placebo-controlled.. Asymptomatic or mildly symptomatic SARS-CoV-2 RNA positive vitamin D deficient (25(OH)D<20 ng/ml) individuals.. Participants were randomised to receive daily 60 000 IU of cholecalciferol (oral nano-liquid droplets) for 7 days with therapeutic target 25(OH)D>50 ng/ml (intervention group) or placebo (control group). Patients requiring invasive ventilation or with significant comorbidities were excluded. 25(OH)D levels were assessed at day 7, and cholecalciferol supplementation was continued for those with 25(OH)D <50 ng/ml in the intervention arm. SARS-CoV-2 RNA and inflammatory markers fibrinogen, D-dimer, procalcitonin and (CRP), ferritin were measured periodically.. Proportion of patients with SARS-CoV-2 RNA negative before day-21 and change in inflammatory markers.. Forty SARS-CoV-2 RNA positive individuals were randomised to intervention (n=16) or control (n=24) group. Baseline serum 25(OH)D was 8.6 (7.1 to 13.1) and 9.54 (8.1 to 12.5) ng/ml (p=0.730), in the intervention and control group, respectively. 10 out of 16 patients could achieve 25(OH)D>50 ng/ml by day-7 and another two by day-14 [day-14 25(OH)D levels 51.7 (48.9 to 59.5) ng/ml and 15.2 (12.7 to 19.5) ng/ml (p<0.001) in intervention and control group, respectively]. 10 (62.5%) participants in the intervention group and 5 (20.8%) participants in the control arm (p<0.018) became SARS-CoV-2 RNA negative. Fibrinogen levels significantly decreased with cholecalciferol supplementation (intergroup difference 0.70 ng/ml; P=0.007) unlike other inflammatory biomarkers.. Greater proportion of vitamin D-deficient individuals with SARS-CoV-2 infection turned SARS-CoV-2 RNA negative with a significant decrease in fibrinogen on high-dose cholecalciferol supplementation.. NCT04459247.

Topics: Adult; Biomarkers; C-Reactive Protein; Cholecalciferol; COVID-19; COVID-19 Drug Treatment; Dietary Supplements; Female; Ferritins; Fibrin Fibrinogen Degradation Products; Fibrinogen; Humans; Male; Middle Aged; Procalcitonin; RNA, Viral; SARS-CoV-2; Vitamin D; Vitamin D Deficiency

The optimal treatment regimen for correcting 25-hydroxyvitamin D (25OHD) deficiency in children with chronic kidney disease (CKD) is not known. We compared cholecalciferol dosing regimens for achieving and maintaining 25OHD concentrations ≥30 ng/mL in children with CKD stages 2-4.. An open-label, multicentre randomized controlled trial randomized children with 25OHD concentrations <30 ng/mL in 1:1:1 to oral cholecalciferol 3000 IU daily, 25 000 IU weekly or 100 000 IU monthly for 3 months (maximum three intensive courses). In those with 25OHD ≥30 ng/mL, 1000 IU cholecalciferol daily (maintenance course) was given for up to 9 months. Primary outcome was achieving 25OHD ≥30 ng/mL at the end of intensive phase treatment.. Ninety children were randomized to daily (n = 30), weekly (n = 29) or monthly (n = 31) treatment groups. At the end of intensive phase, 70/90 (77.8%) achieved 25OHD ≥30 ng/mL; 25OHD concentrations were comparable between groups (median 44.3, 39.4 and 39.3 ng/mL for daily, weekly and monthly groups, respectively; P = 0.24) with no difference between groups for time to achieve 25OHD ≥30 ng/mL (P = 0.28). There was no change in calcium, phosphorus and parathyroid hormone, but fibroblast growth factor 23 (P = 0.002) and klotho (P = 0.001) concentrations significantly increased and were comparable in all treatment groups. Irrespective of dosing regimen, children with glomerular disease had 25OHD concentrations lower than non-glomerular disease (25.8 versus 41.8 ng/mL; P = 0.007). One child had a 25OHD concentration of 134 ng/mL, and 5.5% had hypercalcemia without symptoms of toxicity.. Intensive treatment with oral cholecalciferol as daily, weekly or monthly regimens achieved similar 25OHD concentrations between treatment groups, without toxicity. Children with glomerular disease required higher doses of cholecalciferol compared with those with non-glomerular disease.

Topics: Child; Cholecalciferol; Dietary Supplements; Humans; Hypercalcemia; Parathyroid Hormone; Renal Insufficiency, Chronic; Vitamin D Deficiency

Vitamin D-fibroblast growth factor-23 (FGF-23)-klotho forms an axis that takes part at least in cardiovascular complications in patients with chronic kidney disease. This study aimed to assess the effects of cholecalciferol supplementation on FGF23 and α-klotho in patients with hypovitaminosis D requiring hemodialysis.. In a single-center, parallel-arm, randomized, double-blind, placebo-controlled trial, 86 patients with hypovitaminosis D requiring hemodialysis were enrolled. The patients were randomized into 2 groups (n = 43 each) to receive either 50,000 IU of cholecalciferol or placebo every week for 12 weeks. Accordingly, the serum levels of FGF23 and klotho were measured by ELISA and compared between both groups.. Serum 25OH(D) levels increased in participants who received cholecalciferol supplementation compared with participants who received placebo (P = .006). In addition, serum FGF23 decreased and α-klotho levels increased in the supplemented group compared with placebo. However, the before-after differences between cholecalciferol supplement and placebo were significant only for α-klotho (P = .035). These effects were not accompanied by changes in the levels of phosphate, total and ionized calcium, and intact parathyroid hormone.. Cholecalciferol supplementation of 50,000 IU for 12 weeks increases α-klotho levels in the serum of kidney failure patients undergoing hemodialysis. This may suggest that patients receiving maintenance hemodialysis can benefit from using cholecalciferol supplementation and increase in serum α-klotho levels.

Topics: Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Fibroblast Growth Factors; Humans; Male; Renal Dialysis; Vitamin D; Vitamin D Deficiency

This randomised clinical trial (RCT) was created to assess the influence of 1,25-dihydroxyvitamin D (VD. This RCT was designed to examine the follow-up (2 months) effect of either 50 000 IU VD. The combination therapy (n-3FA plus VD3) for 8 weeks significantly increased A1c levels (5.79 ± 0.34 vs 5.41 ± 0.33, P < .001). Tukey test for post hoc comparisons of A1c at follow-up showed that the A1c mean levels were remarkably higher in the D+ study group comparing to the control group (5.78 vs 5.38).. The intervention of n-3FA alone or in combination with high doses of VD

Topics: Cholecalciferol; Dietary Supplements; Fatty Acids, Omega-3; Female; Glycated Hemoglobin; Humans; Male; Vitamin D; Vitamin D Deficiency

Animal and cell models indicated that vitamin D modulates inflammatory activity, which is considered relevant in the pathogenesis of arterial hypertension and cardiovascular diseases. We therefore aimed to investigate the effect of vitamin D supplementation on systemic markers of inflammation in a cohort of hypertensive patients.. Vitamin D. ClinicalTrials.gov Identifier: NCT02136771; EudraCT No. 2009-018,125-70. Start Date: 2011-04-06.

Topics: Aged; Austria; Biomarkers; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Hypertension; Inflammation Mediators; Male; Middle Aged; Time Factors; Treatment Outcome; Vitamin D; Vitamin D Deficiency; Vitamins

Post-Stroke depression affects between 12% and 72% of patients who have suffered a stroke. The association between low serum levels of 25-hydroxyvitamin D (25(OH) D) and increased risk of depression is reported in both stroke and non-stroke patients. Similarly, high 25(OH) D levels might be associated with greater functional improvement during rehabilitation program.We wanted to investigate the effects of an intensive rehabilitation on poststroke outcomes. We wondered if the daily rehabilitation of motor and cognitive functions could also have an effect on mood and functional abilities in addition to or as an alternative to vitamin D supplementation.We conducted a 12-week, randomized trial, double blind, parallel, monocentric clinical trial of 40 patients undergoing intensive neuro-rehabilitation treatment at a specialized care facility for ischemic or hemorrhagic brain stroke. Participants were randomly assigned, in a 1:1 ratio, to 1 of 2 parallel groups: in the experimental group, 2000 IU/day of oral cholecalciferol was administered; in the control group patients were not taking vitamin D supplementation. Patients underwent a text evaluation to investigate psychological and motor outcomes.Significant intra-group difference in outcomes measures was found but not between control group and experimental group. In the vitamin D group, we highlighted significant differences between T0 and T1 in calcium (P < .001), vitamin D (P < .001), in Montgomery Aasberg Depression Rating Scale (P = .001), and in Functional Independent Measures (P < .001). In the health control group, we found a significant difference in calcium (P = .003), vitamin D (P < .001), Montgomery Aasberg Depression Rating Scale (P = 0.006), in general self-efficacy (P = .009), and in Functional Independent Measures (P < .001).Our results show that the beneficial effect on mood and functional recovery is mainly due to neurorehabilitation rather than vitamin D supplementation.

Topics: Calcium; Cholecalciferol; Dietary Supplements; Double-Blind Method; Humans; Stroke; Vitamin D; Vitamin D Deficiency; Vitamins

Patients with advanced chronic kidney disease should be vaccinated against hepatitis B. In observational studies vitamin D insufficiency is associated with a reduced seroconversion rate. The effect of cholecalciferol supplementation on hepatitis B vaccination response in haemodialysis patients with vitamin D insufficiency is unknown.. In this randomized open label pilot study 40 unvaccinated haemodialysis patients with 25(OH)D insufficiency (<30 ng/mL) were enrolled. In the supplementation group, we administered cholecalciferol orally in a dose of 28,000 IU weekly for a maximum of 12 weeks. Hepatitis B vaccination (HBvaxPRO 40 µg i.m. months 0, 1, 6) was performed after achieving a 25(OH)D level >30 ng/mL or after completing three months of supplementation despite failure to achieve the target level. In the control group, patients were vaccinated immediately after randomization. Anti-hepatitis B-antibody titer (anti-HBs) was measured eight weeks after completing the vaccination course.. Thirty-seven (26 male, 11 female) patients aged 65 (13.5) years underwent randomization with 17 patients allocated to the control group and 20 patients included in the supplementation group. After 12 weeks of cholecalciferol supplementation, mean (SD) 25(OH)D concentration increased from 15.0 (8.0) to 31.0 (7.1) ng/mL, but remained unchanged in the control group (14.0 (7.1) to 11.6 (7.5) mg/mL). Neither the number of patients with seroconversion (anti-HBs titer ≥ 10 IU/L; n = 6 (35.3%) vs n = 3 (27.3%), p = 0.704), nor the number of patients with seroprotection (anti-HBs titer >100 IU/L; n = 4 (23.5%) vs n = 2 (18.2%) differed between treatment groups. Cholecalciferol supplementation was safe without treatment-related adverse events.. In this small pilot study, high-dose oral cholecalciferol supplementation did not improve the hepatitis B vaccination response in haemodialysis patients with vitamin D insufficiency. This clinical trial was registered within EudraCT (EudraCT number 2011-004621-26).

Topics: Cholecalciferol; Dietary Supplements; Female; Hepatitis B; Humans; Male; Pilot Projects; Renal Dialysis; Vaccination; Vitamin D; Vitamin D Deficiency

Although approximately 50% of Chinese with type 2 diabetes mellitus (T2DM) patients have vitamin D deficiency, studies regarding vitamin D supplementation on insulin resistance (IR) have mainly focused on non-Asians. Endurance exercise training (ET) enhances insulin-mediated glucose metabolism, which plays a critical role in T2DM prevention and control. However, the combined effects of vitamin D supplementation and ET on IR in T2DM patients are unclear. The objectives of this study is to investigate the synergistic effect of vitamin D supplementation combined with exercise training intervention on IR in T2DM patients.. We propose a 3-month randomized controlled trial among 60 T2DM patients aged 40-65, newly diagnosed with T2DM ≤ 1 year, and with stable HbA1c level (≤ 8.0%) in the past 3 months. The participants will be randomly allocated to the vitamin D group, vitamin D combined with exercise training group, exercise training group, and control group (CG) using a computer-generated random number sequence. At baseline, participants will undergo a medical review, anthropometric measurements, dual X-ray absorptiometry, a 75-g oral glucose tolerance test (OGTT), ankle-brachial index measurements, and physical fitness measurements and will complete related lifestyle questionnaires. Fasting blood lipid and glucose levels were also measured. In a 3-month intervention period, vitamin D intervention group will receive a dose of 1000 IU daily; exercise group will perform a 1-h endurance exercise 3 times per week (maximal heart rate, 60-80%), and the control group will receive apparently identical tablets. Additionally, all participants will be advised to maintain their normal diet and physical activities during the intervention. All measurements will be repeated at 3-month follow-up after the intervention with the primary outcome measure expressed as a change from baseline in insulin sensitivity and secretion. Secondary outcome measures will compare the changes in anthropometry, ankle-brachial index, and physical fitness factors (e.g., peak oxygen uptake, hand grip strength). Data will be managed and analyzed using the Statistical Package for the Social Sciences.. This is the first study to conduct a randomized trial to clearly determine the independent and combined effects of vitamin D supplementation and endurance exercise trial on IR in Chinese T2DM patients as measured by OGTT. The findings from the proposed study will not only provide new evidences that vitamin D supplementation plays an important role in IR management but also develop a simple and efficient method to improve IR-associated metabolic diseases for T2DM patients.. Chinese Clinical Trial Registry ChiCTR1800015383 , Registered on 28 March 2018.

Topics: Cholecalciferol; Diabetes Mellitus, Type 2; Dietary Supplements; Exercise; Hand Strength; Humans; Insulin Resistance; Randomized Controlled Trials as Topic; Vitamin D; Vitamin D Deficiency

Vitamin D insufficiency, a vitamin D status or serum 25(OH)D concentration of ≤75 nmol/L, is highly prevalent in individuals with a spinal cord injury (SCI). Vitamin D is important for the functioning of the musculoskeletal, immune and respiratory systems, which are relevant determinants of secondary health conditions in SCI. An insufficiency should be treated with vitamin D supplementation. However, there is a lack of evidence regarding the optimal dosage and duration of vitamin D supplementation for individualised and long-term management of the vitamin D status in the context of SCI. This paper presents the protocol for the vitamin D supplementation in chronic spinal cord injury (VitD-SCI) trial that aims to investigate the effect of a 12-month intake of vitamin D supplementation on vitamin D status as well as on several secondary parameters among individuals with a chronic SCI.. The VitD-SCI trial is a randomised, placebo-controlled, double-blinded, parallel-group, superiority trial, conducted at the Swiss Paraplegic Centre. A total of 45 participants living with an SCI for at least 3 years (chronic SCI) and a vitamin D insufficiency at the first study visit, will be randomly assigned to one of three intervention groups. Participants receive either a monthly dosage of 24 000 IU or 48 000 IU vitamin D or a placebo for 12 months. Measurements taking place every 3 months include the assessment of vitamin D status (primary outcome) as well as bone mineral density, handgrip strength, fatigue, mood, pain and pressure injuries (secondary outcomes). Safety and tolerance of vitamin D supplementation will also be evaluated.. The Swiss Ethics Committee for Northwest/Central Switzerland (EKNZ, 2020-01493) and the Swiss Agency for Therapeutic Products (Swissmedic, 2020DR3150) approved this study. Findings will be disseminated through peer-reviewed publications.. NCT04652544 and SNCTP000004032.

Topics: Cholecalciferol; Dietary Supplements; Hand Strength; Humans; Randomized Controlled Trials as Topic; Spinal Cord Injuries; Vitamin D; Vitamin D Deficiency

To compare the differences in musculoskeletal health with vitamin D alone in comparison with vitamin D with physical activity (PA) among chronic kidney disease (CKD) patients.. An open labeled, randomized, controlled trial was conducted at two tertiary care centers in Pakistan. Patients with CKD stage 2-4 and vitamin D deficiency (<20 ng/mL) were recruited in the trial. Both the arms were given oral vitamin D (cholecalciferol) drops (4000 IU) once daily for three months. One arm received only vitamin D (VD arm), while the second arm received vitamin D along with PA (VDPA arm).. Of the 1,235 CKD stage 2-4 subjects contacted, forty-six subjects were enrolled. Eighteen were assigned to VD arm and twenty-eight were assigned to VDPA arm. Between groups comparison shows that bicep strength increases from 15 to 17 kg. Likewise, back flexibility and aerobic fitness also increased among those who receive vitamin D and physical activity, however these differences were not statistically significant (p>0.05). Sensitivity analysis within group comparison shows rise of bicep strength from 13.8 kg to 15.2 kg in the VD alone arm (p=0.05); however, in the VDPA arm, there is a greater difference of 14.3 kg to 17.2 kg (p<0.001).. Targeted PA among CKD patients has potential to improve bicep strength and back flexibility. However, as the sample size was small, further studies would be required to suggest whether a PA should be included as part of the treatment regimen.

Topics: Cholecalciferol; Exercise; Humans; Muscle Strength; Pakistan; Renal Insufficiency, Chronic; Vitamin D; Vitamin D Deficiency

The objective of this study was to evaluate the effect of vitamin D3 on total homocysteine (tHcy) and C-reactive protein (CRP) levels and liver and kidney function tests in overweight women with vitamin D deficiency. Therefore, a randomised, double-blind placebo, controlled clinical trial was conducted on 100 eligible women. Subjects were randomly divided into two groups: the placebo (n 50) and the vitamin D (n 50) which received 1250 µg vitamin D3 per week for 2 months. The participants' 25-hydroxyvitamin D (25(OH)D), tHcy, CRP, alanine aminotransferase (ALT), aspartate aminotransferase (AST), urea, creatinine and estimated glomerular filtration rate (eGFR) were measured and compared before and after treatment. Results showed that the tHcy, CRP, AST, ALT and eGFR levels after the 2nd month of vitamin D3 intervention were significantly (P < 0·001) decreased and the 25(OH)D, urea and creatinine levels were significantly (P < 0·001) increased in the treatment group. In the placebo group, no significant changes were identified throughout the follow-up period. In conclusion, vitamin D3 intervention with a treatment dose of 1250 µg/week for at least 2 months may help in lowering Hcy and CRP levels and may improve liver function tests, which in turn might help in minimising the risk of CVD and liver diseases among overweight women but negatively affect kidney function.

Topics: Adolescent; Adult; Alanine Transaminase; Aspartate Aminotransferases; C-Reactive Protein; Cardiovascular Diseases; Cholecalciferol; Double-Blind Method; Female; Glomerular Filtration Rate; Heart Disease Risk Factors; Homocysteine; Humans; Kidney Function Tests; Liver Diseases; Liver Function Tests; Middle Aged; Overweight; Treatment Outcome; Urea; Vitamin D; Vitamin D Deficiency; Young Adult

Hypovitaminosis D has been associated with many cardio-metabolic disorders, although their pathogenetic link still remains unclear. Our aim was to evaluate whether 1-year vitamin D (D) supplementation could improve glycemic control, lipid profile, systolic (SBP) and diastolic (DBP) blood pressure levels and body composition.. One-year D supplementation restored D status and had a beneficial effect on fasting glucose (FG, mean percentage changes ± SD, - 1.8% ± 23.1 vs. + 18.8% ± 30.0), glycosylated haemoglobin (HbA1c, - 13.7% ± 14.5 vs. - 4.2% ± 14.1), SBP (- 13.4% ± 8.5 vs. - 2.4% ± 12.6) and HDL-cholesterol levels (- 2.1% ± 14.0 vs. - 10.9% ± 12.9; p < 0.05 for all comparisons) in + D vs. - D patients, respectively. In the former, a reduction in HBA1c, SBP and DBP levels, BMI, fat mass index (FMI) and ratio (FMR) was observed after 1 year (p < 0.05 for all comparisons vs. baseline). We noticed a relationship between 1-year mean percentage changes of serum 25OHD and SBP levels (R = - 0.36, p < 0.05).. One-year cholecalciferol supplementation, able to restore D status, significantly improves FG, HbA1c, SBP and HDL-cholesterol levels in patients with poor-controlled type 2 diabetes mellitus and D deficiency.

Topics: Aged; Blood Pressure; Body Mass Index; Calcium-Regulating Hormones and Agents; Cholecalciferol; Cholesterol, HDL; Diabetes Mellitus, Type 2; Female; Glycated Hemoglobin; Humans; Lipid Metabolism; Male; Pilot Projects; Treatment Outcome; Vitamin D; Vitamin D Deficiency

The objective of this study was to investigate the effect of vitamin D treatment on androgen levels and hirsutism scores in overweight women with PCOS.. A prospective, randomized, double-blind, placebo-controlled clinical study was conducted at King Abdullah University Hospital in Irbid, Jordan. Overweight Jordanian females aged 18-49 years with vitamin D deficiency and PCOS (n = 60) were assigned to two groups: the treatment group (n = 30) who received 50,000 IU per week of vitamin D. After receiving the treatment for 12 consecutive weeks, the levels of total testosterone, parathyroid hormone, free androgen index, and hirsutism score were significantly decreased (P < 0.001), and the levels of 25-hydroxyvitamin D (25(OH)D), sex hormone binding globulin, and phosphorus were significantly increased (P < 0.05). Furthermore, significant changes were observed in ovarian volume and follicle numbers and size ultrasonography, and in the regularity of the menstrual cycle (P < 0.001). In the placebo group, no significant changes were observed in either androgen levels, hirsutism score, or menstrual regularity.. Vitamin D. NCT02328404.

Topics: Adolescent; Adult; Androgens; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Hirsutism; Humans; Jordan; Middle Aged; Overweight; Parathyroid Hormone; Polycystic Ovary Syndrome; Prospective Studies; Testosterone; Treatment Outcome; Vitamin D; Vitamin D Deficiency; Vitamins; Young Adult

Vitamin D has anti-inflammatory and immune regulatory functions.. The authors investigated the effect of vitamin D supplementation in children with inflammatory bowel disease (IBD) and hypovitaminosis D on disease activity, quality of life (QOL), inflammatory markers, and cytokines.. This randomized double-blinded controlled clinical trial included 120 children with IBD and hypovitaminosis D; 22 of them were excluded later. Patients were randomized to receive either oral vitamin D3 in a dose of 2000 IU/day or placebo for 6 months. The primary outcome was to evaluate the effect of vitamin D supplementation on the IBD activity score. The secondary outcomes were to assess the QOL, inflammatory markers, cytokines, the safety of vitamin D, and to correlate serum vitamin D level with various clinical and laboratory variables.. Vitamin D supplementation significantly decreased the IBD activity score in the vitamin D group compared with the placebo group. Moreover, QOL significantly improved after vitamin D supplementation. Inflammatory markers, for example, erythrocyte sedimentation rate, C-reactive protein, and fecal calprotectin and interleukin-2 IL-12, IL-17, IL-23, and tumor necrosis factor-alpha significantly decreased in the vitamin D group. However, IL-10 significantly increased after vitamin D supplementation. Vitamin D was significantly inversely correlated with the activity score, QOL score, levels of all inflammatory markers, the frequency of hospitalization, and emergency department visits.. Vitamin D supplementation may have a beneficial effect in children with IBD.

Topics: Child; Cholecalciferol; Dietary Supplements; Double-Blind Method; Humans; Inflammatory Bowel Diseases; Quality of Life; Vitamin D; Vitamin D Deficiency

Vitamin D supplementations for asthma control had shown inconsistent results. We aimed to study efficacy and safety of vitamin D supplementation in asthmatic children who were vitamin D deficient.. This double-blind, randomized controlled trial enrolled asthmatic children of 4-12 years of age who had 25-hydroxyvitamin D [25(OH)D] levels <20 ng/mL. The participants were randomized to receive either vitamin D orally 1000 IU/d for 9 months or similar-looking placebo. The primary outcomes were the proportion of children having the Childhood Asthma Control Test (CACT) score of ≥20 at the end of the treatment and adverse effects.. The trial included 250 children (125 in each group) with a mean age of 8.1 ± 2.3 years and 180 boys. The baseline parameters were similar between the groups, including CACT score (21.7 ± 4.2 vs 21.9 ± 3.6, vitamin D vs placebo). At the end of the study, the proportion of asthmatic children who had CACT score ≥ 20 was similar between vitamin D and placebo group (93.6% vs 92.0%, P = .625). The number of exacerbations of asthma and side effect profile was also identical between the groups. 25(OH)D levels increased significantly in the vitamin D group (18.06 ± 7.11 vs 12.03 ± 5.98 ng/mL, P < .001). The results did not change when we did subgroup analysis for children with baseline CACT score < 20 and 25(OH)D levels at the end of the study ≥20 ng/mL.. Vitamin D supplementation in asthmatic children with vitamin D deficiency did not improve control of asthma.

Topics: Asthma; Child; Cholecalciferol; Dietary Supplements; Double-Blind Method; Humans; Infant, Newborn; Male; Vitamin D; Vitamin D Deficiency

The relationship between maternal and infant vitamin D and early childhood growth remains inadequately understood.. This work aimed to investigate how maternal and child 25-hydroxyvitamin D (25[OH]D) and vitamin D supplementation affect growth during the first 2 years of life.. A randomized, double-blinded, single-center intervention study was conducted from pregnancy until offspring age 2 years. Altogether 812 term-born children with complete data were recruited at a maternity hospital. Children received daily vitamin D3 supplementation of 10 μg (group 10) or 30 μg (group 30) from age 2 weeks to 2 years. Anthropometry and growth rate were measured at age 1 and 2 years.. Toddlers born to mothers with pregnancy 25(OH)D greater than 125 nmol/L were at 2 years lighter and thinner than the reference group with 25(OH)D of 50 to 74.9 nmol/L (P < .010). Mean 2-year 25(OH)D concentrations were 87 nmol/L in group 10 and 118 nmol/L in group 30 (P < .001). When group 30 was compared with group 10, difference in body size was not statistically significant (P > .053), but group 30 had slower growth in length and head circumference between 6 months and 1 year (P < .047), and more rapid growth in weight and length-adjusted weight between 1 and 2 years (P < .043). Toddlers in the highest quartile of 25(OH)D (> 121 nmol/L) were shorter (mean difference 0.2 SD score [SDS], P = .021), lighter (mean difference 0.4 SDS, P = .001), and thinner (in length-adjusted weight) (mean difference 0.4 SDS, P = .003) compared with the lowest quartile (< 81.2 nmol/L).. Vitamin D and early childhood growth may have an inverse U-shaped relationship.

Topics: Adult; Body Size; Body Weight; Child Development; Child, Preschool; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Finland; Humans; Infant; Infant, Newborn; Male; Pregnancy; Prenatal Exposure Delayed Effects; Vitamin D; Vitamin D Deficiency

To assess the efficacy of different doses of vitamin D. Mean(SD) of age and BMI Z-score were 9.3 (1.7) years and 2.55 (0.73), respectively. The median (IQR) for 25(OH)D was 11.5 (8.9), 11.7 (10.5), 12.2 (10.2) ng/mL (28.75, 29.25, and 30.50 nmol/L) at baseline and 23.1 (8.0), 25.6 (8.3), 28.6 (10.4) ng/mL (57.75, 64.00, and 71.50 nmol/L) at the end of 12 months in 600, 1000, and 2000 IU, respectively (p values for dose, time, and the interaction being < 0.0001, < 0.0001,and 0.082, respectively). Prevalence of vitamin D deficiency (< 20 ng/mL) was 80.2, 77.5, and 75.5% in 600, 1000, and 2000 IU groups at baseline, respectively, which decreased to 34, 18.4, and 7.5%, respectively, at 12 months. Patterns of iPTH, calcium, phosphorus, and alkaline phosphatase response over time did not differ significantly among groups (p values = 0.452, 0.670, 0.377, 0.895, respectively).. Increases in 25(OH)D concentration were found with supplementation of 1000 and 2000 IU, compared with 600 IU/days, whereas there was no evidence of iPTH suppression or change in serum calcium, phosphorus, and alkaline phosphatase among children with excess weight.

Topics: Adolescent; Child; Cholecalciferol; Dietary Supplements; Female; Humans; Male; Obesity; Overweight; Parathyroid Hormone; Vitamin D; Vitamin D Deficiency

At present, although cholecalciferol represents the form of vitamin D of choice for the treatment of vitamin D deficiency, there is a growing interest in calcifediol.. This study aimed to evaluate the efficacy and the safety of two different daily doses of calcifediol.. Fifty osteopenic/osteoporotic women with serum levels of 25-hydroxyvitamin D (25OHD) between 10 and 20 ng/ml were randomized to a 6-month treatment with oral calcifediol 20 µg/day (n = 25) or oral calcifediol 30 µg/day (n = 25). In all, we measured the time course of the levels of 25OHD and other biochemical parameters. Moreover, we evaluated handgrip strength and serum levels of myostatin.. The peak increase in 25OHD levels was reached after 90 days of treatment in group 1 (59.3 ng/ml) and after only 60 days in group 2 (72.3 ng/ml); thereafter in both groups, the levels of 25OHD showed a tendency towards stabilization. After 30 days, all the patients treated with 30 µg/day had values of 25OHD > 30 ng/ml. Handgrip strength showed a modest but progressive increase which reached the statistical significance in the 30 µg/day group. This latter group also presented a modest and non-significant decrease in serum levels of myostatin.. Calcifediol is able to rapidly normalize the vitamin D deficiency, and the 30 µg daily dosage could be suggested in those patients who need to rapidly reach optimal 25OHD levels. Moreover, the 6-month treatment with calcifediol at a dose of 30 µg results in a modest but significant increase in upper limb strength.

Topics: Calcifediol; Cholecalciferol; Dietary Supplements; Female; Hand Strength; Humans; Muscle Strength; Postmenopause; Vitamin D; Vitamin D Deficiency

The improvement of muscular strength is a well-known extra-skeletal effect of Vitamin D. The aim of the study was to evaluate the effectiveness of the calcifediol supplementation compared to various cholecalciferol administration schedules in increasing 25(OH)D serum levels and improving muscular function.. 107 post-menopausal women with hypovitaminosis D were assigned to receive Vitamin D supplementation according to four different regimens: colecalciferol single, monthly, or weekly oral dose and calcifediol weekly oral dose. Serum levels of 25(OH)D and muscular function of lower limbs (Sit-to-Stand test and Timed-Up-and-Go test) were evaluated at baseline and during 6 months follow-up.. Calcifediol and weekly cholecalciferol induced a greater and faster increase of serum 25(OH)D, compared to monthly or single-dose cholecalciferol administration. The 25(OH)D increase was associated with an improvement of muscle function of lower limbs. The larger increase of serum 25(OH)D observed with calcifediol and with weekly cholecalciferol was associated with a concomitant greater improvement of muscle strength.. Supplementation with calcifediol is more effective and faster compared to cholecalciferol in increasing 25(OH)D serum levels and is associated with a greater improvement of muscular function, thus representing a therapeutic alternative for treatment of hypovitaminosis D.

Topics: Body Mass Index; Calcifediol; Cholecalciferol; Dietary Supplements; Female; Humans; Italy; Muscle Strength; Muscular Diseases; Nutrition Therapy; Postmenopause; Postural Balance; Vitamin D; Vitamin D Deficiency

Vitamin D plays an important role in the release of the placenta and implantation, and low levels are a risk factor for pre-eclampsia. Studies have also shown that symptomatic treatment of vitamin D3 deficiency can effectively reduce the risk of pre-eclampsia. In this study, vitamin D3 supplementation was performed on the risk of pre-eclampsia to observe its effect.. From January 2016 to December 2018, 450 women with maternal treatment and delivery in our hospital underwent an open-label randomized study. The pregnant women were divided into low-dose, medium-dose, and high-dose groups. Compare the incidence of pre-eclampsia and the dose effect of vitamin D levels.. In the maternal and perinatal periods of the 450 maternal women, the 25[OH] index of the three groups of pregnant women was significantly increased, while the high-dose increase index was more obvious. The relative risk reduction rate was significantly lower. Compared with the low-dose and middle-dose groups, the high-dose group had a significantly lower incidence of pre-eclampsia, while the IUGR index was lower, and other obstetric indicators were comparable.. Vitamin D supplementation can effectively reduce the incidence of pre-eclampsia, while reducing the IUGR index, which has important value and significance in its clinical application.

Topics: Adult; Cholecalciferol; Dietary Supplements; Dose-Response Relationship, Drug; Drug Monitoring; Female; Humans; Incidence; Pre-Eclampsia; Pregnancy; Pregnancy Outcome; Risk Assessment; Risk Factors; Vitamin D Deficiency; Vitamins

FM is a chronic musculoskeletal disorder characterized by the presence of generalized pain. There are contradictory results regarding the prevalence and supplementation effect of vitamin D deficiency on FM patients. We aim to determine the safety and efficacy of a 12-week vitamin D supplementation on FM patients.. We conducted a randomized, placebo-controlled, double-blind clinical trial. We included female participants of 18 years old or older, who met 1990 or 2010 ACR criteria for fibromyalgia. The Spanish validated FIQ and the VAS of pain were applied at baseline. The participants were then randomized to receive placebo or 50,000 IU of Vitamin D. We included 80 patients. There was no statistical difference in the initial and final FIQ between both groups. The FIQ delta also did not prove to be different at the end of the study. The increase in vitamin D levels in the intervention group was corroborated. Regarding serious adverse effects, none was reported in both groups. There was no statistical difference in minor adverse events.. In this double-blind placebo-controlled randomized study conducted to measure the efficacy and safety of vitamin D exclusively in patients with FM, we found that there is no evidence of a trend in favor of vitamin D treatment, since we did not observe improvement in the VAS of pain or FIQ.. Clinical Trials.gov number: NCT03369379 Key Points • There are conflicting results in vitamin D to treat fibromyalgia. • In this double-blind, randomized controlled trial, we did not find a difference in the VAS nor FIQ with vitamin D supplementation. • The increase in vitamin D levels in the intervention group was corroborated.

Topics: Adolescent; Adult; Cholecalciferol; Double-Blind Method; Female; Fibromyalgia; Humans; Treatment Outcome; Vitamin D; Vitamin D Deficiency; Vitamins

Low vitamin D (serum or plasma 25-hydroxyvitamin D (25(OH)D)) is a global pandemic and associates with a greater prevalence in all-cause and cardiovascular mortality and morbidity. Open-heart surgery is a form of acute stress that decreases circulating 25(OH)D concentrations and exacerbates the preponderance of low vitamin D in a patient population already characterized by low levels. Although supplemental vitamin D increases 25(OH)D, it is unknown if supplemental vitamin D can overcome the decreases in circulating 25(OH)D induced by open-heart surgery. We sought to identify if supplemental vitamin D protects against the acute decrease in plasma 25(OH)D propagated by open-heart surgery during perioperative care. Participants undergoing open-heart surgery were randomly assigned (double-blind) to one of two groups: (a) vitamin D (n = 75; cholecalciferol, 50,000 IU/dose) or (b) placebo (n = 75). Participants received supplements on three separate occasions: orally the evening before surgery and either orally or per nasogastric tube on postoperative days 1 and 2. Plasma 25(OH)D concentrations were measured at baseline (the day before surgery and before the first supplement bolus), after surgery on postoperative days 1, 2, 3, and 4, at hospital discharge (5-8 days after surgery), and at an elective outpatient follow-up visit at 6 months. Supplemental vitamin D abolished the acute decrease in 25(OH)D induced by open-heart surgery during postoperative care. Moreover, plasma 25(OH)D gradually increased from baseline to day 3 and remained significantly increased thereafter but plateaued to discharge with supplemental vitamin D. We conclude that perioperative vitamin D supplementation protects against the immediate decrease in plasma 25(OH)D induced by open-heart surgery. ClinicalTrials.gov Identifier: NCT02460211.

Topics: Aged; Biomarkers; Cardiac Surgical Procedures; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Male; Middle Aged; Perioperative Care; Time Factors; Treatment Outcome; Utah; Vitamin D; Vitamin D Deficiency

Vascular calcification is an independent risk factor for cardiovascular diseases and all-cause mortality in end stage renal disease, and particularly in hemodialysis patients. Vitamin D deficiency has been shown to be associated with vascular calcification among this category of patients. Cholecalciferol or vitamin D3; the native inactivated 25-hydroxy vitamin D [25(OH)D], has been proposed to have a good impact on vascular calcification and vitamin D deficiency. However, clinical data is still limited.. A prospective, randomized, placebo-controlled study was carried out to evaluate the effect of oral cholecalciferol on vascular calcification and 25(OH)D levels in hemodialysis patients. A total of sixty eligible hemodialysis patients were randomly assigned to either a treatment group (Oral 200.000IU Cholecalciferol per month) or a placebo group, for 3 months. Serum 25-hydroxy vitamin D (25(OH)D), fetuin-A, fibroblast growth factor (FGF-23), osteoprotegerin (OPG), calcium, phosphorus, their product (CaXP) and intact parathyroid hormone (iPTH) levels, were all assessed at baseline and at the end of the study. ClinicalTrials.gov registration number: NCT03602430. Cholecalciferol significantly increased serum levels of 25(OH)D and fetuin-A in the treatment group (p-value < 0.001), while no significant difference was observed in the placebo group. Cholecalciferol administration showed no effect on either FGF-23 or OPG. None of the treatment group patients experienced any adverse effects.. Cholecalciferol was shown to be an effective, tolerable, inexpensive pharmacotherapeutic option to overcome vitamin D deficiency, with a possible modulating effect on fetuin-A, among hemodialysis patients. CLINICALTRIALS.. NCT03602430.

Topics: Adult; alpha-2-HS-Glycoprotein; Biomarkers; Cholecalciferol; Egypt; Female; Fibroblast Growth Factor-23; Humans; Kidney Diseases; Male; Middle Aged; Prospective Studies; Renal Dialysis; Single-Blind Method; Time Factors; Treatment Outcome; Vascular Calcification; Vitamin D; Vitamin D Deficiency; Vitamins

The efficacy of vitamin D3 supplementation in coronavirus disease 2019 (COVID-19) remains unclear.. To investigate the effect of a single high dose of vitamin D3 on hospital length of stay in patients with COVID-19.. This was a multicenter, double-blind, randomized, placebo-controlled trial conducted in 2 sites in Sao Paulo, Brazil. The study included 240 hospitalized patients with COVID-19 who were moderately to severely ill at the time of enrollment from June 2, 2020, to August 27, 2020. The final follow-up was on October 7, 2020.. Patients were randomly assigned to receive a single oral dose of 200 000 IU of vitamin D3 (n = 120) or placebo (n = 120).. The primary outcome was length of stay, defined as the time from the date of randomization to hospital discharge. Prespecified secondary outcomes included mortality during hospitalization; the number of patients admitted to the intensive care unit; the number of patients who required mechanical ventilation and the duration of mechanical ventilation; and serum levels of 25-hydroxyvitamin D, total calcium, creatinine, and C-reactive protein.. Of 240 randomized patients, 237 were included in the primary analysis (mean [SD] age, 56.2 [14.4] years; 104 [43.9%] women; mean [SD] baseline 25-hydroxyvitamin D level, 20.9 [9.2] ng/mL). Median (interquartile range) length of stay was not significantly different between the vitamin D3 (7.0 [4.0-10.0] days) and placebo groups (7.0 [5.0-13.0] days) (log-rank P = .59; unadjusted hazard ratio for hospital discharge, 1.07 [95% CI, 0.82-1.39]; P = .62). The difference between the vitamin D3 group and the placebo group was not significant for in-hospital mortality (7.6% vs 5.1%; difference, 2.5% [95% CI, -4.1% to 9.2%]; P = .43), admission to the intensive care unit (16.0% vs 21.2%; difference, -5.2% [95% CI, -15.1% to 4.7%]; P = .30), or need for mechanical ventilation (7.6% vs 14.4%; difference, -6.8% [95% CI, -15.1% to 1.2%]; P = .09). Mean serum levels of 25-hydroxyvitamin D significantly increased after a single dose of vitamin D3 vs placebo (44.4 ng/mL vs 19.8 ng/mL; difference, 24.1 ng/mL [95% CI, 19.5-28.7]; P < .001). There were no adverse events, but an episode of vomiting was associated with the intervention.. Among hospitalized patients with COVID-19, a single high dose of vitamin D3, compared with placebo, did not significantly reduce hospital length of stay. The findings do not support the use of a high dose of vitamin D3 for treatment of moderate to severe COVID-19.. ClinicalTrials.gov Identifier: NCT04449718.

Topics: Adult; Brazil; Cholecalciferol; COVID-19; COVID-19 Drug Treatment; Double-Blind Method; Female; Hospital Mortality; Humans; Intensive Care Units; Length of Stay; Male; Middle Aged; Respiration, Artificial; Treatment Failure; Vitamin D; Vitamin D Deficiency; Vitamins

This study aimed to evaluate the potential anti-inflammatory effects of vitamin D supplementation under uremic conditions, both in vivo and in vitro, and its effects on the parameters of mineral metabolism.. Thirty-two hemodialysis patients were randomly assigned to receive placebo (N=14) or cholecalciferol (N=18) for six months. Serum levels of calcium, phosphate, total alkaline phosphatase, intact parathyroid hormone (iPTH), and vitamin D were measured at baseline and after three and six months. The levels of fibroblast growth factor-23 (FGF-23), interleukin-1β (IL-1β), and high-sensitivity C-reactive protein (hs-CRP) were also measured at baseline and at six months. Human monocytes were used for in vitro experiments and treated with cholecalciferol (150 nM) and uremic serum. Cell viability, reactive oxygen species (ROS) production, and cathelicidin (CAMP) expression were evaluated using the 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide assay, dichloro-dihydro-fluorescein diacetate assay, and real time-quantitative polymerase chain reaction, respectively.. Both patient groups were clinically and biochemically similar at baseline. After six months, the levels of vitamin D and iPTH were higher and lower, respectively, in the cholecalciferol group than in the placebo group (p<0.05). There was no significant difference between the parameters of mineral metabolism, such as IL-1β and hs-CRP levels, in both groups. Treatment with uremic serum lowered the monocyte viability (p<0.0001) and increased ROS production (p<0.01) and CAMP expression (p<0.05); these effects were counterbalanced by cholecalciferol treatment (p<0.05).. Thus, cholecalciferol supplementation is an efficient strategy to ameliorate hypovitaminosis D in hemodialysis patients, but its beneficial effects on the control of secondary hyperparathyroidism are relatively unclear. Even though cholecalciferol exhibited anti-inflammatory effects in vitro, its short-term supplementation was not effective in improving the inflammatory profile of patients on hemodialysis, as indicated by the IL-1β and hs-CRP levels.

Topics: Anti-Inflammatory Agents; Cholecalciferol; Dietary Supplements; Fibroblast Growth Factor-23; Humans; Parathyroid Hormone; Renal Dialysis; Vitamin D; Vitamin D Deficiency

Atrial fibrillation (AF) is the most common heart rhythm disturbance, continues to increase in incidence, and results in significant morbidity and mortality. The marine omega-3 fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), and vitamin D have been reported to have both benefits and risks with respect to incident AF, but large-scale, long-term randomized trial data are lacking.. To test the effects of long-term administration of marine omega-3 fatty acids and vitamin D on incident AF.. An ancillary study of a 2 × 2 factorial randomized clinical trial involving 25 119 women and men aged 50 years or older without prior cardiovascular disease, cancer, or AF. Participants were recruited directly by mail between November 2011 and March 2014 from all 50 US states and were followed up until December 31, 2017.. Participants were randomized to receive EPA-DHA (460 mg/d of EPA and 380 mg/d of DHA) and vitamin D3 (2000 IU/d) (n = 6272 analyzed); EPA-DHA and placebo (n = 6270 analyzed); vitamin D3 and placebo (n = 6281 analyzed); or 2 placebos (n = 6296 analyzed).. The primary outcome was incident AF confirmed by medical record review.. Among the 25 119 participants who were randomized and included in the analysis (mean age, 66.7 years; 50.8% women), 24 127 (96.1%) completed the trial. Over a median 5.3 years of treatment and follow-up, the primary end point of incident AF occurred in 900 participants (3.6% of study population). For the EPA-DHA vs placebo comparison, incident AF events occurred in 469 (3.7%) vs 431 (3.4%) participants, respectively (hazard ratio, 1.09; 95% CI, 0.96-1.24; P = .19). For the vitamin D3 vs placebo comparison, incident AF events occurred in 469 (3.7%) vs 431 (3.4%) participants, respectively (hazard ratio, 1.09; 95% CI, 0.96-1.25; P = .19). There was no evidence for interaction between the 2 study agents (P = .39).. Among adults aged 50 years or older, treatment with EPA-DHA or vitamin D3, compared with placebo, resulted in no significant difference in the risk of incident AF over a median follow-up of more than 5 years. The findings do not support the use of either agent for the primary prevention of incident AF.. ClinicalTrials.gov Identifiers: NCT02178410; NCT01169259.

Topics: Aged; Atrial Fibrillation; Cholecalciferol; Dietary Supplements; Docosahexaenoic Acids; Dose-Response Relationship, Drug; Double-Blind Method; Drug Therapy, Combination; Eicosapentaenoic Acid; Female; Humans; Male; Middle Aged; Treatment Failure; Vitamin D Deficiency; Vitamins

Despite the well-recognized effect of vitamin D in metabolism and homeostasis, there is now growing interest in its probable association with pneumonia. This study aims to supply vitamin D3 (Cholecalciferol) (100,000 IU) to pneumonic children to minimize the duration of illness and improve their outcome.. A double-blinded, randomized, placebo-controlled trial was conducted in a Pediatric Cairo University affiliated hospital. An intervention arm (93 children) and a control arm (98 children), who had pneumonia with an insufficient or deficient level of vitamin D and whose parental permission was obtained, were enrolled in the trial. All children were treated with antibiotics according to WHO guidelines. Children were given a single injection of 1 mL of 100,000 IU of vitamin D3 or placebo. Clinical data were recorded every eight hours for all children. Outcomes were assessed 7 days after vitamin D injection.The primary outcome variable was the change in serum level of 25(OH)D, while the secondary outcomes were the medical state of the assigned cases (improvement or death) and duration between enrollment and hospital discharge for improved cases.. In the supplementation group, the percentage of patients who suffered either deficient (38.7%) or insufficient levels (61.3%) of 25 (OH)D at day one had significantly decreased in the seventh day to (11.8%) and (52.7%), respectively. Kaplan--Meier plots highlighted that the median time to recover of the placebo group was significantly longer than that of the supplementation group (Log Rank P value < .001).. VDD was detected in pediatric critical care children. In pneumonic children with high VDD, it is illustrated that Vitamin D supplementation is accompanied by lowered mortality risk and pSOFA scores, reduced time to recover, and improved PaO2/FiO2.. Trial Identifier number: NCT04244474. Registered on 27 January 2020- Retrospectively registered at ClinicalTrials.gov https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S0009JXO&selectaction=Edit&uid=U0004UO8&ts=152&cx=9cceq6.

Topics: Child; Child, Preschool; Cholecalciferol; Dietary Supplements; Double-Blind Method; Egypt; Female; Hospitals, Pediatric; Humans; Infant; Male; Pneumonia; Tertiary Care Centers; Treatment Outcome; Vitamin D; Vitamin D Deficiency

Long-term cognitive impairment frequently occurs after critical illness; no treatments are known to improve long-term cognition.. Does a single high-dose (540,000 International Units) enteral treatment of vitamin D3 given shortly after hospital admission in critically ill patients who are vitamin D deficient improve long-term global cognition or executive function?. This study evaluated long-term cognitive outcomes among patients enrolled in a multicenter, blinded, randomized clinical trial comparing vitamin D3 treatment vs placebo in critically ill adults with vitamin D deficiency. Global cognition was measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). Executive function was measured with a composite score derived from three Delis-Kaplan Executive Function System subscales. Outcomes were assessed at a median of 443 days (interquartile range, 390-482 days) after randomization and were compared using multivariate proportional odds regression. Adjusted ORs of > 1.0 would indicate better outcomes in the vitamin D3 group compared with the placebo group.. Ninety-five patients were enrolled, including 47 patients randomized to vitamin D3 treatment and 48 patients randomized to placebo. The adjusted median RBANS score at follow-up was 79.6 (95% CI, 73.0-84.0) in the vitamin D3 group and 82.1 (95% CI, 74.7-84.6) in the placebo group (adjusted OR, 0.83; 95% CI, 0.50-1.38). The adjusted median executive function composite scores were 8.1 (95% CI, 6.8-9.0) and 8.7 (95% CI, 7.4-9.3), respectively (adjusted OR, 0.72; 95% CI, 0.36-1.42).. In vitamin D-deficient, critically-ill adults, a large dose of enteral vitamin D3 did not improve long-term global cognition or executive function.. ClinicalTrials.gov; No.: NCT03733418; URL: www.clinicaltrials.gov.

Topics: Cholecalciferol; Cognition; Cognitive Dysfunction; Critical Illness; Executive Function; Female; Humans; Long Term Adverse Effects; Male; Middle Aged; Neuropsychological Tests; Pulse Therapy, Drug; Treatment Outcome; Vitamin D Deficiency; Vitamins

Guidelines for the dosage of vitamin D supplementation vary widely globally.. To investigate the impact of 2 vitamin D doses, bracketed between the IOM recommended dietary allowance (RDA) and the upper tolerable limit, on vitamin D nutritional status in elderly individuals.. This post hoc analysis of data collected from a 12-month, double-blind, randomized control trial included 221 ambulatory participants (≥ 65 years) with a mean BMI of 30.2 kg/m2 and a mean baseline serum 25-hydroxyvitamin D [25(OH)D] level of 20.4 ± 7.4 ng/mL, who were recruited from 3 outpatient centers in Lebanon. All participants received 1000 mg of elemental calcium daily from calcium citrate plus the daily equivalent of either 600 IU or 3750 IU of vitamin D3.. Mean 25(OH)D level at 12 months was 26.0 ng/mL with low dose and 36.0 ng/mL with high dose vitamin D3. The proportion of participants reaching a value ≥ 20 ng/mL was 86% in the low dose, and 99% in the high dose arms, with no gender differences. The increment of 25(OH)D per 100 IU/day was 1 ng/mL with the low dose, and 0.41 ng/mL with the high dose. Serum 25(OH)D levels at 1 year were highly variable in both treatment arms. Baseline 25(OH)D level and vitamin D dose-but not age, BMI, gender, or season-were significant predictors of serum 25(OH)D level post-intervention.. The IOM Recommended Dietary Allowance (RDA) of 600 IU/day does not bring 97.5% of ambulatory elderly individuals above the desirable threshold of 20 ng/mL. Country-specific RDAs are best derived taking into account the observed variability and predictors of achieved 25(OH)D levels.

Topics: Aged; Aging; Body Mass Index; Calcium Citrate; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Male; Obesity; Overweight; Recommended Dietary Allowances; Seasons; Sex Factors; Vitamin D; Vitamin D Deficiency; Vitamins

Circulating osteoprogenitor (COP) cells are a relatively newly discovered mesenchymal precursors population in the peripheral blood. While some aspects of their physiology have been documented in vitro, little is known about their behavior in vivo. To facilitate understanding regarding their potential role in the management of musculoskeletal disease, more research into how these cells respond to growth factors and hormones in vivo is still required. To this end, we performed a randomized controlled pilot study investigating the effect of vitamin D supplementation on COP cells in healthy older adults. Twenty-two individuals were recruited and stratified through their baseline vitamin D levels into deficient (<35 nmol/L), insufficient (35-49 nmol/L) and sufficient (>50 nmol/L) groups, and then randomized to receive either a 50,000 IU bolus dose of vitamin D, along with a 1000 IU daily supplement for six weeks, or the 1000 IU supplement alone. Participants were assessed at baseline, week three, and week six, with the primary outcome being a change in the number of COP cells. Secondary outcomes were vitamin D, markers of bone formation and resorption, parathyroid hormone, and calcium. The study showed that, independently of the dosing, increasing vitamin D levels led to a concomitant 52% increase in COP cell number (p < 0.001). There were no differences between strata, or any of the secondary outcomes in the trial. This suggests that COP cells are regulated in some way by vitamin D, similar to the bone marrow mesenchymal stem cell. Future studies are needed to evaluate the long-term effects of vitamin D supplementation, and how COP cells may be involved in chronic musculoskeletal disease.

Topics: Aged; Cholecalciferol; Dietary Supplements; Double-Blind Method; Humans; Pilot Projects; Vitamin D; Vitamin D Deficiency; Vitamins

Muscle strength decreases as kidney failure progresses. Low muscle strength affects more than 50% of hemodialysis patients and leads to daily life activities impairment. In the general population, numerous studies have linked low 25OH-vitamin D (25OHD) concentrations to the loss of the muscle strength and low physical performances. Data on native vitamin D and muscle function are scarce in the chronic kidney disease (CKD) population, but low 25OHD levels have been associated with poor muscle strength. We present in this article the protocol of an ongoing study named VITADIAL testing if cholecalciferol supplementation in hemodialysis patients with low 25OHD improves their muscle strength.. VITADIAL is a prospective open randomized French multicenter study. All patients will have 25OHD levels ≤50nmol/L at randomization. One group will receive 100,000 UI cholecalciferol once a month during 6 months; the other group will receive no treatment during 6 months. In order to randomize patients with 25OHD ≤50nmol/L, supplemented patients will undergo a 3 months wash-out period renewable 3 times (maximum of 12 months wash-out) until 25OHD reaches a level ≤50nmol/L. The main objective of this study is to analyze if a 6-month period of oral cholecalciferol (i.e., native vitamin D) supplementation improves muscle strength of hemodialysis patients with low 25OHD vitamin D levels. Muscle strength will be assessed at 0, 3, and 6 months, by handgrip strength measured with a quantitative dynamometer. Secondary objectives are (1) to analyze 25OHD plasma levels after vitamin D wash-out and/or supplementation, as well as factors associated with 25OHD lowering speed during wash-out, and (2) to analyze if this supplementation improves patient's autonomy, reduces frailty risk, and improves quality of life. Fifty-four patients are needed in each group to meet our main objective.. In the general population, around 30 randomized studies analyzed the effects of vitamin D supplementation on muscle strength. These studies had very different designs, sizes, and studied population. Globally, these studies and the meta-analysis of studies favor a beneficial effect of vitamin D supplementation on muscle strength, but this effect is mainly found in the subgroup of aged patients and those with the lowest 25OHD concentrations at inclusion. We reported a positive independent association between 25OHD and handgrip strength in a population of 130 hemodialysis patients in a dose-dependent manner. In our cohort, a plateau effect was observed above 75 nmol/L. Only two randomized studies analyzed the effect of native vitamin D supplementation on muscle strength in hemodialysis patients, but unfortunately, these two studies were underpowered. VITADIAL is a trial specifically designed to assess whether cholecalciferol might benefit to hemodialysis patient's muscle strength.. ClinicalTrials.gov NCT04262934 . Registered on 10 February 2020 - Retrospectively registered.

Topics: Aged; Cholecalciferol; Dietary Supplements; Hand Strength; Humans; Meta-Analysis as Topic; Multicenter Studies as Topic; Muscle Strength; Prospective Studies; Quality of Life; Randomized Controlled Trials as Topic; Renal Dialysis; Vitamin D; Vitamin D Deficiency

Vitamin D has shown to play a role in multiple diseases due to its skeletal and extraskeletal actions. Furthermore, vitamin D deficiency has become a worldwide health issue. Few supplementation guidelines mention calcifediol treatment, despite being the direct precursor of calcitriol and the biomarker of vitamin D status. This 1-year, phase III-IV, double-blind, randomized, controlled, multicenter clinical trial assessed the efficacy and safety of calcifediol 0.266 mg soft capsules in vitamin D-deficient postmenopausal women, compared to cholecalciferol. Results reported here are from a prespecified interim analysis, for the evaluation of the study's primary endpoint: the percentage of patients with serum 25-hydroxyvitamin D (25(OH)D) levels above 30 ng/ml after 4 months. A total of 303 patients were enrolled, of whom 298 were included in the intention-to-treat (ITT) population. Patients with baseline levels of serum 25(OH)D <20 ng/ml were randomized 1:1:1 to calcifediol 0.266 mg/month for 12 months, calcifediol 0.266 mg/month for 4 months followed by placebo for 8 months, and cholecalciferol 25,000 IU/month for 12 months. At month 4, 35.0% of postmenopausal women treated with calcifediol and 8.2% of those treated with cholecalciferol reached serum 25(OH)D levels above 30 ng/ml (p < 0.0001). The most remarkable difference between both drugs in terms of mean change in serum 25(OH)D levels was observed after the first month of treatment (mean ± standard deviation change = 9.7 ± 6.7 and 5.1 ± 3.5 ng/ml in patients treated with calcifediol and cholecalciferol, respectively). No relevant treatment-related safety issues were reported in any of the groups studied. These results thus confirm that calcifediol is effective, faster, and more potent than cholecalciferol in raising serum 25(OH)D levels and is a valuable option for the treatment of vitamin D deficiency. © 2021 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).

Topics: Calcifediol; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Postmenopause; Vitamin D; Vitamin D Deficiency

The aim of this study was to evaluate the efficiency of a buccal spray form of vitamin D compared to single oral dose (stoss therapy) and oral drops therapy in the treatment of vitamin D deficiency.. Ninety healthy children and adolescents (3-18 years) with vitamin D deficiency [serum level of 25-hydroxyvitamin D (25(OH) D) <12 ng/mL] were randomized to receive vitamin D3 buccal spray (2000 U, n=30, group 1) for six weeks, oral drops (2000 U, n=30, group 2) for six weeks and a single oral dose (300 000 U) vitamin D3 (n=30, group 3). Serum calcium, phosphorus, alkaline phosphatase, parathyroid hormone and 25(OH)D levels of the patients were measured at baseline and after the treatment on the 42. All three groups had a significant increase in serum 25(OH)D concentrations (p<0.001). In group 1, baseline mean 25(OH)D was 8.0±0.41 ng/mL, which rose to 22.1 (17.8-28.2) ng/mL after treatment with a mean increase of 15.6±1.3 ng/mL. Similarly in group 2, baseline, post-treatment and mean increase in 25(OH)D concentrations were 7.9±0.45 ng/mL, 24.4 (20.6-29.6) ng/mL and 17.3±1.1 ng/mL while for group 3 these values were 7.6±0.47 ng/mL, 40.3 (29.4-58.4) ng/mL and 34.3±3.2 ng/mL, respectively.. We conclude that vitamin D3 supplementation with buccal spray and oral drops is equally effective in terms of raising vitamin D concentrations in short-term treatment of vitamin D deficiency.

Topics: Administration, Buccal; Adolescent; Child; Child, Preschool; Cholecalciferol; Female; Humans; Male; Oral Sprays; Treatment Outcome; Vitamin D Deficiency

This study aimed to evaluate the effect of cholecalciferol supplementation on the body composition and metabolic profile of children with hypertriacylglycerolemia.. This is a randomized, triple-masked, placebo-controlled, crossover trial of 44 Brazilian children with hypertriacylglycerolemia, age 4 to 11 y. The sample included eutrophic and overweight/obese children according to body mass index for age, with sufficient and insufficient vitamin D basal levels. The intervention lasted 34 wk, with two periods of 12 wk each separated by a 10-wk washout. The two groups, supplemented and placebo, received five drops of cholecalciferol (equivalent to 1000 international unit/d) and five drops of sunflower oil, respectively, daily for 12 wk. Sociodemographic, economic, sunscreen use, percentage of body surface area daily exposed to sun, physical activity, anthropometry (body mass and height), body composition (waist circumference, body fat percentage, fat-free mass, triceps, and subscapular skinfolds), biochemical profile (25-hydroxyvitamin D, fasting glucose, and lipid fractions), blood pressure, and food intake data were collected.. Of the 44 children who concluded the study, 56.80% were female, 54.50% were of brown race, 81.82% had sufficient serum 25-hydroxyvitamin D (≥75 nmol/L), and 50.00% were overweight/obese according to body mass index for age. There was a reduction in serum total cholesterol (P < 0.001), low-density lipoprotein cholesterol (P < 0.001), nonhigh-density lipoprotein cholesterol (P < 0.001), total cholesterol/high-density lipoprotein cholesterol (P = 0.001), and low/high-density lipoprotein cholesterol ratios (P < 0.001) in the supplemented group compared with the placebo group.. Cholecalciferol supplementation improved the lipid profile of children with hypertriacylglycerolemia without altering body composition.

Topics: Child; Child, Preschool; Cholecalciferol; Cross-Over Studies; Dietary Supplements; Double-Blind Method; Female; Humans; Pediatric Obesity; Vitamin D; Vitamin D Deficiency

GC/DBP effects on response to vitamin D supplementation have not been well-studied. Thus we assessed free and total 25-OHD after vitamin D treatment across the six common GC haplotypes.. This double-blind, randomized study compared two vitamin D3 doses in healthy, urban-dwelling 6-month to 10-year-old children at-risk for vitamin D deficiency. Randomization was stratified by GC haplotype.. Children were randomized to receive 2800 or 7000 International Units of vitamin D3 weekly. 25-OHD and 1,25(OH)2D were sampled at baseline and after 1-6 months of supplementation.. One hundred ninety-two of 225 enrolled subjects completed the study. After one month, total 25-OHD increased with both doses and were higher with 7000 IU/week (85.5 ± 22.8 nmol/L) compared to 2800 IU/week (76.8 ± 18.0 nmol/L), despite equivalent baseline levels. No further significant increase occurred at 6 months (89.8 ± 35.5 and 74.3 ± 18.3 nmol/L, respectively). Free 25-OHD similarly changed. 25-OHD differed among GC groups at baseline. Although no significant effects of individual GC haplotypes on incremental changes were evident, a trend toward an effect of combined 'at risk' GC alleles on response was evident (P = 0.06). Total 1,25(OH)2D showed modest increases, moreso with the larger dose. In urban-dwelling children at-risk for vitamin D deficiency, 1 month of vitamin D3 2800 IU/week increased 25-OHD across all GC haplotype groups, and somewhat enhanced with 7000 IU/week with no further significant increases after 6 months of supplementation. Free 25-OHD measures offer no monitoring advantage over total 25-OHD.

Topics: 25-Hydroxyvitamin D 2; Child; Child, Preschool; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Haplotypes; Humans; Infant; Male; Prospective Studies; Vitamin D Deficiency

Vitamin D deficiency has been associated with an increased risk of COVID-19 severity. This multi-center randomized clinical trial aims to determine the effects of 5000 IU versus 1000 IU daily oral vitamin D3 supplementation in the recovery of symptoms and other clinical parameters among mild to moderate COVID-19 patients with sub-optimal vitamin D status.. A total of 69 reverse transcriptase polymerase chain reaction (RT-PCR) SARS-CoV-2 positive adults who were hospitalized for mild to moderate COVID-19 disease were allocated to receive once daily for 2 weeks either 5000 IU oral vitamin D3 (. Vitamin D supplementation for 2 weeks caused a significant increase in serum 25(OH)D levels in the 5000 IU group only (adjusted. A 5000 IU daily oral vitamin D3 supplementation for 2 weeks reduces the time to recovery for cough and gustatory sensory loss among patients with sub-optimal vitamin D status and mild to moderate COVID-19 symptoms. The use of 5000 IU vitamin D3 as an adjuvant therapy for COVID-19 patients with suboptimal vitamin D status, even for a short duration, is recommended.

Topics: Administration, Oral; Adult; Aged; Blood Glucose; Cholecalciferol; COVID-19; COVID-19 Drug Treatment; Dietary Supplements; Female; Hospitalization; Humans; Kaplan-Meier Estimate; Lipids; Male; Middle Aged; Nutritional Status; SARS-CoV-2; Saudi Arabia; Severity of Illness Index; Time Factors; Treatment Outcome; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D concentrations are a function of sunlight exposure and dietary intake. However, current dietary vitamin D recommendations do not consider differences in country-specific sunlight availability or spontaneous individual exposure.. We aimed to investigate the effects of vitamin D supplementation and sunlight exposure on vitamin D concentrations in Brazilian women living in high compared with low latitudes.. In 2 parallel, double-blind, randomized placebo-controlled trials, Brazilian women living in England (51°N) composed "without ultraviolet B (UVB) exposure" groups and those living in Brazil (16°S) composed the "with UVB exposure" groups (mean age, 31.39 ± 8.7 years). Participants received 15 μg cholecalciferol or placebo daily for 12 weeks during wintertime. Serum 25-hydroxyvitamin D [25(OH)D] concentrations, the primary outcome, were assessed by HPLC-MS/MS, vitamin D intakes were assessed by 4-day diet diaries, and sunlight exposure was assessed by UVB dosimeters. The effects of supplementation and UVB exposure were tested by the intention to treat with a linear mixed model.. The 25(OH)D concentrations increased in both supplemented groups [from 75.1 ± 22.0 to 84.8 ± 21.0 nmol/L (P = 0.004) in the group with UVB exposure; from 38.1 ± 15.9 to 55.1 ± 12.2 nmol/L (P < 0.001) in the group without UVB exposure], with no significant changes in either placebo group. Concentrations in both supplemented groups were higher than those in the placebo group without UVB exposure (P = 0.0002 in the group with UVB exposure; P = 0.0035 in the group without UVB exposure). Postintervention 25(OH)D concentrations were significantly affected by serum 25(OH)D concentrations at baseline (P < 0.0001) and by intervention (placebo or supplement; P > 0.0001), with a large effect size (Cohen's D = 0.768), but were not affected by UVB exposure (with or without; P = 0.1386), nor by the interaction between the intervention (placebo or supplement) and UVB exposure (with or without; P = 0.9845).. Moderate supplementation of 15 ug/d cholecalciferol, in accordance with current recommendations, supports an adequate vitamin D status in adult women, irrespective of latitude, and might concomitantly prevent an increase in parathyroid hormone. The Interaction Between Vitamin D Supplementation and Sunlight Exposure in Women Living in Opposite Latitudes (D-SOL) study was registered at clinicaltrials.gov as NCT03318029.

Topics: Adult; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Seasons; Sunlight; Tandem Mass Spectrometry; Vitamin D; Vitamin D Deficiency; Young Adult

To evaluate the efficacy of daily supplementation of 200 mL milk fortified with 240 IU of vitamin D2 (ergocalciferol).. Double-blind randomized controlled trial.. School-based study in Delhi between October and December, 2019.. 235 healthy children aged 10-14 years.. Daily supplementation of 200 mL milk fortified with 240 IU of ergocalciferol in intervention group (n=119) and 200 mL of plain milk in control group (n =116) for 3 months.. Change in serum 25 hydroxy vitamin D (25(OH)D), parathyroid hormone (PTH), bone formation and resorption markers, and urinary calcium creatinine ratio (U-Ca/CrR).. The mean (SD) baseline serum 25(OH) D level in control and fortification groups was 11.9 (3.8) and 11.4 (3.6) ng/mL (P=0.23), respectively. The serum 25(OH)D levels did not increase post-intervention with the dose used for fortification, but were significantly higher in intervention group as compared to control group [10.8 (3.4) vs 6.7 (3.5) ng/mL; P<0.001]. A higher proportion of secondary hyperparathyroidism was observed post-intervention in control (39%) than in intervention group (13.3%); P<0.001. Serum carboxy-terminal telopeptide levels were similar in both groups but the serum procollagen type1 N-terminal propeptide levels were higher in the control than intervention group (P<0.007), following supplementation.. Supplementation of milk fortified with approximately 240 IU vitamin D2 for three months did not achieve sufficient serum 25(OH)D levels in Indian children with vitamin D deficiency during winter.

Topics: Animals; Child; Cholecalciferol; Dietary Supplements; Double-Blind Method; Ergocalciferols; Food, Fortified; Humans; Milk; Parathyroid Hormone; Schools; Vitamin D; Vitamin D Deficiency

Variability in the 25-hydroxyvitamin D [25(OH)D] response to prenatal and postpartum vitamin D supplementation is an important consideration for establishing vitamin D deficiency prevention regimens.. We aimed to examine interindividual variation in maternal and infant 25(OH)D following maternal vitamin D supplementation.. In a randomized trial of maternal vitamin D supplementation (Maternal Vitamin D for Infant Growth Trial), healthy pregnant women (n = 1300) received a prenatal cholecalciferol (vitamin D-3) dose of 0, 4200, 16,800, or 28,000 IU/wk from 17 to 24 wk of gestation followed by placebo to 6 mo postpartum. A fifth group received 28,000 IU cholecalciferol/wk both prenatally and postpartum. In a subset of participants, associations of 25(OH)D with hypothesized explanatory factors were estimated in women at delivery (n = 655) and 6 mo postpartum (n = 566), and in their infants at birth (n = 502) and 6 mo of age (n = 215). Base models included initial 25(OH)D and supplemental vitamin D dose. Multivariable models were extended to include other individual characteristics and specimen-related factors. The model coefficient of determination (R2) was used to express the percentage of total variance explained.. Supplemental vitamin D intake and initial 25(OH)D accounted for the majority of variance in maternal 25(OH)D at delivery and postpartum (R2 = 70% and 79%, respectively). Additional characteristics, including BMI, contributed negligibly to remaining variance (<5% increase in R2). Variance in neonatal 25(OH)D was explained mostly by maternal delivery 25(OH)D and prenatal vitamin D intake (R2 = 82%). Variance in 25(OH)D in later infancy could only partly be explained by numerous biological, sociodemographic, and laboratory-related characteristics, including feeding practices (R2 = 43%).. Presupplementation 25(OH)D and vitamin D supplemental dose are the major determinants of the response to maternal prenatal vitamin D intake. Vitamin D dosing regimens to prevent maternal and infant vitamin D deficiency should take into consideration the mean 25(OH)D concentration of the target population.

Topics: Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Infant; Infant, Newborn; Postpartum Period; Pregnancy; Vitamin D; Vitamin D Deficiency

The objective of this extension phase of the quasi-experimental GERIA-COVID study was to determine whether vitamin D3 supplementation taken prior to or during COVID-19 was associated with better 3-month survival in geriatric patients hospitalized for COVID-19.. Intervention group was defined as all participants supplemented with vitamin D3 prior to or during COVID-19 (n = 67). Supplements were either bolus vitamin D3 (ie, 50,000 IU per month, or 80,000 IU or 100,000 IU or 200,000 IU every 2-3 months), or daily supplementation with 800 IU. Comparator group involved those without vitamin D supplements (n = 28). Outcome was 3-month mortality. Covariables were age, sex, functional abilities, history of malignancies, cardiomyopathy, undernutrition, number of acute health issues, antibiotics use, systemic corticosteroids use, and 25(OH)D concentration.. 76.1 % (n = 51) of participants survived at 3 months in Intervention group, compared to only 53.6 % (n = 15) in Comparator group (P = 0.03). The fully-adjusted hazard ratio for 3-month mortality was HR = 0.23 [95 %CI: 0.09;0.58](P = 0.002) in Intervention group compared to Comparator group. Intervention group had also longer survival time (log-rank P = 0.008).. Vitamin D3 supplementation was associated with better 3-month survival in older COVID-19 patients.

Topics: Aged, 80 and over; Cardiomyopathies; Case-Control Studies; Cholecalciferol; Comorbidity; COVID-19; Dietary Supplements; Drug Administration Schedule; Female; Health Services for the Aged; Humans; Male; Malnutrition; Neoplasms; Proportional Hazards Models; SARS-CoV-2; Vitamin D; Vitamin D Deficiency

Experimental studies suggest that vitamin D receptor signaling may benefit the gut microbiome. In humans, whether vitamin D supplementation directly alters the gut microbiome is not well studied.. To determine whether correcting vitamin D deficiency with cholecalciferol (vitamin D3, D3) or calcifediol (25-hydroxyvitamin D3, 25(OH)D3) changes gut microbiome composition.. 18 adults with vitamin D deficiency (25-hydroxyvitamin D [25(OH)D] <20 ng/mL) received 60 µg/day of D3 or 20 µg/day of 25(OH)D3 for 8 weeks. Changes in serum 25(OH)D, 1,25-diydroxyvitamin D (1,25(OH)2D), and 24,25-dihydroxyvitamin D (24,25(OH)2D) were assessed. We characterized composition of the fecal microbiota using 16S rRNA gene sequencing, and examined changes in α-diversity (Chao 1, Faith's Phylogenetic Diversity, Shannon Index), β-diversity (DEICODE), and genus-level abundances (DESeq2).. Vitamin D3 and 25(OH)D3 groups were similar. After 8 weeks of vitamin D3, mean 25(OH)D and 24,25(OH)2D increased significantly, but 1,25(OH)2D did not (25(OH)D: 17.8-30.1 ng/mL, P = .002; 24,25(OH)2D: 1.1 to 2.7 ng/mL, P =0.003; 1,25(OH)2D: 49.5-53.0 pg/mL, P = .9). After 8 weeks of 25(OH)D3, mean 25(OH)D, 24,25(OH)2D, and 1,25(OH)2D increased significantly (25(OH)D: 16.7-50.6 ng/mL, P < .0001; 24,25(OH)2D: 1.3-6.2 ng/mL, P = .0001; 1,25(OH)2D: 56.5-74.2 pg/mL, P = .05). Fecal microbial α-diversity and β-diversity did not change with D3 or 25D3 supplementation. Mean relative abundance of Firmicutes increased and mean relative abundance of Bacterioidetes decreased from baseline to 4 weeks, but returned to baseline by study completion. DESeq2 analysis did not confirm any statistically significant taxonomic changes.. In a small sample of healthy adults with vitamin D deficiency, restoration of vitamin D sufficiency with vitamin D3 or 25(OH)D3 did not lead to lasting changes in the fecal microbiota.

Topics: Adolescent; Adult; Biomarkers; Calcifediol; Cholecalciferol; Dietary Supplements; Feces; Female; Follow-Up Studies; Gastrointestinal Microbiome; Humans; Male; Pilot Projects; Prognosis; Vitamin D Deficiency; Vitamins; Young Adult

Comparative pharmacodynamic (PD) analyses on different dosing schedules for cholecalciferol supplementation are limited. This was an open-label, randomized, parallel-group study involving 75 healthy individuals deficient in vitamin D (baseline 25OHD < 20 ng/mL) receiving oral cholecalciferol with three different dosing regimens: Group A: 10,000 IU/day for 8 weeks followed by 1000 IU/day for 4 weeks; Group B: 50,000 IU/week for 12 weeks and Group C: 100,000 IU every other week for 12 weeks. Regulators of calcium and phosphate homeostasis, bone turnover markers and Wnt inhibitors were measured at baseline, Day 28, 53, 84, and 112. The 1,25OH2D increased at each time point. The increase was greater (

Topics: Adult; Biomarkers; Bone Remodeling; Calcium; Cholecalciferol; Female; Fibroblast Growth Factor-23; Healthy Volunteers; Humans; Male; Middle Aged; Phosphates; Vitamin D Deficiency; Vitamins

Although adults with low vitamin D status are at increased risk of acute respiratory infection (ARI), randomized controlled trials of vitamin D supplementation have provided inconsistent results.. We performed a randomized, double-blinded, placebo-controlled trial of 5110 adults aged 50-84 years. In 2011-2012, participants were randomized to an initial oral dose of 200 000 IU vitamin D3 followed by 100 000 IU monthly (n = 2558) or placebo (n = 2552) until late 2013 (median follow-up, 1.6 years). Participants reported upper and lower ARIs on monthly questionnaires. Cox models analyzed time to first ARI (upper or lower) by treatment group.. Participants' mean age was 66 years and 58% were male; 83% were of European/other ethnicity, with the rest Maori, Polynesian, or South Asian. Mean (SD) baseline blood 25-hydroxyvitamin D [25(OH)D] level was 63 (24) nmol/L; 25% were <50 nmol/L. In a random sample (n = 441), vitamin D supplementation increased mean 25(OH)D to 135 nmol/L at 3 years, while those on placebo remained at 63 nmol/L. During follow-up, 3737 participants reported ≥1 ARI: 74.1% in the vitamin D group versus 73.7% in the placebo group. The hazard ratio for vitamin D compared with placebo was 1.01 (95% CI, 0.94, 1.07). Similar results were seen in most subgroups, including those with baseline 25(OH)D <50 nmol/L and in analyses of the upper/lower components of the ARI outcome.. Monthly high-dose vitamin D supplementation does not prevent ARI in older adults with a low prevalence of profound vitamin D deficiency at baseline. Whether effects of daily or weekly dosing differ requires further study.. Australian New Zealand Clinical Trials Registry, identifier ACTRN12611000402943.

Topics: Aged; Aged, 80 and over; Australia; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Male; Middle Aged; Respiratory Tract Infections; Vitamin D; Vitamin D Deficiency

This randomized controlled trial aimed to test whether vitamin D (VD) supplementation affects measures of physical performance in VD-deficient, mildly trained children. Thirty-six recreationally soccer player boys were randomly assigned to single dose (200 000 IU) of VD3 (

Topics: Athletes; Athletic Performance; Child; Cholecalciferol; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Exercise; Humans; Male; Soccer; Vitamin D Deficiency

Intravenous aminobisphosphonates (N-BPs) can induce an acute phase reaction (APR) in up to 40% to 70% of first infusions, causing discomfort and often requiring intervention with analgesics or antipyretics.. Our aim was to explore the risk factors of APR in a large sample of patients with Paget's disease of bone (PDB) and to assess the possible preventive effects of vitamin D administration.. An observational analysis was performed in 330 patients with PDB at the time of N-BP infusion. Then, an interventional study was performed in 66 patients with active, untreated PDB to evaluate if vitamin D administration (oral cholecalciferol 50 000 IU/weekly for 8 weeks before infusion) may prevent APR.. In a retrospective study, APR occurred in 47.6% and 18.3% of naive or previously treated patients, respectively. Its prevalence progressively increased in relation to the severity of vitamin D deficiency, reaching 80.0% in patients with 25-hydroxyvitamin D (25OHD) levels below 10 ng/mL (relative risk (RR) = 3.7; 95% confidence interval (CI) 2.8-4.7, P < .0001), even in cases previously treated with N-BPs. Moreover, APR occurred more frequently in patients who experienced a previous APR (RR = 2.8; 95% CI 1.5-5.2; P < .001) or in carriers of SQSTM1 mutation (RR = 2.3; 95% CI 1.3-4.2; P = .005). In the interventional study, vitamin D supplementation prevented APR in most cases, equivalent to a RR of 0.31 (95% CI 0.14-0.67; P < .005) with respect to prevalence rates of the observational cohort. A similar trend was observed concerning the occurrence of hypocalcemia.. The achievement of adequate 25OHD levels is recommended before N-BP infusion in order to minimize the risk of APR or hypocalcemia in PDB.

Topics: Acute-Phase Reaction; Administration, Oral; Aged; Aged, 80 and over; Bone Density Conservation Agents; Cholecalciferol; Dietary Supplements; Diphosphonates; Female; Humans; Infusions, Intravenous; Male; Middle Aged; Osteitis Deformans; Prevalence; Retrospective Studies; Treatment Outcome; Vitamin D; Vitamin D Deficiency

Vitamin D deficiency is now a recognised problem affecting multiple physiological functions. The aim of the present study was to evaluate the effect of a single dose of vitamin D3 injection on the inflammatory, muscular damage, metabolic and cardiovascular responses to an acute bout of resistance exercise (RE) in vitamin D-deficient resistance-trained males. Blood samples from fourteen vitamin D-deficient resistance-trained males were obtained during two separate trials: lower vitamin D (LVD) and higher vitamin D (HVD, after vitamin D3 injection). Metabolic, inflammatory, muscle damage and cardiovascular markers were evaluated at baseline, immediately and 1 h after RE. There were significant trial-by-time interactions for insulin and homeostatic model assessment of insulin resistance (HOMA-IR) which significantly (P < 0·05) declined for 1 h after RE in the HVD trial compared with the LVD trial. Homeostasis model assessment of β-cell function (HOMA-β) declines at 1 h post-RE in the HVD trial. There was also a time effect for blood sugar which significantly (P < 0·05) decreased and for creatine kinase, lactate dehydrogenase and IL-6 which increased significantly 1 h post-RE in both trials. There were no significant changes in other inflammatory and cardiovascular markers following both trials. A single injection of vitamin D3 improved insulin resistance and β-cell function following RE in previously vitamin D-deficient resistance-trained males. Conversely, the injection did not change muscle damage and the inflammatory response to acute RE. Intramuscular vitamin D replacement may have key implications for the promotion of glucose metabolism and lowering the risk of diabetes in vitamin D-deficient individuals.

Topics: Adult; Biomarkers; Cholecalciferol; Cross-Over Studies; Humans; Injections; Insulin Resistance; Insulin-Secreting Cells; Male; Muscle, Skeletal; Resistance Training; Treatment Outcome; Vitamin D; Vitamin D Deficiency; Young Adult

The primary aim was to determine the effectiveness of a single high-dose of oral vitamin D3 (stoss therapy) in children with inflammatory bowel disease (IBD) and hypovitaminosis D. Our secondary aim was to examine the safety of stoss therapy.. We conducted a randomized, prospective study of 44 patients, ages 6 to 21 years, with IBD and 25-hydroxyvitamin D (25-OHD) concentrations <30 ng/mL. Patients were randomized to receive 50,000 IU of vitamin D3 once weekly for 6 weeks (standard of care, SOC group) or 300,000 IU once (stoss group). Serum 25-OHD levels were obtained at baseline, 4 and 12 weeks. Safety monitoring labs were performed at week 4.. Thirty-nine of 44 enrolled patients (19 stoss, 20 SOC) completed the study. Baseline vitamin D levels were not significantly different between the groups. Stoss therapy resulted in a substantial rise in 25-OHD levels at week 4, equivalent to the weekly regimen (53.6 ± 17.3 vs 54.6 ± 17.5 ng/mL). At week 12, serum 25-OHD levels decreased in both groups, significantly lower in the stoss group, but remained close to 30 ng/mL (29.8 ± 7.1 vs 40.4 ± 11.9 ng/mL, P = 0.04). A significant interaction with treatment group over time was observed (P = 0.0003). At the week-4 time point, all patients who received stoss therapy had normal serum calcium and PTH levels. Eighty percentage of patients preferred stoss therapy to the weekly regimen.. Stoss therapy was safe and effective in raising 25-OHD in children with IBD commensurate to that of the weekly regimen.

Topics: Adolescent; Adult; Child; Cholecalciferol; Dietary Supplements; Humans; Inflammatory Bowel Diseases; Prospective Studies; Vitamin D; Vitamin D Deficiency; Young Adult

Maintenance of the serum 25-hydroxyvitamin D (25-OH-D) concentration at recommended levels is essential due to its role in the regulation of anabolic hormones and athletic performance. However, the results of the clinical experiments in athletes are controversial. The present study aimed to investigate the effect of vitamin D3 supplement on serum levels of anabolic hormones, cortisol, anaerobic and aerobic performance in active males. In this double-blind, randomized controlled trial, 46 active males randomly assigned to vitamin D3 supplement (VDS; 2000 IU/day) or placebo for 12 weeks. The Wingate test, VO

Topics: Aerobiosis; Anaerobiosis; Analysis of Variance; Athletic Performance; Body Mass Index; Cholecalciferol; Double-Blind Method; Exercise; Fatigue; Growth Hormone; Humans; Hydrocortisone; Insulin-Like Growth Factor I; Iran; Male; Oxygen Consumption; Parathyroid Hormone; Placebos; Seasons; Testosterone; Time Factors; Vitamin D; Vitamin D Deficiency; Young Adult

This trial was conducted to explore the protective effect on β-cell function of adding vitamin D3 to DPP-4 inhibitors to treat patients with latent autoimmune diabetes in adults (LADA).. 60 LADA patients were randomized to group A (n = 21) - conventional therapy with metformin (1-1.7 g/day) and/or insulin treatment; group B (n = 20) - saxagliptin (5 mg/day) plus conventional therapy; and group C (n = 19) - vitamin D3 (2000 IU/day) plus saxagliptin and conventional therapy for 12 months. Fasting and 2-hour postprandial blood samples were collected to measure blood glucose, glycosylated hemoglobin and C-peptide levels at baseline and after 3, 6 and 12 months of treatment.. During the 12 months of follow-up, the levels of fasting C-peptide (FCP), 2-hour postprandial C-peptide (PCP) and the C-peptide index (CPI, serum C-peptide-to-plasma glucose level ratio) were maintained in group C. In contrast to those in group A and group B, FCP levels decreased significantly in group B, and CPI levels declined significantly in group A during the 1-year treatment (P < .05). Additionally, the levels of GADA titers in group C significantly decreased compared with those at baseline (P < .05), but no significant differences in GADA titers levels were detected in group A and group B. No significant differences were found among the three groups in the levels of FCP, PCP, the CPI or GADA titers.. The data suggested that adding 2000 IU/day vitamin D3 to saxagliptin might preserve β-cell function in patients with LADA.

Topics: Adamantane; Adolescent; Adult; Aged; Cholecalciferol; Dipeptides; Dipeptidyl-Peptidase IV Inhibitors; Drug Therapy, Combination; Female; Follow-Up Studies; Humans; Insulin-Secreting Cells; Latent Autoimmune Diabetes in Adults; Male; Middle Aged; Prognosis; Vitamin D Deficiency; Vitamins; Young Adult

While observational studies revealed inverse associations between serum vitamin D levels [25(OH)D] and depression, randomized controlled trials (RCT) in children and adolescents are lacking. This RCT examined the effect of an untreated vitamin D deficiency compared to an immediate vitamin D. At admission, 49.3% of the screened patients (n = 280) had vitamin D deficiency. Although the intervention led to a higher increase of 25(OH)D levels in the VG than in the PG (treatment difference: + 14 ng/ml; 95% CI 4.86-23.77; p = 0.003), the change in BDI-II scores did not differ (+ 1.3; 95% CI - 2.22 to 4.81; p = 0.466). In contrast, DISYPS parental ratings revealed pronounced improvements of depressive symptoms in the VG (- 0.68; 95% CI - 1.23 to - 0.13; p = 0.016).. Whereas this study failed to show a vitamin D supplementation effect on self-rated depression in adolescent in- or daycare patients, parents reported less depressive symptoms in VG at the end of our study. Future trials should consider clinician-rated depressive symptoms as primary outcome.. "German Clinical Trials Register" ( https://www.drks.de ), registration number: DRKS00009758.

Topics: Adolescent; Child; Cholecalciferol; Depression; Dietary Supplements; Double-Blind Method; Humans; Vitamin D; Vitamin D Deficiency; Vitamins

The interaction of CD40 ligand (CD40L) and CD40 triggers the induction of pro-inflammatory cytokines. It has been proposed that vitamin D deficiency might be an important factor, which causes or aggregates the autoimmune situations. The aim of the present study was to assess the effect of vitamin D on CD40L gene expression in patients with ulcerative colitis (UC).. Ninety mild-to-moderate UC patients were randomized to receive a single injection of 7.5 mg cholecalciferol or 1 mL normal saline. At baseline and 90 days following the intervention, RNA samples from whole blood were obtained. Fold changes in CD40L mRNA expression were determined for each patient using the 2-ΔΔCq method. The data were analyzed.. The serum levels of vitamin D and calcium increased only in the vitamin D group (p<0.05). Relative to baseline values, the CD40L gene expression fold change was significantly lower in the vitamin D group compared with the placebo group (median±interquartile range: 0.34±0.30 vs 0.43±1.20, respectively, p=0.016).. The results of this study showed that vitamin D administration in mild-to-moderate UC patients led to the downregulation of the CD40L gene, which is an essential part of inflammatory pathways.

Topics: Adult; Calcium; CD40 Ligand; Cholecalciferol; Colitis, Ulcerative; Cytokines; Double-Blind Method; Down-Regulation; Female; Gene Expression; Humans; Injections, Subcutaneous; Male; RNA; Treatment Outcome; Vitamin D; Vitamin D Deficiency

This study aimed to evaluate whether vitamin D deficiency is associated with the severity of symptoms of irritable bowel syndrome (IBS) patients. Stress and gut inflammation can increase the serum level of corticotropin-releasing hormone (CRH) and interleukin-6 (IL-6), leading to a change in bowel movements. The aim of this study was to evaluate the anti-inflammatory and psychological effects of vitamin D3 supplementation on the symptom improvement of patients with a diarrhea-predominant form of IBS (IBS-D).. Eighty-eight IBS-D patients (age: 18-65 years) based on Rome IV criteria who suffered from vitamin D deficiency and/or insufficiency were enrolled in this randomized, placebo-controlled trial from February 2017 to May 2018 at Rasoul-e-Akram Hospital, Tehran, Iran. Participants were randomly divided into two groups. The intervention group received 50,000 IU vitamin D3 weekly and the control group received a placebo for 9 weeks. All patients received Mebeverine 135 mg twice a day besides supplementation. The IBS Severity Score System (IBS-SSS), serum 25(OH) vitamin D3, CRH, and IL-6 were measured before and after interventions.. Seventy-four patients completed the study. The severity of IBS symptoms (p < 0.01) and IL-6 (p = 0.02) decreased significantly in the intervention group as compared to the control group, but there was no significant difference in the serum level of CRH. Also, in the treatment group, IBS-SSS and IL-6 were significantly reduced at the end of the study from baseline (p < 0.01 and p < 0.03, respectively).. Our findings indicate that vitamin D3 supplementation can modulate the serum level of CRH and IL-6 and can improve symptoms in IBS-D patients. Vitamin D3 supplementation should be considered in IBS-D patients who suffer from vitamin D deficiency and/or insufficiency.. Ziele: Diese Studie untersucht den Zusammenhang zwischen Vitamin-D-Mangel und dem Schweregrad der Symptome von Patienten mit Reizdarmsyndrom (irritable bowel syndrome, IBS). Stress und Darmentzündung können erhöhte Serumkonzentrationen von Corticotropin-Releasing Hormone (CRH) und Interleukin-6 (IL-6) zur Folge haben, die zu Veränderungen des Stuhlverhaltens führen. Mit der vorliegenden Studie sollten die entzün­dungshemmenden und psychischen Effekte einer Vitamin-D3-Supplementierung auf die Symptomverbesse­rung von Patienten mit diarrhödominantem Reizdarmsyndrom (diarrhea-predominant form of IBS, IBS-D) beurteilt werden. Methoden: In diese randomisierte, placebokontrollierte Studie, die von Februar 2017 bis Mai 2018 am Rasoul-e-Akram Hospital in Teheran, Iran, durchgeführt wurde, wurden 88 Patienten mit IBS-D gemäß den Rom-IV-Kriterien (Alter: 18–65 Jahre) aufgenommen. Die Studienteilnehmer wurden randomisiert einer von zwei Gruppen zugeordnet. Die Interventionsgruppe erhielt wöchentlich über 9 Wochen 50’000 IU Vitamin D3, und die Kontrollgruppe erhielt ein Placebo. Alle Patienten erhielten neben der Supplementierung zweimal täglich Mebeverin 135 mg. Vor und nach der Intervention erfolgten eine Beurteilung der Krankheitsschwere gemäß IBS Severity Score System (IBS-SSS) sowie eine Bestimmung der Serumkonzentrationen von 25(OH)-Vitamin D3, CRH und IL-6. Ergebnisse: Vierundsiebzig Teilnehmer schlossen die Studienteilnahme ab. Der Schweregrad der IBS-Symptome (p < 0,01) und die IL-6-Serumkonzentration(p = 0,02) gingen in der Interventionsgruppe im Vergleich zur Kontrollgruppe signifikant zurück, während bei der CRH-Serumkonzentration kein signifikanter Unterschied zu beobachten war. Ferner zeigte sich in der Behandlungsgruppe bei Studienende ein signifikanter Rückgang des IBS-SSS und der IL-6-Serumkonzentration gegenüber Studienbeginn (p < 0,01 bzw. p < 0,03). Schlussfolgerung: Unsere Ergebnisse zeigen, dass eine Vitamin-D3-Supplementierung die Serumspiegel von CRH und IL-6 verändern und die Symptome von Patienten mit IBS-D verbessern kann. Bei Patienten mit IBS-D, die an einem Vitamin-D3-Mangel und/oder einer Vitamin-D3-Insuffizienz leiden, sollte eine Supplementierung mit Vitamin D3 in Betracht gezogen werden.

Topics: Adolescent; Adult; Aged; Biomarkers; Cholecalciferol; Corticotropin-Releasing Hormone; Diarrhea; Dietary Supplements; Double-Blind Method; Female; Humans; Interleukin-6; Irritable Bowel Syndrome; Male; Middle Aged; Vitamin D Deficiency; Young Adult

Low vitamin D levels have been associated with allergic diseases. Vitamin D has potent immunomodulatory properties, but the mechanisms remain unclear. We have investigated the effect of oral vitamin D supplementation on circulating immune cell phenotypes in infants.. A double-blinded randomised controlled trial was conducted to investigate the effect of oral vitamin D supplementation (400 IU/d) on eczema and immune development. A subset of 78 infants was included in this analysis. Phenotypic analysis of immune cell subsets was performed using flow cytometry.. Vitamin D supplementation resulted in median 25(OH)D levels of 80.5 vs 59.5 nmol/L in the placebo group at 3 months of age (P = .002) and 87.5 vs 77 nmol/L at 6 months of age (P = .08). We observed significant changes in immune cell composition from birth (cord blood) to 6 months of age. Vitamin D supplementation did not impact these changes, nor did immune cell composition correlate with plasma 25(OH)D levels. Through exploratory analysis, we identified possible associations with eczema development and increased abundance of naïve CD4. Vitamin D supplementation in infants who were vitamin D sufficient at birth did not affect developmental changes in immune cells during the first 6 months of life. However, immune cell profiles at birth and at 6 months of age were associated with early life eczema.

Topics: Cholecalciferol; Dietary Supplements; Double-Blind Method; Eczema; Female; Humans; Infant; Infant, Newborn; Vitamin D; Vitamin D Deficiency; Vitamins

Transient hypocalcemia due to parathyroid gland or vessel manipulation is a common complication following thyroidectomy. Considering the role of 25-hydroxyvitamin D (25(OH)D) in calcium hemostasis, this study aimed to evaluate the effect of preoperative vitamin D supplementation on hypocalcemia incidence in thyroidectomy patients.. In this randomized clinical trial, 100 patients scheduled for total thyroidectomy and suffering from preoperative moderate or severe vitamin D deficiency were enrolled. Patients were randomly allocated to either study or control groups using the sealed envelope method. Patients in the study group received vitamin D3 50,000-unit pearl weekly for 4 weeks prior to the operation. The control group received placebo. Total and ionized serum calcium levels were checked before surgery, the day after surgery, and 2 weeks postoperatively.. No significant difference was observed in terms of demographic data. During serial total calcium checks (5 episodes), total calcium levels changed significantly in patients who had received vitamin D supplements compared to the control group (P = 0.043). Symptomatic hypocalcemia incidence was significantly lower in patients supplemented with 25-hydroxyvitamin D (25(OH)D) (P = 0.04). Also, the requirement for intravenous calcium administration in order to treat the hypocalcemia symptoms was significantly lower in the study in comparison to the control group (P = 0.03).. Vitamin D supplementation in patients with vitamin D deficiency might lead to a lower incidence of early-onset symptomatic hypocalcemia; hence, requiring less calcium supplementation for the management of hypocalcemia.

Topics: Adenocarcinoma, Follicular; Adult; Calcium; Cholecalciferol; Female; Goiter, Nodular; Humans; Hypocalcemia; Male; Postoperative Complications; Preoperative Care; Thyroid Cancer, Papillary; Thyroid Diseases; Thyroid Neoplasms; Thyroidectomy; Vitamin D; Vitamin D Deficiency; Vitamins

To assess the effects of a single dose of vitamin D on 25-hydroxyvitamin D (25OHD) levels and clinical outcomes in children with vitamin D deficiency (VDD) and sepsis.. In this randomized, controlled trial, eligible children with VDD and sepsis were assigned to receive one dose of 150,000 IU of cholecalciferol or placebo. Serum concentrations of 25OHD, angiotensin-II (Ang-II), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α) were assessed at baseline and 8 days after treatment. The cardiovascular Sequential Organ Failure Assessment (cv-SOFA) score, septic shock incidence, duration of ventilation, and mortality were also examined.. One hundred nine participants fulfilled the study requirements. The two groups had comparable baseline characteristics. Ang-II, IL-6, and TNF-α concentrations were all reduced after vitamin D supplementation. Furthermore, the cv-SOFA score (1.76 ± 0.8 vs. 2.3 ± 1.1) and incidence of septic shock (7% vs. 20%) were lower in the treatment group than in the control group. The duration of ventilation and mortality rates did not differ between two groups.. A single dose of vitamin D improved 25OHD levels and the incidence of septic shock in children with VDD and sepsis.

Topics: Administration, Oral; Child; Child, Preschool; Cholecalciferol; Double-Blind Method; Female; Humans; Incidence; Infant; Male; Organ Dysfunction Scores; Prospective Studies; Sepsis; Severity of Illness Index; Shock, Septic; Treatment Outcome; Vitamin D; Vitamin D Deficiency

Although high-dose vitamin D supplementation is common, effects on arterial calcification remain unexplored. Tibial artery calcification was identified and quantified over 3 years in participants randomized to 400, 4000, or 10,000 IU vitamin D. To determine whether vitamin D supplementation has a dose-dependent effect on development and progression of arterial calcification.. Of 311 randomized participants, 302 (400: 105, 4000: 96, 10,000: 101) were eligible for analysis of arterial calcification (54% male, mean (SD) age 62 (4) years, mean (SD) 25-hydroxyvitamin D 78.9 (19.9) nmol/L). At baseline, 85 (28%) had tibial artery calcification, and mean (95% CI) calcification quantity was 2.8 mgHA (95% CI 1.7-3.9). In these 85 participants, calcification quantity increased linearly by 0.020 mgHA/month (95% CI 0.012-0.029) throughout the study, with no evidence of a treatment-group effect (p = 0.645 for interaction). No participants developed new arterial calcifications during the study.. In this population of community-dwelling adults who were vitamin D replete at baseline, supplementation with vitamin D 400, 4000, or 10,000 IU/day did not have differential effects on the development or progression of arterial calcification over 3 years.. clinicaltrials.gov (NCT01900860).

Topics: Adult; Aged; Calcinosis; Canada; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Male; Middle Aged; Vitamin D; Vitamin D Deficiency; Vitamins

A low serum 25-hydroxyvitamin D (25(OH) D) concentration has been associated with a higher risk of type 2 diabetes mellitus (T2DM), especially in older people. Our aim in this randomized controlled trial was to evaluate the effect of vitamin D treatment on inflammatory markers in non-obese Lebanese patients with T2DM, living in Beirut, Lebanon.. The vitamin D group showed higher blood levels of (25(OH) D) (. Six months of vitamin D supplementation led to a decrease in some inflammatory markers in patients with T2DM. Additional studies with a larger sample and a longer period are advised in this regard. This trial was registered at ClinicalTrial.gov; Identifier number: NCT03782805.

Topics: Aged; Blood Glucose; C-Reactive Protein; Cholecalciferol; Diabetes Mellitus, Type 2; Dietary Supplements; Female; Humans; Insulin Resistance; Interleukin-6; Lebanon; Male; Tumor Necrosis Factor-alpha; Vitamin D; Vitamin D Deficiency; Vitamins

Traumatic brain injury (TBI) is the most common trauma worldwide and is a leading cause of injury-related death and disability. Inflammation is initiated as a result of the TBI, which is in association with severity of illness and mortality in brain trauma patients, especially in subdural hemorrhage and epidural hemorrhage cases. A high percentage of adults admitted to the intensive care unit with TBI are diagnosed with vitamin D deficiency; this deficiency may induce impaired immune responses and increase the risk of infections. Vitamin D intervention has been shown to modulate pro- and anti-inflammatory cytokines in non-critically ill patients, but to date, there is no substantial data on the effectiveness of vitamin D for the improvement of immune function in traumatic brain injury patients.. A randomized clinical trial (RCT) will be performed on 74 Iranian adults 18-65 years old with brain trauma and will be treated daily with vitamin D supplements (100,000 IU oral drop) or a similar placebo (1000 IU) for 5 days.. If this randomized clinical trial demonstrates reductions in inflammatory cytokines, it would provide evidence for a multicenter clinical trial to evaluate the efficacy of vitamin D supplementation in neurocritically ill patients. Since vitamin D supplements are inexpensive and safe, this clinical trial could have the potential to improve clinical outcomes in traumatic brain injury patients through reduction of inflammation and infection-associated morbidity and mortality rates.. Iranian Registry of Clinical Trials, IRCT20180619040151N3 . Registered on 10 August 2019.

Topics: Adolescent; Adult; Aged; Brain Injuries, Traumatic; Cholecalciferol; Humans; Iran; Middle Aged; Randomized Controlled Trials as Topic; Vitamin D; Vitamin D Deficiency; Young Adult

To assess whether increment of vitamin D daily intake results in improved serum25(OH) vitamin D levels and reduced respiratory morbidity in premature infants.. A randomized double-blind clinical pilot trial, including preterm infants born at 32 + 6 to 36 + 6 weeks of gestation. The control group received 400 international units (IU) of cholecalciferol daily compared to 800 IU daily in the intervention group. Levels of 25(OH) vitamin D were measured at birth and 6 and 12 months of age. Respiratory morbidity was followed until 1 year of age.. Fifty subjects were recruited during the study period; the median measured 25(OH) vitamin D levels in the control vs intervention groups were: 26.5 vs 34 nmol/L (P = .271) at birth, 99 vs 75.5 nmol/L (P = .008) at 6 months and 72.5 vs 75 nmol/L (P = .95) at 12 months of age. Infants with insufficient vitamin D (<75 nmol/L) levels had higher respiratory morbidity. Serum vitamin 25(OH) D is a fair predictor for respiratory symptoms (area under the curve [AUC], 0.697; 95% confidence interval [CI], 0.509-0.885; P = .047) and for recorded acute respiratory illnesses (AUC, 0.745; 95% CI, 0.569-0.922; P = .012).. Doubling the daily intake of vitamin D in premature infants did not increase serum 25(OH) vitamin D level, due to poor compliance in the intervention group. We found an inverse association between serum 25(OH) vitamin D and respiratory symptoms, indicating vitamin D deficiency is a fair predictor for respiratory morbidity.

Topics: Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Infant; Infant, Newborn; Infant, Premature; Male; Morbidity; Pilot Projects; Respiratory Tract Diseases; Vitamin D Deficiency; Vitamins

Topics: Bone Density; Cholecalciferol; Dietary Supplements; Female; Fibroblast Growth Factor-23; Humans; Male; Vitamin D; Vitamin D Deficiency

Severe asthma exacerbations cause significant morbidity and costs. Whether vitamin D3 supplementation reduces severe childhood asthma exacerbations is unclear.. To determine whether vitamin D3 supplementation improves the time to a severe exacerbation in children with asthma and low vitamin D levels.. The Vitamin D to Prevent Severe Asthma Exacerbations (VDKA) Study was a randomized, double-blind, placebo-controlled clinical trial of vitamin D3 supplementation to improve the time to severe exacerbations in high-risk children with asthma aged 6 to 16 years taking low-dose inhaled corticosteroids and with serum 25-hydroxyvitamin D levels less than 30 ng/mL. Participants were recruited from 7 US centers. Enrollment started in February 2016, with a goal of 400 participants; the trial was terminated early (March 2019) due to futility, and follow-up ended in September 2019.. Participants were randomized to vitamin D3, 4000 IU/d (n = 96), or placebo (n = 96) for 48 weeks and maintained with fluticasone propionate, 176 μg/d (6-11 years old), or 220 μg/d (12-16 years old).. The primary outcome was the time to a severe asthma exacerbation. Secondary outcomes included the time to a viral-induced severe exacerbation, the proportion of participants in whom the dose of inhaled corticosteroid was reduced halfway through the trial, and the cumulative fluticasone dose during the trial.. Among 192 randomized participants (mean age, 9.8 years; 77 girls [40%]), 180 (93.8%) completed the trial. A total of 36 participants (37.5%) in the vitamin D3 group and 33 (34.4%) in the placebo group had 1 or more severe exacerbations. Compared with placebo, vitamin D3 supplementation did not significantly improve the time to a severe exacerbation: the mean time to exacerbation was 240 days in the vitamin D3 group vs 253 days in the placebo group (mean group difference, -13.1 days [95% CI, -42.6 to 16.4]; adjusted hazard ratio, 1.13 [95% CI, 0.69 to 1.85]; P = .63). Vitamin D3 supplementation, compared with placebo, likewise did not significantly improve the time to a viral-induced severe exacerbation, the proportion of participants whose dose of inhaled corticosteroid was reduced, or the cumulative fluticasone dose during the trial. Serious adverse events were similar in both groups (vitamin D3 group, n = 11; placebo group, n = 9).. Among children with persistent asthma and low vitamin D levels, vitamin D3 supplementation, compared with placebo, did not significantly improve the time to a severe asthma exacerbation. The findings do not support the use of vitamin D3 supplementation to prevent severe asthma exacerbations in this group of patients.. ClinicalTrials.gov Identifier: NCT02687815.

Topics: Adolescent; Adrenal Cortex Hormones; Asthma; Child; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Male; Symptom Flare Up; Treatment Failure; Vitamin D; Vitamin D Deficiency; Vitamins

Bariatric patients often suffer from vitamin D (VD) deficiency, and both, morbid obesity and VD deficiency, are related to an adverse effect on cardiovascular disease (CVD) risk. Therefore, we assessed the change of known CVD risk factors and its associations during the first 12 months following one-anastomosis gastric bypass (OAGB).. In this secondary analysis, CVD risk factors, medical history and anthropometric data were assessed in fifty VD deficient (25-hydroxy-vitamin D (25(OH)D) <75 nmol/l) patients, recruited for a randomized controlled trial of VD supplementation. Based on previous results regarding bone-mass loss and the association between VD and CVD risk, the study population was divided into patients with 25(OH)D ≥50 nmol/l (adequate VD group; AVD) and into those <50 nmol/l (inadequate VD group; IVD) at 6 and 12 months (T6/12) postoperatively. In the whole cohort, substantial remission rates for hypertension (38%), diabetes (30%), and dyslipidaemia (41%) and a significant reduction in CVD risk factors were observed at T12. Changes of insulin resistance markers were associated with changes of total body fat mass (TBF%), 25(OH)D, and ferritin. Moreover, significant differences in insulin resistance markers between AVD and IVD became evident at T12.. These findings show that OAGB leads to a significant reduction in CVD risk factors and amelioration of insulin resistance markers, which might be connected to reduced TBF%, change in 25(OH)D and ferritin levels, as an indicator for subclinical inflammation, and an adequate VD status. REGISTERED AT CLINICALTRIALS.GOV: (Identifier: NCT02092376) and EudraCT (Identifier: 2013-003546-16).

Topics: Adult; Austria; Biomarkers; Cardiovascular Diseases; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Gastric Bypass; Heart Disease Risk Factors; Humans; Insulin Resistance; Male; Middle Aged; Obesity, Morbid; Protective Factors; Risk Assessment; Time Factors; Treatment Outcome; Vitamin D; Vitamin D Deficiency

This study assessed the effects of weekly vitamin D (VD) supplementation on clinical and biological parameters after scaling and root planning (SRP) in the treatment of periodontitis and served to validate the VD dosage regimen.. It was a monocentric, randomized, double-blind, placebo-controlled clinical trial with 6 months follow-up. Healthy Caucasian periodontitis patients presenting serum 25(OH) vitamin D3 below 30 ng/mL were randomly allocated to test group (SRP + VD 25,000 international units (IU)/week) or the control group (SRP + placebo).. A total of 59 patients were screened, 27 were included and 26 completed 3 months (M) and 21 completed 6M control. Test (. In this short-term pilot study, no significant differences were observed between two groups. However, supplementation with VD tended to improve the treatment of periodontitis in patients with initial 25(OH) vitamin D3 < 30 ng/mL and proved safe and efficacious. NCT03162406.

Topics: Adult; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Male; Middle Aged; Periodontitis; Pilot Projects; Vitamin D; Vitamin D Deficiency

Prevalence of vitamin D insufficiency/deficiency has been noted in athletic populations, although less is known about recreationally active individuals. Biofortification of natural food sources (e.g. UV radiated mushrooms) may support vitamin D status and is therefore of current scientific and commercial interest. The aim of this study was to assess the impact of a mushroom-derived food ingredient on vitamin D status in recreationally active, healthy volunteers.. Twenty-eight participants were randomly assigned to either: 25 μg (1000 IU) encapsulated natural mushroom-derived vitamin D. Vitamin D status (25(OH)D. The use of a UV radiated mushroom food ingredient was effective in maintaining 25(OH)D

Topics: 25-Hydroxyvitamin D 2; Adult; Agaricales; Calcifediol; Cholecalciferol; Diet; Double-Blind Method; Ergocalciferols; Food, Fortified; Humans; Vitamin D Deficiency

Observational and experimental data reinforce the concept that vitamin D is associated with the pathogenesis of arterial hypertension. We investigated the effect of a single dose of 100,000 IU of cholecalciferol, in office blood pressure (BP), and 24-h ambulatory blood pressure monitoring (ABPM) in patients with type 2 diabetes mellitus (DM), hypertension, and hypovitaminosis D. Forty-three patients were randomized to a placebo or cholecalciferol group. BP was assessed by office measurements and 24-h ABPM, before and after intervention. At week 8, a greater decrease in median ABPM values was observed in cholecalciferol supplementation than in the placebo group for systolic 24-h (- 7.5 vs. - 1; P = 0.02), systolic daytime (- 7 vs. - 1; P = 0.007), systolic nighttime (- 7.0 vs. 3; P = 0.009), diastolic 24-h (- 3.5 vs. - 1; P = 0.037), and daytime DBP (- 5 vs. 0; P = 0.01). Office DBP was also reduced after vitamin D supplementation. A single dose of vitamin D

Topics: Aged; Blood Pressure; Blood Pressure Monitoring, Ambulatory; Cholecalciferol; Diabetes Mellitus, Type 2; Dietary Supplements; Double-Blind Method; Female; Humans; Hypertension; Male; Middle Aged; Treatment Outcome; Vitamin D Deficiency

Despite abundant cross-sectional evidence that low vitamin D status is associated with risk of cognitive decline in ageing, interventional evidence for benefits of vitamin D supplementation is lacking. This study was a 6 month randomised, double-blinded placebo-controlled clinical trial of the effects of vitamin D3 (D3), enhanced vitamin D2 in a mushroom matrix (D2M), standard mushroom (SM) and placebo (PL) on cognition and mood in

Topics: 25-Hydroxyvitamin D 2; Affect; Agaricales; Calcifediol; Cholecalciferol; Cognition; Cognitive Dysfunction; Dietary Supplements; Double-Blind Method; Ergocalciferols; Female; Humans; Male; Middle Aged; Seasons; Treatment Outcome; Vitamin D; Vitamin D Deficiency

Allergic contact dermatitis following exposure to

Topics: Allergens; Cholecalciferol; Dermatitis; Dietary Supplements; Double-Blind Method; Female; Humans; Interleukin-10; Male; Middle Aged; Plant Weeds; Quality of Life; Severity of Illness Index; Vitamin D; Vitamin D Deficiency; Vitamins

Paediatric vitamin D (25-hydroxyvitamin D (25OHD)) deficiency can lead to nutritional rickets and extra-skeletal complications. Compliance with daily therapy can be difficult, making high-dose, short-term vitamin D (stoss) therapy attractive to correct vitamin D deficiency. We compared the effectiveness and safety of standard versus stoss therapy in treating childhood 25OHD deficiency.. Children aged 2-16 years with 25OHD <50 nmol/L were randomised to either standard (5000 IU daily for 80 days) or stoss (100 000 IU weekly for 4 weeks) cholecalciferol. Participants underwent an evaluation of effectiveness and safety. The 25OHD level, random spot calcium: creatinine ratio (Ca:Cr) and compliance were measured at 12 weeks.. A total of 151 children were enrolled in the study (68 standard and 83 stoss), median age 9 years (inter-quartile range (IQR): 6-12 years). Baseline 25OHD levels were 26 nmol/L (IQR: 19-35 nmol/L) and 32 nmol/L (IQR: 24-39 nmol/L) in the standard and stoss groups, respectively. At 12 weeks, the median 25OHD level was significantly greater in the standard versus stoss group (81 vs. 67 nmol/L; P = 0.005); however, >80% of participants in both groups achieved sufficiency (25OHD > 50 nmol/L) and had normal urinary Ca:Cr, with no significant difference seen between groups. Compliance was similar in the two groups.. Compared to stoss, standard therapy achieved higher 25OHD levels at 12 weeks; however, in both groups, there was a similar proportion of participants who achieved 25OHD sufficiency, with no evidence of toxicity. Unlike other studies, simplifying the treatment regimen did not improve compliance. These results support stoss therapy as an effective and safe alternative therapy for the treatment of paediatric vitamin D deficiency.

Topics: Adolescent; Calcifediol; Calcium; Child; Child, Preschool; Cholecalciferol; Humans; Vitamin D; Vitamin D Deficiency; Vitamins

To investigate the effects of cholecalciferol supplementation on the progression of motor disability in a cohort of amyotrophic lateral sclerosis (ALS) patients with low blood 25-hydroxyvitamin D3 [25(OH)D] levels, on the basis of the hypothesis of potential neuroprotective effects of vitamin D supplementation.. Forty-eight ALS patients, 34 with deficient (<20 ng/mL) and 14 with insufficient (20-29 ng/mL) serum levels of 25(OH)D, were randomized and treated by 3 different doses of cholecalciferol [50.000, 75.000 and 100.000 international units (IU) /month] and evaluated after 6-months. Assessment of motor dysfunction at baseline and after 6 months included ALS Functional Rating Scale-Revised (ALFRS-R) and upper motor neuron (UMN) scores and blood samples for 25(OH)D levels.. Clinical data of 33 patients were available after 6 months. Analysis of Covariance (ANCOVA), with pre-treatment measurements included as covariate, did not show statistically significant differences in the ALSFRS-R (p > 0.05) and UMN (p > 0.05) among the patient groups who underwent 3 different doses of cholecalciferol. Conversely, the treatment with 75.000 IU/month or 100.000 IU/month induced a significant increase in serum levels of 25(OH)D in comparison with the supplementation with 50.000 IU/month; no significant differences were found between 75.000 IU/month and 100.000 IU/month.. Our findings highlighted that 6-month supplementation of vitamin D in ALS patients had no significant effects on motor dysfunction. However, it is recommended to prevent medical complications of vitamin D deficiency in ALS patients as well as in other populations of neurodegenerative patients, characterized by low mobility and decreased sun exposure.

Topics: Amyotrophic Lateral Sclerosis; Cholecalciferol; Dietary Supplements; Disabled Persons; Humans; Motor Disorders; Vitamin D; Vitamin D Deficiency

To evaluate the safety and efficacy of cholecalciferol in patients with relapsing-remitting MS (RRMS).. In this double-blind, placebo-controlled parallel-group, 2-year study, 181 patients with RRMS were randomized 1:1. Key inclusion criteria were a low serum 25-hydroxy vitamin D (25OHD) concentration (<75 nmol/L), a treatment with interferon beta-1a 44 μg (SC 3 times per week) 4 months ± 2 months before randomization, and at least one documented relapse during the previous 2 years. Patients received high-dose oral cholecalciferol 100,000 IU or placebo every other week for 96 weeks. Primary outcome measure was the change in the annualized relapse rate (ARR) at 96 weeks. Secondary objectives included safety and tolerability of cholecalciferol and efficacy assessments (ARR, MRI parameters, and Expanded Disability Status Scale [EDSS]).. The primary end point was not met. In patients who completed the 2-year follow-up (45 with cholecalciferol and 45 with placebo), all efficacy parameters favored cholecalciferol with an ARR reduction (. Although the primary end point was not met, these data suggest a potential treatment effect of cholecalciferol in patients with RRMS already treated with interferon beta-1a and low serum 25OHD concentration. Together with the good safety profile, these data support the exploration of cholecalciferol treatment in such patients with RRMS.. NCT01198132.. This study provides Class II evidence that for patients with RRMS and low serum 25OHD, cholecalciferol did not significantly affect ARRs.

Topics: Adult; Cholecalciferol; Double-Blind Method; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Interferon beta-1a; Male; Middle Aged; Multiple Sclerosis, Relapsing-Remitting; Vitamin D Deficiency

Inadequate levels of vitamin D may lead to poor performance in professional dancers. Therefore, dietary supplementation may be essential in this population. This longitudinal pilot study to a randomized controlled trial assessed dancer compliance with self-directed oral vitamin D supplementation. Seventy-one dancers, 41 females and 30 males with a mean age of 31.1 years, were recruited from The Royal Ballet, London. Baseline serum 25(OH)D levels were measured and dancers were interviewed, examined, and provided with oral supplements for the winter period, November 2011 to March 2012. Dancers with normal serum 25(OH)D levels were provided with maintenance supplements (1,000 IU/ day) and those with insufficient or deficient serum 25(OH)D levels were given a loading dose of 60,000 IU weekly for 2 and 6 weeks, respectively. Serum 25(OH) D levels were measured at 1 and 2 years and dancers were sampled for compliance with instructions. Mean compliance during loading and maintenance was 86% and 50%, respectively. Mean serum 25(OH)D levels at start and end of the study period were 79.3 ± 31.6 nmol/L and 78.68 ± 19.8 nmol/L, respectively. Only one-third of dancers with insufficient (N = 5) and deficient (N = 5) serum vitamin D levels improved to normal values. It is concluded that professional ballet dancers demonstrate good compliance with self-directed loading doses of vitamin D supplementation but poor compliance with maintenance doses. Poor maintenance compliance may have accounted for the low rates of serum vitamin D level improvement among dancers with insufficient or deficient levels.

Topics: Adult; Cholecalciferol; Dancing; Dietary Supplements; Dose-Response Relationship, Drug; Female; Humans; Male; Patient Compliance; Pilot Projects; Seasons; Vitamin D; Vitamin D Deficiency

Irritable bowel syndrome (IBS) is a common gastrointestinal disorder that is more prevalent in women. Vitamin D deficiency and hormonal disorders are also prevalent in Iranian women, and may influence the severity of clinical outcomes mediated by microinflammation, oxidative stress and intestinal permeability pathways. Our objective was to investigate the effects of co-administration of soy and vitamin D on some inflammatory, antioxidant and gut permeability markers in women with IBS.. In a randomized clinical trial, women (18-75 years of age) were randomly allocated into four groups to receive soy isoflavones (40 mg/day), cholecalciferol (50,000 IU/15 days), both soy isoflavones and cholecalciferol, or placebo for six weeks. The outcomes were plasma inflammatory markers, antioxidant status and fecal protease activity at week 0 and week 6.. After the intervention, plasma inflammatory markers and fecal protease activity were reduced significantly in all treatment groups compared to the placebo group; however, there was no significant effect on antioxidant status.. This study suggests combined supplementation of soy isoflavones and active vitamin D can improve some biochemical parameters regarding inflammation and intestinal permeability of IBS in women.. Clinical.Trials.govNCT02026518.

Topics: Adolescent; Adult; Aged; Antioxidants; Biomarkers; Cholecalciferol; Dietary Supplements; Feces; Female; Gastrointestinal Tract; Humans; Inflammation; Iran; Irritable Bowel Syndrome; Isoflavones; Middle Aged; Permeability; Serine Proteases; Tumor Necrosis Factor-alpha; Vitamin D; Vitamin D Deficiency; Young Adult

Observational studies have demonstrated an association between vitamin D deficiency and increased risk of morbidity and mortality in critically ill patients. Cohort studies and pilot trials have suggested promising beneficial effects of vitamin D replacement in the critical ill, at least in patients with severe vitamin D deficiency. As vitamin D is a simple, low-cost and safe intervention, it has potential to improve survival in critically ill patients.. In this randomised, placebo-controlled, double-blind, multicentre, international trial, 2400 adult patients with severe vitamin D deficiency (25-hydroxyvitamin D≤12 ng/mL) will be randomised in a 1:1 ratio by www.randomizer.at to receive a loading dose of 540 000 IU cholecalciferol within 72 hours after intensive care unit (ICU) admission, followed by 4000 IU daily for 90 days or placebo. Hypercalcaemia may occur as a side effect, but is monitored by regular checks of the calcium level. The primary outcome is all-cause mortality at 28 days after randomisation. Secondary outcomes are: ICU, hospital, 90-day and 1-year mortality; hospital and ICU length of stay, change in organ dysfunction on day 5 as measured by Sequential Organ Function Assessment (SOFA) score, number of organ failures; hospital and ICU readmission until day 90; discharge destination, self-reported infections requiring antibiotics until day 90 and health-related quality of life. Recruitment status is ongoing.. National ethical approval was obtained by the Ethics Committee of the University of Graz for Austria, Erasme University Brussels (Belgium) and University Hospital Frankfurt (Germany), and will further be gained according to individual national processes. On completion, results will be published in a peer-reviewed scientific journal. The study findings will be presented at national and international meetings with abstracts online.. NCT03188796, EudraCT-No: 2016-002460-13.

Topics: Adult; Cholecalciferol; Clinical Trials, Phase III as Topic; Critical Illness; Double-Blind Method; Drug Administration Schedule; Female; Humans; Intensive Care Units; Male; Multicenter Studies as Topic; Randomized Controlled Trials as Topic; Vitamin D Deficiency; Vitamins

Vitamin D inadequacy is pervasive in the oldest-old. Many vitamin D metabolites are available for supplementation, their effects on the recovery of adequate serum levels remain unknown. We investigate the effects of supplementation with cholecalciferol (D3) and calcifediol (25D3) on serum levels of 25(OH)D, 1-25(OH)D, bone and inflammatory markers, ultimately identifying clinical predictors of successful treatment. Sixty-seven oldest-old individuals were randomized to weekly administration of 150 mcg of 25D3 or D3, from hospital admission to 7 months after discharge. Supplementation of 25D3 and D3 were associated with increasing serum levels of 25(OH)D (

Topics: Aged, 80 and over; Biomarkers; C-Reactive Protein; Calcifediol; Cholecalciferol; Dietary Supplements; Drug Administration Schedule; Female; Hand Strength; Hospitalization; Humans; Male; Parathyroid Hormone; Polypharmacy; Treatment Outcome; Vitamin D; Vitamin D Deficiency

Type 2 diabetes increases the risk of cognitive decline which adversely impacts self-management of the disease. Evidence also supports a relationship between low serum 25(OH)D levels and poor cognition. The purpose of this trial was to assess vitamin D supplementation on cognitive executive functioning in persons living with type 2 diabetes.. Thirty participants were randomized to either the low-dose allocation (. To our knowledge, this is the first randomized control trial to examine the effects of vitamin D supplementation on cognitive function in people with type 2 diabetes. However, no significant differences in cognitive outcomes between participants who received high-dose therapy and those who received low dose were found.

Topics: Aged; Biomarkers; Chicago; Cholecalciferol; Cognition; Cognition Disorders; Diabetes Mellitus, Type 2; Double-Blind Method; Female; Humans; Male; Middle Aged; Time Factors; Treatment Outcome; Vitamin D; Vitamin D Deficiency

Vitamin D deficiency is a common, potentially reversible contributor to morbidity and mortality among critically ill patients. The potential benefits of vitamin D supplementation in acute critical illness require further study.. We conducted a randomized, double-blind, placebo-controlled, phase 3 trial of early vitamin D. A total of 1360 patients were found to be vitamin D-deficient during point-of-care screening and underwent randomization. Of these patients, 1078 had baseline vitamin D deficiency (25-hydroxyvitamin D level, <20 ng per milliliter [50 nmol per liter]) confirmed by subsequent testing and were included in the primary analysis population. The mean day 3 level of 25-hydroxyvitamin D was 46.9±23.2 ng per milliliter (117±58 nmol per liter) in the vitamin D group and 11.4±5.6 ng per milliliter (28±14 nmol per liter) in the placebo group (difference, 35.5 ng per milliliter; 95% confidence interval [CI], 31.5 to 39.6). The 90-day mortality was 23.5% in the vitamin D group (125 of 531 patients) and 20.6% in the placebo group (109 of 528 patients) (difference, 2.9 percentage points; 95% CI, -2.1 to 7.9; P = 0.26). There were no clinically important differences between the groups with respect to secondary clinical, physiological, or safety end points. The severity of vitamin D deficiency at baseline did not affect the association between the treatment assignment and mortality.. Early administration of high-dose enteral vitamin D

Topics: Adult; Cholecalciferol; Critical Illness; Double-Blind Method; Female; Humans; Kaplan-Meier Estimate; Length of Stay; Male; Middle Aged; Organ Dysfunction Scores; Treatment Failure; Vitamin D; Vitamin D Deficiency; Vitamins

To examine the effect of 25-hydroxyvitamin D (25(OH)D) levels recommended by Endocrine Society guidelines (>30 ng/mL) on cognition in healthy older African-American women over 3 years.. Randomized, double-blind, placebo-controlled clinical trial.. Bone Mineral Research Center at New York University Winthrop Hospital.. Healthy postmenopausal African American women aged 65 and older (N=260; mean age 68.2 ± 4.9; 46% college education or higher).. Half of the women were randomized to receive vitamin D (adjusted to achieve a serum level > 30 ng/mL) with calcium (diet and supplement total of 1,200 mg), and half were randomized to receive placebo with calcium (1,200 mg).. Cognitive assessments every 6 months using the Mini-Mental State Examination (MMSE) to detect cognitive decline. Mean MMSE scores were calculated over time for both groups. Those with MMSE scores less than 21 at baseline were excluded.. There was no difference in cognition over time between older African-American women with serum concentrations of 25(OH)D of 30 ng/mL and greater than those taking placebo. There is no evidence to support vitamin D intake greater than the recommended daily allowance in this population for preventing cognitive decline. J Am Geriatr Soc 67:81-86, 2019.

Topics: Aged; Aged, 80 and over; Black or African American; Cholecalciferol; Cognition; Cognitive Dysfunction; Dementia; Dietary Supplements; Double-Blind Method; Female; Healthy Volunteers; Humans; Osteoporosis, Postmenopausal; Physical Functional Performance; Postmenopause; Recommended Dietary Allowances; Treatment Outcome; Vitamin D; Vitamin D Deficiency; Vitamins

This randomised placebo-controlled trial aimed to determine the effect of 16-weeks cholecalciferol supplementation on calcium-phosphate homeostasis and bone mineral density (BMD) in overweight and obese adults. Fifty-four vitamin D-deficient (25OHD<50 nmol/L), overweight and obese adults (mean age 32 ± 8.5 years) were included in the trial. Participants were randomly assigned to receive either a bolus oral dose of 100,000 IU cholecalciferol followed by 4000 IU cholecalciferol/d or a matching placebo for 16 weeks. Before and after the intervention, serum calcium, phosphate, 25-hydroxyvitamin D [25(OH)D], intact parathyroid hormone (iPTH) and C-terminal plasma fibroblast growth factor-23 (cFGF-23) concentrations were measured. Whole-body BMD was assessed using dual-energy X-ray absorptiometry (DXA) and diet and sun exposure were assessed using self-administered questionnaires. There were no significant differences in baseline characteristics between the vitamin D and placebo group. After 16-weeks of vitamin D supplementation, mean changes in 25(OH)D concentration were higher in the vitamin D group (57 nmol/L 95% CI 49, 65) compared with placebo (2 nmol/L 95% CI -4, 8), P < 0.001. Additionally, iPTH concentrations declined in the vitamin D group (-1.19 pmol/L 95% CI -1.9, -0.47) compared with placebo (0.14 pmol/L 95% CI -0.49, 0.77), P = 0.006. There were no significant differences in calcium, phosphate, iPTH and cFGF-23 concentrations and whole-body BMD between vitamin D and placebo at follow-up. Inverse correlations were observed between mean change in serum iPTH and cFGF-23 in the vitamin D group only (r=-0.41, P = 0.029). In individuals with greater vitamin D deficiency at baseline (25(OH)D < 30 nmol/L), there was a significant increase in mean whole-body BMD (0.01 g/cm

Topics: Adult; Bone Density; Calcium; Cholecalciferol; Fibroblast Growth Factor-23; Fibroblast Growth Factors; Humans; Obesity; Overweight; Parathyroid Hormone; Phosphates; Placebo Effect; Vitamin D; Vitamin D Deficiency; Vitamins

To determine which vitamin D dose, formulation, and schedule most effectively and safely achieves a 25-hydroxyvitamin D (25[OH]D) level of >30 ng/mL (75 nmol/L).. In this prospective study, 100 subjects from the NY Harbor HCS Brooklyn Campus, ages 25 to 85 years, with 25(OH)D <30 ng/mL (<75 nmol/L), were randomized into four groups: cholecalciferol (D3) 2,000 international units (IU) daily; D3 3,000 IU daily; ergocalciferol (D2) 50,000 IU weekly; and D2 50,000 IU twice weekly. All were supplemented with 500 mg calcium carbonate daily. 25(OH)D, parathyroid hormone (PTH), urinary calcium, urinary creatinine, and other variables were measured during 7 visits over 12 months.. All groups achieved a mean vitamin D level >30 ng/mL (>75 nmol/L) by visit 4 (5 months). Those receiving 50,000 IU D2 twice weekly displayed the most rapid and robust response, with 25(OH)D reaching >30 ng/mL (>75 nmol/L) after only 1 month and plateauing at 60 ng/mL (150 nmol/L) by 7 months. Although no statistically significant difference was seen in mean 25(OH)D levels between groups 1 through 3, subjects on 50,000 IU D2 weekly more consistently showed higher mean levels than either groups 1 or 2. No episodes of significant hypercalcemia occurred. There was a negative correlation in mean PTH levels and mean vitamin D levels in group 4 and all groups combined.. All four schedules of vitamin D replacement were effective in safely achieving and maintaining 25(OH)D >30 ng/mL (>75 nmol/L). D2 50,000 IU twice weekly provided the most rapid attainment and highest mean levels of vitamin D.. 25(OH)D = 25-hydroxyvitamin D; BMI = body mass index; BUN = blood urea nitrogen; Ca/Cr = calcium/creatinine; D2 = ergocalciferol; D3 = cholecalciferol; IU = international units; PTH = parathyroid hormone.

Topics: Adult; Aged; Aged, 80 and over; Cholecalciferol; Dietary Supplements; Humans; Middle Aged; Parathyroid Hormone; Prospective Studies; Vitamin D; Vitamin D Deficiency; Vitamins

There is limited information on the influence of vitamin D on physical performance in black Americans.. To determine if maintenance of serum 25(OH)D >75 nmol/L prevents a decline in physical performance.. The Physical Performance, Osteoporosis and Vitamin D in African American Women (PODA) trial had a prospective, randomized, placebo controlled, double-dummy design with two arms: one of which is placebo vitamin D3 adjusted to maintain serum 25(OH)D >75 nmol/L.. The target population was healthy elderly black women with serum 25(OH)D between 20 and 65 nmol/L. The trial was 3 years in duration with measurement of physical performance every 6 months: grip strength, Short Physical Performance Battery (SPPB), 10 chair rises, and 6-minute walk distance. A total of 260 women entered the study and 184 completed 3 years. Mean age was 68.2 years. Baseline 25(OH)D was 53 nmol/L; total SPPB was 11 (10 to 12).. Research center in an academic health center.. Prevention of decline in physical performance measures.. Participants were randomly assigned to placebo or active vitamin D. Vitamin D3 dose was adjusted to maintain serum 25(OH)D >75 nmol/L.. There was a decline with time in grip strength and the 6-minute walk test. The SPBB increased with time. There were no substantial differences between the placebo and active vitamin D3 groups with respect to the temporal patterns observed for any of the performance measures.. There is no benefit of maintaining serum 25(OH)D >75 nmol/L in preventing the decline in physical performance in healthy black American women.

Topics: Aged; Black or African American; Case-Control Studies; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Follow-Up Studies; Humans; Middle Aged; Osteoporosis; Physical Functional Performance; Prognosis; Prospective Studies; Vitamin D Deficiency; Vitamins

Patients on long term anti-epileptic drug therapy are prone for Vitamin D deficiency for a myriad of reasons. The aim of this research was to study the effect of high dose vitamin D supplementation on vitamin D nutrition status of children newly started on anti-epileptic drug therapy.. This randomized controlled trial was conducted in a tertiary care Children's Hospital at New Delhi from November 2011 to March 2013. Eighty three children in the age group 5-10 years newly started on anti-epileptic drugs (AED) were randomized into two groups; group A - the intervention group, to whom 60,000 IU vitamin D3 was given orally/month under direct supervision along with AED for a period of 6 months, and group B- the control group, to whom AED without vitamin D3 was given. Serum 25(OH)D, ionized calcium (iCa), total calcium (tCa), inorganic phosphate (iP), alkaline phosphatase (ALP) and parathyroid hormone (PTH) levels were assayed at baseline and at the end of 6 months and were compared within and between the two groups.. The mean 25(OH)D in Group A was maintained at 6 months follow up [ 26 ng/ml, 95% CI 20-34 ng/ml] compared to baseline [25 ng/ml, 95% CI -19 to 33 ng/ml] [ p = 0.83]. In group B, there was a significant decrease in 25(OH)D levels at 6 months [13 ng/ml (95% CI 9 ng/ml-17 ng/ml)] compared to baseline [18 ng/ml (95% CI 13-24 ng/ml)] [p = 0.01]. At 6 months, mean serum 25(OH)D was significantly higher in group A as compared to group B (p = 0.005).. To conclude, oral administration of 60,000 IU vitamin D3/month is sufficient to maintain serum 25(OH)D level and prevent development of vitamin D deficiency in children newly started on AED over a period of 6 months. Non supplementation leads to the lowering of serum 25(OH)D in these children.. CTRI/2017/08/009234.

Topics: Alkaline Phosphatase; Anticonvulsants; Child; Child, Preschool; Cholecalciferol; Dietary Supplements; Epilepsy; Female; Humans; Male; Nutrition Therapy; Nutritional Status; Parathyroid Hormone; Phosphates; Treatment Outcome; Vitamin D; Vitamin D Deficiency

Vitamin D deficiency is a global problem that may be improved by vitamin D supplementation; however, the individual's response to the intervention varies. We aimed to investigate possible genetic factors that may modify the impact of environmental exposure on vitamin D status. The candidate gene variant we investigated was the Gc gene-rs4588 polymorphism at the vitamin D receptor (DBP) locus.. A total of 619 healthy adolescent Iranian girls received 50000 IU of vitamin D. Our results revealed that the rs4588 polymorphism might be associated with serum 25-hydroxy vitamin D both at baseline (p value = 0.03) and after intervention (p value = 0.008). It seemed that the outcome of the intervention was gene-related so that the subjects with common AA genotype were a better responder to vitamin D supplementation (Changes (%) 469.5 (427.1) in AA carriers vs. 335.8 (530) in GG holders), and carriers of the less common GG genotype experienced a rise in fasting blood glucose after 9 weeks (Changes (%) 0 (1.5)). Our findings also showed that the statistical interaction between this variant and supplementation was statistically significant (intervention effect p-value<0.001 and p-value SNP effect = 0.03). The regression model also revealed that after adjusted for potential confounders, likelihood of affecting serum 25(OH)D in individuals who were homozygous for the uncommon allele G was less than those homozygous for the more common AA genotype (OR = 4.407 (1.82-8.89); p = 0.001).. Serum vitamin 25(OH) D following vitamin 25(OH) D

Topics: Adolescent; Alleles; Child; Cholecalciferol; Dietary Supplements; Female; Genetic Association Studies; Genetic Predisposition to Disease; Genotype; Humans; Iran; Receptors, Calcitriol; Regression Analysis; Surveys and Questionnaires; Vitamin D; Vitamin D Deficiency; Vitamin D-Binding Protein

The role of vitamin D supplementation on vascular calcification (VC) in patients with chronic kidney disease (CKD) is controversial. The objective of this study was to evaluate the effects of long-term cholecalciferol supplementation on VC in nondialysis patients with CKD stages 3-4 with hypovitaminosis D.. During the study, VC did not change in the treated insufficient group (418 [81-611] to 364 [232-817] AU, P = 0.25) but increased in the placebo group (118 [37-421] to 199 [49-490] AU, P = 0.01). The calcium score change was inversely correlated with 25(OH)D change (r = -0.45; P = 0.037) in the treated insufficient group but not in the placebo group. Renal function did not change in the insufficient, treated, and placebo groups. In multivariate analysis, there was no difference in VC progression between the treated and placebo insufficient groups (interaction P = 0.92). In the deficient group, VC progressed (265 [84-733] to 333 [157-745] AU; P = 0.006) and renal function declined (33 [26-43] to 23 [17-49] mL/min/1.73 m. Vitamin D supplementation did not attenuate VC progression in CKD patients with hypovitaminosis D.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Cholecalciferol; Dietary Supplements; Disease Progression; Double-Blind Method; Female; Humans; Male; Middle Aged; Parathyroid Hormone; Prospective Studies; Renal Insufficiency, Chronic; Vascular Calcification; Vitamin D; Vitamin D Deficiency; Vitamins; Young Adult

End-stage renal disease results in B cell lymphopenia and low levels of vitamin D. Since the link between vitamin D deficiency and B lymphocytes dysfunction are not clear in patients with end-stage renal disease, we suggest that vitamin D adequacy and factors related to the homeostasis of these cells should be investigated. B lymphocytes homeostasis is a process mainly regulated signals of grown and death as interleukin (IL)-7, B cell-activating factor (BAFF)/BAFF-receptor and CD95 expression.. As vitamin D serum levels were reduced in patients with end stage renal disease and it is associated with human B homeostasis, we evaluated the effect of cholecalciferol supplementation on dialysis.. Randomized, double blind clinical trial in dialysis patients with 25OH Vitamin D deficiency for a period of 12 weeks.. In a pilot study, we investigated the effect of cholecalciferol supplementation (100,000 UI once per week or placebo. In vitro, peripheral blood mononuclear cells isolated by Ficoll-Hypaque centrifugation from 12 healthy volunteers were incubated with healthy or uremic serum in the presence or absence of 25 (OH)DC with 5% CO.. There was an increase in the serum 25(OH)D level in the cholecalciferol group. No differences were found in BAFF and IL7 levels and CD95 and BAFF-R expression in B lymphocytes from patients on dialysis after cholecalciferol supplementation. Uremic serum induced an increase in the IL-7, BAFF, BAFF-R and CD95 expression compared with the control. However, we observed no effect of incubation of 25(OH)D3 and 1,25(OH)2D3 on the expression of IL-7, BAFF, BAFF-R and CD95 when incubated in the presence of normal or uremic serum.. Our results suggest that vitamin D is not involved in mechanisms of regulation of differentiation and survival in B lymphocytes. In conclusion, further studies are needed to explore the effects of vitamin D on B lymphocytes to better evaluate the possible impact of vitamin D on humoral response in the CKD population.

Topics: Adult; Aged; B-Cell Activating Factor; B-Lymphocytes; Cholecalciferol; Dietary Supplements; Double-Blind Method; fas Receptor; Female; Humans; Interleukin-7; Kidney Failure, Chronic; Lymphopenia; Male; Middle Aged; Pilot Projects; Renal Dialysis; Uremia; Vitamin D; Vitamin D Deficiency; Vitamins

The effect of vitamin D supplementation on muscle function in older adults has been tested in randomized trials with mixed results, which may be due to differences in the study participant characteristics, including baseline vitamin D status. The results of 2 meta-analyses of randomized trials suggested a beneficial effect of vitamin D supplementation on muscle function in older adults with low baseline serum 25-hydroxyvitamin D [25(OH)D].. We aimed to test the effect of 12 mo of vitamin D supplementation on lower-extremity power and function in older community-dwelling adults screened for low serum 25(OH)D.. This was a single-center, double-blind, randomized, placebo-controlled trial that included 100 community-dwelling men and women ≥60 y old who had serum 25(OH)D ≤20 ng/mL at screening and a mean ± SD serum 25(OH)D of 20.2 ± 6.7 ng/mL at baseline. Participants were randomly assigned to 800 IU vitamin D3/d (intervention) or placebo. Those in the intervention group whose serum 25(OH)D was <28 ng/mL after 4 mo were given an additional 800 IU vitamin D3/d, whereas all other participants received placebo as an additional pill.. After 12 mo, the mean ± SD serum 25(OH)D was 32.5 ± 5.1 ng/mL in the intervention group and 19.8 ± 7.3 ng/mL in the control group (treatment × time P < 0.001). The change in leg press power, function, and strength did not differ between the 2 groups over 12 mo (all treatment × time P ≥ 0.60), nor did the change in lean mass (treatment × time P ≥ 0.89).. Increasing serum 25(OH)D to >32 ng/mL (on average) over 12 mo did not affect lower-extremity power, strength, or lean mass in older community-dwelling adults. This trial was registered at clinicaltrials.gov as NCT02293187.

Topics: Aged; Body Composition; Cholecalciferol; Dietary Supplements; Female; Humans; Lower Extremity; Male; Middle Aged; Muscle Strength; Muscle, Skeletal; Vitamin D; Vitamin D Deficiency; Vitamins

New evidence supports the use of supplemental vitamin D in the prevention of exacerbation of asthma; however, the optimal posology to sufficiently raise serum levels while maximising adherence is unclear. The objective was to ascertain the efficacy of high-dose vitamin D. Children (N = 47) were randomised (intervention, 23; control, 24) in the fall. There was a significant adjusted group difference in the Δ25OHD (95% confidence interval) of 57.8 (47.3, 68.4) nmol/L, p < 0.0001), with a time (p < 0.0001) and group*time interaction effect (p < 0.0001), in favour of the intervention. A significant group difference in the Δ25OHD was observed 10 days after the first (119.3 [105.8, 132.9] nmol/L) and second (100.1 [85.7, 114.6] nmol/L) bolus; it did not reach statistical significance at 3.5 and 7 months. At 3.5 and 7 months, respectively, 63% and 56% of the intervention group were vitamin D sufficient (≥ 75 nmol/L) compared to 39% and 36% of the control group. Hypercalciuria, all without hypercalcaemia, was observed in 8.7% of intervention and 10.3% of control samples at any time point. Exacerbations requiring rescue oral corticosteroids, which appear as a promising primary outcome, occurred at a rate of 0.87/child.. ClinicalTrials.gov, NCT02197702 (23 072014). Registered on 23 July 2014.

Topics: Administration, Oral; Age Factors; Asthma; Biomarkers; Child, Preschool; Cholecalciferol; Drug Administration Schedule; Female; Humans; Infant; Male; Pilot Projects; Preliminary Data; Quebec; Seasons; Time Factors; Treatment Outcome; Vitamin D; Vitamin D Deficiency

In India, there is a lack of information about the adequate daily dose of vitamin D3 supplementation in school children. Hence, we undertook this study to evaluate the adequacy and efficacy of different doses of vitamin D3 in schoolchildren. A total of 1008 vitamin D-deficient (VDD) children, aged 6-16 years with serum 25-hydroxyvitamin D (25(OH)D) levels <50nmol/l, were cluster randomised into three groups (A-344, B-341 and C-232) for supplementation (600, 1000 and 2000 IU daily) of vitamin D3 under supervision for 6 months. Of the 1008 subjects who completed the study, 938 (93 %) were compliant. Baseline and post-supplementation fasting blood and urine samples were evaluated for Ca, phosphates, alkaline phosphatase, 25(OH)D and parathormone and urine Ca:creatinine ratio. The mean age of the subjects was 11·7 (sd 2·4) years, and the overall mean baseline serum 25(OH)D level was 24·3 (SD 9·5)nmol/l. Post-supplementation rise in serum 25(OH)D in compliant group was maximum with 2000 IU (70·0 (SD 30·0)nmol/l), followed by 1000 IU (46·8 (SD 22·5)nmol/l) and 600 IU (36·5 (SD 18·5)nmol/l), and serum 25(OH)D levels of ≥50nmol/l were achieved in 71·5, 81·8 and 92·9 % by groups A, B and C, respectively. Secondary hyperparathyroidism decreased from 31·7 to 8·4 % post-supplementation. Two participants developed hypercalciuria, but none developed hypercalcaemia. Children with VDD benefit maximum with the daily supplementation of 2000 IU of vitamin D3. Whether recommendations of 400 IU/d by Indian Council of Medical Research or 600 IU by Indian Academy of Pediatrics or Institute of Medicine would suffice to achieve vitamin D sufficiency in children with VDD remains debatable.

Topics: Adolescent; Alkaline Phosphatase; Calcium; Child; Cholecalciferol; Creatinine; Dietary Supplements; Female; Humans; Hyperparathyroidism, Secondary; India; Male; Parathyroid Hormone; Phosphates; Prospective Studies; Single-Blind Method; Students; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D deficiency is common in peritoneal dialysis (PD) patients, so its supplementation has been advocated as potentially beneficial.. Double-blind, placebo-controlled, randomized clinical trial. Subjects on PD treated with high calcium peritoneal dialysate (Ca 3.5 mEq/l) and serum levels of 25-hydroxi vitamin D (25D) < 20 ng/ml were randomized to receive cholecalciferol (4800 IU/daily) or placebo for 16 weeks. The outcome measures were the effects on the osteogenic biomarkers osteoprotegerin (primary endpoint), intact fibroblast growth factor-23 (iFGF23), osteocalcin, osteopontin, iPTH, 1,25-dyhydroxivitamin D (1,25D), and interleukin-6.. Fifty-eight subjects were randomly assigned. Baseline characteristics were similar in both groups. Cholecalciferol supplemented subjects had a significant increase in serum 25D (from 11.4 ± 5.0 to 28.3 ± 10.3 ng/ml), 1,25D and iFGF23 compared with placebo group. iFGF23 levels increased an average of 10,875 pg/ml per month (95% CI 11,778-88,414) in the cholecalciferol group and was unchanged in the placebo group (2829 pg/ml, 95% CI - 2181 to 14,972). Extremely high iFGF23 levels (> 30,000 pg/ml) were observed in 74% of subjects receiving cholecalciferol although iFGF23 returned to baseline values after 32 weeks of withdrawal. The observed changes in iFGF23 correlated with 1,25D levels and were not modified by other variables. No difference was observed between groups in osteoprotegerin or other osteogenic biomarkers levels.. Cholecalciferol supplementation increases serum 25D levels in subjects on PD exposed to high calcium dialysate, yet it induces an exponential increase of iFGF23 in most patients, which disappear after withdrawal of supplementation and may be a major concern for this maneuver.

Topics: Adult; Aged; Biomarkers; Carotid Intima-Media Thickness; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Fibroblast Growth Factor-23; Fibroblast Growth Factors; Humans; Interleukin-6; Male; Middle Aged; Osteocalcin; Osteopontin; Osteoprotegerin; Parathyroid Hormone; Peritoneal Dialysis; Prospective Studies; Renal Insufficiency, Chronic; Vitamin D; Vitamin D Deficiency; Vitamins

Nanoemulsion formulation of vitamin D3 have been shown to have better bioavailability than the coarse emulsion preparation in vitro and in vivo animal studies. In the absence of randomised trial in humans, comparing the efficacy of nanotechnology-based miscellised vitamin D3 over conventional vitamin D3, we undertook this study. A total of 180 healthy adults were randomised to receive either micellised (DePura, group A) or conventional vitamin D3 (Calcirol, group B) at a monthly dose of 60 000 IU (1500μg) for 6 months. The outcome parameters were serum 25-hydroxyvitamin D (25(OH)D), parathyroid hormone (PTH), Ca, phosphate, alkaline phosphatase and urinary Ca:creatinine ratio. A total of eighty-nine subjects in group A and seventy-seven in group B completed the trial. Subjects in both the groups had a significant increase in their serum 25(OH)D levels following supplementation (group A: 21·5 (sd 10·9) to 76·7 (sd 18·8) nmol/l (P<0·001); group B: 22·8 (sd 10·4) to 57·8 (sd 16·0) nmol/l (P<0·001)). Participants in micellised group had an additional increase of 20·2 (95 % CI 14·0, 26·4) nmol/l in serum 25(OH)D levels (P<0·001). The difference between the groups was 17·5 (95 % CI 11·8, 23·1) nmol/l, which remained statistically significant (P<0·001) even after adjustment for age and sex. Significant decline in mean serum PTH was observed in both the groups. No hypercalcaemia or hypercalciuria was noted. Although supplementation with both the preparations resulted in a significant rise in serum 25(OH)D levels, micellised vitamin D3 appeared to be more efficacious in achieving higher levels of serum 25(OH)D.

Topics: Adult; Body Mass Index; Calcifediol; Cholecalciferol; Dietary Supplements; Drug Carriers; Female; Healthy Volunteers; Humans; India; Male; Micelles; Middle Aged; Nanomedicine; Parathyroid Hormone; Solubility; Vitamin D Deficiency; Young Adult

To examine whether vitamin D supplementation in patients with depression would result in a reduction in Hamilton D-17 depression score (primary outcome) at 3 and 6 months compared to controls and to explore the correlations between serum vitamin D and symptoms of depression, wellbeing, systolic blood pressure, and waist circumference. In this outpatient multicentre study conducted between 2010 and 2013, patients, 18-65 years old, diagnosed with mild to severe depression were randomly assigned to receive D supplementation 70 micrograms daily or placebo on top of standard treatment. Participants, care givers and those assessing the outcomes were blinded to group assignment.. At baseline, 23 patients had a normal 25(OH)D level, 22 had insufficiency (< 25 nmol/L), and 17 had deficiency (25-50 nmol/L). No significant reduction in depression was seen after vitamin D supplementation compared to placebo at Hamilton (18.4-18.0; p = 0.73 at 12 weeks). Vitamin D supplementation did not provide a reduction in symptom score among patients with depression. Trial registration The trial was registered in the National Board of Health (EudraCT: 2011-002585-20) and in ClinicalTrials.Gov (NCT01390662).

Topics: Adolescent; Adult; Aged; Cholecalciferol; Depression; Dietary Supplements; Double-Blind Method; Female; Humans; Male; Middle Aged; Severity of Illness Index; Treatment Outcome; Vitamin D Deficiency; Vitamins; Young Adult

The present clinical study aims to describe protocol to evaluate the effects of vitamin D3 supplementation on the cardiovascular risk factors in a population of rotating shift workers.. A randomized, double-blind, placebo-controlled, parallel group clinical trial testing 2 oral dosages of cholecalciferol (14,000 IU and 28,000 IU per week) for 12 months.. The primary outcome for evaluation is an 18% reduction in hypertriglyceridemia (≥150 mg/dL) between pre and postintervention measurements. Baseline characteristics of the study population will be summarized separately within each randomized group, and will use tests for continuous and categorical variables. For all tests, a P < .05 will be considered significant. The analysis of primary and secondary outcomes will use an intention-to-treat population and a per-protocol population. The primary and secondary outcomes will be compared separately between each treatment group and placebo, using binary logistic regression or regressão de Poisson for proportions (for binary outcomes) and using linear regression for differences in means (for continuous endpoints), with 95% confidence intervals.. Rotating shift workers, adults aged between 18 and 60 years, with hypovitaminosis D and alterations in at least 1 of the following parameters: fasting glucose, high-density lipoprotein cholesterol, triglycerides, low-density lipoprotein cholesterol, blood pressure, and waist circumference.. This clinical trial aims to contribute to the gap in knowledge about the potential, dose, and time of vitamin D supplementation to generate beneficial effects on triglycerides in a population at increased risk for hypertriglyceridemia and vitamin D deficiency.

Topics: Adolescent; Adult; Age Factors; Blood Glucose; Blood Pressure; Cardiovascular Diseases; Cholecalciferol; Dietary Supplements; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Lipids; Male; Middle Aged; Reserpine; Risk Factors; Sex Factors; Shift Work Schedule; Vitamin D Deficiency; Waist Circumference; Young Adult

Topics: Adult; Biomarkers; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Lipidomics; Lipids; Obesity; Postprandial Period; Treatment Outcome; Vitamin D Deficiency

Findings on the effects of vitamin D on cognitive performance have been inconsistent and no clinical trials with detailed cognitive testing in healthy older adults have been reported.. We tested whether 2000 IU is superior to 800 IU vitamin D3/d for cognitive performance among relatively healthy older adults.. We analyzed data on cognitive performance as the secondary outcome of a 2-y double-blind randomized controlled trial that originally investigated the effect of vitamin D3 on knee function and pain in seniors with osteoarthritis. Participants were randomly assigned to either 2000 or 800 IU vitamin D3/d. Capsules had identical appearances and taste. A total of 273 community-dwelling older adults aged ≥60 y were enrolled 6-8 wk after unilateral joint replacement. Inclusion required a baseline Mini Mental State Examination (MMSE) score of 24. We implemented a detailed 2-h cognitive test battery. The primary cognitive endpoint was the score achieved in the MMSE. Secondary endpoints included a composite score of 7 executive function tests, auditory verbal and visual design learning tests, and reaction times.. At baseline, mean age was 70.3 y, 31.4% were vitamin D-deficient [25(OH)D <20 ng/mL], and mean ± SD MMSE score was 28.0 ± 1.5. Although the mean ± SD 25(OH)D concentrations achieved differed significantly between treatment groups at 24-mo follow-up (2000 IU = 45.1 ± 10.2 ng/mL; 800 IU = 37.5 ± 8.8 ng/mL; P < 0.0001), none of the primary or secondary endpoints of cognitive performance differed between treatment group. Results by treatment were similar for predefined subgroups of baseline 25(OH)D status (deficient compared with replete) and age (60-69 y compared with ≥70 y).. Our study does not support a superior cognitive benefit of 2000 IU compared with 800 IU vitamin D/d among relatively healthy older adults over a 24-mo treatment period. This trial was registered at clinicaltrials.gov as NCT00599807.

Topics: Aged; Cholecalciferol; Cognition; Dietary Supplements; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Male; Memory; Middle Aged; Osteoarthritis, Knee; Pain; Reaction Time; Vitamin D; Vitamin D Deficiency

Low vitamin D levels are associated with poorer outcomes after stroke. However, it is not clear whether post-stroke vitamin D supplementation can improve these outcomes. In this study, we investigated the effects of vitamin D supplementation on outcomes in hospitalized patients undergoing rehabilitation after acute stroke. A multicenter, randomized, controlled, double-blind, parallel-group trial was conducted from January 2012 through July 2017. One hundred patients admitted to a convalescent rehabilitation ward after having an acute stroke were randomized, and each one received either vitamin D3 (2000 IU/day) or a placebo. The primary outcome was a gain in the Barthel Index scores at week 8. Secondary outcomes were seen in Barthel Index efficiency, hand grip strength, and calf circumference at week 8. Ninety-seven patients completed the study. There were no significant differences in the demographic characteristics between the groups. The mean (±standard deviation) gain in the Barthel Index score was 19.0 ± 14.8 in the supplementation group and 19.5 ± 13.1 in the placebo group (

Topics: Activities of Daily Living; Aged; Body Weights and Measures; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Hand Strength; Humans; Male; Middle Aged; Physical Functional Performance; Stroke; Stroke Rehabilitation; Vitamin D Deficiency; Vitamins

Despite the availability of consensus guidelines for the treatment of vitamin D deficiency, prospective trials are lacking to examine alternative dosing strategies for adult patients with cystic fibrosis (CF) who do not meet therapeutic goals with standard regimens.. The primary objective of this study was to determine the efficacy of high-dose cholecalciferol supplementation in increasing serum vitamin D (25-OHD) levels in adult patients with CF.. Patients were eligible for inclusion if they were 18 years or older, had baseline 25-OHD levels lower than 30 ng/ml, and were diagnosed with CF and pancreatic insufficiency. Patients were given a single dose of cholecalciferol 300,000 or 500,000 IU based on baseline 25-OHD levels. Response was defined by 25-OHD and ionized calcium levels at 3 months. At 6 months, responders received a second dose of the same strength, and nonresponders were given a weekly supplement of cholecalciferol 50,000 IU in addition to cholecalciferol 500,000 IU. A second 25-OHD level was obtained at 9 months.. Of the 46 patients enrolled, 32 patients (70%) completed the study. Baseline levels of 25-OHD significantly increased over time in the per protocol population at 3 and 9 months. A total of 16 patients (50%) were considered nonresponders and required weekly supplementation.. A protocol using high-dose cholecalciferol or high-dose plus weekly cholecalciferol is safe and effective in treating adult patients with CF and pancreatic insufficiency.

Topics: Adult; Cholecalciferol; Cystic Fibrosis; Dietary Supplements; Dose-Response Relationship, Drug; Exocrine Pancreatic Insufficiency; Female; Humans; Male; Prospective Studies; Vitamin D Deficiency; Vitamins; Young Adult

To determine whether vitamin D3 supplementation improves insulin sensitivity, using the hyperinsulinemic-euglycemic clamp.. This single-centre, double-blind, placebo-controlled trial randomised 96 participants at high risk of diabetes or with newly diagnosed type 2 diabetes to vitamin D3 5000 IU daily or placebo for 6 months.. We assessed at baseline and 6 months: (1) primary aim: peripheral insulin sensitivity (M-value using a 2-h hyperinsulinemic-euglycemic clamp); (2) secondary aims: other insulin sensitivity (HOMA2%S, Matsuda) and insulin secretion (insulinogenic index, C-peptide area under the curve, HOMA2-B) indices using a 2-h oral glucose tolerance test (OGTT); β-cell function (disposition index: M-value × insulinogenic index); fasting and 2-h glucose post OGTT; HbA1c; anthropometry.. Baseline characteristics were similar between groups (% or mean ± s.d.): women 38.5%; age 58.7 ± 9.4 years; BMI 32.2 ± 4.1 kg/m2; prediabetes 35.8%; diabetes 20.0%; 25-hydroxyvitamin D (25(OH)D) 51.1 ± 14.2 nmol/L. At 6 months, mean 25(OH)D reached 127.6 ± 26.3 nmol/L and 51.8 ± 16.5 nmol/L in the treatment and placebo groups, respectively (P < 0.001). A beneficial effect of vitamin D3 compared with placebo was observed on M-value (mean change (95% CI): 0.92 (0.24-1.59) vs -0.03 (-0.73 to 0.67); P = 0.009) and disposition index (mean change (95% CI): 267.0 (-343.4 to 877.4) vs -55.5 (-696.3 to 585.3); P = 0.039) after 6 months. No effect was seen on other outcomes.. In individuals at high risk of diabetes or with newly diagnosed type 2 diabetes, vitamin D supplementation for 6 months significantly increased peripheral insulin sensitivity and β-cell function, suggesting that it may slow metabolic deterioration in this population.

Topics: Aged; Cholecalciferol; Diabetes Mellitus, Type 2; Dietary Supplements; Double-Blind Method; Drug Administration Schedule; Female; Glucose Tolerance Test; Humans; Insulin Resistance; Male; Middle Aged; Prediabetic State; Treatment Outcome; Vitamin D; Vitamin D Deficiency

There was inconsistent evidence about the benefit of vitamin D plus evening primrose oil (EPO) supplement intake on lipid profiles and reduced oxidative stress among women with polycystic ovary syndrome (PCOS). The current study was performed to evaluate the effects of vitamin D plus EPO supplementation on lipid profiles and biomarkers of oxidative stress in vitamin D-deficient women with PCOS.. This randomized, double-blind, placebo-controlled trial was performed among 60 vitamin D-deficient women with PCOS. Participants were randomly assigned into two groups to receive either 1000 IU vitamin D3 plus 1000 mg EPO (n = 30) or placebo (n = 30) for 12 weeks. Metabolic profiles were quantified at baseline and after the 12-week intervention.. Compared with the placebo group, women in vitamin D and EPO co-supplementation group had significant increases in serum 25-hydroxyvitamin D (25(OH)D) (+10.7 ± 8.4 vs. -0.5 ± 1.6 ng/mL, p < 0.001) and plasma total glutathione (GSH) (+62.7 ± 58.0 vs. -0.7 ± 122.7 µmol/L, p = 0.01), while there were significant decreases in triglycerides (-7.3 ± 23.8 vs. +6.9 ± 26.3 mg/dL, p = 0.03), very low-density lipoprotein (VLDL) cholesterol levels (-1.5 ± 4.7 vs. +1.4 ± 5.3 mg/dL, p = 0.03), total/high-density lipoprotein cholesterol ratio (-0.3 ± 0.4 vs. -0.02 ± 0.4, p = 0.02), and malondialdehyde (MDA) concentration (-0.4 ± 0.4 vs. +0.5 ± 1.8 µmol/L, p = 0.008).. Overall, vitamin D and EPO co-supplementation for 12 weeks among vitamin D-deficient women with PCOS significantly improved triglycerides, VLDL cholesterol, GSH, and MDA levels.

Topics: Adult; Biomarkers; Cholecalciferol; Cholesterol, HDL; Cholesterol, VLDL; Dietary Supplements; Double-Blind Method; Drug Therapy, Combination; Female; gamma-Linolenic Acid; Glutathione; Humans; Hypolipidemic Agents; Linoleic Acids; Malondialdehyde; Oenothera biennis; Outcome Assessment, Health Care; Oxidative Stress; Plant Oils; Polycystic Ovary Syndrome; Triglycerides; Vitamin D; Vitamin D Deficiency; Young Adult

Fibroblast growth factor-23 plays an important role in regulating systemic phosphate homeostasis, and vitamin D metabolism. However, the effect of Cholecalciferol therapy on FGF. This is a double-blind, randomized clinical trial on 119 vitamin D deficient patients in 2016. Biochemical variables of treatment and placebo groups were analyzed after 12 weeks of 50,000 IU of Cholecalciferol vs. placebo therapy once a week, by SPSS18.. We propose that in these patients 1,25(OH)

Topics: Adolescent; Adult; Aged; Biomarkers; Bone Density Conservation Agents; Calcium; Case-Control Studies; Cholecalciferol; Double-Blind Method; Female; Fibroblast Growth Factor-23; Fibroblast Growth Factors; Follow-Up Studies; Humans; Male; Middle Aged; Parathyroid Hormone; Prognosis; Vitamin D; Vitamin D Deficiency; Young Adult

Adequate vitamin D status contributes to bone fragility risk reduction and possibly other pathological conditions that occur with aging. In response to pharmaceutical vitamin D. Using fortified yogurt, we investigated in one randomized controlled trial how both baseline status, as assessed by measuring s25OHD prior the onset of the trial, and the season of enrollment quantitatively influenced the response to the supplemented (Suppl.) of vitamin D. All enrolled participants adhered to the protocol throughout the 24-week study: Gr.Suppl.0 (n = 45), Gr.Suppl.5 (n = 44), and Gr.Suppl.10 (n = 44). Over the 16 intervention and 8 follow-up weeks, s25OHD increased in both supplemented groups, more in Gr.Suppl.10 than in Gr.Suppl.5. At the end of the intervention, the subject proportion with s25OHD ≥ 50 nmol/L was 37.8, 54.5, and 63.6% in Gr.Suppl.0, Gr.Suppl.5, and Gr.Suppl.10, respectively. The constant rate of s25OHD per supplemental VitD

Topics: Aged; Cholecalciferol; Female; Food, Fortified; Humans; Menopause; Middle Aged; Seasons; Treatment Outcome; Vitamin D; Vitamin D Deficiency; Yogurt

Results of animal models and cross-sectional cohort studies have suggested a beneficial role for vitamin D in male reproduction.. Determine the effect of vitamin D and calcium supplementation on semen quality in infertile men with serum 25-hydroxyvitamin-D (25OHD) levels ≤50 nmol/L.. A single-center, triple-blinded, randomized clinical trial.. A total of 1427 infertile men were screened to include 330; 1002 men did not meet inclusion criteria and 95 did not wish to participate.. The active group received cholecalciferol 300,000 IU initially, then 1400 IU cholecalciferol and 500 mg of calcium daily for 150 days; the other group received placebo.. Serum concentrations of 25OHD and 1,25-dihydroxyvitamin D3 were significantly higher in men in the treatment group compared with the placebo group. Vitamin D supplementation was not associated with changes in semen parameters, although spontaneous pregnancies tended to be higher in couples in which the man was in the treatment group [7.3% vs 2.4%, Δ5.0% (-0.6%; 10.5%)]. Vitamin D treatment in a subgroup of oligozoospermic men increased the chance for a live birth compared with placebo [35.6% vs 18.3%, Δ17.3% (1.6%; 32.9%)]. Moreover, serum inhibin B levels were higher in men deficient in vitamin D who were randomly assigned to receive high-dose vitamin D [193 pg/mL vs 143 pg/mL, Δ49 pg/mL (8; 91 pg/mL)]; however, the increase in sperm concentration was not significantly higher than in the placebo group (P = 0.07).. High-dose vitamin D supplementation did not improve semen quality in vitamin D-insufficient infertile men. The positive impact of vitamin D supplementation on live birth rate and serum inhibin B in oligozoospermic and vitamin D-deficient men may be of clinical importance and warrant verification by others.

Topics: Adult; Calcium; Cholecalciferol; Dietary Supplements; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Infertility, Male; Male; Middle Aged; Oligospermia; Pregnancy; Pregnancy Outcome; Pregnancy Rate; Semen Analysis; Sperm Count; Sperm Motility; Vitamin D; Vitamin D Deficiency

In this randomized double-blind placebo-controlled 24-week trial, cholecalciferol supplementation at 50,000 IU/week effectively improved bone microarchitecture parameters in juvenile-onset systemic lupus erythematosus (JoSLE) patients, as assessed by high-resolution peripheral quantitative computed tomography (HR-pQCT) at tibia site. An increase in the trabecular number and a decrease in the trabecular separation were observed, suggesting that vitamin D supplementation may be recommended for JoSLE patients with its deficiency.. Vitamin D has an important effect on bone but there are no trials that directly address the boosting of serum levels of 25-hydroxyvitamin D (25OHD) in bone microarchitecture in JoSLE patients. The aim of this study was to evaluate the effect of vitamin D supplementation on bone microarchitecture parameters using HR-pQCT in JoSLE patients.. This study was a randomized double-blind placebo-controlled 24-week trial. Forty female JoSLE patients were randomized (1:1) to receive oral cholecalciferol at 50,000 IU/week (JoSLE-VitD) or placebo (JoSLE-PL). The medications remained stable throughout the study. Serum levels of 25OHD were measured using a radioimmunoassay. The bone microarchitecture and volumetric bone density were analyzed using HR-pQCT at tibia site.. At baseline, the groups were similar with respect to their age, body mass index, organ involvement, glucocorticoid dose, immunosuppressant use, serum 25OHD levels, and HR-pQCT parameters. After 24 weeks, higher 25OHD levels were observed in the JoSLE-VitD group compared to the JoSLE-PL group [31.3 (8.6) vs. 16.5 (5.8) ng/mL, p < 0.001]. An increase in the trabecular number [∆Tb.N 0.16 (0.24) vs. 0.03 (0.19) 1/mm, p = 0.024] and a decrease in the trabecular separation [∆ThSp -0.045 (0.067) vs. 0.001 (0.009) mm, p = 0.017] were found in the JoSLE-VitD group compared to the JoSLE-PL group at tibia site. No differences were observed in other structural parameters [trabecular (Tb.Th) or cortical thickness (Ct.Th)], volumetric bone mineral densities, cortical porosity, and biomechanical parameters (p > 0.05).. This study suggests that cholecalciferol supplementation for 24 weeks effectively improved the bone microarchitecture parameters, mainly the trabecular number, in JoSLE patients.. NCT01892748.

Topics: Adolescent; Bone Density; Bone Density Conservation Agents; Cancellous Bone; Cholecalciferol; Dietary Supplements; Double-Blind Method; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Lupus Erythematosus, Systemic; Tomography, X-Ray Computed; Vitamin D; Vitamin D Deficiency; Young Adult

Disruption of gut microbiota may exacerbate severity of cystic fibrosis (CF). Vitamin D deficiency is a common comorbidity in patients with CF that may influence composition of the gut microbiota.. Compare microbiota of vitamin D-sufficient and -insufficient CF patients and assess impact of a weekly high-dose vitamin D3 bolus regimen on gut and airway microbiome in adults with CF and vitamin D insufficiency (25-hydroxyvitamin D < 30 ng/mL).. Forty-one subjects with CF were classified into two groups: vitamin D insufficient (n = 23) and vitamin D sufficient (n = 18). Subjects with vitamin D insufficiency were randomized to receive 50,000 IU of oral vitamin D3 or placebo weekly for 12 weeks. Sputum and stool samples were obtained pre- and postintervention and 16S ribosomal RNA genes sequenced using Illumina MiSeq technology.. Gut microbiota differed significantly based on vitamin D status with Gammaproteobacteria, which contain numerous, potentially pathogenic species enriched in the vitamin D-insufficient group. Principal coordinates analysis showed differential gut microbiota composition within the vitamin D-insufficient patients following 12 weeks treatment with placebo or vitamin D3 (permutation multivariate analysis of variance = 0.024), with Lactococcus significantly enriched in subjects treated with vitamin D3, whereas Veillonella and Erysipelotrichaceae were significantly enriched in patients treated with placebo.. This exploratory study suggests that vitamin D insufficiency is associated with alterations in microbiota composition that may promote inflammation and that supplementation with vitamin D has the potential to impact microbiota composition. Additional studies to determine the impact of vitamin D on microbiota benefit clinical outcomes in CF are warranted.

Topics: Adult; Cholecalciferol; Cystic Fibrosis; Dietary Supplements; Double-Blind Method; Drug Administration Schedule; Female; Gastrointestinal Microbiome; Humans; Male; Microbiota; Middle Aged; Pilot Projects; Respiratory System; Vitamin D Deficiency; Young Adult

Low vitamin D status is common in patients with heart failure and may influence bone health. A daily vitamin D dose of 4000 IU (moderately high dose) for 3 years had however no effect on parameters of bone metabolism, even in patients with very low vitamin D status.. In this pre-specified secondary analysis of a randomized controlled trial, we assessed in 158 male HF patients (vitamin D group: n = 80; placebo group: n = 78) between-group differences in calciotropic hormones (25OHD, 1,25-dihydroxyvitamin D [1,25(OH). A daily vitamin D

Topics: Biomarkers; Bone Density Conservation Agents; Bone Remodeling; Bone Resorption; Cholecalciferol; Dietary Supplements; Drug Administration Schedule; Heart Failure; Humans; Male; Middle Aged; Vitamin D; Vitamin D Deficiency

Low plasma 25-hydroxy-vitamin D (25OHD) is associated with polycystic ovary syndrome (PCOS). Vitamin D deficiency may contribute to the development of insulin resistance, visceral fat and low level of adiponectin which are common feature in PCOS women. This study aimed to evaluate the effect of vitamin D supplementation on insulin resistance, visceral fat, and adiponectin in hypovitaminosis D women with polycystic ovary syndrome.. In this randomized, placebo-controlled clinical trial, 44 PCOS women aged 20-38 years with plasma 25OHD <20 ng/mL were randomized in the intervention or placebo groups and followed for 8 weeks. Participants received 50,000 IU of oral vitamin D3 once weekly in the intervention group or placebo. The visceral adipose tissue, Insulin resistance (HOMA-IR), HOMA-B, QUICKI, and circulating adiponectin were compared before and after the intervention within groups using paired tests and the mean changes were analyzed between two groups by independent t-test.. Of 44 eligible participates, 36 patients (81.8%) completed the study. After 8 week intervention, vitamin D supplementation compared to the placebo group significantly decreased fasting plasma glucose (FPG) (7.67 ± 7.66 versus 1.71 ± 7.50 mg/dL, p = .001) and significantly increased homeostasis model of assessment-estimated B cell function (HOMA-B) (129.76 ± 121.02 versus 48.32 ± 128.35, p = .014), Adiponectin (5.17 ± 8.09 versus -5.29 ± 8.64 mg/dL, p = .001), and serum vitamin D level (28.24 ± 6.47 versus 3.55 ± 4.25 ng/mL, p = .001).. Vitamin D supplementation in vitamin D deficient women with PCOS, improved the FPG, HOMA-B, Adiponectin, and serum vitamin D level.

Topics: Adiponectin; Adult; Blood Glucose; Cholecalciferol; Dietary Supplements; Female; Hormone Replacement Therapy; Humans; Insulin; Insulin Resistance; Intra-Abdominal Fat; Polycystic Ovary Syndrome; Treatment Outcome; Vitamin D Deficiency; Young Adult

Vitamin D deficiency is common and associated with mortality in chronic kidney disease (CKD) patients. Cardiovascular disease (CVD) is the commonest cause of mortality in CKD patients. In a randomized, double blind, placebo controlled trial, we have recently reported favorable effects of vitamin D supplementation on vascular & endothelial function and inflammatory biomarkers in vitamin D deficient patients with non-diabetic stage 3-4 CKD (J Am Soc Nephrol 28: 3100-3108, 2017). Subjects in the placebo group who had still not received vitamin D after completion of the trial received two oral doses 300,000 IU of oral cholecalciferol at 8 weeks interval followed by flow mediated dilatation (FMD), pulse wave velocity (PWV), circulating endothelial and inflammatory markers (E-Selectin, vWF, hsCRP and IL-6), 125 (OH)

Topics: Biomarkers; Cardiovascular Diseases; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Male; Middle Aged; Pulse Wave Analysis; Renal Insufficiency, Chronic; Vitamin D Deficiency; Vitamins

Vitamin D (VD) plays an important role in bone mineralization. The present study investigates the effect of VD supplementation alone on bone turnover markers in younger postmenopausal women. It has been shown that VD supplementation in postmenopausal women with hypovitaminosis D is associated with a reduction in bone turnover markers.. The purpose of this study is to evaluate the effect of VD supplementation alone on bone turnover markers in younger postmenopausal women.. In this double-blind, placebo-controlled trial, 160 women were randomized into the VD group (supplementation with 1000 IU of vitamin D3/day, orally; n = 80) or placebo group (n = 80). Women aged 50-65 years with amenorrhea ≥ 12 months and normal bone mineral density were included. The intervention lasted 9 months, and the participants were assessed at the beginning and end of treatment. Serum levels of total calcium, parathormone (PTH), alkaline phosphatase (AP), and 24-h urine calcium were determined. Serum C-terminal telopeptide of type I collagen (s-CTX) and procollagen type 1 N-terminal propeptide (P1NP) were measured by immunoassay as markers of bone resorption and formation, respectively. Plasma 25-hydroxyvitamin-D [25(OH)D] concentrations were measured by HPLC. Intention-to-treat analysis was performed using ANOVA, Student's t test, Tukey's test, and gamma distribution.. Over the period of 9 months, 25(OH)D concentrations increased from 15.0 ± 7.5 to 27.5 ± 10.4 ng/mL (+ 45.4%) in the VD group and decreased from 16.9 ± 6.7 to 13.8 ± 6.0 ng/mL (- 18.5%) in the placebo group (p < 0.001). There was a decrease (- 21.3%) of PTH levels in the VD group with a significant difference between groups at the end of the study (p < 0.001). No significant differences were observed in the other laboratory parameters (total calcium, AP, and calciuria) in either group (p > 0.05). A comparison of bone turnover markers showed a significant reduction in of s-CTX (- 24.2%, p < .0001) and P1NP (- 13.4%, p = 0.003) levels in the VD group. No significant variations in bone turnover markers were observed in the placebo group (s-CTX, - 6.9%, p = 0.092 and P1NP, - 0.6%, p = 0.918).. In younger postmenopausal women with VD deficiency, isolated supplementation with 1000 IU of vitamin D3 for 9 months is associated with a reduction in bone turnover markers. However, any between-group differences was not observed in bone turnover markers.

Topics: Aged; Alkaline Phosphatase; Biomarkers; Bone Remodeling; Calcium; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Middle Aged; Parathyroid Hormone; Postmenopause; Vitamin D Deficiency

Insufficient vitamin D status (serum 25-hydroxyvitamin D (S-25(OH)D)0·05 for differences between ethnic groups). In conclusion, high prevalence of vitamin D insufficiency existed among East African women living in Finland, despite higher vitamin D intake than their Finnish peers. Moderate vitamin D3 supplementation was effective in increasing S-25(OH)D in both groups of women, and no ethnic differences existed in the response to supplementation.

Topics: Adult; Africa, Eastern; Cholecalciferol; Dietary Supplements; Ethnicity; Female; Finland; Humans; Middle Aged; Vitamin D; Vitamin D Deficiency

On the basis of the immunomodulatory actions of vitamin D (VD), we investigated the effects of high-dose VD therapy over a 3 mo period on the immune response in patients with Addison's disease (AD).. This randomized, controlled, crossover trial included 13 patients with AD who received either cholecalciferol (4000 IU/d) for 3 mo followed by 3 mo placebo oil or the sequential alternative placebo followed by verum. Glucocorticoid replacement doses remained stable. The primary outcome measures were changes in 25-hydroxyvitamin D3 (25(OH)D. Three months of treatment with cholecalciferol achieved sufficient 25(OH)D

Topics: Addison Disease; Adult; Calcifediol; Cholecalciferol; Cross-Over Studies; Double-Blind Method; Female; Humans; Male; Middle Aged; Monocytes; Pilot Projects; T-Lymphocytes, Regulatory; Treatment Outcome; Vitamin D Deficiency; Vitamins

Some studies have demonstrated that higher baseline plasma levels of 25-hydroxivitamin D [25(OH)D] are associated with a significant reduction in colorectal cancer (CRC) incidence. Patients with metastatic CRC (mCRC) tend to be vitamin D insufficient, but the effect of vitamin D on the survival of mCRC patients still remains uncertain. In this study, we evaluated the association between cholecalciferol 2,000 IU daily supplementation and survival of mCRC patients.. Seventy-two patients with mCRC were included. Seventy-one patients with 25(OH)D levels <75 nmol/l were randomized to receive standard chemotherapy or standard chemotherapy with cholecalciferol 2,000 IU daily. The primary endpoint was overall survival (OS) and the secondary endpoint was progression-free survival (PFS). The follow-up period was 46 mo.. All but one patient (98.6%) was vitamin D insufficient. There was no statistically significant difference in OS or PFS between those who received vitamin D supplements and controls.. The majority of patients with mCRC are vitamin D insufficient at the time of diagnosis. In our study, adding 2,000 IU of cholecalciferol daily for 2 yr to standard chemotherapy did not show any benefit in OS or PFS.

Topics: Aged; Cholecalciferol; Colorectal Neoplasms; Dietary Supplements; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Vitamin D Deficiency

Topics: Adolescent; Adolescent Nutritional Physiological Phenomena; Africa; Asia; Calcifediol; Child; Child Nutritional Physiological Phenomena; Child, Preschool; Cholecalciferol; Cohort Studies; Delayed-Action Preparations; Dietary Supplements; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Infant; Infant Nutritional Physiological Phenomena; Lost to Follow-Up; Male; Middle East; Patient Compliance; Refugees; Vitamin D Deficiency; Western Australia

Emerging evidence supports a positive, bidirectional and clinical relevant interaction between parathyroid hormone (PTH) and the renin-angiotensin-aldosterone-system (RAAS). A beneficial effect of the widely used RAAS inhibitors might include a PTH-lowering effect, as high PTH levels may be harmful to cardiovascular health. We aimed to investigate whether PTH levels are lowered by short-term treatment with an angiotensin 2 receptor blocker (valsartan) independently of coadministration of vitamin D3. Secondary end-points included effects on blood pressure, cardiac conduction and concentrations of renin and aldosterone.. In a double-blind placebo-controlled trial, we included 81 otherwise healthy postmenopausal women with high PTH levels (>6.9 pmol/L) and vitamin D insufficiency (25(OH)D < 50 nmol/L). Participants received 2 weeks of treatment with valsartan 80 mg/d, vitamin D3 70 μg/d, valsartan plus vitamin D3 or double placebo.. Valsartan treatment did not affect plasma PTH, although treatment reduced diastolic blood pressure (P = .01) and the aldosterone/renin ratio (P < .001). We found no associations between calciotropic hormones and RAAS markers. Vitamin D3 supplementation reduced PTH by 3.4% (25th, 75th -9.0 to 8.7) compared to a 7.1% increase (25th, 75th -2.4 to 30.9) in the placebo group (P = .01), but did not affect blood pressure, cardiac conduction or concentrations of renin and aldosterone.. Independently of vitamin D3, short-term valsartan treatment did not reduce PTH. Vitamin D3 reduced PTH but did not affect blood pressure, cardiac conduction or the RAAS. The study does not support a direct association between PTH and aldosterone or a blood pressure-lowering effect of vitamin D3.

Topics: Aged; Aldosterone; Angiotensin Receptor Antagonists; Blood Pressure; Cholecalciferol; Double-Blind Method; Electrocardiography; Female; Humans; Male; Middle Aged; Parathyroid Hormone; Postmenopause; Valsartan; Vitamin D Deficiency

Despite evidence on the association between hypovitaminosis D and adverse pregnancy outcomes and the positive impact of vitamin D supplementation, no evidence exists supporting a universal screening program in pregnancy as part of routine prenatal care.. We sought to determine the effectiveness of a prenatal screening program on optimizing 25-hydroxyvitamin D [25(OH)D] levels and preventing pregnancy complications. Also, to identify a safe regimen, we compared several regimens in a subgroup of vitamin D-deficient pregnant women.. Two cities of Masjed-Soleyman and Shushtar from Khuzestan province, Iran, were selected as the screening and nonscreening arms, respectively. Within the screening arm, a randomized controlled trial was conducted on 800 pregnant women.. Health centers of Masjed-Soleyman and Shushtar cities.. Pregnant women aged 18 to 40 years.. Women with moderate [25(OH)D, 10 to 20 ng/mL] and severe [25(OH)D, <10 ng/mL] deficiency were randomly divided into four subgroups and received vitamin D3 (D3) until delivery.. Maternal concentration of 25(OH)D at delivery and rate of pregnancy complications.. After supplementation, only 2% of the women in the nonscreening site met the sufficiency level (>20 ng/mL) vs 53% of the women in the screening site. Adverse pregnancy outcomes, including preeclampsia, gestational diabetes mellitus, and preterm delivery, were decreased by 60%, 50%, and 40%, respectively, in the screening site. A D3 injection in addition to monthly 50,000 IU maintenance therapy contributed the most to achievement of sufficient levels at delivery.. A prenatal vitamin D screening and treatment program is an effective approach in detecting deficient women, improving 25(OH)D levels, and decreasing pregnancy adverse outcomes.

Topics: Adolescent; Adult; Cholecalciferol; Dietary Supplements; Female; Humans; Infant, Newborn; Pregnancy; Pregnancy Complications; Pregnancy Outcome; Prenatal Diagnosis; Program Evaluation; Treatment Outcome; Vitamin D Deficiency; Young Adult

By treating obesity, one of the major epidemics of this past century, through bariatric surgery, we may cause complications due to malnourishment in a growing population. At present, vitamin D deficiency is of interest, especially in patients with inferior absorption of fat-soluble nutrients after biliopancreatic diversion with duodenal switch (BPD/DS).. Twenty BPD/DS patients, approximately 4 years postoperatively, were randomized to either intramuscular supplementation of vitamin D with a single dose of 600,000 IU cholecalciferol, or a control group. Patients were instructed to limit their supplementation to 1400 IU of vitamin D and to avoid the influence of UV-B radiation; the study was conducted when sunlight is limited (December to May).. Despite oral supplementation, a pronounced deficiency in vitamin D was seen (injection 19.3; control 23.2 nmol/l) in both groups. The cholecalciferol injection resulted in elevated 25[OH]D levels at 1 month (65.4 nmol/l), which was maintained at 6 months (67.4 nmol/l). This resulted in normalization of intact parathyroid hormone (PTH) levels. No changes in vitamin D or PTH occurred in the control group.. In BPD/DS patients, having hypovitaminosis D despite full oral supplementation, a single injection of 600,000 IU of cholecalciferol was effective in elevating vitamin D levels and normalizing levels of intact PTH. The treatment is simple and highly effective and thus recommended, especially in cases of reduced UV-B radiation.

Topics: Anastomosis, Surgical; Bariatric Surgery; Cholecalciferol; Humans; Obesity, Morbid; Vitamin D Deficiency

Topics: Adult; Belgium; Biomarkers; Calcifediol; Cholecalciferol; Dietary Supplements; Drug Administration Schedule; Female; Fibroblast Growth Factor-23; Humans; Male; Middle Aged; Time Factors; Treatment Outcome; Up-Regulation; Vitamin D Deficiency; Young Adult

Bone turnover markers (BTMs) are proposed as alternative indicators for bone mineral density in diagnosis and management of osteoporosis. However, little is known about the effects of vitamin D supplementation on BTMs in nonwhite populations.. We aimed to investigate the responses in BTMs after vitamin D supplementation in Asians.. In this secondary data analysis of a randomized, double-blind, placebo-controlled trial, 448 Chinese adults [mean ± SD age: 31.9 ± 8.0 y; mean ± SD body mass index (kg/m2): 22.1 ± 2.6; 69% were women] with vitamin D deficiency (serum 25-hydroxyvitamin D [25(OH)D] <50 nmol/L) received 2000 IU/d cholecalciferol or placebo for 20 wk. Serum concentrations of 25(OH)D, parathyroid hormone (PTH), calcium, and markers of bone formation and resorption were measured at weeks 0 and 20. Intention-to-treat analysis was applied, and between-group differences were compared by general linear models with adjustments.. Cholecalciferol supplementation increased the serum bone alkaline phosphatase (BALP) concentration (+1.7 ± 1.9 µg/L) significantly more than placebo (+1.1 ± 1.7 µg/L; P = 0.004), but not circulating concentrations of procollagen type I N-terminal propeptide (PINP), β-isomerized C-terminal telopeptide of type I collagen (β-CTX), or tartrate-resistant acid phosphatase 5b (TRAP5b) (P ≥ 0.53). Notably, a pooled analysis indicated that changes in serum 25(OH)D were positively associated with changes in serum BALP, PINP, and TRAP5b (r = 0.07-0.16, P ≤ 0.02), but inversely with changes in PTH (r = -0.15, P < 0.001). Among cholecalciferol-treated participants, individuals who achieved serum 25(OH)D ≥75 nmol/L had greater increases in serum β-CTX (224% compared with 146%; P = 0.02) and TRAP5b (22.2% compared with 9.1%; P = 0.007), but smaller decreases in serum calcium (-1.3% compared with -1.9%; P = 0.005) and calcium-phosphorus product (-2.6% compared with -3.3%; P = 0.02) compared with those with serum 25(OH)D <75 nmol/L.. Daily supplementation with 2000 IU cholecalciferol for 20 wk may promote bone formation in Chinese adults with vitamin D deficiency. More studies are needed to elucidate the potential clinical implications of BTMs.This trial was registered at clinicaltrials.gov as NCT01998763.

Topics: Adult; Alkaline Phosphatase; Asian People; Biomarkers; Bone Density; Bone Remodeling; China; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Male; Parathyroid Hormone; Peptide Fragments; Procollagen; Tartrate-Resistant Acid Phosphatase; Vitamin D; Vitamin D Deficiency; Young Adult

Use of vitamin D. To determine associations between free vitamin D3 concentrations and rates of treatment failure and exacerbations in patients with asthma participating in the Vitamin D Add-on Therapy Enhances Corticosteroid Responsiveness in Asthma (VIDA) trial.. Free concentrations were directly measured by enzyme-linked immunosorbent assay and stratified into low, medium, and high groups: less than 5pg/mL (n = 65), 5 to 9pg/mL (n = 84), and greater than 9pg/mL (n = 48) after 12 weeks of supplementation with oral vitamin D3 and associated with outcomes.. Outcomes did not associate with free concentrations: overall treatment failure rates were 0.60 (95% confidence interval [CI] 0.46-0.78), 0.53 (95%CI 0.40- 0.70), and 0.69 (95%CI 0.54-0.90)/person-year (P = .51), respectively; overall exacerbation rates were 0.28 (95%CI 0.17-0.48), 0.15 (95%CI 0.08-0.30) and 0.42 (95%CI 0.27-0.66)/person-year (P = .22). Mean (standard deviation) baseline free concentrations were lower in non-Hispanic blacks and Hispanics compared with non-Hispanic whites: 4.10 (1.33) and 4.38 (1.11) pg/mL vs 5.16 (1.65) pg/ml, (P < .001 and P = 0.038), respectively. Mean (standard deviation) baseline free concentrations differed between females and males: 4.57 (1.58) and 5.08 (1.41) (P = .026); and between non-overweight (body mass index [BMI] < 25) and overweight (BMI > 25): 5.45 (1.86) vs 4.54 (1.39) (P < .001). The free fraction differed by race and sex but not by BMI.. The use of free concentrations was inferior to total concentrations as a biomarker of efficacy of vitamin D

Topics: Adrenal Cortex Hormones; Adult; Asthma; Body Mass Index; Cholecalciferol; Dietary Supplements; Disease Progression; Female; Humans; Male; Risk; Sex Factors; Treatment Failure; Vitamin D Deficiency; Vitamin D-Binding Protein

Low serum 25-hydroxyvitamin D [25(OH)D] has been associated with unfavorable cardiometabolic risk profiles in many observational studies in children, but very few randomized controlled trials have investigated this.. We explored the effect of winter-time cholecalciferol (vitamin D3) supplementation on cardiometabolic risk markers in young, white, 4- to 8-y-old healthy Danish children (55°N) as part of the pan-European ODIN project.. In the ODIN Junior double-blind, placebo-controlled, dose-response trial, 119 children (mean ± SD age: 6.7 ± 1.5 y; 36% male; 82% normal weight) were randomly allocated to 0, 10 or 20 µg/d of vitamin D3 for 20 wk (October-March). Cardiometabolic risk markers including BMI-for-age z score (BMIz), waist circumference, systolic and diastolic blood pressure, serum triglycerides and cholesterol (total, LDL, HDL, and total:HDL), plasma glucose and insulin, and whole-blood glycated hemoglobin were measured at baseline and endpoint as secondary outcomes together with serum 25(OH)D. Intervention effects were evaluated in linear regression models as between-group differences at endpoint adjusted for baseline value of the outcome, and additionally for age, sex, baseline serum 25(OH)D, BMIz, time since breakfast, and breakfast content.. Mean ± SD serum 25(OH)D was 56.7 ± 12.3 nmol/L at baseline and differed between groups at endpoint with concentrations of 31.1 ± 7.5, 61.8 ± 10.6, and 75.8 ± 11.5 nmol/L in the 0-, 10-, and 20 µg/d groups, respectively (P < 0.0001). Vitamin D3 supplementation had no effect on any of the cardiometabolic risk markers in analyses adjusted for baseline value of the outcome (all P ≥ 0.05), and additional covariate adjustment did not change the results notably.. Preventing the winter decline in serum 25(OH)D with daily vitamin D3 supplementation of 10 or 20 µg had no cardiometabolic effects in healthy 4- to 8-y-old Danish children. This trial was registered at www.clinicaltrials.gov as NCT02145195.

Topics: Biomarkers; Blood Glucose; Blood Pressure; Body Mass Index; Cardiovascular Diseases; Child; Child, Preschool; Cholecalciferol; Denmark; Dietary Supplements; Double-Blind Method; Female; Humans; Insulin; Lipids; Male; Reference Values; Risk Factors; Seasons; Vitamin D; Vitamin D Deficiency; Vitamins; Waist Circumference

Epidemiologic studies have supported inverse associations between low serum 25-hydroxyvitamin D [25(OH)D] and cardiometabolic risk markers, but few randomized trials have investigated the effect of vitamin D supplementation on these markers in adolescents.. The objective of this study was to investigate the effect of winter-time cholecalciferol (vitamin D3) supplementation on cardiometabolic risk markers in white, healthy 14- to 18-y-old adolescents in the UK (51°N) as part of the ODIN Project.. In a dose-response trial, 110 adolescents (mean ± SD age: 15.9 ± 1.4 y; 43% male; 81% normal weight) were randomly assigned to receive 0, 10 or 20 μg/d vitamin D3 for 20 wk (October-March). Cardiometabolic risk markers including BMI-for-age z score (BMIz), waist circumference, systolic and diastolic blood pressure, fasting plasma triglycerides, cholesterol (total, HDL, LDL, and total:HDL), and glucose were measured at baseline and endpoint as secondary outcomes, together with serum 25(OH)D. Intervention effects were evaluated in linear regression models as between-group differences at endpoint, adjusted for the baseline value of the outcome variable and additionally for age, sex, Tanner stage, BMIz, and baseline serum 25(OH)D.. Mean ± SD baseline serum 25(OH)D was 49.1 ± 12.3 nmol/L and differed between groups at endpoint with concentrations of 30.7 ± 8.6, 56.6 ± 12.4, and 63.9 ± 10.6 nmol/L in the 0, 10, and 20 μg/d groups, respectively (P ≤ 0.001). Vitamin D3 supplementation had no effect on any of the cardiometabolic risk markers (all P > 0.05), except for lower HDL (-0.12 mmol/L; 95% CI: -0.21, 0.04 mmol/L; P = 0.003) and total cholesterol (-0.21 mmol/L; 95% CI: -0.42, 0.00 mmol/L; P = 0.05) in the 20 μg/d than in the 10 μg/d group, which disappeared in the fully adjusted analysis (P = 0.27 and P = 0.30, respectively).. Supplementation with vitamin D3 at 10 and 20 μg/d, which increased serum 25(OH)D concentrations during the winter-time, had no effect on markers of cardiometabolic risk in healthy 14- to 18-y-old adolescents. This trial was registered at clinicaltrials.gov as NCT02150122.

Topics: Adolescent; Biomarkers; Blood Glucose; Blood Pressure; Body Mass Index; Cardiovascular Diseases; Cholecalciferol; Denmark; Dietary Supplements; Female; Humans; Insulin; Lipids; Male; Reference Values; Risk Factors; Seasons; Vitamin D; Vitamin D Deficiency; Vitamins; Waist Circumference

The liver is involved in the metabolism of vitamin D. The prevalence of osteopenia in alcoholic liver disease (ALD) patients is 34-48%, and the prevalence of osteoporosis is 11-36%. Advanced liver disease is considered a risk factor for the development of osteoporosis. The aim of this study was to establish the relationship between vitamin D level and Child-Pugh score in patients with alcoholic liver cirrhosis (ALC), and to evaluate the effects of oral vitamin D supplementation.. Seventy male ALC patients in the absence of active alcohol intake were enrolled and their clinical and laboratory data were recorded. A supplementation of cholecalciferol 1000 IU/day was administered. The vitamin D status was analyzed during the study, in patients stratified by Child-Pugh score.. The study was completed by fifty patients. At the enrollment, the mean level of vitamin D was 60.73±28.02, 50.53±39.52 and 26.71±12.81 nmol/L, respectively for Child-Pugh score class A, B and C. During vitamin D supplementation it was found in all the patients a significant increase of its levels during the first six months (P<0.05). However, in class C the improvement was consistent also after year (P<0.05). At the end of the study, two of seven patients initially in class C changed in class A, four from class C to B, and one remained in class C (P=0.012). Out of seventeen patients initially in class B, eleven changed to class A, and six remained in class B.. In patients with ALC, higher level of vitamin D level is related with lower Child-Pugh score. The supplementation of 1000 IU/day of vitamin D in these patients was optimal for a period of at least six months. A decrease in the Child-Pugh score was also found, with a redistribution of the patients in different classes.

Topics: Bilirubin; Bone Diseases, Metabolic; Cholecalciferol; Dietary Supplements; Humans; International Normalized Ratio; Liver Cirrhosis, Alcoholic; Male; Middle Aged; Osteoporosis; Prospective Studies; Serum Albumin; Severity of Illness Index; Treatment Outcome; Vitamin D; Vitamin D Deficiency

Chinese PMO women (n = 219) were treated with 12-month ALN/D5600 (n = 111) or calcitriol (n = 108). Changes in 25(OH) D at month 12 were post hoc analyzed by the baseline 25 (OH) D status using the longitudinal analysis. The main safety outcome measures included serum calcium and phosphate and 24-h urine calcium, and the repeated measures mixed model was used to assess the frequencies of the calcium-phosphate metabolic disorders.. Absolute change in mean serum 25(OH) D level was the greatest in VD-deficient patients and least in VD-sufficient patients at months six and 12 (both, P < 0.01). Serum calcium level remained significantly lower in the ALN/D5600 treatment group than in the calcitriol treatment group throughout the 12 months. Mean 24-h urine calcium slightly increased in the ALN/D5600 treatment group and significantly increased in the calcitriol treatment group (+ 1.1 and + 0.9 mmol/L at months six and 12; both, P < 0.05). Calcitriol treatment was associated with more frequent hypercalciuria at month six (9.4% vs. 18.5%, P = 0.05), but not at month 12 (12.3% vs. 13.0%).. Baseline VD status predicted 25(OH) D improvement in PMO patients on 12-month ALN/D5600 treatment. The daily use of 0.25 μg of calcitriol was associated with more frequent hypercalciuria at month six, compared to ALN/5600 treatment, necessitating the safety re-evaluation of calcitriol at a higher dosage.

Topics: Aged; Aged, 80 and over; Alendronate; Biomarkers; Bone Density; Bone Density Conservation Agents; Calcifediol; Calcium Phosphates; China; Cholecalciferol; Female; Humans; Hypercalciuria; Middle Aged; Osteoporosis, Postmenopausal; Treatment Outcome; Vitamin D; Vitamin D Deficiency

Cardiovascular Disease (CVD) and related disorders remain a leading cause of health disparities and premature death for African Americans. Hypovitaminosis D is disproportionately prevalent in African Americans and has been linked to CVD and CVD risk factors including hypertension, diabetes and obesity. Thus, hypovitaminosis D may represent a common pathway influencing CV risk factors in a select subgroup of persons. The purpose of this paper is to report the study design of a prospective eight week prospective double-blind randomized, placebo-controlled trial (n = 330 allocated 2:1 to intervention vs. control) to assess the effect of placebo vs. high-dose oral cholecalciferol (100,000 IU vitamin D3 at baseline and week 2) on 6-week change of select biologic cardiometabolic risk factors (including parathyroid hormone to assess biologic activity, pro-inflammatory/pro-thrombotic/fibrotic markers, insulin sensitivity and vitamin D metabolites) and their relationship to vitamin D administration and modification by vitamin D receptor polymorphisms in overweight, hypertensive African Americans with hypovitaminosis D. Findings from this trial will present insights into potential causal links between vitamin D repletion and mechanistic pathways of CV disease, including established and novel genomic markers.

Topics: Black or African American; Cholecalciferol; Cytokines; Double-Blind Method; Humans; Hypertension; Inflammation; Insulin Resistance; Overweight; Parathyroid Hormone; Vitamin D Deficiency; Vitamin D-Binding Protein; Vitamins

Vitamin D deficiency is a common health problem. Vitamin D supplements are used to improve vitamin D status; however, there are contradictory data related to what doses to give and how often they should be given. Many studies have investigated the effects of vitamin D supplementation on muscle strength, but the results remain controversial. We aimed to compare the effects and safety of single high-dose with daily low-dose oral colecalciferol on 25(OH)D levels and muscle strength in postmenopausal women with vitamin D deficiency or insufficiency.. Sixty healthy postmenopausal women who had serum vitamin D levels < 20 ng/mL (50 nmol/L) were enrolled in the study. Group 1 (n = 32) was given daily oral dosages of 800 IU vitamin D3, and group 2 (n = 28) was given a single oral dose of 300,000 IU vitamin D3. Serum vitamin D levels and muscle strengths were measured at the beginning, 4th, and 12th week. Muscle strength tests were performed at 60° using a Biodex system 3 isokinetic dynamometer.. Pretreatment vitamin D levels did not differ between the two groups (10.2 ± 4.4 ng/mL (25,4 ± 10,9 nmol/L); 9.7 ± 4.4 ng/mL (24,2 ± 10,9 nmol/L), p > 0.05). A significant increase in vitamin D levels was observed in both groups at 4 and 12 weeks after vitamin D3 treatment. The increase in the single-dose group was significantly higher than the daily low-dosage group at the 4th week (35.9 ± 9.6 ng/mL (89,6 ± 23,9 nmol/L), 16.9 ± 5.8 ng/mL (42,1 ± 14,4 nmol/L), p = 0.01). The increase in the single-dose group was significantly higher than in the daily low dosage group at the 12th week (23.4 ± 4.7 ng/mL (58,4 ± 11,7 nmol/L), 19.8 ± 7.2 ng/mL (49,4 ± 17,9 nmol/L), p = 0.049). The quadriceps muscle strength score increased significantly in the daily group at the 4th week (p = 0.038). The hamstring muscle strength score increased significantly in the daily group at the 12th week (p = 0.037).. Although daily administration routes are more effective in improving muscle strength, a single administration is more effective in increasing vitamin D levels.. ISRCTN14226530 (04.07.2018), Name of the registry: ISRCTN registry, The study was retrospectively registered.

Topics: Administration, Oral; Aged; Cholecalciferol; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Humans; Middle Aged; Muscle Strength; Postmenopause; Treatment Outcome; Vitamin D; Vitamin D Deficiency

Emerging data supports an association between parathyroid hormone (PTH) and aldosterone. It has been speculated, that potential adverse cardiovascular effects of vitamin D insufficiency may partly be caused by the development of secondary hyperparathyroidism with increased activity of the renin-angiotensin-aldosterone system (RAAS). We aimed to investigate the effect of normalizing vitamin D status and/or reducing PTH levels on RAAS activity and other markers of cardiovascular health.. In a double-blinded study during wintertime, we randomized 81 healthy postmenopausal women with secondary hyperparathyroidism (PTH > 6.9 pmol/l) and 25-hydroxy-vitamin D (25(OH)D) levels < 50 nmol/l to 12 weeks of treatment with vitamin D3 70 µg/day (2800 IU/day) or identical placebo. Markers of cardiovascular health were defined as changes in the plasma RAAS, glycated hemoglobin, lipids, and lipoproteins, blood pressure, vascular stiffness, heart rate, and cardiac conductivity.. Compared to placebo, vitamin D3 treatment significantly increased plasma levels of 25(OH)D and 1,25(OH). Vitamin D3 supplementation normalized vitamin D levels and reduced PTH. The supplement increased levels of HDL, but had no effects on RAAS activity or other indices of cardiovascular health.

Topics: Aged; Aged, 80 and over; Blood Pressure; Cardiovascular System; Cholecalciferol; Double-Blind Method; Female; Heart Rate; Hormone Replacement Therapy; Humans; Hyperparathyroidism; Middle Aged; Treatment Outcome; Vascular Stiffness; Vitamin D Deficiency

To determine the relationship between vitamin D status and exercise performance in a large, prospective cohort study of young men and women across seasons (study 1). Then, in a randomized, placebo-controlled trial, to investigate the effects on exercise performance of achieving vitamin D sufficiency (serum 25(OH)D ≥ 50 nmol·L) by a unique comparison of safe, simulated-sunlight and oral vitamin D3 supplementation in wintertime (study 2).. In study 1, we determined 25(OH)D relationship with exercise performance in 967 military recruits. In study 2, 137 men received either placebo, simulated sunlight (1.3× standard erythemal dose in T-shirt and shorts, three times per week for 4 wk and then once per week for 8 wk) or oral vitamin D3 (1000 IU·d for 4 wk and then 400 IU·d for 8 wk). We measured serum 25(OH)D by high-pressure liquid chromatography tandem mass spectrometry and endurance, strength and power by 1.5-mile run, maximum dynamic lift and vertical jump, respectively.. In study 1, only 9% of men and 36% of women were vitamin D sufficient during wintertime. After controlling for body composition, smoking, and season, 25(OH)D was positively associated with endurance performance (P ≤ 0.01, ΔR = 0.03-0.06, small f effect sizes): 1.5-mile run time was ~half a second faster for every 1 nmol·L increase in 25(OH)D. No significant effects on strength or power emerged (P > 0.05). In study 2, safe simulated sunlight and oral vitamin D3 supplementation were similarly effective in achieving vitamin D sufficiency in almost all (97%); however, this did not improve exercise performance (P > 0.05).. Vitamin D status was associated with endurance performance but not strength or power in a prospective cohort study. Achieving vitamin D sufficiency via safe, simulated summer sunlight, or oral vitamin D3 supplementation did not improve exercise performance in a randomized-controlled trial.

Topics: Adult; Athletic Performance; Cholecalciferol; Dietary Supplements; Exercise; Female; Humans; Male; Military Personnel; Prospective Studies; Seasons; Sunlight; United Kingdom; Vitamin D; Vitamin D Deficiency; Young Adult

To evaluate the efficacy of stoss therapy using fortified biscuit for vitamin D-deficient children.. A total of 108 children aged 30-72 months with vitamin D deficiency were studied in a randomized single-blind clinical trial. The deficient children were assigned to three groups, namely, vitamin D-fortified biscuit (BG), capsule vitamin D (CG), and ampoule vitamin D (AG). Capsules and biscuits containing 50,000 IU of cholecalciferol were consumed twice per week for 3 consecutive weeks. Ampoules with 300,000 IU of cholecalciferol were injected intramuscularly in a single dose. Three weeks after treatment, serum 25(OH)D concentrations were measured, and the three groups were compared.. Each method of treatment could increase the mean serum 25(OH)D concentration to optimal level. Serum 25(OH)D concentrations ≥100 ng/mL were observed in six children, including four from AG and two from CG (P = 0.09). The comparison of the mean serum 25(OH)D concentrations after treatment showed between ampoule and capsule (P = 0.3) and capsule and biscuit (P = 0.62) were insignificant; however, the ampoule and biscuit groups differed significantly (P = 0.012).. Stoss therapy using fortified biscuit may be an effective way to improve compliance in children who cannot take capsules without adverse effects and may also be recommended for prevention purposes.

Topics: Child; Child, Preschool; Cholecalciferol; Cross-Sectional Studies; Female; Food, Fortified; Humans; Male; Single-Blind Method; Vitamin B 12; Vitamin D; Vitamin D Deficiency

The intent of this study was to test the effect of Top-D, a topical Vitamin D preparation, in delivering vitamin D.. Five hundred and fifty healthy patients, with vitamin D insufficiency and deficiency were recruited after written informed consent. Demographic data was recorded, adequate history and clinical examination was done to rule out any metabolic diseases. Complete blood picture, serum calcium, phosphorous, Parathormone and 25 Hydroxy-vitamin D3 (25OHD) was carried out before enrollment of the patients. Patients were divided randomly into two groups 350 in study group and 200 in the control group. Patients in the study group were given Top-D (Vitamin D3 gel made from proniosomal technology) to apply daily on the skin. Top-D 1 g contained 5000 IU of vitamin D3. The control group was given 1 g of Aloe vera gel to be applied every day. The two groups had no knowledge to which group they belong. After 4 months serum 25OHD was tested again.. Three hundred and forty five patients in study group and 192 in control group completed the study. The mean age of the patients in the both the groups was 42 years (18-80 years). The pretreatment 25OHD level in the study group was 11.03 ± 4.57 (2-12) ng/l compared to the control group 10.36 ± 4.09 (2-21) and post treatment the levels were 37.17 ± 6.04 (12-54) ng/ml and 10.51 ± 3.5 (2-19) ng/ml (p < 0.001).. The results of this study indicate that transdermal route of vitamin D is potentially, safe and can give desired results to raise the vitamin D levels. This route is an alternate route for supplementation of vitamin D which should be utilized.

Topics: Administration, Topical; Adult; Aged; Cholecalciferol; Female; Gels; Humans; Male; Middle Aged; Patient Compliance; Treatment Outcome; Vitamin D Deficiency; Vitamins; Young Adult

Topics: Adult; Aged; Cholecalciferol; Community-Acquired Infections; Dietary Supplements; Double-Blind Method; Female; Humans; Length of Stay; Male; Middle Aged; New Zealand; Placebo Effect; Pneumonia; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D insufficiency may be associated with increased risk of upper respiratory tract infection (URTI) in athletes. This study examined the effects of vitamin D₃ supplementation on salivary immune functions and symptoms of URTI in vitamin D-insufficient taekwondo athletes. Twenty-five male taekwondo athletes, aged 19⁻22 years with vitamin D insufficiency [serum 25-hydroxyvitamin-D concentrations (25(OH)D, 31.3 ± 1.39 nmol/L)], participated in this study. They were randomized to receive 5000 IU/day of vitamin D₃ (

Topics: Athletes; Body Composition; Cholecalciferol; Humans; Lactoferrin; Male; Martial Arts; Respiratory Tract Infections; Saliva; Seasons; Vitamin D; Vitamin D Deficiency; Vitamins; Young Adult

Iron deficiency (ID) and vitamin D deficiency (VDD) are significant pediatric health issues in New Zealand and Australia and remain prevalent micronutrient deficiencies in young children globally.. We aimed to investigate the effect of a micronutrient-fortified, reduced-energy growing-up milk (GUMLi) compared with cow milk (CM) consumed for 1 y on dietary iron and vitamin D intakes and the status of New Zealand and Australian children at 2 y of age.. The GUMLi Trial was a multicenter, double-blind, randomized controlled trial in 160 healthy 1-y-old New Zealand and Australian children conducted in 2015-2017. Participants were randomly assigned 1:1 to receive GUMLi (1.7 mg Fe/100 mL; 1.3 µg cholecalciferol/100 mL) or CM (0.02 mg Fe/100 mL; 0.06 µg cholecalciferol/100 mL) for 12 mo. Secondary outcomes, reported here, included change in dietary iron and vitamin D intakes, iron status, and 25-hydroxyvitamin D [25(OH)D] concentrations from blood samples at age 2 y. All regression models were adjusted for baseline outcome and study center.. GUMLi was a large contributor to dietary intakes of iron and vitamin D after 12 mo when compared with intakes from food and CM. The adjusted mean difference between groups for serum ferritin concentrations was 17.8 µg/L (95% CI: 13.6, 22.0 µg/L; P < 0.0001), and for 25(OH)D it was 16.6 nmol/L (95% CI: 9.9, 23.3 nmol/L; P < 0.0001). After 12 mo, ID was present in 16 (24%) participants in the CM group and 5 (7%) participants in the GUMLi group (P = 0.009), and the prevalence of VDD in the CM group increased to 14% (n = 10) and decreased to 3% (n = 2) (P = 0.03) in the GUMLi group.. In comparison with CM, GUMLi significantly improved dietary iron and vitamin D intakes and the iron and vitamin D status of healthy children at 2 y of age. This trial was registered with the Australian New Zealand Clinical Trials Registry (www.anzctr.org.au) as ACTRN12614000918628.

Topics: Anemia, Iron-Deficiency; Animals; Child, Preschool; Cholecalciferol; Diet; Dietary Supplements; Double-Blind Method; Female; Food, Fortified; Humans; Iron; Iron, Dietary; Male; Micronutrients; Milk; Nutritional Status; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D deficiency is highly prevalent among children with epilepsy. Lack of high-quality evidence led to variability among scientific societies recommendations. Therefore, we aim to determine the efficacy of different common doses used in the pediatric practice to maintain optimal 25-hydroxy vitamin D (25 [OH] vitamin D) level in children with epilepsy and normal baseline 25 (OH) vitamin D level over 6 months of supplementation.. This is a protocol for phase IV pragmatic randomized superiority controlled open-label trial at King Saud University Medical City in Riyadh. Children with epilepsy and receiving chronic antiepliptic medication and normal baseline 25 (OH) vitamin D level will be randomly assigned to receive Cholecalciferol 400 IU/day versus 1000 IU/day for 6 months. Our primary outcome is the proportion of children with vitamin D insufficiency (25 (OH) vitamin D level < 75nmol/L) at 6 months. Secondary outcomes include seizure treatment failure, seizure frequency, parathyroid hormone (PTH) levels, bone mineral density, and safety.. Our trial is set out to evaluate the efficacy of common different vitamin D maintenance doses on 25 (OH) vitamin D level, seizure control, and bone health for children with epilepsy. The results of our study will possibly help in shaping current vitamin D guidelines for vitamin D supplementation in children with epilepsy and provide a link between 25 (OH) vitamin D level and seizure control.

Topics: Adolescent; Bone Density; Child; Cholecalciferol; Clinical Protocols; Dietary Supplements; Epilepsy; Female; Humans; Male; Nutritional Status; Parathyroid Hormone; Treatment Outcome; Vitamin D; Vitamin D Deficiency; Vitamins

The aim of the the study is to compare the effects of cholecalciferol and calcitriol on bone mineral metabolism in women with vitamin D deficiency. Calcitriol was associated with a significant increase in bone mineral density at the lumbar spine in patients with low vitamin D levels.. Active vitamin D analogs may have larger impact in decreasing bone loss and fracture rate compared to cholecalciferol in osteoporosis. However, their effects in the treatment of vitamin D deficiency compared to cholecalciferol are not clear. The aim of the present study is to compare the effects of cholecalciferol and calcitriol on bone mineral metabolism and bone mineral density in pre- and postmenopausal women with vitamin D deficiency.. This was a 6-month prospective, open-label, controlled clinical trial. Eligible 120 participants were pre- and postmenopausal women diagnosed with vitamin D deficiency. Forty-three subjects (group 1) received 1000 IU of cholecalciferol and 1 g of calcium daily. The other 77 subjects (group 2) received 0.5 μg calcitriol in addition to 400 IU of cholecalciferol and 1 g of calcium daily.. Oral vitamin D supplementation did not increase bone mineral density after 6 months of intervention in group 1. On the other hand, bone mineral density at the lumbar spine increased from 0.809 ± 0.172 to 0.848 ± 0.161 g/cm. Oral daily calcitriol was associated with a significant increase in bone mineral density at the lumbar spine in patients with low vitamin D, elevated PTH, and osteoporosis.

Topics: Bone Density; Bone Density Conservation Agents; Calcitriol; Calcium; Cholecalciferol; Dietary Supplements; Female; Humans; Lumbar Vertebrae; Middle Aged; Osteoporosis; Prospective Studies; Treatment Outcome; Vitamin D; Vitamin D Deficiency

Obesity and overweight are associated with vitamin D deficiency and hyperhomocysteinemia, all of which are contributing factors for developing cardiovascular disease (CVD). Therefore, we hypothesized that improving serum 25-hydroxyvitamin D [25(OH)D] levels may decrease the body weight and total homocysteine concentrations among overweight reproductive women. To test our hypothesis, a randomized, double-blind placebo-controlled clinical trial, registered under ClinicalTrials.gov Identifier No. NCT03310307, was conducted on 100 overweight reproductive women that were allocated into two groups, namely, the treatment group (n = 50), which received 50 000 IU vitamin D

Topics: Adult; Body Mass Index; Body Weight; Calcium; Cardiovascular Diseases; Cholecalciferol; Double-Blind Method; Female; Homocysteine; Humans; Obesity; Overweight; Parathyroid Hormone; Phosphorus; Vitamin D; Vitamin D Deficiency; Young Adult

Vitamin D is involved in bone metabolism and in many various extra-skeletal diseases such as malabsorption syndromes, cardiovascular and metabolic diseases, cancer, and autoimmune and neurological diseases. However, data on the optimal route of administration are not consistent. The aims of our study were to analyze not only the influence of daily vs. monthly administration of vitamin D on bone metabolism and bone turnover, but also the effects of different routes of administration on fat mass in a cohort of adults with low levels of 25(OH) vitamin D3 at baseline. We analyzed 44 patients with hypovitaminosis at baseline and after six months of two different regimens of administration: seven drops (1750 IU)/day vs. 50,000 IU/month. We found that the two regimens were equivalent; 36 out of 44 patients reached the normal range of vitamin D after six months of treatment. Interestingly, the main determinant of vitamin D at baseline was the waist circumference. In addition, 22 patients treated by monthly regimen were evaluated after 18 months of treatment. At the end of follow-up, patients showed normal levels of vitamin D, with increased calcium levels and decreased bone turnover. Waist circumference also decreased. Our results support the efficacy of vitamin D3 given monthly both for correcting hypovitaminosis and for maintaining vitamin D levels. The relationship between serum 25(OH)vitamin D3 concentration and waist circumference supports vitamin D having a protective role in the current setting, since waist size is directly associated with the risk of cardiovascular and metabolic diseases.

Topics: Adipose Tissue; Aged; Aged, 80 and over; Bone and Bones; Bone Remodeling; Calcifediol; Cholecalciferol; Dietary Supplements; Female; Humans; Male; Vitamin D; Vitamin D Deficiency; Waist Circumference

To compare the adequacy and efficacy of different doses of vitamin D3 in pre-pubertal girls.. Cluster Randomized controlled trial.. Public school in Delhi, India, between August 2015 and February 2016.. 216 healthy pre-pubertal girls, aged 6.1-11.8 years.. Daily supplementation with 600 IU (n=74), 1000 IU (n=67) or 2000 IU (n=75) of vitamin D3 under supervision for 6 months.. Primary: Rise in serum 25 hydroxy Vitamin D (25(OH)D); Secondary: Change in bone formation and resorption markers.. Following 6 months of supplementation, the mean (SD) rise in serum 25(OH)D was maximum with 2000 IU (24.09 (8.28) ng/mL), followed by with 1000 IU (17.96 (6.55) ng/mL) and 600 IU (15.48 (7.00) ng/mL). Serum 25(OH)D levels of ≥20 ng/mL were seen in 91% in 600 IU group , 97% in 1000 IU group and 100% in 2000 IU group. The overall mean (SD) rise in urinary calcium creatinine ratio (0.05 (0.28) to 0.13 (0.12) mg/mg), and serum procollagen type I N-terminal propeptide (538.9 (199.78) to 655.5 (218.24) ng/mL), and reduction in serum carboxy-terminal telopeptide (0.745 (0.23) to 0.382 (0.23) ng/mL) was significant (P<0.01). The change in the above parameters was comparable among the three groups after adjustment for age.. Daily vitamin D supplementation with 600 IU to 2000 IU for 6 months results in Vitamin D sufficiency in >90% of pre-pubertal girls.

Topics: Biomarkers; Bone and Bones; Child; Cholecalciferol; Dietary Supplements; Female; Humans; India; Vitamin D; Vitamin D Deficiency

Accumulating evidence has proposed a correlation between vitamin D (25(OH)D) insufficiency and cardiovascular (CV) disease. Vitamin D associated effects on endothelial function have been suggested to be a possible culprit. The present study investigated the association of vitamin D3 treatment on markers of endothelial dysfunction in patients with arterial hypertension.. The Styrian Vitamin D Hypertension Trial is a double-blind, placebo-controlled, single-centre study conducted at the Medical University of Graz, Austria. A total of 200 study participants with arterial hypertension and 25(OH)D levels below 30ng/mL were enrolled. The study participants were randomized to receive 2800 IU of vitamin D3 per day as oily drops (n=100) or placebo (n=100) for a duration of eight weeks. The present study uses an analysis of covariance (ANCOVA) to investigate the effect of vitamin D3 treatment on symmetric (SDMA) and asymmetric dimethylarginine (ADMA). A total of 187 participants (mean [SD] age 60.0 [11.3] years; 47% women; 25(OH)D 21.2 [5.6]ng/mL; mean systolic blood pressure of 131.4 [8.9] mmHg on a median of 2 antihypertensive drugs) completed the trial. Mean treatment effect was -0.004 (95%CI [-0.03 to 0.04]; P=0.819) on ADMA and 0.001 (95%CI [-0.05 to 0.05]; P=0.850) on SDMA. In the subgroup analysis patients with a 25(OH)D concentration <20ng/mL had a significant increase in their log l-arginine/ADMA ratio (mean treatment effect 18.4 95%CI [1.84-34.9]μmol/L/μmol/L; P=0.030). ClinicalTrials.gov Identifier: NCT02136771 EudraCT number: 2009-018125-70 CONCLUSIONS: Vitamin D3 supplementation in hypertensive patients with low 25-hydroxyvitamin D has no significant effect on ADMA and SDMA.

Topics: Aged; Analysis of Variance; Arginine; Blood Pressure; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Hypertension; Male; Middle Aged; Vitamin D; Vitamin D Deficiency

Falls are a serious health problem in the aging population. Because low levels of vitamin D have been associated with increased fall rates, many trials have been performed with vitamin D; two meta-analyses showed either a small effect or no effect of vitamin D on falls. We conducted a study of the effect of vitamin D on serum 25 hydroxyvitamin D (25OHD) and data on falls was collected as a secondary outcome. In a 12-month double blind randomized placebo trial, elderly women, mean age 66 years, were randomized to one of seven daily oral doses of vitamin D or placebo. The main inclusion criterion for study was a baseline serum 25OHD<20ng/ml (50nmol/L). A history of falls was collected at baseline and fall events were collected every 3 months. Results showed that the effect of vitamin D on falls followed a U-shaped curve whether analyzed by dose or serum 25OHD levels. There was no decrease in falls on low vitamin D doses 400, 800 IU, a significant decrease on medium doses 1600, 2400,3200 IU (p=0.020) and no decrease on high doses 4000, 4800 IU compared to placebo (p=0.55). When compared to 12-month serum 25OHD quintiles, the faller rate was 60% in the lowest quintile <25ng/ml (<50nmol/L), 21% in the low middle quintile 32-38ng/ml (80-95nmo/L), 72% in the high middle quintile 38-46ng/ml (95-115nmo/L) and 45% in the highest quintile 46-66ng/ml (115-165nmol/L). In the subgroup with a fall history, fall rates were 68% on low dose, 27% on medium doses and 100% on higher doses. Fall rates on high doses were increased compared to medium doses (Odds Ratio 5.6.95% CI: 2.1-14.8). In summary, the maximum decrease in falls corresponds to a 12- month serum 25OHD of 32-38ng/ml (80-95nmol/L) and faller rates increase as serum 25OHD exceed 40-45ng/ml (100-112.5nmol/L). The Tolerable upper limit (TUL) recently increased in 2010 from 2000 to 4000 IU/day may need to be reduced in elderly women especially in those with a fall history.

Topics: Accidental Falls; Aged; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Middle Aged; Vitamin D; Vitamin D Deficiency; Vitamins

To assess the efficacy and safety of a single cholecalciferol loading protocol in nursing home (NH) residents taking no VitD supplementation at regular basis.. Randomized single-blind controlled study.. One NH.. All residents.. From March 21st to May 19th, 2015, NH residents were randomly assigned to either 4x100'000IU to be taken every 2 weeks (treatment group) or an individualized regimen according to baseline 25(OH)VitD level (control group).. 25(OH)VitD, calcium, phosphorus, parathyroid hormone, alkaline phosphatase, and creatinine serum levels were centrally measured at day 7 after the last dose in both groups, and at baseline in the control group.. 111 residents (mean age 85.1±6.7 years) were randomized to the treatment (N=53) or the control group (N=58). No significant difference in terms of demographic characteristics, risk for osteoporosis, and past history of VitD supplementation was measured. At baseline, 37.9%, 25.5% and 5.2% were respectively sub-optimal, insufficient, and deficient for VitD. Whatever the study group, at the 7th day after the last dose of cholecalciferol, 100% of residents reached serum values ≥20ng/mL (p value for non-inferiority <0.001 and p value for superiority p=1.00) and 93.6 vs. 88.2% reached values ≥30ng/mL in the treatment and control group respectively (p value for non-inferiority <0.01 and p value for superiority p=0.48). While mean value was higher in the treatment group (50.2±615.4 vs. 35.8±66.5ng/mL; p<0.0001), none of participants have seen their value >150 ng/mL. Not any biological adverse effects was measured.. This study confirmed that a single loading protocol is at least as effective and safe as tailored regimen in terms of the ability to rapidly normalize 25(OH)VitD values. The often required dosage of 25(OH)VitD is reasonably not necessary to initiate VitD supplementation protocol in this vulnerable population.

Topics: Aged; Aged, 80 and over; Alkaline Phosphatase; Calcifediol; Calcium; Cholecalciferol; Creatinine; Dietary Supplements; Female; Humans; Male; Middle Aged; Nursing Homes; Parathyroid Hormone; Phosphorus; Single-Blind Method; Vitamin D Deficiency

Vitamin D is important for bone mass accrual during growth. Additionally, it is considered a requirement for a multitude of processes associated with, for example, the development of immunity. Many countries apply vitamin D supplementation strategies in infants, but the guidelines are not based on scientific evidence and aim at prevention of rickets. It remains unclear whether the recommended doses are sufficient for the wide array of other effects of vitamin D. The VIDI trial performed in Finland is the first large randomised controlled study for evaluation of the effects of different vitamin D supplemental doses in infancy on: 1. bone strength 2. infections and immunity 3. allergy, atopy and asthma 4. cognitive development 5. genetic regulation of mineral homeostasis METHODS/DESIGN: VIDI, a randomised controlled double-blinded single-centre intervention study is conducted in infants from the age of 2 weeks to 24 months. Participants, recruited at Helsinki Maternity Hospital, are randomised to receive daily either 10 μg (400 IU) or 30 μg (1 200 IU) of vitamin D3 supplementation. Both groups are assessed at 6 months of age for calcium homeostasis, and at 12 and 24 months of age for parameters associated with bone strength, growth, developmental milestones, infections, immunity, atopy-related diseases, and genetic factors involved in these functions.. The study enables evaluation of short and long term effects of supplemental vitamin D on growth, immune functions and skeletal and developmental parameters in infants, and the effects of genetic factors therein. The results enable institution of evidence-based guidelines for vitamin D supplementation in infancy.. ClinicalTrials.gov, NCT01723852 , registration date 6.11.2012.

Topics: Bone Development; Child Development; Child, Preschool; Cholecalciferol; Clinical Protocols; Dietary Supplements; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Evidence-Based Medicine; Female; Humans; Immune System; Infant; Infant, Newborn; Male; Treatment Outcome; Vitamin D Deficiency; Vitamins

Multiple Sclerosis is associated with deficient serum 25 hydroxyvitamin D (25 (OH)D) level and cognitive impairment. The aim of this study is to evaluate cognitive performance in MS patients with deficient 25 (OH)D (<25 ng/ml) compared to patients with sufficient levels (>35 ng/ml), then to evaluate the change in cognitive performance after 3 months of vitamin D3 oral replacement. Eighty-eight MS patients with relapsing remitting and clinically isolated type of MS, older than 18 years treated with interferon beta were enrolled. Cognitive testing was performed at baseline and at 3 months using the Montreal Cognitive Assessment (MoCA), Stroop, Symbol Digit Modalities (SDMT) and Brief Visuospatial Memory Test (BVMT-R). Serum 25 (OH)D was measured at baseline and at the end of the study. Vitamin D3 replacement improved the MS patients' cognitive performance after 3 months on the MoCA and BVMT-Delayed Recall (DR). Sufficient serum 25 (OH)D level predicted better cognitive performance on the BVMT-DR at baseline (β: 1.74, p: <0.008) and 3 months (β: 1.93, p: <0.01) after adjusting for all measured confounding variables. Vitamin D

Topics: Adult; Calcifediol; Cholecalciferol; Cognition; Female; Humans; Male; Middle Aged; Multiple Sclerosis; Multivariate Analysis; Neuropsychological Tests; Prospective Studies; Quality of Life; Vitamin D Deficiency; Vitamins; Young Adult

Obesity is associated not only with an array of metabolic disorders (e.g. insulin resistance, hiperinsulinemia, impaired tolerance of glucose, lipid disorders) but also skeletal and joint abnormalities. Recently, a pleiotropic role of vitamin D has been emphasized. Obese children frequently present with vitamin D deficiency, and greater fat mass is associated with lower serum concentration of this vitamin. Although some evidence suggests that weight loss may affect vitamin D status, this issue has not been studied extensively thus far. The aim of a double-blind placebo-controlled study is to assess long-term health effects of vitamin D supplementation in vitamin D deficient obese children participating in an integrated weight-loss programme.. A randomized double-blind, placebo-controlled trial analysing the effects of vitamin D3 supplementation in overweight or obese vitamin D deficient (<30 ng/ml) children participating in an integrated weight-loss programme. Children are randomized to receive either vitamin D (1200 IU) or placebo for 26 weeks. Primary endpoints include changes in BMI (body mass index), body composition and bone mineral density at the end of the study period, and secondary endpoints - the changes in laboratory parameter reflecting liver and kidney function (transaminases, creatinine) and glucose homeostasis (glucose and insulin levels during oral glucose tolerance test).. The effects of vitamin D supplementation in obese individuals, especially children, subjected to a weight-loss program are still poorly understood. Considering physiological processes associated with puberty and adolescent growth, we speculate that supplementation may enhance weight reduction and prevent bone loss in obese children deficient in this vitamin.. NCT 02828228 ; Trial registration date: 8 Jun 2016; Registered in: ClinicalTrials.gov. The trial was registered retrospectively.

Topics: Adolescent; Child; Cholecalciferol; Clinical Protocols; Dietary Supplements; Double-Blind Method; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Male; Pediatric Obesity; Treatment Outcome; Vitamin D Deficiency; Vitamins; Weight Reduction Programs

Cohort studies have reported increased incidence of cardiovascular disease (CVD) among individuals with low vitamin D status. To date, randomized clinical trials of vitamin D supplementation have not found an effect, possibly because of using too low a dose of vitamin D.. To examine whether monthly high-dose vitamin D supplementation prevents CVD in the general population.. The Vitamin D Assessment Study is a randomized, double-blind, placebo-controlled trial that recruited participants mostly from family practices in Auckland, New Zealand, from April 5, 2011, through November 6, 2012, with follow-up until July 2015. Participants were community-resident adults aged 50 to 84 years. Of 47 905 adults invited from family practices and 163 from community groups, 5110 participants were randomized to receive vitamin D3 (n = 2558) or placebo (n = 2552). Two participants retracted consent, and all others (n = 5108) were included in the primary analysis.. Oral vitamin D3 in an initial dose of 200 000 IU, followed a month later by monthly doses of 100 000 IU, or placebo for a median of 3.3 years (range, 2.5-4.2 years).. The primary outcome was the number of participants with incident CVD and death, including a prespecified subgroup analysis in participants with vitamin D deficiency (baseline deseasonalized 25-hydroxyvitamin D [25(OH)D] levels <20 ng/mL). Secondary outcomes were myocardial infarction, angina, heart failure, hypertension, arrhythmias, arteriosclerosis, stroke, and venous thrombosis.. Of the 5108 participants included in the analysis, the mean (SD) age was 65.9 (8.3) years, 2969 (58.1%) were male, and 4253 (83.3%) were of European or other ethnicity, with the remainder being Polynesian or South Asian. Mean (SD) baseline deseasonalized 25(OH)D concentration was 26.5 (9.0) ng/mL, with 1270 participants (24.9%) being vitamin D deficient. In a random sample of 438 participants, the mean follow-up 25(OH)D level was greater than 20 ng/mL higher in the vitamin D group than in the placebo group. The primary outcome of CVD occurred in 303 participants (11.8%) in the vitamin D group and 293 participants (11.5%) in the placebo group, yielding an adjusted hazard ratio of 1.02 (95% CI, 0.87-1.20). Similar results were seen for participants with baseline vitamin D deficiency and for secondary outcomes.. Monthly high-dose vitamin D supplementation does not prevent CVD. This result does not support the use of monthly vitamin D supplementation for this purpose. The effects of daily or weekly dosing require further study.. clinicaltrials.gov Identifier: ACTRN12611000402943.

Topics: Aged; Aged, 80 and over; Angina Pectoris; Arrhythmias, Cardiac; Arteriosclerosis; Cardiovascular Diseases; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Heart Failure; Humans; Hypertension; Male; Middle Aged; Myocardial Infarction; New Zealand; Proportional Hazards Models; Stroke; Venous Thrombosis; Vitamin D Deficiency; Vitamins

The prevalence of Vitamin D deficiency is increasing worldwide, which has be shown to be associated with increased risk of cardiovascular disease (CVD), autoimmune disease, and metabolic syndrome. These conditions are also associated with a heightened state of inflammation. The aim of the current study was to evaluate the effect of vitamin D supplementation on serum C-Reactive Protein (CRP) level and Neutrophil-to-lymphocyte ratio (NLR) distribution in a large cohort of adolescent girls. A total of 580 adolescent girls were recruited follow by evaluation of CRP and hematological parameters before and after supplementation with vitamin D supplements as 9 of 50000 IU cholecalciferol capsules for 9 weeks taken at weekly intervals. At baseline, serum hs-CRP level was 0.9 (95%CI: 0.5-1.8), while this value after intervention was reduced to 0.8 (95%CI: 0.3-1.6; P = 0.007). Similar results were also detected for NLR (e.g., NLR level was 1.66 ± 0.72 and 1.53 ± 0.67, P = 0.002, before and after therapy with compliance rate of >95.2%). Moreover, we found an association between hs-CRP and BMI, triglyceride, white blood cell count, and lymphocytes. Interestingly we observed a significant reduction in neutrophil count and CRP level after high dose vitamin D supplementation. Our findings showed that the high dose supplementation of vitamin D affects measures of systemic inflammation: reductions in High Sensitivity C-Reactive Protein level and Neutrophil-to-lymphocyte ratio (NLR) distribution. J. Cell. Biochem. 118: 4317-4322, 2017. © 2017 Wiley Periodicals, Inc.

Topics: Adolescent; Body Mass Index; C-Reactive Protein; Child; Cholecalciferol; Female; Follow-Up Studies; Humans; Inflammation; Lymphocyte Count; Triglycerides; Vitamin D; Vitamin D Deficiency

Vitamin D3 (cholecalciferol) dose required to maintain sufficiency in non- Caucasian women with postmenopausal osteoporosis (PMO) inthe tropics has not been well studied. Some guidelines mandate 800-1000 IU vitamin D/day but the Endocrine Society (US) advocates 1500-2000 IU/day to maintain 25-hydroxyvitamin-D (25(OH)D) concentration at >75 nmol/L. We aimed to establish oral cholecalciferol dose required to maintain 25(OH)D concentration at >75 nmol/L in PMO Chinese Malaysian women, postulating lower dose requirements amongst light-skinned subjects in the tropics.. 90 Chinese Malaysian PMO women in Kuala Lumpur, Malaysia (2°30'N) with baseline serum 25(OH)D levels >=50 nmol/L were recruited. Prior vitamin D supplements were discontinued and subjects randomized to oral cholecalciferol 25,000 IU/4-weekly (Group-A) or 50,000 IU/4-weekly (Group- B) for 16 weeks, administered under direct observation. Serum 25(OH)D, PTH, serum/urinary calcium were measured at baseline, 8 and 16 weeks.. Baseline characteristics, including osteoporosis severity, sun exposure (~3 hours/week), and serum 25(OH)D did not differ between treatment arms. After 16 weeks, 91% of women sufficient at baseline, remained sufficient on 25,000 IU/4-weekly compared with 97% on 50,000 IU/4-weekly with mean serum 25(OH)D 108.1±20.4 and 114.7±18.4 SD nmol/L respectively (p=0.273). At trial's end, 39% and 80% of insufficient women at baseline attained sufficiency in Group A and Group B (p=0.057). Neither dose was associated with hyperparathyroidism or toxicity.. Despite pretrial vitamin D supplementation and adequate sun exposure, 25.6% Chinese Malaysian PMO women were vitamin D insufficient indicating sunshine alone cannot ensure sufficiency in the tropics. Both ~900 IU/day and ~1800 IU/day cholecalciferol can safely maintain vitamin D sufficiency in >90% of Chinese Malaysian PMO women. Higher doses are required with baseline concentration <75 nmol/L.

Topics: Aged; Asian People; Calcium; China; Cholecalciferol; Dietary Supplements; Dose-Response Relationship, Drug; Female; Humans; Malaysia; Middle Aged; Osteoporosis, Postmenopausal; Sunlight; Tropical Climate; Vitamin D; Vitamin D Deficiency

The aim of this study was to investigate the effects of vitamin D (VD) on the interaction among functional, echocardiographic and hormonal parameters in patients with heart failure (HF) and VD deficiency.. In a randomized, double blind trial, 35 patients with HF and VD<20 ng/mL, received either 300,000 U of oral cholecalciferol followed by 50,000 U/month for 6 months, or placebo treatment.. Changes in the 6 Minute Walking Test (6MWT) assessed at 3 and 6 months in treatment group was the primary end point. Secondary endpoints were echocardiographic and hormonal changes. The same targets were compared in treated and placebo groups as secondary endpoints. In the treatment group the 6MWT improved at 3 (from 210±104 mt to 225±94 mt; P=0.033) but not at 6 months (from 210±104 mt to 217±94 mt; P=0.288) while PTH dropped at 3 (from 76.8±50.5 to 50.2±20.3 pg/mL; P=0.025), but not at 6 months. 6MWT improvement was negatively related to baseline VD levels. Variation in 6MWT did not significantly differ among groups at 3 (13.6±23.3 vs. 3.6±17.3; P 0.175) and 6 months (12.1±31.4 vs. 0.2±23.2; P 0.225). Left atrial size increased in the placebo group (from 50.8±20.7 to 61.7±36.0 mL/m2; P=0.010). Other hormonal parameters remained unchanged.. In summary, the treatment of VD deficiency in patients with HF improved 6MWT after 3 months along with a decrease in PTH levels. However when compared with the placebo arm, treatment of VD deficiency did not influence the final outcomes.

Topics: Aged; Aged, 80 and over; Cholecalciferol; Dietary Supplements; Double-Blind Method; Echocardiography; Exercise Test; Female; Follow-Up Studies; Heart Failure; Humans; Male; Pilot Projects; Time Factors; Treatment Outcome; Vitamin D Deficiency

Single-nucleotide polymorphisms (SNPs) in genes related to vitamin D metabolism have been associated with serum 25-hydroxyvitamin D [25(OH)D] concentration, but these relationships have not been examined following antenatal cholecalciferol supplementation.. To determine whether SNPs in DHCR7, CYP2R1, CYP24A1, and GC are associated with the response to gestational cholecalciferol supplementation.. Within-randomization group analysis of the Maternal Vitamin D Osteoporosis Study trial of antenatal cholecalciferol supplementation.. Hospital antenatal clinics.. In total, 682 women of white ethnicity (351 placebo, 331 cholecalciferol) were included. SNPs at rs12785878 (DHCR7), rs10741657 (CYP2R1), rs6013897 (CYP24A1), and rs2282679 (GC) were genotyped.. 1000 IU/d cholecalciferol from 14 weeks of gestation until delivery.. 25(OH)D at randomization and 34 weeks of gestation were measured in a single batch (Liaison; Diasorin, Dartford, UK). Associations between 25(OH)D and the SNPs were assessed by linear regression using an additive model [β represents the change in 25(OH)D per additional common allele].. Only rs12785878 (DHCR7) was associated with baseline 25(OH)D [β = 3.1 nmol/L; 95% confidence interval (CI), 1.0 to 5.2 nmol/L; P < 0.004]. In contrast, rs10741657 (CYP2R1) (β = -5.2 nmol/L; 95% CI, -8.2 to -2.2 nmol/L; P = 0.001) and rs2282679 (GC) (β = 4.2 nmol/L; 95% CI, 0.9 to 7.5 nmol/L; P = 0.01) were associated with achieved 25(OH)D status following supplementation, whereas rs12785878 and rs6013897 (CYP24A1) were not.. Genetic variation in DHCR7, which encodes 7-dehyrocholesterol reductase in the epidermal vitamin D biosynthesis pathway, appears to modify baseline 25(OH)D. In contrast, the response to antenatal cholecalciferol supplementation was associated with SNPs in CYP2R1, which may alter 25-hydroxylase activity, and GC, which may affect vitamin D binding protein synthesis or metabolite affinity.

Topics: Adult; Alleles; Cholecalciferol; Cholestanetriol 26-Monooxygenase; Cytochrome P450 Family 2; Dietary Supplements; Double-Blind Method; Female; Genotype; Humans; Linear Models; Multivariate Analysis; Oxidoreductases Acting on CH-CH Group Donors; Polymorphism, Single Nucleotide; Pregnancy; Treatment Outcome; Vitamin D; Vitamin D Deficiency; Vitamin D-Binding Protein; Vitamin D3 24-Hydroxylase; Vitamins; Young Adult

Bipolar depression is difficult to treat. Vitamin D supplementation is well tolerated and may improve mood via its neurotransmitter synthesis regulation, nerve growth factor enhancement and antioxidant properties. Vitamin D adjunct reduces unipolar depression, but has not been tried in bipolar depression.. 18-70yos with DSM IV bipolar depression and Vitamin D deficiency (<30 ng/ml) were randomized in a controlled double blind trial of 5000IU Vitamin D. 16 VitD vs 17 placebo subjects did not differ in baseline characteristics (mean = 44 yo, SD = 13), VitD level (19.2 ± 65.8  g/ml vs 19.3 ± 5.5 ng/ml respectively) or mood ratings (MADRS 21.3 ± 6.4 vs 22.8 ± 6.9 respectively). At 12wks, the placebo group VitD levels remained unchanged, while the VitD group levels increased to 28 ng/ml. MADRS score decreased significantly in both placebo (mean = 6.42 (95% CI [2.28 to 10.56]) and VitD groups (mean = 9.54 (95% CI[3.51 to 15.56]) (p = 0.031), but there were no differences between treatment groups (time by treatment interaction estimate: 0.29, t. In this small study, despite a greater rise in Vitamin D levels in the VitD supplementation group, there was no significant difference reduction in depressive symptoms. However both groups' VitD levels remained deficient. Vitamin D

Topics: Adolescent; Adult; Affect; Aged; Anxiety; Bipolar Disorder; Cholecalciferol; Comorbidity; Dietary Supplements; Double-Blind Method; Female; Humans; Male; Middle Aged; Outcome Assessment, Health Care; Vitamin D Deficiency; Young Adult

Low 25-hydroxyvitamin D (25OHD) levels (< 75 nmol/l) are inversely associated with anemia prevalence. Since anemia and low 25OHD levels are common in patients with heart failure (HF), we aimed to investigate whether vitamin D supplementation can reduce anemia prevalence in advanced HF.. EVITA (Effect of Vitamin D on Mortality in Heart Failure) is a randomized, placebo-controlled clinical trial in patients with initial 25OHD levels < 75 nmol/l. Participants received either 4000 IU vitamin D. In the vitamin D and placebo group, baseline proportions of patients with anemia (Hb < 12.0 g/dL in females and < 13.0 g/dL in males) were 17.2% and 10.6%, respectively (P = 0.19). At study termination, the proportion of patients with anemia in the vitamin D and placebo groups was 32.2% and 31.8%, respectively (P > 0.99). There was no between-group difference in change in the Hb concentrations (- 0.04 g/dL [95%CI:-0.53 to 0.45 g/dL]; P = 0.87). Results regarding anemia risk and Hb concentrations were similar in the subgroup of patients with chronic kidney disease (vitamin D group: n = 26; placebo group: n = 23). Moreover, results did not differ substantially when data analysis was restricted to patients with deficient baseline 25OHD levels.. A daily vitamin D supplement of 4000 IU did not reduce anemia prevalence in patients with advanced HF. Data challenge the clinical relevance of vitamin D supplementation to increase Hb levels.. The study was registered at EudraCT (No. 2010-020793-42) and clinicaltrials.gov ( NCT01326650 ).

Topics: Anemia; Cholecalciferol; Dietary Supplements; Female; Heart Failure; Hemoglobins; Humans; Male; Middle Aged; Placebos; Vitamin D; Vitamin D Deficiency

In this post hoc analysis of the VITdAL-ICU study, an RCT in critically ill adults with 25-hydroxyvitamin D levels ≤20 ng/ml, vitamin D3 did not have a significant effect on β-Crosslaps and osteocalcin.. Observational studies have shown accelerated bone loss in ICU survivors. A reversible contributor is vitamin D deficiency. In a post hoc analysis of the VITdAL-ICU study, we evaluated the effect of high-dose vitamin D3 on the bone turnover markers (BTM) β-Crosslaps (CTX) and osteocalcin (OC).. The VITdAL-ICU study was a randomized, double-blind, placebo-controlled trial in critically ill adults with 25-hydroxyvitamin D levels ≤20 ng/ml who received placebo or high-dose vitamin D3 (a loading dose of 540,000 IU and starting 1 month after the loading dose five monthly maintenance doses of 90,000 IU). In this analysis on 289 survivors (209 telephone, 80 personal follow-up visits), BTM were analyzed on days 0, 3, 7, 28, and 180; self-reported falls and fractures were assessed. Bone mineral density (BMD) was measured after 6 months.. At baseline, CTX was elevated; OC was low in both groups-after 6 months, both had returned to normal. There were no differences between groups concerning BTM, BMD, falls, or fractures. In linear mixed effects models, CTX and OC showed a significant change over time (p < 0.001, respectively), but there was no difference between the vitamin D and placebo group (p = 0.688 and p = 0.972, respectively).. Vitamin D supplementation did not have a significant effect on BTM. Further studies should assess the effectiveness of vitamin D on musculoskeletal outcomes in ICU survivors.

Topics: Aged; Bone Density; Bone Density Conservation Agents; Bone Remodeling; Cholecalciferol; Collagen; Critical Illness; Double-Blind Method; Female; Follow-Up Studies; Humans; Intensive Care Units; Male; Middle Aged; Osteocalcin; Peptide Fragments; Vitamin D; Vitamin D Deficiency

Vitamin D has significant immunomodulatory effects on both adaptive and innate immune responses. Observational studies indicate that adults infected with HIV with low vitamin D status may be at increased risk of mortality, pulmonary tuberculosis, and HIV disease progression. Growing observational evidence also suggests that low vitamin D status in pregnancy may increase the risk of adverse birth and infant health outcomes. As a result, antiretroviral therapy (ART) adjunct vitamin D. The Trial of Vitamins-5 (ToV5) is an individually randomized, double-blind, placebo-controlled trial of maternal vitamin D. The ToV5 will provide causal evidence on the effect of vitamin D. ClinicalTrials.gov identifier: NCT02305927 . Registered on 29 October 2014.

Topics: Age Factors; Anti-HIV Agents; Birth Weight; Child Development; Cholecalciferol; Clinical Protocols; Dietary Supplements; Double-Blind Method; Female; HIV Infections; Humans; Infant; Infant, Newborn; Infant, Small for Gestational Age; Maternal Health; Maternal Health Services; Maternal Mortality; Pregnancy; Pregnancy Complications, Infectious; Research Design; Tanzania; Time Factors; Treatment Outcome; Vitamin D Deficiency

The pivotal role of vitamin D (vit D) in skeletal health is well known. Neonatal vit D storage at birth is dependent on maternal levels, and newborns receive 50-70% of their mother's 25-hydroxyvitamin D [25(OH)D]. Deficiency of vit D can lead to prematurity bone disease, with an incidence of up to 55% in infants weighing < 1000 g. The aim of this study is to assess the effectiveness of monitored supplementation of vit D in a population of preterm infants.. Preterm infants born at 24-32 weeks of gestation will be recruited within the first 7 days of life. Depending on the type of feeding, and after reaching partial enteral feeding or at 7 days of life, vit D supplementation will consist of 500 IU and an additional 150-300 IU/kg included in human milk fortifiers (if fed exclusively with breast milk) or 190 IU/kg in milk formulas. Subjects will be randomised to either monitored (with an option of dose modification based on 25(OH)D levels as per protocol) or standard therapy up to 52 weeks of post-conceptional age (PCA). The primary outcome measure will be the number of neonates with deficiency or excess levels of 25(OH)D at 40  ±2 weeks of PCA. Additional 25(OH)D levels will be measured at birth, at 4 and 8 weeks of age, and/or at 35 and 52  ±2 weeks of PCA. Secondary objectives will include the incidence of osteopenia, nephrocalcinosis and nephrolithiasis. Serum parameters of calcium phosphorus metabolism will also be measured.. Despite multiple years of research and numerous publications, there is still a lack of consensus in regard to how much vit D infants should receive and how long they should receive it. Because 80% of calcium and phosphorus placental transfer occurs between 24 and 40 weeks of gestation, preterm infants are especially prone to adverse effects of vit D insufficiency. However, both inadequate and excessive amounts of vit D may be unsafe and lead to serious health issues. The results of our study may shed new light on these concerns and contribute to optimising vit D supplementation.. ClinicalTrials.gov, NCT03087149 . Registered on 15 March 2017.

Topics: Biomarkers; Bone Diseases, Metabolic; Cholecalciferol; Clinical Protocols; Dietary Supplements; Gestational Age; Humans; Incidence; Infant; Infant, Newborn; Infant, Premature; Nephrocalcinosis; Nephrolithiasis; Poland; Premature Birth; Research Design; Time Factors; Treatment Outcome; Vitamin D; Vitamin D Deficiency

Although vitamin D is well known for its function in calcium homeostasis and bone mineralization, several studies have shown positive effects on muscle strength and physical function. In addition, vitamin D has been associated with pulmonary function and the incidence of airway infections. As vitamin D deficiency is highly prevalent in chronic obstructive pulmonary disease (COPD) patients, supplementation might have a beneficial effect in these patients.. To assess the effect of vitamin D supplementation on respiratory muscle strength and physical performance in vitamin D-deficient COPD patients. Secondary outcomes are pulmonary function, handgrip strength, exacerbation rate, and quality of life.. We performed a randomized, double-blind, placebo-controlled pilot trial. Participants were randomly allocated to receive 1,200 IU vitamin D3 per day (n=24) or placebo (n=26) during 6 months. Study visits were conducted at baseline, and at 3 and 6 months after randomization. During the visits, blood was collected, respiratory muscle strength was measured (maximum inspiratory and expiratory pressure), physical performance and 6-minute walking tests were performed, and handgrip strength and pulmonary function were assessed. In addition, participants kept a diary card in which they registered respiratory symptoms.. At baseline, the mean (standard deviation [SD]) serum 25-hydroxyvitamin D (25(OH)D) concentration (nmol/L) was 42.3 (15.2) in the vitamin D group and 40.6 (17.0) in the placebo group. Participants with vitamin D supplementation had a larger increase in serum 25(OH)D compared to the placebo group after 6 months (mean difference (SD): +52.8 (29.8) vs +12.3 (25.1),. Vitamin D supplementation did not affect (respiratory) muscle strength or physical performance in this pilot trial in vitamin D-deficient COPD patients.

Topics: Adult; Aged; Biomarkers; Cholecalciferol; Dietary Supplements; Disease Progression; Double-Blind Method; Drug Administration Schedule; Exercise Tolerance; Female; Hand Strength; Humans; Lung; Male; Middle Aged; Muscle Strength; Netherlands; Pilot Projects; Pulmonary Disease, Chronic Obstructive; Quality of Life; Recovery of Function; Respiratory Muscles; Time Factors; Treatment Outcome; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D deficiency is common in children with neurodisabilities. Oral vitamin D3 may not be absorbed appropriately due to dysphagia and tube feeding. The aim of this study was to compare efficacy of vitamin D3 buccal spray with that of oral drops.. Twenty-four children with neurodisabilities (5-17 years) and vitamin D deficiency (25(OH)D ≤20 ng/mL) were randomized to receive vitamin D3 buccal spray 800 IU/daily (n = 12) or oral drops 750 IU/daily (n = 12) for 3 months during winter.. Both groups had a significant increase in 25(OH)D (z = 150; p < 0.0001). The differences between baseline and final parathyroid hormone measurements did not reach significance in both groups. Markers of bone formation and resorption did not change significantly in both groups. The satisfaction with the formulation was significantly higher in the patients using spray.. Vitamin D3 supplementation with buccal spray and oral drops are equally effective in short-term treatment of vitamin D deficiency in children with neurodisabilities. Buccal spray may be more acceptable by the patients.

Topics: Adolescent; Cerebral Palsy; Child; Child, Preschool; Cholecalciferol; Dietary Supplements; Drug Delivery Systems; Epilepsy; Female; Humans; Male; Treatment Outcome; Vitamin D Deficiency

To determine how long vitamin D lasts after supplementation ceases, the marker of status was measured 2 and 3 years after a 1-year trial. Compared to placebo, the proportion of vitamin D-deficient women was still lower, if they had taken daily vitamin D3, after 2 years, indicating its longevity.. The purpose of this study was to determine longevity of vitamin D status following cessation of vitamin D3 supplementation, 2 and 3 years after a 1-year randomised, double-blind placebo controlled trial and to investigate possible predictive factors.. Caucasian non-smoking postmenopausal women randomised to ViCtORY (2009-2010), who had not taken vitamin D supplements since the trial ended, were invited to attend follow-up visits. Total 25-hydroxyvitamin D (25OHD) and 24,25-dihydroxyvitamin D (24,25OH2D) were measured by dual tandem mass spectrometry of serum samples following removal of protein and de-lipidation; the original randomised controlled trial (RCT) samples were re-analysed simultaneously. Vitamin D-binding protein (VDBP) was measured by monoclonal immunoassay.. In March 2012 and March 2013, 159 women (mean (SD) age 67.6 (2.1) years) re-attended, equally distributed between the original treatment groups: daily vitamin D3 (400 IU, 1000 IU) and placebo. One month after the RCT ended (March 2010), the proportion of women in placebo, 400 IU and 1000 IU vitamin D3 groups, respectively, with 25OHD < 25 nmol/L was 15, 0 and 0 (chi-square p < 0.001, n = 46, 44, 54). After 2 years (March 2012), it was 22, 4 and 4% (p = 0.002, n = 50, 48, 57); after 3 years, it was 23, 13 and 15% (p = 0.429, n = 48, 45, 52). The respective proportions of women with 24,25OH2D < 2.2 nmol/L were 50, 2 and 2% (1 month, p < 0.001, n = 46, 44, 54); 42, 33 and 12% (2 years, p = 0.002, n = 50, 48, 57); and 45, 27 and 29% (3 years, p = 0.138, n = 47, 45, 51). VDBP was a predictor of circulating 25OHD longevity (beta for VDBP in μg/mL 0.736; 95% CI 0.216-1.255, p = 0.006) but not 24,25OH2D.. Four hundred international units or 1000 IU of daily vitamin D3 showed benefits over placebo 2 years after supplementation ceased in keeping 25OHD > 25 nmol/L.

Topics: Administration, Oral; Aged; Cholecalciferol; Diet; Dietary Supplements; Double-Blind Method; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Middle Aged; Postmenopause; Sunlight; Tandem Mass Spectrometry; Vitamin D; Vitamin D Deficiency; Withholding Treatment

This study examined the effects of weekly 35,000 IU vitamin D supplementation for 4 weeks on bone turnover markers (BTMs). There was improvement in the levels of parathyroid hormone (PTH), osteocalcin, and carboxy-terminal telopeptides of crosslinks of type 1 collagen (βCTX) which paralleled the increase in vitamin D levels.. The effects of vitamin D supplementation on bone turnover markers (BTMs) have been inconsistent. This study examined the effects of weekly 35,000 IU vitamin D supplementation for 1 month on BTMs.. Sixty-eight vitamin D deficient adolescent females were given 35,000 IU of vitamin D3 for 4 weeks. Pre and post intervention blood samples were taken for 25(OH) D, PTH, osteocalcin and βCTX.. There was a significant increase in serum 25 (OH) D in the post intervention period which was accompanied by a significant decrease in PTH, osteocalcin and βCTX (P < 0.001).. We concluded that weekly 35,000 IU vitamin D supplementation for 4 weeks results in significant improvement of BTMs.

Topics: Adolescent; Adolescent Health Services; Biomarkers; Bone Remodeling; Cholecalciferol; Collagen Type I; Dietary Supplements; Drug Administration Schedule; Female; Humans; Osteocalcin; Parathyroid Hormone; Peptides; Saudi Arabia; Surveys and Questionnaires; Vitamin D Deficiency

We investigated the daily dose of vitamin D needed to achieve serum 25-hydroxyvitamin D [25(OH)D] sufficiency among schoolchildren at risk for deficiency.. The Daily D Health Study was a randomized double-blind vitamin D supplementation trial among racially/ethnically diverse schoolchildren (n = 685) in the northeastern United States. Children were supplemented with vitamin D3 at 600, 1000, or 2000 IU/d for 6 months. Measurements included serum 25(OH)D at baseline (October to December), 3 months (January to March), 6 months (April to June), and 12 months (6 months after supplementation).. At baseline, mean ± standard deviation serum 25(OH)D level was 22.0 ± 6.8 ng/mL, with 5.5% severely vitamin D deficient (<12 ng/mL), 34.1% deficient (12 to 19 ng/mL), 49.0% insufficient (20 to 29 ng/mL), and 11.4% sufficient (≥30 ng/mL). The lowest levels of serum 25(OH)D were found among black (17.9 ± 6.7 ng/mL) and Asian children (18.9 ± 4.8 ng/mL), with no baseline differences by weight status. Serum 25(OH)D increased over 6 months in all three dose groups. The 2000 IU/d group achieved a higher mean serum 25(OH)D level than the other two dose groups (33.1 vs 26.3 and 27.5 ng/mL; P < 0.001), with 59.9% of this group attaining sufficiency at 3 months and only 5.3% remaining severely deficient/deficient at 6 months. All dose groups demonstrated a fall in 25(OH)D at 12 months.. Children at risk for vitamin D deficiency benefited from daily sustained supplementation of 2000 IU/d compared with lower doses closer to the current recommended daily allowance for vitamin D intake. This benefit occurred over the winter months, when serum 25(OH)D level tend to fall.

Topics: Adolescent; Anthropometry; Asian; Black or African American; Child; Cholecalciferol; Dietary Supplements; Double-Blind Method; Ethnicity; Female; Humans; Male; Seasons; Skin Pigmentation; Vitamin D; Vitamin D Deficiency; Vitamins

To evaluate the effect of a single early high-dose vitamin D supplement on fracture union in patients with hypovitaminosis D and a long bone fracture.. Between July 2011 and August 2013, 113 adults with a long bone fracture were enrolled in a prospective randomised double-blind placebo-controlled trial. Their serum vitamin D levels were measured and a total of 100 patients were found to be vitamin D deficient (< 20 ng/ml) or insufficient (< 30 ng/mL). These were then randomised to receive a single dose of vitamin D. In all, 100 (89%) patients had hypovitaminosis D. Both treatment and control groups had similar demographics and injury characteristics. The initial median vitamin D levels were 16 ng/mL (interquartile range 5 to 28) in both groups (p = 0.885). A total of 14 patients were lost to follow-up (seven from each group), two had fixation failure (one in each group) and one control group patient developed an infection. Overall, the nonunion rate was 4% (two per group). No patient showed signs of clinical toxicity from their supplement.. Despite finding a high level of hypovitaminosis D, the rate of union was high and independent of supplementation with vitamin D

Topics: Adult; Aged; Aged, 80 and over; Cholecalciferol; Double-Blind Method; Drug Administration Schedule; Female; Follow-Up Studies; Fracture Fixation; Fractures, Bone; Fractures, Ununited; Humans; Male; Middle Aged; Prospective Studies; Treatment Outcome; Vitamin D Deficiency; Vitamins

Vitamin D deficiency has been linked to poor outcomes after total hip replacement (THR) or total knee replacement (TKR), including lower patient-reported outcome measures (PROMs), peri-prosthetic infection and longer hospital stay. We present a randomised feasibility trial protocol designed to prospectively investigate the influence of vitamin D testing, and subsequent supplementation for deficiency, prior to THR/TKR.. One hundred adult patients undergoing primary THR/TKR for osteoarthritis at two NHS hospital trusts in North East England will be recruited. Exclusion criteria include lack of mental capacity, revision surgery, participants already taking vitamin D/calcium supplements, or a known contraindication to vitamin D treatment. Participants will be ineligible for the trial if they have an estimated glomerular filtration rate < 30 ml/minute. We will measure patients' vitamin D levels at baseline, and those identified as deficient (vitamin D < 50 nmol/L) will be randomised to receive either vitamin D supplementation or no supplementation prior to, and for 6 months following, surgery. Patients with a normal vitamin D level (≥50 nmol/L) will receive no supplementation. Vitamin D levels will be rechecked on the day of surgery and again at 6 months. Patients will also complete a lifestyle questionnaire, as well as the Oxford hip or knee and EQ-5D-3 L PROM questionnaires, at baseline and at 6 months following surgery. The aims are to determine the feasibility of the methodology and to gather data to inform the conduct of a future, larger trial to investigate if supplementation with vitamin D, in those who are deficient, prior to THR/TKR improves outcomes as measured by PROM scores.. Previous reports have measured vitamin D levels and correlated this to outcome, but we can find no randomised trial in which researchers investigated the effect of supplementation. The aim of this trial is to determine if vitamin D deficiency is a modifiable risk factor for poor outcome after THR/TKR.. ISRCTN Registry, ISRCTN14533082 . Registered on 3 April 2017.

Topics: Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee; Cholecalciferol; Clinical Protocols; Dietary Supplements; England; Feasibility Studies; Humans; Osteoarthritis, Hip; Osteoarthritis, Knee; Patient Reported Outcome Measures; Postoperative Complications; Prospective Studies; Research Design; Risk Factors; Time Factors; Treatment Outcome; Vitamin D; Vitamin D Deficiency

Clinical trials are scant and equivocal on whether vitamin D can ameliorate arterial stiffness, particularly in populations at high risk for vitamin D deficiency and cardiovascular disease (CVD). This study determined the dose-response effects of vitamin D3 supplementation on arterial stiffness in overweight African Americans with vitamin D deficiency.. Seventy overweight African Americans (aged 13-45 years) with serum 25-hydroxyvitamin D [25(OH)D] levels ≤ 20 ng/mL were randomized to monthly oral supplementation of 18,000 IU (~600 IU/day, n = 17), 60,000 IU (~2000 IU/day, n = 18), or 120,000 IU (~4000 IU/day, n = 18) of vitamin D3 or placebo (n = 17) for 16-weeks. The arterial stiffness measurements, carotid-femoral pulse wave velocity (PWV) and carotid-radial PWV, were assessed by applanation tonometry at baseline and 16 weeks.. Vitamin D3 supplementation demonstrated a dose-response increase in serum 25(OH)D concentrations between groups (P<0.01). A significant downward linear trend was observed for carotid-femoral PWV (P<0.01), as the mean changes in carotid-femoral PWV across the four treatment groups were 0.13 m/s (95% CI: -0.24, 0.51 m/s) for placebo, 0.02 m/s (95% CI: -0.34, 0.38 m/s) for 600 IU/day group, -0.11 m/s (95% CI: -0.50, 0.27 m/s) for the 2,000 IU/day group, and -0.70 m/s (95% CI: -1.07, -0.32 m/s) for the 4,000 IU/day group. Findings were similar for carotid-radial PWV (P = 0.03), as the mean changes in carotid-radial PWV across the four treatment groups were 0.24 m/s (95% CI: -0.45, 0.92 m/s) for placebo, 0.09 m/s (95% CI: -0.54, 0.73 m/s) for 600 IU/day group, -0.57 m/s (95% CI: -1.20, 0.07 m/s) for the 2,000 IU/day group, and -0.61 m/s (95% CI: -1.25, 0.02 m/s) for the 4,000 IU/day group.. Arterial stiffness was improved by vitamin D3 supplementation in a dose-response manner in overweight African Americans with vitamin D deficiency.

Topics: Adolescent; Adult; Arteries; Black or African American; Cholecalciferol; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Male; Obesity; Placebos; Vascular Stiffness; Vitamin D Deficiency; Young Adult

Hypovitaminosis D exists postburn. However, evidence-based guidelines for vitamin D repletion are unknown. This investigation examined differences between D. Fifty patients with total body surface area burn of 55.7% ± 2.6% and full-thickness injury of 40.8% ± 3.8% were enrolled, ranging in age from 0.7-18.4 years. All participants received multivitamin supplementation per standardized clinical protocol. In addition, 100 IU/kg D. There were no significant differences in serum vitamin D levels between groups, but >10% of patients had low D25 at discharge, and percent deficiency worsened by the 1-year follow up for the placebo (75%), D. The high incidence of low serum D25 levels 1 year following serious thermal injury indicates prolonged compromise. Continued treatment with vitamin D

Topics: Adolescent; Biomarkers; Burns; Child; Child, Preschool; Cholecalciferol; Critical Illness; Dietary Supplements; Double-Blind Method; Ergocalciferols; Female; Humans; Infant; Male; Parathyroid Hormone; Prospective Studies; Treatment Outcome; Vitamin D Deficiency; Vitamins

The Nutrition Societies in Germany, Austria, and Switzerland recommend a daily intake of 20 µg vitamin D. The study was conducted in Halle (Saale), Germany (51. Daily supplementation of 20 µg vitamin D

Topics: Adult; Aged; Biomarkers; Blood Pressure; Calcifediol; Cardiovascular Diseases; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Germany; Humans; Male; Middle Aged; Nutritional Status; Placebos; Risk Factors; Seasons; Vitamin D Deficiency

To compare between weekly and daily cholecalciferol in patients with hypovitaminosis D and to determine the optimal maintenance dose.. Seventy-one volunteers with hypovitaminosis D were randomly assigned to 2 dose regimens: cholecalciferol 50 000 IU weekly for 8 weeks, then 50 000 IU monthly for 2 months (group A) and 7000 IU daily for 8 weeks, then 12 500 IU weekly for 2 months (group B). Cholecalciferol was stopped for 2 months and reintroduced as 50 000 IU bimonthly for group A and 50 000 IU monthly for group B.. Two months after therapy, the mean serum 25-hydroxyvitamin D (25(OH)D) level increased from 11.4 to 51.2 ng/mL and from 11.7 to 44.9 ng/mL in groups A and B, respectively ( P = .065). The levels of 25(OH)D declined similarly in both groups during maintenance and after holding therapy. After resuming cholecalciferol, 25(OH)D levels increased to 33.8 and 28.8 ng/mL in groups A and B, respectively ( P = .027). There was a negative correlation between serum 25(OH)D levels and body mass index (BMI; P = .040).. Timing and frequency of the dosing (daily vs weekly) have no effect on the rise in serum 25(OH)D levels as long as the accumulative dose of cholecalciferol is similar. Cholecalciferol 50 000 IU bimonthly is required to maintain sufficient 25(OH)D levels.

Topics: Adult; Cholecalciferol; Dietary Supplements; Dose-Response Relationship, Drug; Female; Humans; Jordan; Male; Vitamin D; Vitamin D Deficiency; Young Adult

There is little consensus on the most efficacious vehicle substance for vitamin D supplements. Fat malabsorption may impede the ability of patients with cystic fibrosis (CF) to absorb vitamin D in an oil vehicle. We hypothesized that vitamin D contained in a powder vehicle would be absorbed more efficiently than vitamin D contained in an oil vehicle in patients with CF.. In this double-blind, randomized controlled trial, hospitalized adults with CF were given a one-time bolus dose of 100,000 IU of cholecalciferol (D. This trial was completed by 15 patients with CF. The median (interquartile range) age, body mass index, and forced expiratory volume in 1 second were 23.7 (19.9-33.2) years, 19.9 (18.6-22.6) kg/m. In adults with CF, cholecalciferol is more efficiently absorbed in a powder compared with an oil vehicle. Physicians should consider prescribing vitamin D in a powder vehicle in patients with CF to improve the absorption of vitamin D from supplements.

Topics: Adult; Cholecalciferol; Cystic Fibrosis; Dietary Supplements; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Lipid Metabolism; Male; Parathyroid Hormone; Pilot Projects; Powders; Prospective Studies; Treatment Outcome; Vitamin D; Vitamin D Deficiency; Young Adult

Vitamin D inadequacy is a global health concern in athletes as well as the general population. Whilst the role of vitamin D in skeletal health is well defined, there remains uncertainty over whether vitamin D supplementation has an added benefit beyond bone health.. This randomised placebo-controlled trial in healthy male and female Gaelic footballers (n = 42) investigated the effect of vitamin D. Supplementation significantly increased total 25-hydroxyvitamin D concentrations compared to the placebo group (mean ± SD change from baseline, 36.31 ± 32.34 vs. 6.11 ± 23.93 nmol/L, respectively; P = 0.006). At baseline, 50 and 22 % of footballers presented with vitamin D insufficiency (31-49 nmol/L) and deficiency (<30 nmol/L), respectively. Total 25-hydroxyvitamin D concentration did not significantly correlate with any measure of physical performance. Analysis of covariance (ANCOVA) models demonstrated that vitamin D supplementation over 12 weeks had no significant effect on VO. Twelve-week daily supplementation with 3000 IU (75 µg) vitamin D

Topics: Administration, Oral; Adolescent; Athletes; Body Composition; Calcium; Cholecalciferol; Creatinine; Dietary Supplements; Double-Blind Method; Exercise; Female; Football; Hand Strength; Humans; Lung; Male; Muscle, Skeletal; Nutrition Assessment; Oral Sprays; Oxygen Consumption; Patient Compliance; Sports Nutritional Physiological Phenomena; Treatment Outcome; Vitamin D Deficiency; Young Adult

Adults with diabetes (DM) and chronic kidney disease (CKD) are at risk for vitamin D (vitD) insufficiency, suboptimal bone health and reduced quality of life (QoL) due to limited sunlight exposure, poor vitD intake and CKD.. This open-labeled, randomized clinical trial, compared the impact of daily (2000 IU/D) verses monthly (40,000 IU/month) vitD. Participants (18-80 years) were randomized to daily (n = 60) or monthly (n = 60) vitD. Daily (2000 IU/D) and monthly (40,000 IU/month) vitD

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Alkaline Phosphatase; Body Mass Index; Bone and Bones; Bone Density; Cholecalciferol; Collagen Type I; Diabetes Mellitus; Dietary Supplements; Dose-Response Relationship, Drug; Female; Fibroblast Growth Factor-23; Fibroblast Growth Factors; Humans; Male; Middle Aged; Osteocalcin; Patient Compliance; Peptides; Quality of Life; Renal Insufficiency, Chronic; Vitamin D Deficiency; Young Adult

In vitro studies suggest that vitamin D may reduce hepcidin expression and pro-inflammatory cytokine release from monocytes. However, data assessing the vitamin D-mediated effects on iron recycling in healthy individuals are lacking. We aimed to examine the effect of high-dose vitamin D. This was a pilot, double-blind, placebo-controlled trial in healthy adults (N = 28) randomized to receive a one-time oral dose of 250,000 IU of vitamin D. At baseline, plasma 25-hydroxyvitamin D [25(OH)D], hepcidin, pro-inflammatory cytokine, and ferritin concentrations did not differ between the two groups, and greater than 70% of subjects in both groups were vitamin D deficient (25(OH)D < 20 ng/mL). After 1 week, plasma hepcidin concentrations decreased by 73% from baseline in those who received vitamin D. High-dose vitamin D

Topics: Adult; Anemia, Iron-Deficiency; Asymptomatic Diseases; Biomarkers; Calcifediol; Cholecalciferol; Cohort Studies; Cytokines; Dietary Supplements; Double-Blind Method; Down-Regulation; Female; Ferritins; Georgia; Hepcidins; Humans; Male; Nutritional Status; Pilot Projects; Prevalence; Vitamin D Deficiency; Young Adult

The primary aim of the present study was to examine the effectiveness of daily consumption of vitamin D. This is a single-blinded (i.e., to study participants), randomized, controlled food-based dietary intervention study.. A sample of 79 postmenopausal women (55-75 years old) was randomized either to a control group (CG: n = 39) or an intervention group (IG: n = 40) that consumed, as part of their usual diet, 60 g of either non-enriched or vitamin D. There was a differential response of mean (95 % CI) serum 25(OH)D levels in the IG and CG, with the former increasing and the latter decreasing significantly over the eight weeks of the trial [i.e., by 5.1 (3.4, 6.9) nmol/L vs. -4.6 (-6.4, -2.8) nmol/L, P < 0.001, respectively]. The percentages of study participants with 25(OH)D levels <30 (deficiency) and <50 nmol/L (insufficiency) were significantly higher at follow-up in the CG compared to the IG (41.0 vs. 0 %, P < 0.001 and 74.4 vs. 47.5 %, P < 0.001, respectively). The emotional well-being scale of the HRQL score increased in the IG compared to a decrease in the CG (3.2 vs. -3.8, P = 0.028). However, none of the other seven scales of the HRQL score significantly differentiated between study groups (P > 0.1).. Consumption of 60 g of vitamin D

Topics: Aged; Cheese; Cholecalciferol; Diet; Female; Follow-Up Studies; Food, Fortified; Greece; Humans; Middle Aged; Postmenopause; Quality of Life; Reproducibility of Results; Seasons; Single-Blind Method; Surveys and Questionnaires; Vitamin D Deficiency

We studied the association between CYP2R1 genetic polymorphisms and circulating 25-hydroxyvitamin D [25(OH)D] before and after supplementation with vitamin D3 in 218 elderly. We found differences between 3 and 8 ng/ml in circulating levels at baseline in women but not in the response after 1 year of supplementation.. This study evaluated the association between polymorphisms in four single nucleotide polymorphisms (SNPs) of the CYP2R1 gene and 25(OH)D levels before and 1 year after supplementation with two different doses of vitamin D3 (600 IU daily or a dose equivalent to 3750 IU daily), in a cohort of 218 (96 men and 122 women) Lebanese elderly overweight subjects.. Genotyping was performed for rs12794714, rs10741657, rs1562902, and rs10766197 SNPs using real-time PCR. The 25(OH)D levels were measured by liquid chromatography tandem mass spectrometry.. This study showed a difference in 25(OH)D levels between CYP2R1 genotypes that equates a daily supplementation of 400-800 IU vitamin D, depending on genotype. It underscores possible important genetic contributions for the high prevalence of hypovitaminosis D in the Middle East.

Topics: Aged; Cholecalciferol; Cholestanetriol 26-Monooxygenase; Cytochrome P450 Family 2; Dietary Supplements; Double-Blind Method; Female; Genetic Predisposition to Disease; Genotype; Humans; Male; Polymorphism, Single Nucleotide; Seasons; Vitamin D; Vitamin D Deficiency

In a randomised controlled trial of vitamin D during pregnancy, we demonstrated that women with lower self-efficacy were more likely to experience practical problems with taking the trial medication and that this was associated with lower compliance and achieved 25(OH)-vitamin D concentrations.. The relationship between self-efficacy (the belief that one can carry out a behaviour), compliance with study protocol and outcome was explored within a randomised, double-blind, placebo-controlled trial of vitamin D supplementation in pregnancy.. In the Maternal Vitamin D Osteoporosis Study (MAVIDOS) trial, women with circulating plasma 25(OH)-vitamin D of 25-100 nmol/l in early pregnancy were randomised to either 1000 IU cholecalciferol/day or matched placebo from 14 weeks until delivery. Circulating 25(OH)-vitamin D concentrations were assessed at 14 and 34 weeks' gestation. A sequential sub-sample completed Schwarzer's General Self-Efficacy Scale at 14 and 34 weeks and the Problematic Experiences of Therapy Scale at 34 weeks. Women were interviewed about their experiences of the trial and interview transcripts analysed thematically.. In 203 women, those with higher self-efficacy were less likely to experience practical problems taking the study medication (odds ratio (OR) 0.81 (95 % confidence interval (CI) 0.69-0.95), p = 0.01). Over half reported practical problems associated with poorer compliance with the protocol requiring women to take the medication daily. Compliance in women who experienced practical problems was 94 % compared with 98 % for those with no problems (p < 0.001). Poorer compliance was also associated with lower concentrations of 25(OH)-D in late pregnancy in the treatment group (β = 0.54 nmol/l (95 % CI 0.18-0.89), p = 0.003). Thematic analysis suggested common difficulties were remembering to take the medication every day and swallowing the large capsules.. These findings suggest that differences in self-efficacy influence trial outcomes. Such information may help clinicians anticipate responses to routine vitamin D supplementation in pregnancy and identify those who may need more support to comply.. ISRCTN82927713, registered 11/04/2008.

Topics: Adolescent; Adult; Child; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Medication Adherence; Middle Aged; Pregnancy; Pregnancy Complications; Prenatal Care; Self Efficacy; Treatment Outcome; Vitamin D; Vitamin D Deficiency; Young Adult

Low serum 25-hydroxyvitamin-D (25(OH)D) concentrations are associated with insulin resistance, β-cell dysfunction and type 2 diabetes. We conducted a 24-week double-blind, randomized, placebo-controlled trial to examine the effect of 28 000 IU of vitamin D. A total of 71 participants with serum 25(OH)D ≤65 nmol/L, impaired fasting glucose and elevated glycated hemoglobin were randomly assigned to receive 28 000 IU of vitamin D. Mean baseline serum 25(OH)D was 48.1 and 47.6 nmol/L in the VitD and placebo groups, respectively. Serum 25(OH)D significantly increased to 98.7 nmol/L (51 nmol/L increase; P < .0001) in the VitD group. No significant differences in fasting ( P = .42) or 2hPC glucose ( P = .55) or other indices of glucose metabolism, including β-cell function and insulin sensitivity, were observed between groups. A subgroup analysis of individuals with 25(OH)D < 50 nmol/L and prediabetes did not change these results. The VitD group exhibited a significant reduction in LDL cholesterol (-0.27 vs 0.01 mmol/L, P = .03).. Weekly doses of vitamin D

Topics: Adult; Blood Glucose; Cholecalciferol; Cholesterol, LDL; Diabetes Mellitus, Type 2; Dietary Supplements; Double-Blind Method; Fasting; Female; Glucose Tolerance Test; Glycated Hemoglobin; Humans; Insulin; Insulin Resistance; Insulin-Secreting Cells; Male; Middle Aged; Postprandial Period; Prediabetic State; Risk; Vitamin D; Vitamin D Deficiency; Vitamins

Bariatric patients often suffer from vitamin D deficiency (VDD), and both, morbid obesity and VDD, are related to non-alcoholic fatty liver disease. However, limited data are available regarding best strategies for treating VDD, particularly, in bariatric patients undergoing omega-loop gastric bypass (OLGB). Therefore, we examined the efficacy and safety of a forced vitamin D dosing regimen and intervention effects in liver fibrotic patients.. Compared with control group, higher increase of 25(OH)D (67.9 (21.1) vs. 55.7 nmol/L (21.1); p = 0.049) with lower prevalence of secondary hyperparathyroidism (10 vs. 24 %; p = 0.045) was observed in intervention group. No (serious) adverse events related to study medication were found. The loading dose regimen was more effective in increasing 25(OH)D in patients with significant liver fibrosis while this was not the case for conventional supplementation (placebo with maintenance dose) (71.5 (20.5) vs. 22.5 nmol/L (13.8); p = 0.022; n = 14).. Our findings indicate that a high vitamin D

Topics: Adult; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Gastric Bypass; Humans; Hyperparathyroidism, Secondary; Liver Cirrhosis; Male; Middle Aged; Non-alcoholic Fatty Liver Disease; Obesity, Morbid; Postoperative Period; Prevalence; Vitamin D; Vitamin D Deficiency; Vitamins; Weight Loss

Vitamin D insufficiency in cystic fibrosis is common. Vitamin D3 is currently preferred over D2. We aimed to study the efficacy of vitamin D2 and D3 at increasing serum 25-hydroxyvitamin D (s25OHD) concentrations and their effect on respiratory health in cystic fibrosis.. Sixteen CF patients were randomized to receive vitamin D2 or D3 or to serve as controls. The starting dose of 5000 IU (<16 years old) or 7143 IU/day (⩾16 years old) was further individually adjusted. Three months of intervention were followed by two of washout (ClinicalTrials.gov NCT01321905).. To increase s25OHD, the mean daily dose of vitamin D2 and D3 had to be increased up to 15650 and 8184 IU, respectively. The combined group of vitamin D2 and D3 treated patients decreased plasma IL-8 (P<0.05). Patients provided vitamin D3 improved FVC at the end of the trial (P<0.05). Change in s25OHD was positively correlated with changes in the adult Quality-of-Life respiratory score at the end of supplementation (P=0.006, r=0.90), and with changes in FEV1 (P=0.042, r=0.62) and FVC (P=0.036, r=0.63) at one month of washout.. Vitamin D supplementation may contribute to reduced inflammation and improved lung function in CF.

Topics: Adolescent; Adult; Child; Cholecalciferol; Cystic Fibrosis; Dietary Supplements; Ergocalciferols; Female; Humans; Lung; Male; Pilot Projects; Treatment Outcome; Vital Capacity; Vitamin D; Vitamin D Deficiency; Vitamins; Young Adult

This trial compared the effects of daily treatment with vitamin D or placebo for 1 year on blood tests of vitamin D status. The results demonstrated that daily 4000 IU vitamin D3 is required to achieve blood levels associated with lowest disease risks, and this dose should be tested in future trials for fracture prevention.. The aim of this trial was to assess the effects of daily supplementation with vitamin D3 4000 IU (100 μg), 2000 IU (50 μg) or placebo for 1 year on biochemical markers of vitamin D status in preparation for a large trial for prevention of fractures and other outcomes.. This is a randomized placebo-controlled trial in 305 community-dwelling people aged 65 years or older in Oxfordshire, UK. Outcomes included biochemical markers of vitamin D status (plasma 25-hydroxy-vitamin D [25[OH]D], parathyroid hormone [PTH], calcium and alkaline phosphatase), cardiovascular risk factors and tests of physical function.. Mean (SD) plasma 25(OH)D levels were 50 (18) nmol/L at baseline and increased to 137 (39), 102 (25) and 53 (16) nmol/L after 12 months in those allocated 4000 IU, 2000 IU or placebo, respectively (with 88%, 70% and 1% of these groups achieving the pre-specified level of >90 nmol/L). Neither dose of vitamin D3 was associated with significant deviation outside the normal range of PTH or albumin-corrected calcium. The additional effect on 25(OH)D levels of 4000 versus 2000 IU was similar in all subgroups except for body mass index, for which the further increase was smaller in overweight and obese participants compared with normal-weight participants. Supplementation with vitamin D had no significant effects on cardiovascular risk factors or on measures of physical function.. After accounting for average 70% compliance in long-term trials, doses of 4000 IU vitamin D3 daily may be required to achieve plasma 25(OH)D levels associated with lowest disease risk in observational studies.

Topics: Aged; Alkaline Phosphatase; Bone Density Conservation Agents; Calcium; Cardiovascular Diseases; Cholecalciferol; Dose-Response Relationship, Drug; Double-Blind Method; Female; Follow-Up Studies; Humans; Male; Medication Adherence; Osteoporotic Fractures; Parathyroid Hormone; Physical Fitness; Primary Health Care; Risk Factors; Vitamin D; Vitamin D Deficiency

Cholecalciferol (vitamin D3) improves vascular function and inflammation, potentially providing an explanation for the proposed cardiovascular protection of vitamin D.. We investigated whether cholecalciferol supplementation reduces postprandial arterial dysfunction and inflammation.. Randomized, 1:1, double-blind trial.. Diabetes and Vascular Center, Franciscus Gasthuis, Rotterdam, The Netherlands.. Twenty-four healthy, premenopausal, overweight or obese, vitamin D-deficient women.. A single high (300,000 IU) or low dose (75,000 IU) of cholecalciferol.. The effect of low- and high-dose cholecalciferol on postprandial leukocyte activation markers, pulse wave velocity (PWV), and augmentation index (AIx) during an oral fat loading test, expressed as area under the curve (AUC).. High- and low-dose supplementation increased vitamin D by 163% ± 134% (P < 0.001) and 66% ± 59% (P < 0.001), respectively. Monocyte CD11b-AUC slightly increased after low but not high dose (6% ± 2%, P = 0.012, and 4% ± 1%, P = 0.339, respectively). There were no significant effects on postprandial PWV or AIx by high- or low-dose vitamin D. Fasting complement component 3 (C3) levels decreased by 5.9% (P = 0.004) in the high-dose group and by 4.0% (P = 0.018) in the low-dose group.. A single dose of vitamin D does not seem to reduce arterial stiffness and leukocyte activation in overweight, vitamin D-deficient women. Vitamin D may decrease fasting C3. Possibly, higher vitamin D concentrations may be needed to decrease inflammation and improve vascular function in overweight or obese vitamin D-deficient women.

Topics: Adult; Apolipoprotein A-I; Apolipoproteins B; Area Under Curve; C-Reactive Protein; Cholecalciferol; Cholesterol, HDL; Cholesterol, LDL; Complement C3; Double-Blind Method; Female; Humans; Inflammation; Leukocyte Count; Monocytes; Neutrophils; Obesity; Overweight; Postprandial Period; Pulse Wave Analysis; Triglycerides; Vascular Stiffness; Vitamin D; Vitamin D Deficiency; Vitamins; Young Adult

Variability in 25-hydroxyvitamin D (25(OH)D) change following vitamin D supplementation exists. Vitamin D metabolite measurement might assist in predicting 25(OH)D response and also contribute to defining vitamin D adequacy. This study assessed utility of vitamin D metabolite measurements to predict 25(OH)D response and explored the relationship between parathyroid hormone (PTH) and a "vitamin D composite index" comprised of the sum of serum 25(OH) D, cholecalciferol (vitamin D. Sixty-two postmenopausal women were randomized to daily vitamin D. Baseline 25(OH)D was positively correlated (P<.05) with vitamin D3, 24,25(OH). This study does not support measurement of vitamin D metabolites in a composite index to assist in prediction of 25(OH)D response to supplementation. Overweight individuals have less robust 25(OH) D response to supplementation, but variability precludes prediction of the result following daily supplementation.. BMI = body mass index DXA = dual-energy X-ray absorptiometry LC-MS/MS = liquid chromatography tandem mass spectroscopy 25(OH)D = 25-hydroxyvitamin D 24,25(OH)

Topics: Aged; Aged, 80 and over; Body Mass Index; Cholecalciferol; Chromatography, Liquid; Dietary Supplements; Ergocalciferols; Female; Humans; Middle Aged; Parathyroid Hormone; Prognosis; Tandem Mass Spectrometry; Vitamin D; Vitamin D Deficiency

Topics: Cholecalciferol; Humans; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma; Vitamin D Deficiency

Vitamin D deficiency disproportionately affects nonwhite individuals. Controversy persists over how to best restore low 25D levels, and how to best define vitamin D status [total (protein bound plus free) vs free 25D].. To assess the effects of vitamin D3 (cholecalciferol, or D3) vs 25-hydroxyvitamin D3 (calcifediol, or 25D3) on total and free 25D in a multiethnic cohort of adults, and whether change in parathyroid hormone (PTH) is more strongly associated with total vs free 25D.. Sixteen-week randomized controlled trial. Biochemistries at 0, 4, 8, and 16 weeks.. Academic medical center.. Thirty-five adults ≥18 years of age with 25D levels <20 ng/mL.. Sixty micrograms (2400 IU)/d of D3 or 20 μg/d of 25D3.. Total and free 25D, and PTH.. Baseline total (16.2 ± 3.7 vs 17.0 ± 2.5 ng/mL; P = 0.4) and free (4.2 ± 0.8 vs 4.7 ± 1.0 pg/mL; P = 0.2) 25D were similar between D3 and 25D3 groups, respectively; 25D3 increased total (+25.5 vs +13.8 ng/mL; P = 0.001) and free (+6.6 vs +3.5 pg/mL; P = 0.03) 25D more than D3. By 4 weeks, 87.5% of 25D3 participants had total 25D levels ≥30 ng/mL, compared with 23.1% of D3 participants (P = 0.001). Change in PTH was associated with both total (P = 0.01) and free 25D (P = 0.04).. 25D3 increased total and free 25D levels more rapidly than D3, regardless of race/ethnicity. Free and total 25D were similarly associated with change in PTH.

Topics: Adult; Calcifediol; Calcium; Cholecalciferol; Female; Humans; Male; Middle Aged; Parathyroid Hormone; Vitamin D; Vitamin D Deficiency; Young Adult

Soluble FMS-like tyrosine kinase 1 (sFlt-1) and vascular endothelial growth factor (VEGF) gene expression was significantly downregulated in the maternal subgroup with circulating 25(OH)D ≥100ng/mL compared to the subgroup <100ng/mL.. Here, we report a significant association between maternal vitamin D status and the expression of sFlt-1 and VEGF at the mRNA level. Achieving maternal circulating 25(OH)D ≥100nmoles/L suggests the impact of maternal vitamin D

Topics: Adult; Biomarkers; Cholecalciferol; Comorbidity; Down-Regulation; Female; Humans; Placenta; Pre-Eclampsia; Pregnancy; RNA, Messenger; Transcriptional Activation; Vascular Endothelial Growth Factor A; Vascular Endothelial Growth Factor Receptor-1; Vitamin D; Vitamin D Deficiency; Vitamins; Young Adult

Adolescents with acute lymphoblastic leukemia (ALL) develop osteopenia early in therapy, potentially exacerbated by high rates of concurrent Vitamin D deficiency. We conducted a randomized clinical trial testing a Vitamin D-based intervention to improve Vitamin D status and reduce bone density decline. Poor adherence to home supplementation necessitated a change to directly observed therapy (DOT) with intermittent, high-dose Vitamin D3 randomized versus standard of care (SOC). Compared to SOC, DOT Vitamin D3 successfully increased trough Vitamin 25(OH)D levels (p = .026) with no residual Vitamin D deficiency, 100% adherence to DOT Vitamin D3, and without associated toxicity. However, neither Vitamin D status nor supplementation impacted bone density. Thus, this adherence-optimized intervention is feasible and effective to correct Vitamin D deficiency in adolescents during ALL therapy. Repletion of Vitamin D and calcium alone did not mitigate osteopenia, however, and new, comprehensive approaches are needed to address treatment-associated osteopenia during ALL therapy.

Topics: Adolescent; Bone Density; Bone Density Conservation Agents; Cholecalciferol; Humans; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Vitamin D Deficiency

Middle East Respiratory Syndrome (MERS) is a novel respiratory illness firstly reported in Saudi Arabia in 2012. It is caused by a new corona virus, called MERS corona virus (MERS-CoV). Most people who have MERS-CoV infection developed severe acute respiratory illness.. This work is done to determine the clinical characteristics and the outcome of intensive care unit (ICU) admitted patients with confirmed MERS-CoV infection.. This study included 32 laboratory confirmed MERS corona virus infected patients who were admitted into ICU. It included 20 (62.50%) males and 12 (37.50%) females. The mean age was 43.99 ± 13.03 years. Diagnosis was done by real-time reverse transcription polymerase chain reaction (rRT-PCR) test for corona virus on throat swab, sputum, tracheal aspirate, or bronchoalveolar lavage specimens. Clinical characteristics, co-morbidities and outcome were reported for all subjects.. Most MERS corona patients present with fever, cough, dyspnea, sore throat, runny nose and sputum. The presence of abdominal symptoms may indicate bad prognosis. Prolonged duration of symptoms before patients' hospitalization, prolonged duration of mechanical ventilation and hospital stay, bilateral radiological pulmonary infiltrates, and hypoxemic respiratory failure were found to be strong predictors of mortality in such patients. Also, old age, current smoking, smoking severity, presence of associated co-morbidities like obesity, diabetes mellitus, chronic heart diseases, COPD, malignancy, renal failure, renal transplantation and liver cirrhosis are associated with a poor outcome of ICU admitted MERS corona virus infected patients.. Plasma HO-1, ferritin, p21, and NQO1 were all elevated at baseline in CKD participants. Plasma HO-1 and urine NQO1 levels each inversely correlated with eGFR (. SnPP can be safely administered and, after its injection, the resulting changes in plasma HO-1, NQO1, ferritin, and p21 concentrations can provide information as to antioxidant gene responsiveness/reserves in subjects with and without kidney disease.. A Study with RBT-1, in Healthy Volunteers and Subjects with Stage 3-4 Chronic Kidney Disease, NCT0363002 and NCT03893799.. HFNC did not significantly modify work of breathing in healthy subjects. However, a significant reduction in the minute volume was achieved, capillary [Formula: see text] remaining constant, which suggests a reduction in dead-space ventilation with flows > 20 L/min. (ClinicalTrials.gov registration NCT02495675).. 3 组患者手术时间、术中显性失血量及术后 1 周血红蛋白下降量比较差异均无统计学意义（. 对于肥胖和超重的膝关节单间室骨关节炎患者，采用 UKA 术后可获满意短中期疗效，远期疗效尚需进一步随访观察。.. Decreased muscle strength was identified at both time points in patients with hEDS/HSD. The evolution of most muscle strength parameters over time did not significantly differ between groups. Future studies should focus on the effectiveness of different types of muscle training strategies in hEDS/HSD patients.. These findings support previous adverse findings of e-cigarette exposure on neurodevelopment in a mouse model and provide substantial evidence of persistent adverse behavioral and neuroimmunological consequences to adult offspring following maternal e-cigarette exposure during pregnancy. https://doi.org/10.1289/EHP6067.. This RCT directly compares a neoadjuvant chemotherapy regimen with a standard CROSS regimen in terms of overall survival for patients with locally advanced ESCC. The results of this RCT will provide an answer for the controversy regarding the survival benefits between the two treatment strategies.. NCT04138212, date of registration: October 24, 2019.. Results of current investigation indicated that milk type and post fermentation cooling patterns had a pronounced effect on antioxidant characteristics, fatty acid profile, lipid oxidation and textural characteristics of yoghurt. Buffalo milk based yoghurt had more fat, protein, higher antioxidant capacity and vitamin content. Antioxidant and sensory characteristics of T. If milk is exposed to excessive amounts of light, Vitamins B. The two concentration of ZnO nanoparticles in the ambient air produced two different outcomes. The lower concentration resulted in significant increases in Zn content of the liver while the higher concentration significantly increased Zn in the lungs (p < 0.05). Additionally, at the lower concentration, Zn content was found to be lower in brain tissue (p < 0.05). Using TEM/EDX we detected ZnO nanoparticles inside the cells in the lungs, kidney and liver. Inhaling ZnO NP at the higher concentration increased the levels of mRNA of the following genes in the lungs: Mt2 (2.56 fold), Slc30a1 (1.52 fold) and Slc30a5 (2.34 fold). At the lower ZnO nanoparticle concentration, only Slc30a7 mRNA levels in the lungs were up (1.74 fold). Thus the two air concentrations of ZnO nanoparticles produced distinct effects on the expression of the Zn-homeostasis related genes.. Until adverse health effects of ZnO nanoparticles deposited in organs such as lungs are further investigated and/or ruled out, the exposure to ZnO nanoparticles in aerosols should be avoided or minimised.

Topics: A549 Cells; Acetylmuramyl-Alanyl-Isoglutamine; Acinetobacter baumannii; Acute Lung Injury; Adaptor Proteins, Signal Transducing; Adenine; Adenocarcinoma; Adipogenesis; Administration, Cutaneous; Administration, Ophthalmic; Adolescent; Adsorption; Adult; Aeromonas hydrophila; Aerosols; Aged; Aged, 80 and over; Aging; Agriculture; Air Pollutants; Air Pollution; Airway Remodeling; Alanine Transaminase; Albuminuria; Aldehyde Dehydrogenase 1 Family; Algorithms; AlkB Homolog 2, Alpha-Ketoglutarate-Dependent Dioxygenase; Alzheimer Disease; Amino Acid Sequence; Ammonia; Ammonium Compounds; Anaerobiosis; Anesthetics, Dissociative; Anesthetics, Inhalation; Animals; Anti-Bacterial Agents; Anti-HIV Agents; Anti-Infective Agents; Anti-Inflammatory Agents; Antibiotics, Antineoplastic; Antibodies, Antineutrophil Cytoplasmic; Antibodies, Monoclonal, Humanized; Antifungal Agents; Antigens, Bacterial; Antigens, CD; Antigens, Differentiation, Myelomonocytic; Antimetabolites, Antineoplastic; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Antioxidants; Antitubercular Agents; Antiviral Agents; Apolipoproteins E; Apoptosis; Arabidopsis; Arabidopsis Proteins; Arsenic; Arthritis, Rheumatoid; Asthma; Atherosclerosis; ATP-Dependent Proteases; Attitude of Health Personnel; Australia; Austria; Autophagy; Axitinib; Bacteria; Bacterial Outer Membrane Proteins; Bacterial Proteins; Bacterial Toxins; Bacterial Typing Techniques; Bariatric Surgery; Base Composition; Bayes Theorem; Benzoxazoles; Benzylamines; beta Catenin; Betacoronavirus; Betula; Binding Sites; Biological Availability; Biological Oxygen Demand Analysis; Biomarkers; Biomarkers, Tumor; Biopsy; Bioreactors; Biosensing Techniques; Birth Weight; Blindness; Blood Chemical Analysis; Blood Gas Analysis; Blood Glucose; Blood Pressure; Blood Pressure Monitoring, Ambulatory; Blood-Brain Barrier; Blotting, Western; Body Mass Index; Body Weight; Bone and Bones; Bone Density; Bone Resorption; Borates; Brain; Brain Infarction; Brain Injuries, Traumatic; Brain Neoplasms; Breakfast; Breast Milk Expression; Breast Neoplasms; Bronchi; Bronchoalveolar Lavage Fluid; Buffaloes; Cadherins; Calcification, Physiologic; Calcium Compounds; Calcium, Dietary; Cannula; Caprolactam; Carbon; Carbon Dioxide; Carboplatin; Carcinogenesis; Carcinoma, Ductal; Carcinoma, Ehrlich Tumor; Carcinoma, Hepatocellular; Carcinoma, Non-Small-Cell Lung; Carcinoma, Pancreatic Ductal; Carcinoma, Renal Cell; Cardiovascular Diseases; Carps; Carrageenan; Case-Control Studies; Catalysis; Catalytic Domain; Cattle; CD8-Positive T-Lymphocytes; Cell Adhesion; Cell Cycle Proteins; Cell Death; Cell Differentiation; Cell Line; Cell Line, Tumor; Cell Movement; Cell Nucleus; Cell Phone Use; Cell Proliferation; Cell Survival; Cell Transformation, Neoplastic; Cell Transformation, Viral; Cells, Cultured; Cellulose; Chemical Phenomena; Chemoradiotherapy; Child; Child Development; Child, Preschool; China; Chitosan; Chlorocebus aethiops; Cholecalciferol; Chromatography, Liquid; Circadian Clocks; Circadian Rhythm; Circular Dichroism; Cisplatin; Citric Acid; Clinical Competence; Clinical Laboratory Techniques; Clinical Trials, Phase I as Topic; Clinical Trials, Phase II as Topic; Clostridioides difficile; Clostridium Infections; Coculture Techniques; Cohort Studies; Cold Temperature; Colitis; Collagen Type I; Collagen Type I, alpha 1 Chain; Collagen Type XI; Color; Connective Tissue Diseases; Copper; Coronary Angiography; Coronavirus 3C Proteases; Coronavirus Infections; Cost of Illness; Counselors; COVID-19; COVID-19 Testing; Creatine Kinase; Creatinine; Cross-Over Studies; Cross-Sectional Studies; Cryoelectron Microscopy; Cryosurgery; Crystallography, X-Ray; Cues; Cultural Competency; Cultural Diversity; Curriculum; Cyclic AMP Response Element-Binding Protein; Cyclin-Dependent Kinase Inhibitor p21; Cycloparaffins; Cysteine Endopeptidases; Cytokines; Cytoplasm; Cytoprotection; Databases, Factual; Denitrification; Deoxycytidine; Diabetes Complications; Diabetes Mellitus; Diabetes Mellitus, Experimental; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diagnosis, Differential; Diatoms; Diet; Diet, High-Fat; Dietary Exposure; Diffusion Magnetic Resonance Imaging; Diketopiperazines; Dipeptidyl Peptidase 4; Dipeptidyl-Peptidase IV Inhibitors; Disease Models, Animal; Disease Progression; Disease-Free Survival; DNA; DNA Damage; DNA Glycosylases; DNA Repair; DNA-Binding Proteins; DNA, Bacterial; DNA, Viral; Docetaxel; Dose Fractionation, Radiation; Dose-Response Relationship, Drug; Down-Regulation; Doxorubicin; Drosophila; Drosophila melanogaster; Drug Carriers; Drug Delivery Systems; Drug Liberation; Drug Repositioning; Drug Resistance, Bacterial; Drug Resistance, Multiple, Bacterial; Drug Resistance, Neoplasm; Drug Screening Assays, Antitumor; Drug Synergism; Drug Therapy, Combination; Edema; Edible Grain; Education, Graduate; Education, Medical, Graduate; Education, Pharmacy; Ehlers-Danlos Syndrome; Electron Transport Complex III; Electron Transport Complex IV; Electronic Nicotine Delivery Systems; Emergency Service, Hospital; Empathy; Emulsions; Endothelial Cells; Endurance Training; Energy Intake; Enterovirus A, Human; Environment; Environmental Monitoring; Enzyme Assays; Enzyme Inhibitors; Epithelial Cells; Epithelial-Mesenchymal Transition; Epoxide Hydrolases; Epoxy Compounds; Erythrocyte Count; Erythrocytes; Escherichia coli; Escherichia coli Infections; Escherichia coli Proteins; Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma; Esophagectomy; Estrogens; Etanercept; Ethiopia; Ethnicity; Ethylenes; Exanthema; Exercise; Exercise Test; Exercise Tolerance; Extracellular Matrix; Extracorporeal Membrane Oxygenation; Eye Infections, Fungal; False Negative Reactions; Fatty Acids; Fecal Microbiota Transplantation; Feces; Female; Femur Neck; Fermentation; Ferritins; Fetal Development; Fibroblast Growth Factor-23; Fibroblast Growth Factors; Fibroblasts; Fibroins; Fish Proteins; Flavanones; Flavonoids; Focus Groups; Follow-Up Studies; Food Handling; Food Supply; Food, Formulated; Forced Expiratory Volume; Forests; Fractures, Bone; Fruit and Vegetable Juices; Fusobacteria; G1 Phase Cell Cycle Checkpoints; G2 Phase Cell Cycle Checkpoints; Gamma Rays; Gastrectomy; Gastrointestinal Microbiome; Gastrointestinal Stromal Tumors; Gefitinib; Gels; Gemcitabine; Gene Amplification; Gene Expression; Gene Expression Regulation; Gene Expression Regulation, Bacterial; Gene Expression Regulation, Neoplastic; Gene Expression Regulation, Plant; Gene Knockdown Techniques; Gene-Environment Interaction; Genotype; Germany; Glioma; Glomerular Filtration Rate; Glucagon; Glucocorticoids; Glycemic Control; Glycerol; Glycogen Synthase Kinase 3 beta; Glycolipids; Glycolysis; Goblet Cells; Gram-Negative Bacterial Infections; Granulocyte Colony-Stimulating Factor; Graphite; Greenhouse Effect; Guanidines; Haemophilus influenzae; HCT116 Cells; Health Knowledge, Attitudes, Practice; Health Personnel; Health Services Accessibility; Health Services Needs and Demand; Health Status Disparities; Healthy Volunteers; Heart Failure; Heart Rate; Heart Transplantation; Heart-Assist Devices; HEK293 Cells; Heme; Heme Oxygenase-1; Hemolysis; Hemorrhage; Hepatitis B; Hepatitis B e Antigens; Hepatitis B Surface Antigens; Hepatitis B virus; Hepatitis B, Chronic; Hepatocytes; Hexoses; High-Throughput Nucleotide Sequencing; Hippo Signaling Pathway; Histamine; Histamine Agonists; Histidine; Histone Deacetylase 2; HIV Infections; HIV Reverse Transcriptase; HIV-1; Homebound Persons; Homeodomain Proteins; Homosexuality, Male; Hospice and Palliative Care Nursing; HSP70 Heat-Shock Proteins; Humans; Hyaluronan Receptors; Hydrogen; Hydrogen Peroxide; Hydrogen-Ion Concentration; Hydrolysis; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Hypoglycemia; Hypoglycemic Agents; Hypoxia; Idiopathic Interstitial Pneumonias; Imaging, Three-Dimensional; Imatinib Mesylate; Immunotherapy; Implementation Science; Incidence; INDEL Mutation; Induced Pluripotent Stem Cells; Industrial Waste; Infant; Infant, Newborn; Inflammation; Inflammation Mediators; Infliximab; Infusions, Intravenous; Inhibitory Concentration 50; Injections; Insecticides; Insulin-Like Growth Factor Binding Protein 5; Insulin-Secreting Cells; Interleukin-1; Interleukin-17; Interleukin-8; Internship and Residency; Intestines; Intracellular Signaling Peptides and Proteins; Ion Transport; Iridaceae; Iridoid Glucosides; Islets of Langerhans Transplantation; Isodon; Isoflurane; Isotopes; Italy; Joint Instability; Ketamine; Kidney; Kidney Failure, Chronic; Kidney Function Tests; Kidney Neoplasms; Kinetics; Klebsiella pneumoniae; Knee Joint; Kruppel-Like Factor 4; Kruppel-Like Transcription Factors; Lactate Dehydrogenase 5; Laparoscopy; Laser Therapy; Lasers, Semiconductor; Lasers, Solid-State; Laurates; Lead; Leukocyte L1 Antigen Complex; Leukocytes, Mononuclear; Light; Lipid Peroxidation; Lipopolysaccharides; Liposomes; Liver; Liver Cirrhosis; Liver Neoplasms; Liver Transplantation; Locomotion; Longitudinal Studies; Lopinavir; Lower Urinary Tract Symptoms; Lubricants; Lung; Lung Diseases, Interstitial; Lung Neoplasms; Lymphocyte Activation; Lymphocytes, Tumor-Infiltrating; Lymphoma, Mantle-Cell; Lysosomes; Macrophages; Male; Manganese Compounds; MAP Kinase Kinase 4; Mass Screening; Maternal Health; Medicine, Chinese Traditional; Melanoma, Experimental; Memantine; Membrane Glycoproteins; Membrane Proteins; Mesenchymal Stem Cell Transplantation; Metal Nanoparticles; Metalloendopeptidases; Metalloporphyrins; Methadone; Methane; Methicillin-Resistant Staphylococcus aureus; Mexico; Mice; Mice, Inbred BALB C; Mice, Inbred C57BL; Mice, Inbred ICR; Mice, Knockout; Mice, Nude; Mice, SCID; Mice, Transgenic; Microarray Analysis; Microbial Sensitivity Tests; Microbiota; Micronutrients; MicroRNAs; Microscopy, Confocal; Microsomes, Liver; Middle Aged; Milk; Milk, Human; Minority Groups; Mitochondria; Mitochondrial Membranes; Mitochondrial Proteins; Models, Animal; Models, Molecular; Molecular Conformation; Molecular Docking Simulation; Molecular Dynamics Simulation; Molecular Epidemiology; 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Little is known about the relationship between vitamin D deficiency and adolescents with type 1 diabetes. On the basis of adult studies showing that vitamin D improves insulin sensitivity and decreases inflammatory cytokines linked to microvascular complications, we hypothesized that treating vitamin D deficiency in adolescents with type 1 diabetes would improve glycemia and reduce inflammatory markers.. This was a randomized, prospective, crossover study of 25 adolescents with type 1 diabetes for at least a year (aged: 13-21 yr; 62% female; 62% Hispanic) and vitamin D deficiency (25-OH vitamin D ≤30 ng/mL). Subjects received vitamin D3 (20 000 IU/week) for 6 months, either immediately or after 6 months of observation.. At baseline, 63% of subjects screened were vitamin D deficient and randomized. Interleukin-6 (IL-6) was significantly higher in the vitamin D deficient group compared with the sufficient group (medians: 0.36 vs. 0.18) (p = 0.026), whereas neither C-reactive protein (CRP) nor tumor necrosis factor-α (TNF-α) differed. Vitamin D treatment increased serum levels of 25-OH vitamin D from 22 ± 5.3 to 34.3 ± 12.1 ng/mL (p < 0.01). However, treatment did not affect glycated hemoglobin (HbA1c), insulin dosage, CRP, interleukin-6 (IL-6), or TNF-α.. Vitamin D deficiency is prevalent in the adolescent type 1 diabetes population, and could be associated with changes in inflammatory markers. However, vitamin D repletion over 6 months did not affect glycemia or markers of inflammation in our study, highlighting the need for additional research to validate these findings.

Topics: Adolescent; Biomarkers; Blood Glucose; Cholecalciferol; Cross-Over Studies; Cytokines; Diabetes Mellitus, Type 1; Dose-Response Relationship, Drug; Female; Humans; Inflammation; Male; Prospective Studies; Vitamin D; Vitamin D Deficiency; Vitamins; Young Adult

To determine the dose-response of vitamin D3 supplementation on serum 25-hydroxyvitamin D [25(OH)D] among Chinese adults.. In this 5-arm, randomized, double-blinded controlled trial, 76 healthy participants were assigned to orally administrate 0, 400, 800, 1200 or 2000 IU/d of vitamin D3 for 16 weeks. Serum 25(OH)D, parathyroid hormone, calcium, biomarkers of liver and renal function were measured at multiple time points.. The mean (SD) serum 25(OH)D at baseline was 31.6 (8.7) nmol/L, and the dose-response relationship was curvilinear with a plateau around 6 weeks for all doses. At week 16, 25(OH)D was increased by 6.0 (6.5), 21.7 (15.8), 26.3 (12.6), 32.0 (12.8) and 36.3 (26.0) nmol/L for 0, 400, 800, 1200 and 2000 IU/d (all P ≤ 0.002), corresponding to approximately 19, 53, 67, 77 and 80 % of reversion of vitamin D deficiency, respectively. Daily intake of 800 IU vitamin D3 reached a targeted 25(OH)D ≥ 30 nmol/L in at least 97.5 % of Chinese, but not a targeted 25(OH)D ≥ 50 nmol/L even with 2000 IU/d. Change of 25(OH)D was inversely associated with change of PTH concentration (r = -0.39, P < 0.001) after controlling for age and sex. No between-group differences were observed in terms of the change in serum calcium, alanine transaminase, aspartate aminotransferase, gamma-glutamyltransferase and creatinine (P ≥ 0.22).. Supplementation with 400, 800, 1200 or 2000 IU/d vitamin D could improve the vitamin D deficiency with various degrees. Whether 2000 IU/d vitamin D3 would generate a better result without side effect requires more studies with larger samples in future.

Topics: Adult; Alanine Transaminase; Asian People; Aspartate Aminotransferases; Biomarkers; Body Mass Index; Calcium, Dietary; Cholecalciferol; Creatinine; Dietary Supplements; Dose-Response Relationship, Drug; Double-Blind Method; Female; gamma-Glutamyltransferase; Humans; Kidney; Liver; Male; Middle Aged; Parathyroid Hormone; Socioeconomic Factors; Vitamin D Deficiency; Waist Circumference; Young Adult

Autism spectrum disorder (ASD) is a developmental disorder characterized by pervasive deficits in social interaction, impairment in verbal and non-verbal communication, and stereotyped patterns of interests and activities. Vitamin-D deficiency was previously reported in autistic children. However, the data on the relationship between vitamin D deficiency and the severity of autism are limited.. We performed a case-controlled cross-sectional analysis conducted on 122 ASD children, to assess their vitamin D status compared to controls and the relationship between vitamin D deficiency and the severity of autism. We also conducted an open trial of vitamin D supplementation in ASD children.. Fifty-seven percent of the patients in the present study had vitamin D deficiency, and 30% had vitamin D insufficiency. The mean 25-OHD levels in patients with severe autism were significantly lower than those in patients with mild/moderate autism. Serum 25-OHD levels had significant negative correlations with Childhood Autism Rating Scale (CARS) scores. Of the ASD group, 106 patients with low-serum 25-OHD levels (<30 ng/ml) participated in the open label trial. They received vitamin D3 (300 IU/kg/day not to exceed 5000 IU/day) for 3 months. Eighty-three subjects completed 3 months of daily vitamin D treatment. Collectively, 80.72% (67/83) of subjects who received vitamin D3 treatment had significantly improved outcome, which was mainly in the sections of the CARS and aberrant behavior checklist subscales that measure behavior, stereotypy, eye contact, and attention span.. Vitamin D is inexpensive, readily available and safe. It may have beneficial effects in ASD subjects, especially when the final serum level is more than 40 ng/ml.. UMIN-CTR Study Design: trial Number: R000016846.

Topics: Attention; Autism Spectrum Disorder; Calcifediol; Case-Control Studies; Child; Child Nutritional Physiological Phenomena; Child, Preschool; Cholecalciferol; Cross-Sectional Studies; Dietary Supplements; Egypt; Eye Movements; Humans; Hyperkinesis; Male; Nutritional Status; Patient Compliance; Psychiatric Status Rating Scales; Severity of Illness Index; Social Behavior; Stereotypic Movement Disorder; Vitamin D Deficiency

The co-existence of vitamin D deficiency with obesity and type 2 diabetes is highly prevalent in the United Arab Emirates. We do not have studies evaluating the vitamin D dose response and sufficiency, and if sufficient substitution dose during a longer period could decrease obesity or change fat distribution in obese type 2 diabetic vitamin D deficient Emiratis.. A randomized double-blind clinical trial was conducted for 6 months followed by another 6 months of un-blinded follow up with 87 obese, type 2 diabetic participants. Serum 25-hydroxy vitamin D (S-25(OH)D), anthropometric data, and life-style factors such as diet and sunlight exposure were measured. The study was executed in 3 phases in two arms vitamin D arm (n = 45) and placebo arm (n = 42); in Phase 1 the vitamin D arm received 6000 IU vitamin D3/day (3 months) followed by Phase 2 with 3000 IU vitamin D3/day. During follow up (phase 3) both the arms were un-blinded and supplemented with 2200 IU vitamin D3/day for another 6 months.. At the baseline a significant (p < 0.01) positive association between body fat mass and body weight (r = 0.97) muscle mass (r = 0.47), water mass (r = 0.54), waist circumference (r = 0.82) and serum PTH (r = 0.28) was observed. On supplementation no significant changes in anthropometric dimensions was observed. S-25(OH) D peaked in phase 1 (77.2 ± 30.1 vs 28.5 ± 9.2, p = 0.003) followed by a decrease in phase 2 (62.3 ± 20.8, p = 0.006) paralleled by a decrease in parathyroid hormone in phase 2 (5.9 ± 2.4 vs 4.5 ± 1.8, p < 0.01) compared to baseline in vitamin D group.. This study shows no significant influence of vitamin D supplementation on weight, fat mass or waist circumference in type 2 diabetic obese vitamin D deficient participants of Arab ethnicity after one year. Despite a relatively high daily dose of vitamin D3 we did not achieve target levels of S-25(OH)D above 75 nmol/L in this population. However, supplementation was safe, improved s- 25 (OH)D also reducing the incidence of eucalcemic parathyroid hormone elevation.. ClinicalTrials.gov Identifier: NCT02101151.

Topics: Adult; Aftercare; Body Composition; Body Weight; Cholecalciferol; Diabetes Mellitus, Type 2; Dietary Supplements; Double-Blind Method; Female; Humans; Male; Middle Aged; Obesity; Parathyroid Hormone; United Arab Emirates; Vitamin D Deficiency; Waist Circumference

Vitamin D is critical for skeletal health; hypovitaminosis D is common in pediatric inflammatory bowel disease (IBD), yet optimal repletion therapy is not well studied. We aimed to conduct a pilot trial comparing the efficacy of 2 vitamin D regimens of weekly dosing for the repletion of hypovitaminosis D in pediatric IBD.. Subjects identified from our IBD clinic with 25-hydroxyvitamin D (25[OH]D) concentrations <30 ng/mL were randomized to 10,000 (n = 18) or 5000 (n = 14) IU of oral vitamin D3/10 kg body weight per week for 6 weeks. Serum 25(OH)D, Ca, and parathyroid hormone concentrations were measured at baseline, week 8, and week 12.. In the higher dosing group, serum 25(OH)D increased from 23.7 ± 8.5 ng/mL at baseline to 49.2 ± 13.6 ng/mL at 8 weeks; P < 0.001. In the lower dosing group, serum 25(OH)D increased from 24.0 ± 7.0 ng/mL at baseline to 41.5 ± 9.6 ng/mL at 8 weeks; P < 0.001. At 12 weeks, serum 25(OH)D concentrations were 35.1 ± 8.4 and 30.8 ± 4.2 ng/mL for the higher and lower dose regimens, respectively. Mean serum Ca and parathyroid hormone concentrations did not significantly change during the study. No patient exhibited hypercalcemia, and no serious adverse events occurred.. Both treatment arms were safe and effective at normalizing vitamin D nutriture in pediatric IBD. Although significant repletion of 25(OH)D concentration was achieved in both dosing groups at 8 weeks, this effect was lost by the 12-week follow-up. Maintenance vitamin D therapy following initial repletion is likely required to maintain long-term normalized vitamin D status.

Topics: Adolescent; Calcium; Child; Cholecalciferol; Female; Humans; Inflammatory Bowel Diseases; Male; Parathyroid Hormone; Pediatrics; Pilot Projects; Treatment Outcome; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D insufficiency is common in children with cystic fibrosis (CF), yet data are sparse regarding the most effective form of vitamin D supplementation. The aim of this study was to compare two different vitamin D replacement regimens.. We conducted a randomized controlled trial comparing 50,000 IU of ergocalciferol (vitamin D2) twice weekly for 8 weeks versus 50,000 IU of cholecalciferol (vitamin D3) weekly in patients with CF, pancreatic insufficiency, age 6-21 years and a 25(OH)D<30 ng/mL. The primary outcome was change in serum 25(OH)D concentration. For secondary analyses, we examined changes in IgG, IgE and CRP in patients who normalized their vitamin D levels.. A total of 47 patients completed the trial. The mean pre-treatment 25(OH)D concentration was 23.1 (SD 4.7) ng/mL. The overall mean increase in 25(OH)D was 11.1 (11.9) ng/mL and 31/47 (66%) achieved a 25(OH)D concentration ≥ 30 ng/mL; of the 26 participants who received D2, 18 (69%) achieved sufficiency while 13/21 (62%) participants treated with D3 achieved sufficiency. There was no difference between groups in change of 25(OH)D (p=0.65). Similarly, there was no difference in the number of patients to achieve vitamin D sufficiency between treatments (p=0.6).. Ergocalciferol administered as 50,000 IU twice weekly is as effective as cholecalciferol 50,000 IU weekly for 8 weeks in pediatric patients with CF and vitamin D insufficiency. Only 66% of the patients studied achieved the desired 25(OH)D concentration.

Topics: Administration, Oral; Adolescent; Biomarkers; Child; Cholecalciferol; Cystic Fibrosis; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Therapy, Combination; Ergocalciferols; Exocrine Pancreatic Insufficiency; Female; Follow-Up Studies; Humans; Male; Treatment Outcome; Vitamin D; Vitamin D Deficiency; Vitamins; Young Adult

Obesity in children is associated with vitamin D deficiency and endothelial dysfunction. It is not known if treatment with vitamin D improves endothelial function in obese adolescents.. This study aimed to determine whether treatment with vitamin D3 improves endothelial function in obese adolescents.. Nineteen obese adolescents, 13-18 years of age, with 25-hydroxy vitamin D (25[OH]D) levels <75 nmol L(-1) were treated with 100 000 IU vitamin D3 orally once a month for 3 months in an open-label, single-centre prospective trial. Endothelial function was assessed by flow-mediated dilatation (FMD) of the brachial artery at study entry and 1 month after the third dose of vitamin D3 . Biochemical parameters, including calcium, fasting lipids, glucose, insulin and high-sensitivity C-reactive protein, were also obtained.. Mean 25(OH)D levels increased from 55.9 ± 12.2 to 86.9 ± 16.7 nmol L(-1) (P < 0.01). There was no correlation between 25(OH)D levels and brachial artery FMD. The brachial artery FMD (%) did not change significantly following vitamin D3 treatment (9.5 ± 3.53 vs. 10.3 ± 3.83, P = 0.83). Serum parathyroid hormone declined from 3.8 ± 1.5 to 3.1 ± 1 pmol L(-1) (P = 0.01). The remainder of biochemical measurements did not show a significant change.. Treatment with vitamin D3 , 100 000 IU once a month for 3 months was effective in increasing 25(OH)D levels in obese adolescents but did not impact endothelial function.

Topics: Adolescent; Brachial Artery; C-Reactive Protein; Calcium; Cholecalciferol; Endothelium, Vascular; Female; Humans; Insulin; Insulin Resistance; Lipids; Male; Parathyroid Hormone; Pediatric Obesity; Prospective Studies; Vitamin D; Vitamin D Deficiency

Low vitamin D status has been shown to be associated with coronary artery disease. We planned to research the effects of vitamin D3 supplementation on the severity of coronary artery disease.. We investigated the effect of 0.5 μg vitamin D3 per day in a randomized, placebo-controlled, double-blind study in 90 stable coronary artery disease patients residing in Beijing. Coronary angiography was performed before and after 6 months of treatment that took place between January and June. 25-Hydroxyvitamin D was measured by chemiluminescence assay. Coronary artery disease severity was assessed by using the SYNTAX scores.. In vitamin D supplementation group, there was a significant increase in mean 25-hydroxyvitamin D levels from baseline (19.9 ± 9.8 ng/ml) to 6 months (35.8 ± 12.1 ng/ml; p < 0.001). At 6 months, the primary end point, a difference in the fall of SYNTAX score between the groups was -2.5 (95% CI -5.1 to -0.5; p < 0.001) under intention to treat analysis. Compared with the control group, patients treated with vitamin D3 also had greater decreases in high sensitivity C-reactive protein and renin-angiotensin system activity (p < 0.05).. Vitamin D supplementation has beneficial effects on coronary artery disease; it can be an adjuvant therapy for patients with coronary artery disease.

Topics: Aged; Biomarkers; C-Reactive Protein; China; Cholecalciferol; Coronary Angiography; Coronary Artery Disease; Dietary Supplements; Double-Blind Method; Female; Humans; Intention to Treat Analysis; Male; Middle Aged; Renin-Angiotensin System; Severity of Illness Index; Time Factors; Treatment Outcome; Vitamin D; Vitamin D Deficiency

Restoration of vitamin D sufficiency may reduce asthma exacerbations, events that are often associated with respiratory tract infections and cold symptoms.. To determine whether vitamin D supplementation reduces cold symptom occurrence and severity in adults with mild to moderate asthma and vitamin D insufficiency.. Colds were assessed in the AsthmaNet VIDA (Vitamin D Add-on Therapy Enhances Corticosteroid Responsiveness) trial, in which 408 adult patients were randomized to receive placebo or cholecalciferol (100,000 IU load plus 4,000 IU/d) for 28 weeks as add-on therapy. The primary outcome was cold symptom severity, which was assessed using daily scores on the 21-item Wisconsin Upper Respiratory Symptom Survey.. A total of 203 participants experienced at least one cold. Despite achieving 25-hydroxyvitamin D levels of 41.9 ng/ml (95% confidence interval [CI], 40.1-43.7 ng/ml) by 12 weeks, vitamin D supplementation had no effect on the primary outcome: the average peak WURSS-21 scores (62.0 [95% CI, 55.1-68.9; placebo] and 58.7 [95% CI, 52.4-65.0; vitamin D]; P = 0.39). The rate of colds did not differ between groups (rate ratio [RR], 1.2; 95% CI, 0.9-1.5); however, among African Americans, those receiving vitamin D versus placebo had an increased rate of colds (RR, 1.7; 95% CI, 1.1-2.7; P = 0.02). This was also observed in a responder analysis of all subjects achieving vitamin D sufficiency, regardless of treatment assignment (RR, 1.4; 95% CI, 1.1-1.7; P = 0.009).. Our findings in patients with mild to moderate asthma undergoing an inhaled corticosteroid dose reduction do not support the use of vitamin D supplementation for the purpose of reducing cold severity or frequency.

Topics: Adult; Asthma; Cholecalciferol; Comorbidity; Dietary Supplements; Double-Blind Method; Female; Humans; Male; Prospective Studies; Respiratory Tract Infections; Risk; Severity of Illness Index; Treatment Outcome; Vitamin D Deficiency

Although studies have linked vitamin D deficiency with immune-mediated diseases, data demonstrating a direct effect on T-cell function are sparse.. Our objective was to determine whether oral vitamin D3 influences T-cell activation in humans with vitamin D deficiency.. This was a single-center ancillary study within Vitamin D Therapy in Individuals at High Risk of Hypertension, a double-blind, multicenter, randomized controlled trial.. This study was undertaken in a single academic medical center.. Adults with vitamin D deficiency and untreated pre- or early stage I hypertension were included.. In Vitamin D Therapy in Individuals at High Risk of Hypertension, participants were randomized to either low- (400 IU daily) or high- (4000 IU daily) dose oral vitamin D3 for 6 months. In this ancillary study of 38 patients, we measured CD4+ T-cell activation estimated by intracellular ATP release after stimulation of whole blood with plant lectin phytohemagglutinin collected at baseline (pretreatment) and 2-month follow-up.. Determining whether ATP level changes were significantly different between treatment groups was the main outcome measure.. Treatment with 4000 IU of vitamin D3 decreased intracellular CD4+ ATP release by 95.5 ng/ml (interquartile range, -219.5 to 105.8). In contrast, 400 IU of vitamin D3 decreased intracellular CD4+ ATP release by 0.5 ng/ml (interquartile range, -69.2 to 148.5). In a proportional odds model, high-dose vitamin D3 was more likely than low-dose vitamin D3 to decrease CD4+ ATP release (odds ratio, 3.43; 95% confidence interval, 1.06-1.11).. In this ancillary study of a randomized controlled trial, we found that high-dose vitamin D3 significantly reduced CD4+ T-cell activation compared to low-dose vitamin D3, providing human evidence that vitamin D can influence cell-mediated immunity.

Topics: Adenosine Triphosphate; Adult; Cholecalciferol; Cohort Studies; Dietary Supplements; Dose-Response Relationship, Drug; Double-Blind Method; Female; Follow-Up Studies; Humans; Hypertension; Lymphocyte Activation; Male; Middle Aged; T-Lymphocytes; Vitamin D Deficiency; Vitamins

Human milk is typically low in vitamin D activity (VDA). Whether the vitamin D content of breast milk at birth can be increased by supplementing the mother during pregnancy has not been reported to the best of our knowledge.. We examined the effect of vitamin D supplementation during pregnancy on breast-milk VDA in the first 2 mo of lactation.. Breast-milk samples were obtained from women who were enrolled in a randomized, double-blinded, placebo-controlled trial of vitamin D supplementation during pregnancy. Pregnant women were enrolled at 27 wk of gestation and randomly assigned to the following 3 groups: a placebo group, a group who received one dosage of daily oral vitamin D3 (1000 IU), or a group who received 2 dosages of daily oral vitamin D3 (2000 IU). Serum 25-hydroxyvitamin D [25(OH)D] was measured at enrollment, at 36 wk of gestation, and in cord blood at birth. Study participants who were breastfeeding were invited to provide breast-milk samples for VDA measurement [concentration of vitamin D2, vitamin D3, 25(OH)D2, and 25(OH)D3] at 2 wk and 2 mo postpartum. A linear mixed model was used to compare breast-milk VDA between the 3 study groups.. A total of 75 women provided breast-milk samples (44 women provided breast-milk samples at both 2 wk and 2 mo postpartum). The mean (95% CI) VDA at age 2 wk was 52 IU/L (12, 217 IU/L) in the placebo group, 51 IU/L (17, 151 IU/L) in the 1000-IU group, and 74 IU/L (25, 221 IU/L) in the 2000-IU group; and at age 2 mo, the mean (95% CI) VDA was 45 IU/L (16, 124 IU/L), 43 IU/L (18, 103 IU/L), and 58 IU/L (15, 224 IU/L), respectively. There was no significant interaction in VDA between the sample-collection time and treatment (P = 0.61), but there was a difference between lower- and higher-dosage treatment groups (P = 0.04).. Maternal vitamin D supplementation during pregnancy of 2000 IU/d (compared with 1000 IU/d and with a placebo) results in a higher VDA of breast milk ≥2 mo postpartum. This trial was registered at the Australian New Zealand Clinical Trials Registry as ACTRN12610000483055.

Topics: 25-Hydroxyvitamin D 2; Adult; Calcifediol; Cholecalciferol; Dietary Supplements; Double-Blind Method; Ergocalciferols; Female; Fetal Blood; Humans; Infant, Newborn; Lactation; Male; Maternal Nutritional Physiological Phenomena; Maternal-Fetal Exchange; Milk, Human; New Zealand; Pregnancy; Prenatal Care; Vitamin D; Vitamin D Deficiency; Young Adult

To compare 3 different treatment regimens for vitamin D deficiency in minority adolescents and to explore factors that impact treatment efficacy.. We conducted an 8-week, prospective, open-label, randomized clinical trial in an urban, academic, children's hospital. A total of 183 vitamin D-deficient adolescents, mean 25-hydroxyvitamin D or 25(OH)D 13.7 ± 3.9 ng/mL; mean age 16.6 ± 2.2 years, were randomized into 3 vitamin D3 (cholecalciferol) treatment arms: 50,000 IU/wk; 5000 IU/d; and 1000 IU/d. Serum 25(OH)D and vitamin D binding protein (VDBP) levels were measured pre-and posttreatment; 122 (67%) participants completed posttreatment measures. Complete-case and multiple-imputation, intention-to-treat analyses were performed.. Mean change in 25(OH)D level posttreatment was significantly different among the 3 arms, 24.9 ± 15.1 vs 21.0 ± 15.2 vs 6.2 ± 6.5 ng/mL, for 50,000 IU, 5000 IU, and 1000 IU doses, respectively, P < .001. Both high-dose treatments were effective in increasing the 25(OH)D level out of deficiency range (≥ 20 ng/mL) in more than 80% of participants, and 60% remained deficient after low-dose treatment. Only 72%, 56%, and 2% achieved vitamin D sufficiency (>30 ng/mL) with 50,000 IU, 5000 IU, and 1000 IU doses, respectively, P < .001. Obese participants had substantially less mean change in 25(OH)D level after treatment than normal-weight participants, 13.7 ± 10.7 vs 21.9 ± 16.9 ng/mL, P < .001. Mean baseline VDBP level was almost twice as high in Hispanic compared with black participants (P < .001) and did not alter treatment response or change with treatment.. Adult-sized adolescents require 8 weeks of high-dose cholecalciferol, at least 5000 IU/d, to correct deficiency. Obese adolescents have poorer response to treatment and may need higher doses than nonobese youth. Hispanic and black adolescents have different VDBP levels but similar treatment responses.. ClinicalTrials.gov: NCT01784029.

Topics: Adolescent; Biomarkers; Black or African American; Cholecalciferol; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Hispanic or Latino; Humans; Intention to Treat Analysis; Male; New York; Prospective Studies; Treatment Outcome; Vitamin D; Vitamin D Deficiency; Vitamins; Young Adult

To determine the dose-response relationship between 25-hydroxyvitamin D (25(OH)D) and supplemental vitamin D3 in elderly nursing home residents.. Randomized double-blind investigation.. Nursing home.. Of 81 women (n=51) and men (n=30) (mean age 87.4±8) enrolled, 72 completed the study.. Sixteen weeks of oral vitamin D3 at 800, 2,000, or 4,000 IU/d or 50,000 IU/wk.. The main outcome was 25(OH)D concentrations (tandem mass spectrometry) after 16 weeks. Free 25(OH)D and intact parathyroid hormone (iPTH) were also analyzed. Safety monitoring of calcium and estimated glomerular filtration rate was performed, and adherence and clinical status were measured.. 25(OH)D concentrations increased with dose (P<.001) and were higher with 50,000 IU/wk (P<.001) than other doses and with 4,000 IU/d than 800 or 2,000 IU/d, but 800 IU and 2,000 IU/d did not differ. One subject receiving 800 IU/d had concentrations less than 20 ng/mL. All subjects receiving more than 2000 IU/d had concentrations of 20 ng/mL and greater. Free 25(OH)D concentrations rose with total 25(OH) vitamin D. Total and free 25(OH)D were related to calcium concentrations; only free 25(OH)D was related to iPTH.. 25(OH)D increased linearly with 800 to 4,000 IU/d and 50,000 IU/wk of vitamin D3, without a ceiling effect. Data suggest that some elderly adults will require more than 800 IU/d of vitamin D3 to ensure adequate vitamin D levels. Changes in 25(OH)D with vitamin D3 were related to starting concentrations (greatest with the lowest concentrations and unchanged with 800 and 2,000 IU/d if 20-40 ng/mL). Relationships between serum calcium and iPTH and free 25(OH)D suggest the potential for free 25(OH)D in defining optimal 25(OH)D concentrations.

Topics: Administration, Oral; Aged; Aged, 80 and over; Cholecalciferol; Dose-Response Relationship, Drug; Double-Blind Method; Female; Follow-Up Studies; Humans; Male; Sunlight; Tandem Mass Spectrometry; Time Factors; Treatment Outcome; Vitamin D; Vitamin D Deficiency; Vitamins

Asthma and wheezing begin early in life, and prenatal vitamin D deficiency has been variably associated with these disorders in offspring.. To determine whether prenatal vitamin D (cholecalciferol) supplementation can prevent asthma or recurrent wheeze in early childhood.. The Vitamin D Antenatal Asthma Reduction Trial was a randomized, double-blind, placebo-controlled trial conducted in 3 centers across the United States. Enrollment began in October 2009 and completed follow-up in January 2015. Eight hundred eighty-one pregnant women between the ages of 18 and 39 years at high risk of having children with asthma were randomized at 10 to 18 weeks' gestation. Five participants were deemed ineligible shortly after randomization and were discontinued.. Four hundred forty women were randomized to receive daily 4000 IU vitamin D plus a prenatal vitamin containing 400 IU vitamin D, and 436 women were randomized to receive a placebo plus a prenatal vitamin containing 400 IU vitamin D.. Coprimary outcomes of (1) parental report of physician-diagnosed asthma or recurrent wheezing through 3 years of age and (2) third trimester maternal 25-hydroxyvitamin D levels.. Eight hundred ten infants were born in the study, and 806 were included in the analyses for the 3-year outcomes. Two hundred eighteen children developed asthma or recurrent wheeze: 98 of 405 (24.3%; 95% CI, 18.7%-28.5%) in the 4400-IU group vs 120 of 401 (30.4%, 95% CI, 25.7%-73.1%) in the 400-IU group (hazard ratio, 0.8; 95% CI, 0.6-1.0; P = .051). Of the women in the 4400-IU group whose blood levels were checked, 289 (74.9%) had 25-hydroxyvitamin D levels of 30 ng/mL or higher by the third trimester of pregnancy compared with 133 of 391 (34.0%) in the 400-IU group (difference, 40.9%; 95% CI, 34.2%-47.5%, P < .001).. In pregnant women at risk of having a child with asthma, supplementation with 4400 IU/d of vitamin D compared with 400 IU/d significantly increased vitamin D levels in the women. The incidence of asthma and recurrent wheezing in their children at age 3 years was lower by 6.1%, but this did not meet statistical significance; however, the study may have been underpowered. Longer follow-up of the children is ongoing to determine whether the difference is clinically important.. clinicaltrials.gov Identifier: NCT00920621.

Topics: Adult; Asthma; Child, Preschool; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Fetal Blood; Humans; Male; Pregnancy; Pregnancy Trimester, Third; Recurrence; Respiratory Sounds; Vitamin D; Vitamin D Deficiency; Vitamins; Young Adult

We sought to determine if vitamin D supplementation, to target 25(OH)D concentrations of 30-40 ng/mL, improves endothelial function in Singapore's multi-ethnic type 2 diabetes mellitus population. We randomised 64 type 2 diabetes mellitus patients with hypovitaminosis D to cholecalciferol 4000 International Unit/matching placebo [baseline 25(OH)D < 20 ng/mL] or cholecalciferol 2000 International Unit/matching placebo [baseline 25(OH)D: 20-30 ng/mL] daily for 16 weeks with a down titration at 8 weeks if 25(OH)D > 30 ng/mL. Endothelial function was assessed by peripheral tonometry (reactive hyperaemia index-endothelial peripheral arterial tonometry) and vascular biomarkers: E-selectin, von-Willebrand factor and high-sensitivity C-reactive protein. We compared the change from baseline parameters in the two groups using Student's t-test or Kruskal-Wallis test. A log-normal multivariate regression analysis was used to adjust for relevant baseline variables. The median reactive hyperaemia index in the vitamin D group increased from 0.65 (interquartile range: 0.42) to 0.73 (interquartile range: 0.36), whereas it decreased from 0.73 (interquartile range: 0.65) to 0.65 (interquartile range: 0.38) (p = 0.02) in the placebo group. After adjustment for baseline variables, the change was not statistically significant for reactive hyperaemia index (p = 0.07) and for other vascular biomarkers (p > 0.05). Targeted vitamin D supplementation for 16 weeks resulted in a small but non-significant improvement in endothelial function in a type 2 diabetes mellitus cohort.

Topics: Adult; Aged; Biomarkers; Cholecalciferol; Diabetes Mellitus, Type 2; Diabetic Angiopathies; Dietary Supplements; Double-Blind Method; Endothelium, Vascular; Female; Humans; Hyperemia; Male; Middle Aged; Singapore; Tertiary Care Centers; Time Factors; Treatment Outcome; Vasodilation; Vitamin D; Vitamin D Deficiency

The purpose of this study was to evaluate the clinical effect on the biochemical inflammatory markers of a single oral high dose of cholecalciferol in vitamin D-deficient patients undergoing the surgical removal of lower third molars.A randomized, split-mouth, single-blind study was conducted on 25 vitamin D-deficient patients ranging between 18 and 40 years of age requiring lower third molars extraction and referred at the Oral Surgery Unit of the School of Dentistry of the University of Messina.All patients, with vitamin D3 blood levels ≦30 ng/mL, underwent bilateral surgical removal. The first extraction (control group) being conducted with the administration of a placebo, the second one (test group) being conducted with the preliminary administration of 300,000 IU of cholecalciferol 4 days before the procedure.At each surgery, clinical indexes, such as pain, edema and any functional limitation have been recorded. Clinical and biochemical parameters were registered 4 days before, immediately after, 3 and 7 days after the surgical procedure. The data obtained were processed using paired t-test. The clinical outcome parameters showed a slight to moderate improvement between the control and the vitamin-D treatment group, with statistical significance being obtained regarding the edema at defined time points. Interleukin-1-beta, interleukin-6, and tumor necrosis factor-alpha values were significantly lower (P < 0.01) for the test group after the surgery. The increase of vitamin D serum levels showed an impact on the outcome of the third molar surgery, eliciting a reduced inflammatory response and leading to a more favorable clinical course.

Topics: Administration, Oral; Adolescent; Adult; Cholecalciferol; Edema; Female; Follow-Up Studies; Humans; Inflammation Mediators; Interleukin-1; Interleukin-6; Male; Mandible; Molar, Third; Pain, Postoperative; Placebos; Single-Blind Method; Tooth Extraction; Tooth, Impacted; Treatment Outcome; Trismus; Tumor Necrosis Factor-alpha; Vitamin D Deficiency; Vitamins; Young Adult

Gastric bypass is increasingly used worldwide to treat morbidly obese patients with good results. However, several studies have reported low levels of vitamin D in spite of supplementation. In this randomized clinical trial, we have evaluated two principally different interventions, short-term UVB treatment or a single cholecalciferol injection, to prevent hypovitaminosis D.. Seventy-three patients, randomly treated by UVB (n = 26) or injection (n = 20), and compared to controls (n = 27), were followed for 6 months. Both interventions, 12 treatments of whole-body narrowband UVB and an intramuscular injection of 600,000 IU cholecalciferol, were given in December, when natural sunlight is limited. Blood samples for 25-OH-vitamin D (25[OH]D), intact PTH, calcium, and albumin were obtained at baseline, after 1 and 3 months, and after 6 months for the intervention groups. 25[OH]D was analyzed using a HPLC method.. At baseline, 77.2 % of the patients had 25[OH]D <75 nmol/L. At 3 months, both UVB and cholecalciferol injection resulted in significantly higher 25[OH]D levels than controls (71.6 and 77.9 vs. 48.6 nmol/L, p < 0.05). The levels remained rather constant at 6 months (69.0 and 76.7 nmol/L, respectively); however, only injection therapy resulted in improved levels compared to baseline (55.7 nmol/L, p < 0.001). No toxic effects, nor significant changes in PTH or albumin-adjusted calcium, were seen.. In this randomized trial, both interventions, UVB and cholecalciferol, given as an adjunct to oral supplementation in gastric bypass patients, increased the levels of 25[OH]D. Simplicity makes injection therapy suitable for maintaining vitamin D levels during the Nordic winter.

Topics: Cholecalciferol; Gastric Bypass; Humans; Injections, Intramuscular; Ultraviolet Therapy; Vitamin D Deficiency

The aim of the study was to compare the effects of vitamin D3 supplementation versus placebo on serum sex hormones in postmenopausal women completing a 12-month diet + exercise weight loss program.. Two hundred eighteen overweight or obese women (50-75 y) with serum 25-hydroxyvitamin D at least 10 to less than 32 ng/mL ("insufficient") were randomized to either weight loss + 2,000 IU/day oral vitamin D3, or to weight loss + daily placebo. Serum sex hormone-binding globulin, estrone, total, free, and bioavailable estradiol, and testosterone were measured by radioimmunoassay before randomization and at 12 months. Mean changes were compared between groups (intent-to-treat) using generalized estimating equations.. The 12-month changes in sex hormone-binding globulin, estrone, total, free, and bioavailable estradiol, and testosterone did not differ between groups (all P > 0.05). However, a greater increase in serum 25-hydroxyvitamin D was associated with a greater increase in sex hormone-binding globulin (Ptrend = 0.01), and larger decreases in free and bioavailable estradiol (Ptrend = 0.04, Ptrend = 0.03, respectively). In post-hoc analyses, we compared women randomized to vitamin D whose serum 25-hydroxyvitamin D remained insufficient (n = 38), to women who became replete (25-hydroxyvitamin D ≥32 ng/mL; n = 53). Replete women showed greater reductions in bioavailable estradiol (-1.8 vs -0.7 pg/mL), free testosterone (-0.8 vs -0.3 pg/mL), and bioavailable testosterone (-1.8 vs -0.6 ng/dL), and a greater increase in sex hormone-binding globulin (10.6 vs 4.7 nmol/L) (all P < 0.05), even after adjusting for differences in total 12-month weight loss.. Overall, 12-month changes in sex hormone did not differ between groups. However, vitamin D repletion was associated with greater reductions in sex hormones during weight loss, with a possible dose-dependent effect. Future studies should test higher doses and target circulating 25-hydroxyvitamin D levels when measuring such effects.

Topics: Aged; Cholecalciferol; Diet; Diet, Reducing; Dietary Supplements; Estradiol; Estrone; Exercise; Female; Gonadal Steroid Hormones; Humans; Middle Aged; Obesity; Overweight; Placebos; Postmenopause; Sex Hormone-Binding Globulin; Testosterone; Vitamin D; Vitamin D Deficiency; Weight Loss

Topics: Adrenal Cortex Hormones; Asthma; CD4-Positive T-Lymphocytes; Cholecalciferol; Dendritic Cells; Gene Expression; Humans; Interferon-gamma; Interleukins; Monocytes; Transforming Growth Factor beta; Tumor Necrosis Factor-alpha; Vitamin D Deficiency

The vitamin D recommended doses during pregnancy differ between societies. The WHO guidelines do not recommend routine prenatal supplementation, but they underscore the fact that women with the lowest levels may benefit most. The effects of routine supplementation during pregnancy on maternal and neonatal clinical outcomes have not been investigated in the Middle East, where hypovitaminosis D is prevalent. Our hypothesis is that in Middle Eastern pregnant women, a vitamin D dose of 3000 IU/day is required to reach a desirable maternal 25-hydroxyvitamin D [25(OH)D] level, and to positively impact infant bone mineral content (BMC).. This is a multicentre blinded randomised controlled trial. Pregnant women presenting to the Obstetrics and Gynaecology clinics will be approached. Eligible women will be randomised to daily equivalent doses of cholecalciferol, 600 IU or 3000 IU, from 15 to 18 weeks gestation until delivery. Maternal 25(OH)D and chemistries will be assessed at study entry, during the third trimester and at delivery. Neonatal anthropometric variables and 25(OH)D level will be measured at birth, and bone and fat mass assessment by dual-energy X-ray absorptiometry scan at 1 month. A sample size of 280 pregnant women is needed to demonstrate a statistically significant difference in the proportion of women reaching a 25(OH)D level ≥ 50 nmol/L at delivery, and a difference in infant BMC of 6 (10)g, for a 90% power and a 2.5% level of significance. The proportions of women achieving a target 25(OH)D level will be compared between the two arms, using χ(2). An independent t test will be used to compare mean infant BMC between the two arms. The primary analysis is an intention-to-treat analysis of unadjusted results.. The protocol has been approved by the Institutional Review Board at the American University of Beirut-Lebanon (IM.GEHF.22). The trial results will be published in peer-reviewed medical journals and presented at scientific conferences.. NCT02434380.

Topics: Absorptiometry, Photon; Adolescent; Adult; Bone Density; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Infant; Infant, Newborn; Lebanon; Middle Aged; Pregnancy; Pregnancy Complications; Research Design; Vitamin D; Vitamin D Deficiency; Vitamins; Young Adult

Topics: Adrenal Cortex Hormones; Adult; Asthma; Cholecalciferol; Female; Humans; Male; Middle Aged; Paranasal Sinus Diseases; Treatment Failure; Vitamin D Deficiency

Psychological problems are common among end-stage renal disease patients undergoing dialysis. We aim to evaluate whether high-dose vitamin D3 (VD3) supplementation has beneficial effects on depressive symptoms in dialysis patients. This prospective, randomized, and double-blind trial includes 746 dialysis patients with depression treated in 3 hospitals in Southeast China. Depression was diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders criteria. Patients were randomly assigned to 52-week treatment of oral 50,000 IU/wk VD3 (cholecalciferol) (test group) or a placebo (control group). The presence of depressive symptoms was evaluated using the Chinese version of Beck Depression Inventory (BDI) II both before and after treatment. Sociodemographic data, clinical data, nutritional indexes, inflammatory biomarkers, and plasma VD3 concentrations were also determined. Finally, 726 patients completed the experiments, including 362 tested patients and 364 controls. After 52 weeks, the depressive symptoms were not significantly improved in the test group (mean BDI II scores changed from -1.1 ± 0.3 to -3.1 ± 0.6) versus the control group. Multivariable logistic regression showed BDI scores were not significantly improved in the test group versus the control group with adjustment for age, sex, comorbidity index, dialysis modality, or (OH)D levels (multivariable-adjusted mean change or MAMC [95% confidence interval (CI)], -2.3 [-2.48 to -1.83]) in the whole dialysis population. After stratification by depression types, the findings do support a significant relationship between the VD3 supplementation and the improvement in BDI II scores in dialysis patients with vascular depression (MAMC [95% CI], -4.4 [-5.08 to -2.76]), but the effect was not significant for major depressive disorders (MAMC [95% CI], -0.9 [-1.52 to -0.63]). The high-dose VD3 supplementation did not significantly reduce the depressive symptoms in our total dialysis population, but a beneficial effect on vascular depression was found, probably mainly based on the improvement of cardiovascular risk factors.

Topics: Administration, Oral; Adolescent; Adult; Aged; China; Cholecalciferol; Depression; Depressive Disorder, Major; Dietary Supplements; Double-Blind Method; Female; Humans; Kidney Failure, Chronic; Male; Middle Aged; Prospective Studies; Renal Dialysis; Treatment Outcome; Vitamin D Deficiency; Young Adult

Bread can potentially be a suitable vehicle for fortification with vitamin D.. This study was undertaken to evaluate the following: 1) the bioavailability of vitamin D from the fortified Iranian bread and 2) the possible effects of daily consumption of the fortified bread on certain health aspects.. This was a randomized, double-blind, placebo-controlled trial conducted over 8 weeks in 90 healthy subjects aged 20-60 years.. Subjects were randomly allocated to one of three groups: 1) fortified bread (FP; 50 g bread fortified with 25 μg vitamin D3 plus placebo daily; n = 30); 2) supplement (SP; 50 g plain bread plus 25 μg vitamin D supplement daily; n = 30); and 3) control (CP; 50 g plain bread plus placebo daily; n = 30).. Initial and final anthropometric and biochemical assessments were performed.. The within-group changes of serum 25-hydroxyvitamin D concentrations were 39.0 ± 22.6 (P < .001), 28.9 ± 31.2 (P < .001), and -9.2 ± 12.3 nmol/L in the FP, SP, and CP groups, respectively. Only in FP and SP groups, serum intact PTH concentrations decreased approximately 13.5% and 14.5%, respectively. Visceral fat also showed a significant decrement in FP (-1.05% ± 1.4%; P ≤ .001) and SP (-0.96% ± 1.7%; P = .006). Serum low-density lipoprotein cholesterol concentration showed a within-group reduction in FP (-10.4 ± 11.2 mg/dL; P < .001) and an insignificant decrement in SP (-6.6 ± 20.2 mg/dL; P = .083). Serum high-density lipoprotein increased in both vitamin D-supplemented groups (FP: 9.7 ± 7.6 vs SP: 5.7 ± 6.7 mg/dL; P < .001).. Vitamin D-fortified bread could be potentially effective in raising circulating 25-hydroxyvitamin D levels of the population to nearly adequate levels.

Topics: Adult; Bread; Cholecalciferol; Double-Blind Method; Female; Food, Fortified; Hormone Replacement Therapy; Humans; Iran; Male; Middle Aged; Parathyroid Hormone; Treatment Outcome; Vitamin D; Vitamin D Deficiency

To compare the efficacy of 400 vs 1000 IU oral vitamin D supplementation in preterm neonates of 27 to 34 weeks gestation.. This double-blind randomized controlled trial allocated preterm babies to receive either 400 or 1000 IU of vitamin D3 (n=60 in each group). Primary outcome was prevalence of vitamin D insufficiency (serum vitamin D levels<20 ng ml(-1)) at 40 weeks of corrected gestational age (CGA).. At term CGA vitamin D insufficiency was significantly lower in the 1000 IU group than in the 400 IU group (2% vs 64.6%, P⩽0.001). Although elevated vitamin D levels were seen in 9.8% of babies on 1000 IU per day, this was not associated with clinical or biochemical evidence of toxicity.. Supplementing preterm babies with 1000 IU of vitamin D3 daily decreases the prevalence of vitamin D insufficiency at term CGA. Excess levels of vitamin D may occur at this dose in some babies.

Topics: Calcium; Cholecalciferol; Dietary Supplements; Dose-Response Relationship, Drug; Double-Blind Method; Female; Gestational Age; Humans; India; Infant, Newborn; Male; Tertiary Care Centers; Vitamin D Deficiency

Hypovitaminosis D and inflammation are highly prevalent among patients undergoing dialysis, and the association of both conditions with worse survival has been well recognized. Although a potential role for vitamin D in the immune system has been suggested, the effect of the treatment of hypovitaminosis D on the modulation of the inflammatory response remains unclear. The aim of this study was to investigate the effect of the restoration of the vitamin D status on the expression of vitamin D-regulatory proteins in monocytes and on circulating inflammatory markers in dialysis patients.. In this randomized double-blind placebo-controlled 12-week trial, 38 patients on dialysis with serum 25-hydroxyvitamin D [25(OH)D] <20 ng/mL were randomized either to the cholecalciferol group (n = 20; 50,000 IU of cholecalciferol twice weekly) or to the control group (n = 18; 50 drops of a placebo solution twice weekly). The expression of vitamin D receptor (VDR), CYP27B1, CYP24A1 and interleukin-6 (IL-6) in monocytes was determined by flow cytometry. Serum concentrations of 25(OH)D, interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α) and C-reactive protein (CRP) were measured. The trial is registered at ClinicalTrials.gov #NCT01974245.. After 12 weeks, the serum 25(OH)D increased from 14.3 ± 4.7 ng/mL to 43.1 ± 11.0 ng/mL (p < 0.05) in the cholecalciferol group and did not change in the control group (13.9 ± 4.2 ng/mL to 13.5 ± 4.3 ng/mL; p = 0.56). In monocytes, while CYP27B1 expression and VDR expression increased in the cholecalciferol group (p < 0.05), CYP27B1 expression did not change, and VDR expression decreased in the control group (p < 0.05). There were no changes in IL-6 and CYP24A1 expression in both groups. Serum concentration of IL-6 and CRP decreased from 8.1 ± 6.6 pg/mL to 4.6 ± 4.1 pg/mL (p < 0.05) and from 0.50 (0.10-1.27) mg/dL to 0.28 (0.09-0.62) mg/dL (p < 0.05), respectively only in the cholecalciferol group. Assessed overtime, the treatment group differences in 25(OH) D, PTH, CRP and IL-6, CYP27B1 and VDR remained significant.. Restoration of vitamin D status of patients undergoing dialysis promoted upregulation of CYP27B1 and VDR expression in monocytes and a decrease in circulating inflammatory markers.

Topics: 25-Hydroxyvitamin D3 1-alpha-Hydroxylase; Adult; Aged; Biomarkers; Brazil; C-Reactive Protein; Cholecalciferol; Double-Blind Method; Female; Humans; Inflammation; Interleukin-6; Male; Middle Aged; Monocytes; Placebos; Receptors, Calcitriol; Renal Dialysis; Vitamin D; Vitamin D Deficiency; Vitamin D3 24-Hydroxylase

Controversy persists over: 1) how best to restore low serum 25-hydroxyvitamin D (25D) levels (vitamin D2 [D2] vs vitamin D3 [D3]); 2) how best to define vitamin D status (total [protein-bound + free] vs free 25D); and 3) how best to assess the bioactivity of free 25D.. To assess: 1) the effects of D2 vs D3 on serum total and free 25D; and 2) whether change in intact PTH (iPTH) is more strongly associated with change in total vs free 25D.. Participants previously enrolled in a D2 vs D3 trial were matched for age, body mass index, and race/ethnicity. Participants received 50 000 IU of D2 or D3 twice weekly for 5 weeks, followed by a 5-week equilibration period. Biochemical assessment was performed at baseline and at 10 weeks.. Thirty-eight adults (19 D2 and 19 D3) ≥18 years of age with baseline 25D levels <30 ng/mL were recruited from an academic ambulatory osteoporosis clinic.. Serum measures were total 25D, free 25D (directly measured), 1,25-dihydroxyvitamin D, calcium, and iPTH. Urine measure was fasting calcium:creatinine ratio.. Baseline total (22.2 ± 3.3 vs 23.3 ± 7.2 ng/mL; P = .5) and free (5.4 ± 0.8 vs 5.3 ± 1.7 pg/mL; P = .8) 25D levels were similar between D2 and D3 groups. Increases in total (+27.6 vs +12.2 ng/mL; P = .001) and free (+3.6 vs +6.2 pg/mL; P = .02) 25D levels were greater with D3 vs D2. Percentage change in iPTH was significantly associated with change in free (but not total) 25D, without and with adjustment for supplementation regimen, change in 1,25-dihydroxyvitamin D, and change in calcium.. D3 increased total and free 25D levels to a greater extent than D2. Free 25D may be superior to total 25D as a marker of vitamin D bioactivity.

Topics: Adult; Aged; Biomarkers; Calcium; Case-Control Studies; Cholecalciferol; Dose-Response Relationship, Drug; Ergocalciferols; Homeostasis; Hormone Replacement Therapy; Humans; Middle Aged; Parathyroid Hormone; Vitamin D; Vitamin D Deficiency

Controversy exists over the disparate circulating 25-hydroxyvitamin D [25(OH)D] concentrations between black and white Americans.. We sought to determine whether there are differences in total and directly measured free 25(OH)D concentrations between black and white American adults and how daily supplementation with cholecalciferol changes these concentrations.. Cross-sectional and longitudinal analyses were conducted with the use of data from 2 placebo-controlled, randomized trials at 2 academic medical centers in the United States: CaDDM (Calcium and Vitamin D in Type 2 Diabetes) and DDM2 (Vitamin D for Established Type 2 Diabetes). A total of 208 subjects with pre- or well-controlled diabetes with a mean age of 59.1 y and mean body mass index (BMI; in kg/m(2)) of 31.6 were randomly assigned to receive daily cholecalciferol supplementation at 1 of 2 doses (2000 or 4000 IU) or a matching placebo for 16 wk. We measured serum total 25(OH)D, vitamin D-binding protein (DBP) by 2 different immunoassays (with the use of monoclonal or polyclonal antibodies), parathyroid hormone, and albumin. Free 25(OH)D concentration was directly measured and calculated.. Blacks had lower total 25(OH)D concentrations than whites [adjusted median: 20.3 ng/mL (95% CI: 16.2, 24.5 ng/mL) compared with 26.7 ng/mL (95% CI: 25.2, 28.1 ng/mL), respectively; P = 0.026)], and a higher proportion of blacks had total 25(OH)D concentrations <20 ng/mL (46% compared with 19%, respectively; P < 0.001). Directly measured free 25(OH)D concentrations were lower in blacks than in whites [adjusted median: 4.5 ng/mL (95% CI: 3.7, 5.4 ng/mL) compared with 5.7 ng/mL (95% CI: 5.4, 5.9 ng/mL), respectively; P = 0.044] and were strongly correlated with total 25(OH)D without an effect of race. DBP was lower in blacks when measured by the monoclonal but not the polyclonal antibody immunoassay. Cholecalciferol supplementation increased total and measured free 25(OH)D concentrations proportionally to the dose and without a difference between races.. The relation between free and total 25(OH)D did not vary systematically by race in this multiracial population with pre- or well-controlled diabetes. The results need to be replicated in additional cohorts before concluding that the clinical assessment of vitamin D status in blacks and whites should follow a single standard. The CaDDM and DDM2 trials were registered at clinicaltrials.gov as NCT00436475 and NCT01736865, respectively.

Topics: Aged; Black or African American; Body Mass Index; Cholecalciferol; Cross-Sectional Studies; Diabetes Mellitus, Type 2; Dietary Supplements; DNA-Binding Proteins; Female; Humans; Longitudinal Studies; Male; Middle Aged; Transcription Factors; United States; Vitamin D; Vitamin D Deficiency; White People

Non-alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in Western countries. A meta-analysis has confirmed decreased serum 25-hydroxyvitamin D levels in NAFLD patients. This intervention study investigates whether vitamin D correction ameliorates hepatic steatosis.. We prospectively recruited 40 patients from an outpatient liver clinic with vitamin D deficiency (serum 25-hydroxyvitamin D < 20 ng/ml). Controlled attenuation parameter (CAP) during transient elastography quantified hepatic steatosis. Patients with significant liver fat accumulation were included, which was defined by a CAP value >/= 280 dB/m. Patients received 20,000 IU vitamin D/week for six months, while vitamin D status, liver function tests (LFTs), CAP and body composition were monitored.. The cohort comprised 47.5% women (age 54.9 +/- 12.1 years; BMI 29.5 +/- 3.0 kg/m2). Mean serum vitamin D level was 11.8 +/- 4.8 ng/ml. CAP decreased significantly from baseline (330 +/- 32 vs. 307 +/- 41 dB/m) during supplementation (P = 0.007). A mean CAP reduction relative to baseline was demonstrated at four weeks and three and six months: -5.3 +/- 13.8%; -6.0 +/- 14.6% and -6.4 +/- 13.0%, respectively. During these time points, restoration of serum vitamin D levels was observed (34.6 +/- 12.9, 36.3 +/- 10.2, 34.8 +/- 9.8 ng/ml; P < 0.0001). Liver function tests and body composition remained unchanged.. Hepatic steatosis, as assessed by CAP, significantly improves after only 4 weeks of vitamin D correction. Hepatic steatosis is a dynamic process, that can be monitored in the short-term using such non-invasive methods.

Topics: Adult; Aged; Ambulatory Care Facilities; Biomarkers; Cholecalciferol; Dietary Supplements; Elasticity Imaging Techniques; Female; Germany; Humans; Liver; Male; Middle Aged; Non-alcoholic Fatty Liver Disease; Prospective Studies; Risk Factors; Time Factors; Treatment Outcome; Vitamin D; Vitamin D Deficiency

It is unclear whether and at what dose vitamin D supplementation affects insulin resistance (IR).. We sought to investigate whether vitamin D at doses higher than currently recommended decreases indexes of IR in an ambulatory population of overweight elderly subjects.. This double-blind, randomized, controlled multicenter trial enrolled 257 elderly overweight individuals aged ≥65 y with baseline 25-hydroxyvitamin D [25(OH)D] concentrations between 10 and 30 ng/mL. All subjects received 1000 mg calcium citrate/d, with vitamin D administered weekly at an equivalent dose of 600 or 3750 IU/d. The homeostasis model assessment (HOMA) of IR index at 1 y was the primary outcome. We also assessed the McAuley index.. In total, 222 subjects (55% women) with a mean ± SD age and body mass index (BMI; in kg/m(2)) of 71 ± 4 y and 30 ± 4, respectively, completed the study. Subjects' baseline characteristics, including IR indexes, were similar across groups: 69% had prediabetes, 54% had hypertension (47% were taking antihypertensive medications), and 60% had hyperlipidemia, nearly half of whom were receiving lipid-lowering drugs. At 1 y, mean ± SD serum 25(OH)D increased from 20 ± 7 to 26 ± 7 ng/mL in the low-dose arm (P < 0.0001) and from 21 ± 8 to 36 ± 10 ng/mL in the high-dose arm (P < 0.001). Median HOMA-IR indexes did not change compared with baseline concentrations and were similar in the high- [2.2 (IQR: 1.5, 2.9)] and low-dose [2.3 (IQR: 1.6, 3.3] treatment groups. Adjusted analyses showed that HOMA-IR was predicted by the baseline HOMA index and BMI but not by vitamin D dose, baseline serum 25(OH)D, or change in 25(OH)D.. Vitamin D3 at 3750 IU/d did not improve HOMA-IR compared with the Institute of Medicine Recommended Dietary Allowance of 600 IU/d in elderly overweight individuals. This trial was registered at clinicaltrials.gov as NCT01315366.

Topics: Aged; Body Mass Index; Cholecalciferol; Comorbidity; Dietary Supplements; Double-Blind Method; Female; Humans; Insulin Resistance; Male; Obesity; Overweight; Vitamin D; Vitamin D Deficiency; Vitamins

To assess the prevalence of vitamin D deficiency in Dutch athletes and to define the required dosage of vitamin D3 supplementation to prevent vitamin D deficiency over the course of a year.. Blood samples were collected from 128 highly trained athletes to assess total 25(OH)D concentration. Of these 128 athletes, 54 male and 48 female athletes (18-32 years) were included in a randomized, double blind, dose-response study. Athletes with either a deficient (<50 nmol/l) or an insufficient (50-75 nmol/l) 25(OH)D concentration were randomly assigned to take 400, 1100 or 2200 IU vitamin D3 per day orally for 1 year. Athletes who had a total 25(OH)D concentration above 75 nmol/l at baseline continued with the study protocol without receiving vitamin D supplements. Serum total 25(OH)D concentration was assessed every 3 months, as well as dietary vitamin D intake and sunlight exposure.. Nearly 70% of all athletes showed an insufficient (50-75 nmol/l) or a deficient (<50 nmol/l) 25(OH)D concentration at baseline. After 12 months, serum 25(OH)D concentration had increased more in the 2200 IU/day group (+50±27 nmol/l) than the sufficient group receiving no supplements (+4±17 nmol/l; P<0.01) and the 1100 IU/day group (+25±23 nmol/l; P<0.05). Supplementation with 2200 IU/day vitamin D resulted in a sufficient 25(OH)D concentration in 80% of the athletes after 12 months.. Vitamin D deficiency is highly prevalent in athletes. Athletes with a deficient or an insufficient 25(OH)D concentration can achieve a sufficient 25(OH)D concentration within 3 months by taking 2200 IU/day.

Topics: Adolescent; Adult; Athletes; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Male; Netherlands; Sports Medicine; Vitamin D; Vitamin D Deficiency; Young Adult

Despite numerous animal studies that have illustrated the impact of additional vitamin D in the diet of hens on the resulting egg vitamin D content, the effect of the consumption of such eggs on vitamin D status of healthy individuals has not, to our knowledge, been tested.. We performed a randomized controlled trial (RCT) to investigate the effect of the consumption of vitamin D-enhanced eggs (produced by feeding hens at the maximum concentration of vitamin D3 or serum 25-hydroxyvitamin D [25(OH)D3] lawfully allowed in feed) on winter serum 25(OH)D in healthy adults.. We conducted an 8-wk winter RCT in adults aged 45-70 y (n = 55) who were stratified into 3 groups and were requested to consume ≤2 eggs/wk (control group, in which status was expected to decline), 7 vitamin D3-enhanced eggs/wk, or seven 25(OH)D3-enhanced eggs/wk. Serum 25(OH)D was the primary outcome.. Although there was no significant difference (P > 0.1; ANOVA) in the mean preintervention serum 25(OH)D in the 3 groups, it was ∼7-8 nmol/L lower in the control group than in the 2 groups who consumed vitamin D-enhanced eggs. With the use of an ANCOVA, in which baseline 25(OH)D was accounted for, vitamin D3-egg and 25(OH)D3-egg groups were shown to have had significantly higher (P ≤ 0.005) postintervention serum 25(OH)D than in the control group. With the use of a within-group analysis, it was shown that, although serum 25(OH)D in the control group significantly decreased over winter (mean ± SD: -6.4 ± 6.7 nmol/L; P = 0.001), there was no change in the 2 groups who consumed vitamin D-enhanced eggs (P > 0.1 for both).. Weekly consumption of 7 vitamin D-enhanced eggs has an important impact on winter vitamin D status in adults. This trial was registered at clinicaltrials.gov as NCT02678364.

Topics: 25-Hydroxyvitamin D 2; Aged; Animals; Calcifediol; Chickens; Cholecalciferol; Consumer Behavior; Cooking; Diet; Eggs; Female; Food Preferences; Humans; Ireland; Male; Middle Aged; Nutritive Value; Prevalence; Risk; Seasons; Sensation; Vitamin D Deficiency

Both vitamin D and iron deficiencies are widespread globally, and a relationship between these deficiencies has been suggested. However, there is a paucity of randomised controlled trials assessing the effect of vitamin D supplementation on iron status.. We aimed to investigate whether 16 weeks of daily vitamin D3 supplementation had an effect on serum ferritin, haemoglobin, serum iron and transferrin saturation.. Overall, 251 participants from South Asia, Middle East and Africa aged 18-50 years who were living in Norway were randomised to receive daily oral supplementation of 10 μg vitamin D3, 25 μg vitamin D3, or placebo for 16 weeks during the late winter. Blood samples from baseline and after 16 weeks were analysed for serum 25-hydroxyvitamin D (s-25(OH) D), serum ferritin, haemoglobin and serum iron. In total, 214 eligible participants completed the intervention (86 % of those randomised). Linear regression analysis were used to test the effect of vitamin D3 supplementation combined (10 or 25 μg) and separate doses 10 or 25 μg compared to placebo on change (T2-T1) in each outcome variable adjusted for baseline s-25(OH)D values.. There was no difference in change in the levels of s-ferritin (1.9 μg/L, 95 % CI: -3.2, 7.0), haemoglobin (-0.02 g/dL, 95 % CI: -0.12, 0.09), s-iron (0.4 μg/L, 95 % CI: -0.5, 1.3) or transferrin saturation (0.7 %, 95 % CI: -0.6.1, 2.0) between those receiving vitamin D3 or those receiving placebo. Serum 25-hydroxyvitamin D increased from 29 nmol/L at baseline to 49 nmol/L after the intervention, with little change in the placebo group.. In this population of healthy ethnic minorities from South Asia, the Middle East and Africa who had low vitamin D status, 16 weeks of daily supplementation with 10 or 25 μg of vitamin D3 did not significantly affect the haemoglobin levels or other markers of iron status.

Topics: Adolescent; Adult; Anemia, Iron-Deficiency; Asia; C-Reactive Protein; Cholecalciferol; Dietary Supplements; Dose-Response Relationship, Drug; Double-Blind Method; Ethnicity; Female; Ferritins; Folic Acid; Hemoglobins; Humans; Iron; Linear Models; Male; Middle Aged; Middle East; Norway; Nutritional Status; Transferrin; Vitamin B 12; Vitamin D Deficiency; Young Adult

Low levels of serum 25-hydroxy vitamin D are associated with increased arterial stiffness and hypertension. Supplementation with vitamin D precursors has been proposed as a treatment option for these conditions. We examined the effect of oral cholecalciferol on arterial stiffness and blood pressure in healthy normotensive adults.. 40 healthy adults were randomised in this double-blinded study to either oral cholecalciferol 3000 IU/day or matching placebo and were followed for 16 weeks to examine any effects on pulse wave velocity (PWV), augmentation index (AIx), peripheral and central blood pressure and 24-hour ambulatory blood pressure.. 22 subjects in the cholecalciferol arm and 18 subjects in the placebo arm completed the 16 weeks of follow-up. There was no difference in changes in PWV, AIx corrected for heart rate or central or peripheral blood pressure between the two groups. There was no correlation between serum 25-hydroxy vitamin D and any of these parameters.. Oral cholecalciferol 3000 IU/day does not affect arterial stiffness or blood pressure after 16 weeks of treatment in healthy normotensive adults.. ClinicalTrials.gov NCT00952562.

Topics: Adult; Blood Pressure; Cholecalciferol; Female; Humans; Male; Middle Aged; Treatment Outcome; Vascular Stiffness; Vitamin D; Vitamin D Deficiency

Seventy six hemodialysis (HD) patients were used in a prospective randomized and clinical trial to determine if a multivitamin with vitamin D (cholecalciferol 12,000 IU/week) given during dialysis would improve the vitamin D status of hemodialysis subjects.. Subjects were randomly assigned to two groups: 37 subjects were in the renal multivitamin without vitamin D (MV) group and 39 subjects were in a multivitamin route with vitamin D (MVD) group (12,000 IU of cholecalciferol per week). All subjects were given 2 multivitamin tablets at their 3 HD sessions each week for 20 weeks. Serum 25(OH)D, calcium (Ca), and phosphorus (P) levels were evaluated.. At baseline, mean serum 25(OH)D were below adequate (<30 ng/mL) in the MV group (23.5±12.2 ng/mL) and in the MVD group (20.8±10.3 ng/mL). A significant increase was seen in serum 25(OH)D levels (37.7±11.4 ng/mL; p<0.001) in the MVD group after vitamin D supplementation with no rise in the MV group value (21.7±11.4 ng/mL; p=0.06). Prior to supplementation, 17.9% of patients in the MVD group had adequate serum 25(OH)D level and post supplementation 76.9% in the MVD group had adequate serum 25(OH)D. In the MV group, 18.9% subjects had adequate serum 25(OH)D levels at baseline with 18.9% having 25(OH)D >30 ng/mL at the end of the study. There were no significant differences in group values for serum Ca and P.. The majority of HD subjects given a multivitamin with cholecalciferol at dialysis had improvement in their vitamin D status.. 背景与目的：为确定在透析时给予含维生素D（胆钙化醇12,000 IU/周）的复 合维生素是否能够改善血液透析患者的维生素D 状态，进行该项包括76 位血 液透析（HD）患者的前瞻性随机临床试验。方法与研究设计：受试者被随机分 为两组：37 位分在不含维生素D 的复合维生素组（MV），另外39 位分在含维 生素D 的复合维生素组（MVD，胆钙化醇12,000 IU/周）。所有受试者在HD 第3 阶段每周给予2 片复合维生素，持续20 周。评估其血清25(OH)D、钙和磷 浓度。结果：两组患者基线平均血清25(OH)D 均不足（<30 ng/mL），MV 组 为23.5±12.2 ng/mL，MVD 组为20.8±10.3 ng/mL。补充维生素D 之后，MVD 组血清25(OH)D 浓度显著升高37.7±11.4 ng/mL；p<0.001，而MV 组血清 25(OH)D 浓度没有升高（21.7±11.4 ng/mL；p=0.06）。补充前，MVD 组有 17.9%的患者血清25(OH)D 充足，补充后，MVD 组有76.9%的患者血清 25(OH)D 充足。在MV 组，基线时有18.9%的患者血清25(OH)D 充足，试验结 束时，血清25(OH)D>30 ng/mL 的患者仍然只占18.9%。两组血清钙和磷在补 充前后没有显著变化。结论：大多数HD 患者在透析时给予含胆钙化醇的复合 维生素可以改善他们的维生素D 状态。.

Topics: Aged; Cholecalciferol; Dietary Supplements; Female; Humans; Male; Middle Aged; Prospective Studies; Renal Dialysis; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D is typically supplied in capsule form, both in trials and in clinical practice. However, little is known regarding the efficacy of vitamin D administered via oral sprays - a method that primarily bypasses the gastrointestinal absorption route. This study aimed to compare the efficacy of vitamin D3 liquid capsules and oral spray solution in increasing wintertime total 25-hydroxyvitamin D (25(OH)D) concentrations. In this randomised, open-label, cross-over trial, healthy adults (n 22) received 3000 IU (75 µg) vitamin D3 daily for 4 weeks in either capsule or oral spray form. Following a 10-week washout phase, participants received the opposite treatment for a final 4 weeks. Anthropometrics and fasted blood samples were obtained before and after supplementation, with samples analysed for total 25(OH)D, creatinine, intact parathyroid hormone and adjusted Ca concentrations. At baseline, vitamin D sufficiency (total 25(OH)D>50 nmol/l), insufficiency (31-49 nmol/l) and clinical deficiency (<30 nmol/l) were evident in 59, 23 and 18 % of the participants, respectively. Overall, baseline total mean 25(OH)D concentration averaged 59·76 (sd 29·88) nmol/l, representing clinical sufficiency. ANCOVA revealed no significant difference in the mean and standard deviation change from baseline in total 25(OH)D concentrations between oral spray and capsule supplementation methods (26·15 (sd 17·85) v. 30·38 (sd 17·91) nmol/l, respectively; F=1·044, adjusted r 2 0·493, P=0·313). Oral spray vitamin D3 is an equally effective alternative to capsule supplementation in healthy adults.

Topics: 25-Hydroxyvitamin D 2; Adult; Biomarkers; Calcifediol; Calcium; Capsules; Cholecalciferol; Cross-Over Studies; Dietary Supplements; Female; Humans; Intention to Treat Analysis; Lost to Follow-Up; Male; Northern Ireland; Oral Sprays; Parathyroid Hormone; Patient Compliance; Seasons; Severity of Illness Index; Vitamin D Deficiency; Young Adult

Vitamin D plays a key role in bone health. Consuming adequate vitamin D during young adulthood is important due to the development of peak bone mass; however, many Canadian young adults do not meet vitamin D recommendations. This study aimed to improve knowledge, perceptions, dietary intake and blood concentrations of vitamin D among a sample of young adults.. Using a pre-post design, 90 Ontario adults (38 men, 52 women; 18-25 years), were randomly assigned to intervention or control groups. Participants completed a socio-demographic survey, pre-post food frequency questionnaire, and a vitamin D knowledge questionnaire (3 time-points). The intervention group watched a video, received online information and tracked intake of vitamin D using a mobile application for 12 weeks. A sub-sample of participants completed pre-post blood 25(OH)D. ClinicalTrails.gov registration #: NCT02118129 .

Topics: Adolescent; Adult; Awareness; Bone Density; Cholecalciferol; Diet; Dietary Supplements; Female; Health Behavior; Health Knowledge, Attitudes, Practice; Health Promotion; Humans; Internet; Male; Mobile Applications; Nutritional Requirements; Surveys and Questionnaires; Treatment Outcome; Vitamin D; Vitamin D Deficiency; Young Adult

Vitamin D deficiency is frequent and has been associated with fatigue in uncontrolled trials.. This is the first double-blind placebo-controlled clinical trial to investigate the efficacy of per os vitamin D3 (cholecalciferol) in treating fatigue among otherwise healthy persons with low serum 25-hydroxyvitamin D (25(OH)D) levels. We enrolled 120 individuals (mean age 29 ± 6 years, 53% women) presenting with fatigue and vitamin D deficiency (serum 25(OH)D < 20 μg/L). Participants were randomized to a single oral dose of 100,000 units of vitamin D or placebo. The primary endpoint was intra-individual change in the fatigue assessment scale (FAS) at 4 weeks after treatment.. The mean age of the participants was 29 ± 6 years, 53% were women. Mean FAS decreased significantly more in the vitamin D group (-3.3 ± 5.3; 95% confidence interval [CI] for change -14.1 to 4.1) compared with placebo (-0.8 ± 5.3; 95% CI for change -9.0 to 8.7); (P = 0.01). Amelioration of fatigue was reported more frequently in vitamin D than in placebo group (42 [72%] vs. 31 [50%]; P = 0.01; odds ratio [OR] 2.63, 95% CI for OR 1.23-5.62). Among all participants, improvement in fatigue score correlated with the rise in 25(OH)D level (R = -0.22, P = 0.02).. Vitamin D treatment significantly improved fatigue in otherwise healthy persons with vitamin D deficiency.This study was registered at the www.ClinicalTrials.gov Protocol ID NCT02022475.

Topics: Administration, Oral; Adult; Cholecalciferol; Double-Blind Method; Fatigue; Female; Humans; Male; Self Report; Vitamin D; Vitamin D Deficiency; Vitamins; Young Adult

Patients with chronic kidney disease (CKD) demonstrate complex mineral metabolism derangements and a high prevalence of vitamin D deficiency. However, the optimal method of 25-hydroxyvitamin D (25(OH)D) repletion is unknown, and trials analysing the comparative efficacy of cholecalciferol and ergocalciferol in this population are lacking. We conducted a randomised clinical trial of cholecalciferol 1250μg (50 000 IU) weekly v. ergocalciferol 1250μg (50 000 IU) weekly for 12 weeks in forty-four non-dialysis-dependent patients with stage 3-5 CKD. The primary outcome was change in total 25(OH)D from baseline to week 12 (immediately after therapy). Secondary analyses included the change in 1,25-dihydroxyvitamin D (1,25(OH)2D), parathyroid hormone (PTH), D2 and D3 sub-fractions of 25(OH)D and 1,25(OH)2D and total 25(OH)D from baseline to week 18 (6 weeks after therapy). Cholecalciferol therapy yielded a greater change in total 25(OH)D (45·0 (sd 16·5) ng/ml) v. ergocalciferol (30·7 (sd 15·3) ng/ml) from baseline to week 12 (P<0·01); this observation partially resulted from a substantial reduction in the 25(OH)D3 sub-fraction with ergocalciferol. However, following cessation of therapy, no statistical difference was observed for total 25(OH)D change from baseline to week 18 between cholecalciferol and ergocalciferol groups (22·4 (sd 12·7) v. 17·6 (sd 8·9) ng/ml, respectively; P=0·17). We observed no significant difference between these therapies with regard to changes in serum PTH or 1,25(OH)2D. Therapy with cholecalciferol, compared with ergocalciferol, is more effective at raising serum 25(OH)D in non-dialysis-dependent CKD patients while active therapy is ongoing. However, levels of 25(OH)D declined substantially in both arms following cessation of therapy, suggesting the need for maintenance therapy to sustain levels.

Topics: 25-Hydroxyvitamin D 2; Academic Medical Centers; Adult; Aged; Calcifediol; Calcitriol; Cholecalciferol; Cohort Studies; Dietary Supplements; Double-Blind Method; Ergocalciferols; Female; Follow-Up Studies; Humans; Kansas; Male; Middle Aged; Outpatient Clinics, Hospital; Parathyroid Hormone; Renal Insufficiency, Chronic; Reproducibility of Results; Vitamin D Deficiency

Nonspecific low back pain is known as one of the most common reasons for chronic low back pain (CLBP) that burdens healthcare systems with high costs. According to a hypothesis, CLBP has been associated with vitamin D3 deficiency, the goal of this study is to evaluate the effect of vitamin D3 administration on improvements in CLBP.. This double blind randomized clinical trial included 53 patients aged between 18-40 years with nonspecific CLBP. Pain was measured using the pain visual analogue scale score (VAS), and serum 25-OH-vitamin D level was measured using an enzyme-linked immunosorbent assay kit. The patients were randomly divided into two groups based on sex and weight. Pearl of vitamin D(3) (50 000 IU) or placebo was administered orally every week for 8 weeks. Data were analyzed via SPSS 17th edition software using two-tailed paired t-test and chi-square test.. There were 26 and 27 patients in drug and placebo groups respectively. Out of 53 subjects, 75.47% were female. There was no statistically significant difference in the mean age, sex, and mean weight between the two groups. The mean serum 25-OH-vitamin D level was 18.86 ± 9.24 nmol/L on the first visit. After 8 weeks of intervention, the mean serum 25-OH-vitamin D level changed from 17.88 ± 9.04 to 27.52 ± 9.04 (P = 0.043) and from 19.81 ± 9.60 to 18.91 ± 7.84 (P = 0.248) in drug and placebo groups, respectively. The mean VAS score for pain decreased from 5.42 ± 1.65 to 3.03 ± 3.14 (P = 0.001) and from 6.42 ± 1.62 to 3.11 ± 3.08 (P = 0.001) among drug and placebo groups, respectively. The mean changes in chronic pain were 2.38 ± 2.62, 95% confidence interval (CI) = 1.32-3.44 in the drug group and 3.33 ± 3.67, 95%CI = 0.61-2.55 in the placebo group. No significant statistical difference between the two groups was observed.. According to our results, both vitamin D(3) and placebo treatments improved CLBP and there was no significant difference between vitamin D(3) and placebo groups.

Topics: Administration, Oral; Adolescent; Adult; Biomarkers; Chi-Square Distribution; Cholecalciferol; Dietary Supplements; Double-Blind Method; Drug Administration Schedule; Enzyme-Linked Immunosorbent Assay; Female; Humans; Iran; Low Back Pain; Male; Pain Measurement; Time Factors; Treatment Outcome; Vitamin D; Vitamin D Deficiency; Young Adult

The effect of vitamin D replacement on hemoglobin (Hb) concentration in subjects with concurrent deficiencies of vitamin D and iron is not known.. We report on an investigator-initiated, randomized, single-blinded, placebo-controlled, 12-week interventional trial. Thirty subjects with iron-deficiency anemia (serum ferritin <15 µg/l) were randomized to an intervention arm (cholecalciferol, i.e. vitamin D3, 0.6 million units i.m. once) or placebo. In all subjects, iron deficiency was corrected with parental iron. Other causes of anemia were excluded with appropriate investigation. The primary end point was a rise in Hb concentration.. Baseline parameters of age, BMI, hemogram values and levels of serum ferritin, 25-hydroxyvitamin D [25(OH)D] and parathyroid hormone (PTH) were similar in the 2 arms. Twelve weeks after vitamin D replacement, there was a significant increase in 25 (OH)D levels (57.7 ± 20.5 vs. 14.1 ± 6.2 ng/ml, p < 0.0001) and a decrease in PTH levels (32.4 ± 16.4 vs. 52.9 ± 18.4 pg/ml, p = 0.003) in subjects in the intervention arm when compared to the placebo arm. However, the increments in serum ferritin and Hb concentration in the intervention and placebo arm did not differ.. Vitamin D replacement in subjects with iron-deficiency anemia after iron correction does not improve Hb concentration further.

Topics: Adult; Anemia, Iron-Deficiency; Case-Control Studies; Cholecalciferol; Erythrocyte Indices; Hemoglobins; Humans; Middle Aged; Treatment Outcome; Vitamin D; Vitamin D Deficiency; Young Adult

Observational studies identified associations between vitamin D insufficiency (serum 25(OH)D < 30ng·ml-1) and risk of upper respiratory infection (URI). Swimmers are highly prone to URIs, which might hinder their performance. The aim of this study was to examine if vitamin D3 supplementation reduces URI burden in vitamin D-insufficient swimmers. Fifty-five competitive adolescent swimmers with vitamin D insufficiency were randomized to receive vitamin D3 (2,000IU·d-1) or placebo for 12 winter weeks. A URI symptom questionnaire was completed weekly. Serum 25(OH)D concentrations were measured by radio-immunoassay before and after supplementation. We used linear regression to examine the relation between the change in 25(OH)D concentrations during the trial, and the duration and severity of URIs. There were no between-group differences in the frequency, severity, or duration of URIs. Exploratory analyses revealed that in the placebo group only, the change in 25(OH)D concentrations during the trial was highly associated with the duration of URIs (r = -0.90,p < .001), and moderately associated with the severity of URIs (r = -0.65,p = .043). The between-group differences for duration were highly significant. Vitamin D3 supplementation in adolescent swimmers with vitamin D insufficiency did not reduce URI burden. However, larger decreases in serum 25(OH)D concentrations were associated with significantly longer and more severe URI episodes.

Topics: Adolescent; Biomarkers; Child; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Linear Models; Male; Respiratory Tract Infections; Severity of Illness Index; Swimming; Treatment Outcome; Vitamin D; Vitamin D Deficiency; Vitamins; Young Adult

It is hypothesized that vitamin D insufficiency in athletes might negatively affect sport performance. The objective of this study was to examine the effect of vitamin D3 supplementation on physical performance of adolescent swimmers with vitamin D insufficiency. Fifty-three adolescent competitive swimmers with vitamin D insufficiency (serum 25-hydroxyvitamin-D concentrations (25(OH)D) < 30 ng/ml, mean 24.2 ± 4.8 ng/ml) were randomized to receive 2,000 IU/day of vitamin D3 or placebo for 12 weeks. Swimming performance at several speeds, arm-grip strength, and one-legged balance, were measured before and after supplementation. The age-adjusted changes in performance variables during the study were compared between groups. 25(OH) D concentrations at study end were significantly higher in the vitamin group compared with the placebo group (29.6 ± 6.5 ng/ml vs. 20.3 ± 4.2 ng/ml, p < .001), yet only 48% of the vitamin group became vitamin D sufficient with this dosing. No between-group differences were found in the changes of the performance variables tested. No significant differences in performance were found between participants that became vitamin D sufficient, and those who did not. No significant correlation was found between the change in serum 25(OH)D and age-adjusted balance, strength or swimming performance at study end. Vitamin D3 supplementation that raised serum 25(OH)D concentrations by a mean of 9.3 ng/ml above placebo in adolescent swimmers with vitamin D insufficiency, did not improve physical performance more than placebo.

Topics: Adolescent; Adolescent Nutritional Physiological Phenomena; Athletic Performance; Calcifediol; Child; Child Nutritional Physiological Phenomena; Cholecalciferol; Cohort Studies; Dietary Supplements; Double-Blind Method; Female; Humans; Israel; Male; Muscle Strength; Postural Balance; Severity of Illness Index; Sports Nutritional Physiological Phenomena; Swimming; Vitamin D Deficiency

Burn patients are at risk of hypovitaminosis D and osteopenia or sarcopenia. Vitamin D pleiotropic effects may influence bone and muscle health. The aim of this pilot study was to assess effects of a cholecalciferol (VD3) supplementation and an optimized calcium (Ca) regimen on vitamin D (VD) status, bone and muscle health during sequelar stage of burn injury.. Monocentric randomized controlled trial.. Fifteen adults with thermal burns dating from 2 to 5 years were randomized into two groups. For 12 months, they either received a quarterly IM injection of 200,000IU VD3 and daily oral Ca (Group D) or placebo (Group P). VD status and bone remodeling markers were assessed every 3 months. Knee muscle strength and bone mineral density were, respectively, assessed using isokinetic dynamometry and dual X-ray absorptiometry at initiation (M0) and completion (M12) of the protocol.. Of all the patients, 66% presented with VD deficiency and 53% (with 3 men <40y) were considered osteopenic at inclusion. After one year, calcidiol levels significantly increased in Group D to reach 40 (37-61)ng/ml. No significant change in bone health was observed in both groups while Group D significantly improved quadriceps strength when tested at high velocity.. This VD3 supplementation was safe and efficient to correct hypovitaminosis D in burn adults. When combined with optimized Ca intakes, it demonstrated positive effects on muscle health but not on bone health. A high prevalence of hypovitaminosis D and osteopenia in these patients, as well as their wide range of muscle performances, seem to be worrying when considering rehabilitation and quality of life.

Topics: Adult; Bone Density; Bone Density Conservation Agents; Burns; Calcium; Cholecalciferol; Dietary Supplements; Female; Humans; Knee Joint; Male; Middle Aged; Muscle Strength; Muscle, Skeletal; Pilot Projects; Vitamin D; Vitamin D Deficiency; Vitamins

Although single, high doses of vitamin D effectively maintain vitamin D sufficiency in several populations, no studies have evaluated healthy adults over winter, during which vitamin D status declines. This study investigated whether high-dose vitamin D3 given once to healthy adults before winter will (1) prevent the wintertime decline in vitamin D status, (2) promote vitamin D sufficiency 1 year following the dose and (3) prevent the rise of parathyroid hormone (PTH) concentrations.. In this double-blind, placebo-controlled trial, we assessed plasma 25(OH)D and PTH concentrations at baseline, 5, 90 and 365 days after drug administration in 28 healthy adults. In all, >80% of subjects returned at each time point.. At baseline, the young, healthy participants had a mean plasma 25(OH)D concentration of 17.5±6.1 ng/ml. Only two subjects exhibited plasma 25(OH)D concentrations >30 ng/ml. At 5 days, subjects randomized to vitamin D3 had a higher mean plasma 25(OH)D concentration compared with the placebo group (39.1 vs 19.1 ng/ml, P<0.001). Plasma 25(OH)D concentrations returned to baseline at 90 and 365 days in the vitamin D3 group and remained unchanged in the placebo group. PTH and calcium concentrations were unrelated to changes in 25(OH)D levels and similar between groups over time.. A dose of 250,000 IU of vitamin D3 given once in November resulted in a robust increase in plasma 25(OH)D after 5 days, but it was unable to sustain this increase after 90 days. A larger or more frequent dosing regimen may be needed for long-term vitamin D sufficiency.

Topics: Adult; Calcium; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Healthy Volunteers; Humans; Male; Parathyroid Hormone; Reference Values; Seasons; Vitamin D; Vitamin D Deficiency; Vitamins; Young Adult

The present evidence indicates a reverse correlation between vitamin D status and blood pressure (BP). The present study determined the effect of oral vitamin D supplementation on BP in patients with elevated BP and vitamin D deficiency.. In this randomized, double-blind, placebo-controlled trial, 42 outpatients with elevated BP and vitamin D deficiency were assigned randomly to two groups: the vitamin D-supplemented group (VDG), who received one capsule containing 50 000 IU of cholecalciferol weekly, and the placebo group (PG), who received one similar capsule containing oral liquid paraffin as placebo for 8 weeks. The systolic (SBP) and diastolic (DBP) blood pressures, mean arterial blood pressure (MAP), pulse pressure, serum 25-hydroxyvitamin D, parathormone, calcium, phosphorus, magnesium, sodium, and potassium were measured before and after the intervention.. In all, 92.7% of the VDG recovered from vitamin D deficiency. At the end of the intervention, the mean SBP and DBP, and the MAP decreased significantly in VDG compared with the PG, whereas at the beginning of the intervention, there was no significant difference between the two groups. The mean changes in SBP (-6.4±5.3 vs. 0.9±3.7 mmHg, P(V)<0.001), DBP (-2.4±3.7 vs. 1.0±2.7 mmHg, P(V)=0.003), and MAP (-3.7±3.6 vs. 0.9±2.5 mmHg, P(V)<0.001) were lower in the VDG than PG.. The findings of the study showed that the weekly administration of 50 000 IU of oral vitamin D for 8 weeks as an adjunct supplement of antihypertensive drugs in patients with vitamin D deficiency could help prevent vitamin D deficiency and aid control of SBP, DBP, and MAP.

Topics: Administration, Oral; Adult; Blood Pressure; Cholecalciferol; Double-Blind Method; Female; Humans; Male; Middle Aged; Time Factors; Vitamin D Deficiency; Vitamins

A large body of epidemiological and experimental evidence suggests that vitamin D deficiency may promote hypertension. This raises the possibility that vitamin D supplementation could be a simple intervention to reduce blood pressure, but data from prospective, randomized trials are limited.. A double-blind, randomized, controlled trial was conducted at 4 sites in the United States. We enrolled 534 individuals 18 to 50 years of age with low vitamin D status (25-hydroxyvitamin D levels ≤25 ng/mL) and systolic blood pressure of 120 to 159 mm Hg. Participants were randomized to high-dose (4000 IU/d) versus low-dose (400 IU/d) oral vitamin D3 for 6 months. The primary end point was change in mean 24-hour systolic blood pressure. Secondary end points included change in ambulatory diastolic blood pressure and clinic systolic and diastolic blood pressures. The median age was 38 years, and 62% of participants were men. Forty-six percent of participants were white, and 48% were black. The median 25-hydroxyvitamin D level at baseline was 15.3 ng/mL. Four-hundred fifty-five participants (85%) had at least 1 follow-up blood pressure measurement; 383 participants (72%) completed the full 6-month study. At the end of the study, there was no significant difference in the primary end point (change in mean 24-hour systolic blood pressure, -0.8 versus -1.6 mm Hg in the high-dose and low-dose arms; P=0.71) or in any of the secondary end points. Furthermore, there was no evidence of association between change in 25-hydroxyvitamin D and change in 24-hour systolic blood pressure at 6 months (Spearman correlation coefficient, -0.05, P=0.34). Results were consistent across prespecified subgroups.. Vitamin D supplementation did not reduce blood pressure in individuals with prehypertension or stage I hypertension and vitamin D deficiency. Our findings suggest that the association between vitamin D status and elevated blood pressure noted in observational studies is not causal.. http://www.clinicaltrials.gov. Unique identifier: NCT01240512.

Topics: Adult; Blood Pressure; Cholecalciferol; Double-Blind Method; Female; Follow-Up Studies; Humans; Hypertension; Male; Middle Aged; Prehypertension; Vitamin D Deficiency

To study the effect of Vitamin D3 supplementation on metabolic control in an obese type 2 diabetes Emirati population.. This randomized double-blind clinical trial was conducted with 87 vitamin D-deficient obese, type 2 diabetic participants. The vitamin D-group (n=45) and the placebo group (n=42) were matched for gender, age, HbA1c and 25-hydroxy vitamin D (25(OH) D) at the baseline. The study was divided into two phases of 3 months each; in phase 1, the vitamin D-group received 6000 IU vitamin D3/day followed by 3000 IU vitamin D3/day in phase 2, whereas the placebo group (n=42) received matching placebo.. After supplementation, serum 25(OH) D peaked in the vitamin D-group in phase 1 (77.2±30.1 nmol/l, P=0.003) followed by a decrease in the phase 2 (61.4±18.8 nmol/l, P=0.006), although this was higher compared with baseline. In the placebo group, no difference was observed in the serum 25(OH) D levels throughout the intervention. Relative to baseline serum, parathyroid hormone decreased 24% (P=0.003) in the vitamin D-group in phase 2, but remained unchanged in the placebo group. No significant changes were observed in blood pressure, fasting blood glucose, HbA1c, C-peptide, creatinine, phosphorous, alkaline phosphatase, lipids, C-reactive protein or thyroid stimulating hormone concentrations compared with baseline in either group.. Six months of vitamin D3 supplementation to vitamin D-deficient obese type 2 diabetes patients in the UAE normalized the vitamin D status and reduced the incidence of eucalcemic parathyroid hormone elevation but showed no effect on the metabolic control.

Topics: Adult; Body Mass Index; Calcifediol; Cholecalciferol; Diabetes Mellitus, Type 2; Dietary Supplements; Double-Blind Method; Female; Glycated Hemoglobin; Humans; Hyperparathyroidism, Secondary; Incidence; Lost to Follow-Up; Male; Middle Aged; Obesity; Parathyroid Hormone; Patient Dropouts; United Arab Emirates; Vitamin D Deficiency

Low 25-hydroxyvitamin D levels are common in patients with chronic fatigue syndrome; such patients also manifest impaired vascular health. We tested whether high-dose intermittent oral vitamin D therapy improved markers of vascular health and fatigue in patients with chronic fatigue syndrome.. Parallel-group, double-blind, randomised placebo-controlled trial. Patients with chronic fatigue syndrome according to the Fukuda (1994) and Canadian (2003) criteria were randomised to receive 100,000 units oral vitamin D3 or matching placebo every 2 months for 6 months. The primary outcome was arterial stiffness measured using carotid-femoral pulse wave velocity at 6 months. Secondary outcomes included flow-mediated dilatation of the brachial artery, blood pressure, cholesterol, insulin resistance, markers of inflammation and oxidative stress, and the Piper Fatigue scale. As many as 50 participants were randomised; mean age 49 (SD 13) years, mean baseline pulse wave velocity 7.8 m/s (SD 2.3), mean baseline office blood pressure 128/78 (18/12) mmHg and mean baseline 25-hydroxyvitamin D level 46 (18) nmol/L. 25-hydroxyvitamin D levels increased by 22 nmol/L at 6 months in the treatment group relative to placebo. There was no effect of treatment on pulse wave velocity at 6 months (adjusted treatment effect 0.0 m/s; 95% CI -0.6 to 0.6; p = 0.93). No improvement was seen in other vascular and metabolic outcomes, or in the Piper Fatigue scale at 6 months (adjusted treatment effect 0.2 points; 95% CI -0.8 to 1.2; p = 0.73).. High-dose oral vitamin D3 did not improve markers of vascular health or fatigue in patients with chronic fatigue syndrome.. www.controlled-trials.com, ISRCTN59927814.

Topics: Adult; Biomarkers; Blood Pressure; Brachial Artery; Canada; Cardiovascular Physiological Phenomena; Cholecalciferol; Cholesterol; Dietary Supplements; Dose-Response Relationship, Drug; Double-Blind Method; Fatigue Syndrome, Chronic; Female; Humans; Inflammation; Insulin Resistance; Male; Middle Aged; Oxidative Stress; Pulse Wave Analysis; Treatment Outcome; Vascular Stiffness; Vitamin D Deficiency

Vitamin D deficiency and obesity are both prevalent conditions in the northern countries, especially among immigrants. The aims were to assess the possible relationship between body fat and vitamin D status, and to investigate the effect of body fat on the response to oral vitamin D supplementation in Pakistani immigrants in Denmark. Data were obtained from a 1-year double-blind randomised controlled trial with oral vitamin D supplementation. A total of 122 women and men received either vitamin D3 supplementation (10 or 20 μg/day) or placebo. No association was found between body fat percentage and vitamin D status in a multiple linear regression model (P<0.001). No effect of body fat was seen on the vitamin D status response following the intervention with vitamin D. In conclusion, there was no baseline association between body fat percentage and vitamin D status, and body fat percentage had no effect on the response to vitamin D supplementation.

Topics: Adipose Tissue; Adult; Body Composition; Cholecalciferol; Denmark; Dietary Supplements; Double-Blind Method; Emigrants and Immigrants; Female; Humans; Linear Models; Middle Aged; Obesity; Pakistan; Vitamin D; Vitamin D Deficiency; Vitamins

Patients with chronic obstructive pulmonary disease (COPD) often have vitamin D deficiency, which is associated with increased susceptibility to upper respiratory infection-a major precipitant of exacerbation. Multicentre trials of vitamin D supplementation for prevention of exacerbation and upper respiratory infection in patients with COPD are lacking. We therefore investigated whether vitamin D3 (colecalciferol) supplementation would reduce the incidence of moderate or severe COPD exacerbations and upper respiratory infections.. We did a randomised, double-blind, placebo-controlled trial of vitamin D3 supplementation in adults with COPD in 60 general practices and four Acute National Health Service Trust clinics in London, UK. Patients were allocated to receive six 2-monthly oral doses of 3 mg vitamin D3 or placebo over 1 year in a 1:1 ratio using computer-generated permuted block randomisation. Participants and study staff were masked to treatment assignment. Coprimary outcomes were time to first moderate or severe exacerbation and first upper respiratory infection. Analysis was by intention to treat. A prespecified subgroup analysis was done to assess whether effects of the intervention on the coprimary outcomes were modified by baseline vitamin D status. This trial is registered with ClinicalTrials.gov, number NCT00977873.. 240 patients were randomly allocated to the vitamin D3 group (n=122) and placebo group (n=118). Vitamin D3 compared with placebo did not affect time to first moderate or severe exacerbation (adjusted hazard ratio 0·86, 95% CI 0·60-1·24, p=0·42) or time to first upper respiratory infection (0·95, 0·69-1·31, p=0·75). Prespecified subgroup analysis showed that vitamin D3 was protective against moderate or severe exacerbation in participants with baseline serum 25-hydroxyvitamin D concentrations of less than 50 nmol/L (0·57, 0·35-0·92, p=0·021), but not in those with baseline 25-hydroxyvitamin D levels of at least 50 nmol/L (1·45, 0·81-2·62, p=0·21; p=0·021 for interaction between allocation and baseline serum 25-hydroxyvitamin D status). Baseline vitamin D status did not modify the effect of the intervention on risk of upper respiratory infection (pinteraction=0·41).. Vitamin D3 supplementation protected against moderate or severe exacerbation, but not upper respiratory infection, in patients with COPD with baseline 25-hydroxyvitamin D levels of less than 50 nmol/L. Our findings suggest that correction of vitamin D deficiency in patients with COPD reduces the risk of moderate or severe exacerbation.. UK National Institute for Health Research.

Topics: Aged; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Male; Middle Aged; Pulmonary Disease, Chronic Obstructive; Respiratory Tract Infections; Vitamin D; Vitamin D Deficiency; Vitamins

Low vitamin D serum levels have been associated with unfavourable lipid profile and poorer response to atorvastatin. Aims of this study were to test the effects of 25-hydroxyvitamin D3 (calcifediol) compared to parental vitamin D3 (cholecalciferol) supplementation on modifications of plasma 25(OH)D levels and lipid profile.. Fifty-seven postmenopausal women (aged 59.03 ± 6.73 years) who were at low risk of fracture and with basal plasma 25(OH)D < 30 ng/mL were included if they were on atorvastatin treatment prescribed as appropriate. Recruited women were randomized to receive oral calcifediol or cholecalciferol, both at a dose of 140 μg according to a weekly regimen.. At baseline, 25(OH)D was negatively associated with BMI (r = -0.37; P = 0.004), total cholesterol (r = -0.31; P = 0.01) and LDL-C (r = -0.32; P = 0.02). After 24 weeks, 25(OH)D increased significantly in both groups (P < 0.001), although higher levels were obtained with calcifediol as compared with cholecalciferol (P < 0.001). Only in the calcifediol group, a significant reduction of LDL-C (P = 0.01) and an increase of HDL-C (P = 0.02) were obtained, even after adjustment for age, and baseline BMI, 25(OH)D and lipid levels (P < 0.05). The percentage changes in 25(OH)D levels were associated with the variations of LDL-C (r = -0.44; P = 0.01) and HDL-C levels (r = 0.30; P = 0.10).. Calcifediol administration in osteopenic and dyslipidemic postmenopausal women with low 25(OH)D improves lipid profile when added to an ongoing atorvastatin treatment.

Topics: Administration, Oral; Atorvastatin; Bone Diseases, Metabolic; Calcifediol; Cholecalciferol; Dietary Supplements; Drug Therapy, Combination; Dyslipidemias; Female; Heptanoic Acids; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Lipid Metabolism; Middle Aged; Postmenopause; Pyrroles; Vitamin D; Vitamin D Deficiency; Vitamins

Middle Eastern female immigrants are at an increased risk of vitamin D deficiency and their response to prescribed vitamin D dosages may not be adequate and affected by other factors. The objectives were to determine vitamin D deficiency and its determinants in Middle Eastern women living in Auckland, New Zealand (Part-I), and to determine serum 25-hydroxyvitamin D (serum-25(OH)D) response to two prescribed vitamin D dosages (Part-II) in this population.. Women aged ⩾20 (n=43) participated in a cross-sectional pilot study during winter (Part-I). In Part-II, women aged 20-50 years (n=62) participated in a randomised, double-blind placebo-controlled trial consuming monthly either 50,000, 100,000 IU vitamin D3 or placebo for 6 months (winter to summer).. All women in Part-I and 60% women in Part-II had serum-25(OH)D<50 nmol/l. Serum-25(OH)D was higher in prescribed vitamin D users than nonusers (P=0.001) and in Iranians than Arab women (P=0.001; Part-I). Mean (s.d.) serum-25(OH)D increased in all groups (time effect, P<0.001) and differed between groups (time × dosage interaction, P<0.001; 50,000 IU: from 44.0±16.0 to 70.0±15.0 nmol/l; 100,000 IU: 48.0±11.0 to 82.0±17.0 nmol/l; placebo: 45.0±18.0 to 54.0±18.0 nmol/l). Only 32% and 67% achieved serum-25(OH)D⩾75 nmol/l with 50,000 and 100,000 IU/month, respectively. Predictors of 6-month change in serum-25(OH)D were dose (B-coefficient±s.e.; 14.1±2.4, P<0.001), baseline serum-25(OH)D (-0.6±0.1, P<0.001) and body fat percentage (-0.7±0.3, P=0.01).. Vitamin D deficiency/insufficiency is highly prevalent in this population. Monthly 100,000 IU vitamin D for 6 months is more effective than 50,000 IU in achieving serum-25(OH)D ⩾75 nmol/l; however, a third of women still did not achieve these levels.

Topics: Adult; Arabs; Bone Density Conservation Agents; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Health Status; Humans; Iran; Middle Aged; Middle East; New Zealand; Prevalence; Vitamin D; Vitamin D Deficiency; Vitamins

Little is known about how the genetic variation in vitamin D modulating genes influences ultraviolet (UV)B-induced 25-hydroxyvitamin D [25(OH)D] concentrations. In the Food with vitamin D (VitmaD) study, we showed that common genetic variants rs10741657 and rs10766197 in 25-hydroxylase (CYP2R1) and rs842999 and rs4588 in vitamin D binding protein (GC) predict 25(OH)D concentrations at late summer and after 6-mo consumption of cholecalciferol (vitamin D₃)-fortified bread and milk.. In the current study, called the Vitamin D in genes (VitDgen) study, we analyzed associations between the increase in 25(OH)D concentrations after a given dose of artificial UVB irradiation and 25 single nucleotide polymorphisms located in or near genes involved in vitamin D synthesis, transport, activation, or degradation as previously described for the VitmaD study. Second, we aimed to determine whether the genetic variations in CYP2R1 and GC have similar effects on 25(OH)D concentrations after artificial UVB irradiation and supplementation by vitamin D₃-fortified bread and milk.. The VitDgen study includes 92 healthy Danes who received 4 whole-body UVB treatments with a total dose of 6 or 7.5 standard erythema doses during a 10-d period in winter. The VitmaD study included 201 healthy Danish families who were given vitamin D₃-fortified bread and milk or placebo for 6 mo during the winter.. After UVB treatments, rs10741657 in CYP2R1 and rs4588 in GC predicted UVB-induced 25(OH)D concentrations as previously shown in the VitmaD study. Compared with noncarriers, carriers of 4 risk alleles of rs10741657 and rs4588 had lowest concentrations and smallest increases in 25(OH)D concentrations after 4 UVB treatments and largest decreases in 25(OH)D concentrations after 6-mo consumption of vitamin D₃-fortified bread and milk.. Common genetic variants in the CYP2R1 and GC genes modify 25(OH)D concentrations in the same manner after artificial UVB-induced vitamin D and consumption of vitamin D₃-fortified bread and milk.

Topics: 25-Hydroxyvitamin D 2; Adolescent; Adult; Animals; Bread; Calcifediol; Child; Cholecalciferol; Cholestanetriol 26-Monooxygenase; Cytochrome P450 Family 2; Denmark; Double-Blind Method; Food, Fortified; Genetic Association Studies; Humans; Male; Middle Aged; Milk; Polymorphism, Single Nucleotide; Seasons; Skin; Ultraviolet Therapy; Vitamin D Deficiency; Vitamin D-Binding Protein; Whole-Body Irradiation; Young Adult

A possible association between serum 25-hydroxyvitamin D and testosterone levels has been reported; however, contradictory results have emerged.. To investigate a causal link between vitamin D and testosterone status, we studied the effect of vitamin D supplementation on serum testosterone concentrations in three independent intervention studies including male patients with heart failure (study 1), male nursing home residents (study 2) and male non-Western immigrants in the Netherlands (study 3).. In study 1, 92 subjects were randomized to either vitamin D (2000 IU cholecalciferol daily) or control. Blood was drawn at baseline, after 3 and 6 weeks. In study 2, 49 vitamin D deficient subjects received either vitamin D (600 IU daily) or placebo. Blood was drawn at baseline, after 8 and 16 weeks. In study 3, 43 vitamin D deficient subjects received either vitamin D (1200 IU daily) or placebo. Blood was drawn at baseline, after 8 and 16 weeks. Serum 25-hydroxyvitamin D levels were measured using LC-MS/MS or radioimmunoassay. Testosterone levels were measured using a 2nd generation immunoassay.. Serum 25-hydroxyvitamin D levels significantly increased in all treatment groups (median increase of 27, 30 and 36 nmol/l in studies 1, 2 3, respectively) but not in the control groups. The documented increase in 25-hydroxyvitamin D levels, however, did not affect mean testosterone concentrations at the end of the study (median increase of 0, 0.5 and 0 nmol/l in studies 1, 2 and 3, respectively).. In this post hoc analysis of three small clinical trials of limited duration in men with normal baseline testosterone concentrations, vitamin D supplementation was not associated with an increase in circulating testosterone concentrations.

Topics: Adult; Aged; Aged, 80 and over; Cholecalciferol; Cohort Studies; Dietary Supplements; Emigrants and Immigrants; Heart Failure; Humans; Male; Middle Aged; Netherlands; Nursing Homes; Testosterone; Vitamin D; Vitamin D Deficiency; Vitamins; Young Adult

This study examined the prevalence of vitamin D deficiency in mothers and infants in Tijuana, Mexico and determined the effect of a single oral dose of 50,000 IU vitamin D3 at birth on 25-hydroxyvitamin D (25[OH]D) levels during infancy. Healthy infants were randomized to receive vitamin D3 or placebo at birth. At birth 23% of infants were vitamin D deficient and 77% had vitamin D insufficiency (mean 25[OH]D level 18.9 ng/ml); 10% of mothers were vitamin D deficient and 61% were insufficient. Infants receiving vitamin D3 had higher 25(OH)D levels at two months (N = 29; 33.9 versus 24.2 ng/ml) and six months (N = 21; 36.5 versus 27.4 ng/ml). Exclusively breastfed infants had lower 25(OH)D levels at two months (14.9 versus 33.4 ng/ml). Vitamin D deficiency is common in infants and mothers in Tijuana, Mexico. A single dose of vitamin D3 at birth was safe and significantly increased 25(OH)D levels during infancy.

Topics: Adult; Breast Feeding; Cholecalciferol; Dietary Supplements; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Infant; Infant, Newborn; Male; Mexico; Mothers; Pregnancy; Pregnancy Complications; Vitamin D; Vitamin D Deficiency; Vitamins; Young Adult

The high incidence of cardiovascular disease and vitamin D deficiency in chronic kidney disease patients is well known. Vitamin D activation by omega-3 fatty acid (FA) supplementation may explain the cardioprotective effects exerted by omega-3 FA. We hypothesized that omega-3 FA and 25-hydroxyvitamin D (25(OH)D) supplementation may increase 1,25-dihydroxyvitamin D (1,25(OH)2D) levels compared to 25(OH)D supplementation alone in hemodialysis (HD) patients that have insufficient or deficient 25(OH)D levels. We enrolled patients that were treated for at least six months with 25(OH)D < 30 ng/mL (NCT01596842). Patients were randomized to treatment for 12 weeks with cholecalciferol supplemented with omega-3 FA or a placebo. Levels of 25(OH)D and 1,25(OH)2D were measured after 12 weeks. The erythrocyte membrane FA contents were also measured. Levels of 25(OH)D were increased in both groups at 12 weeks compared to baseline. The 1,25(OH)2D levels at 12 weeks compared to baseline showed a tendency to increase in the omega-3 FA group. The oleic acid and monounsaturated FA content decreased, while the omega-3 index increased in the omega-3 FA group. Omega-3 FA supplementation may be partly associated with vitamin D activation, although increased 25(OH)D levels caused by short-term cholecalciferol supplementation were not associated with vitamin D activation in HD patients.

Topics: Activation, Metabolic; Aged; Cholecalciferol; Diet; Dietary Supplements; Double-Blind Method; Erythrocyte Membrane; Fatty Acids, Omega-3; Female; Humans; Hydroxycholecalciferols; Male; Middle Aged; Oleic Acid; Pilot Projects; Renal Dialysis; Vitamin D; Vitamin D Deficiency; Vitamins

Since vitamin D insufficiency is common worldwide in people with HIV, we explored safety and efficacy of high dose cholecalciferol (D₃) in Botswana, and evaluated potential modifiers of serum 25 hydroxy vitamin D change (Δ25D).. Prospective randomized double-blind 12-week pilot trial of subjects ages 5.0-50.9 years.. Sixty subjects randomized within five age groups to either 4000 or 7000 IU per day of D₃ and evaluated for vitamin D, parathyroid hormone, HIV, safety and growth status. Efficacy was defined as serum 25 hydroxy vitamin D (25D) ≥32 ng/mL, and safety as no simultaneous elevation of serum calcium and 25D. Also assessed were HIV plasma viral RNA viral load (VL), CD4%, anti-retroviral therapy (ART) regime, and height-adjusted (HAZ), weight-adjusted (WAZ) and Body Mass Index (BMIZ) Z scores.. Subjects were 50% male, age (mean±SD) 19.5±11.8 years, CD4% 31.8±10.4, with baseline VL log₁₀ range of <1.4 to 3.8 and VL detectable (>1.4) in 22%. From baseline to 12 weeks, 25D increased from 36±9 ng/ml to 56±18 ng/ml (p<0.0001) and 68% and 90% had 25D ≥32 ng/ml, respectively (p = 0.02). Δ25D was similar by dose. No subjects had simultaneously increased serum calcium and 25D. WAZ and BMIZ improved by 12 weeks (p<0.04). HAZ and CD4% increased and VL decreased in the 7000 IU/d group (p<0.04). Younger (5-13y) and older (30-50y) subjects had greater Δ25D than those 14-29y (26±17 and 28±12 vs. 11±11 ng/ml, respectively, p≤0.001). Δ25D was higher with efavirenz or nevirapine compared to protease inhibitor based treatment (22±12, 27±17, vs. 13±10, respectively, p≤0.03).. In a pilot study in Botswana, 12-week high dose D₃ supplementation was safe and improved vitamin D, growth and HIV status; age and ART regimen were significant effect modifiers.. ClinicalTrials.gov NCT02189902.

Topics: Adolescent; Adult; Botswana; Child; Child, Preschool; Cholecalciferol; Double-Blind Method; Female; HIV Infections; Humans; Male; Middle Aged; Pilot Projects; Prospective Studies; Treatment Outcome; Viral Load; Vitamin D; Vitamin D Deficiency; Young Adult

To determine whether maternal vitamin D supplementation, in the vitamin D deficient mother, prevents neonatal vitamin D deficiency.. Open-label randomized controlled trial.. Metropolitan Melbourne, Australia, tertiary hospital routine antenatal outpatient clinic.. Seventy-eight women with singleton pregnancies with vitamin D deficiency/insufficiency (serum 25-OH Vit D < 75 nmol/l) at their first antenatal appointment at 12-16-week gestation were recruited.. Participants were randomized to vitamin D supplementation (2000-4000 IU cholecalciferol) orally daily until delivery or no supplementation.. The primary outcome was neonatal serum 25-OH vit D concentration at delivery. The secondary outcome was maternal serum 25-OH vit D concentration at delivery.. Baseline mean maternal serum 25-OH vit D concentrations were similar (P = 0·9) between treatment (32 nmol/l, 95% confidence interval 26-39 nmol/l) and control groups (33 nmol/l, 95% CI 26-39 nmol/l). Umbilical cord serum 25-OH vit D concentrations at delivery were higher (P < 0·0001) in neonates of treatment group mothers (81 nmol/l, 95% CI; 70-91 nmol/l) compared with neonates of control group mothers (42 nmol/l, 95% CI; 34-50 nmol/l) with a strongly positive correlation between maternal serum 25-OH Vit D and umbilical cord serum 25-OH vit D concentrations at delivery (Spearman rank correlation coefficient 0·88; P < 0·0001). Mean maternal serum 25-OH Vit D concentrations at delivery were higher (P < 0·0001) in the treatment group (71 nmol/l, 95% CI; 62-81 nmol/l) compared with the control group (36 nmol/l, 95% CI; 29-42 nmol/l).. Vitamin D supplementation of vitamin D deficient pregnant women prevents neonatal vitamin D deficiency.

Topics: Administration, Oral; Adult; Cholecalciferol; Dietary Supplements; Female; Fetal Blood; Humans; Immunoassay; Infant, Newborn; Infant, Newborn, Diseases; Pregnancy; Pregnancy Complications; Tertiary Care Centers; Treatment Outcome; Vitamin D; Vitamin D Deficiency; Vitamins

Up to 75% of the risk of type 2 diabetes is attributable to obesity. Therefore, finding a way to control obesity can be useful for management of diabetes.. This study was performed to assess the effects of vitamin D3 and calcium supplementation on anthropometric measurements and blood pressure in vitamin D insufficient people with type 2 diabetes.. One hundred eighteen patients with diabetes were enrolled in this randomized placebo-controlled clinical trial. All subjects were randomly assigned into 4 groups receiving (1) 50,000 IU/wk vitamin D3 plus (equal to 7143 IU/d) calcium placebo; (2) 1000 mg/d calcium plus vitamin D3 placebo; (3) 50,000 IU/wk vitamin D3 (equal to 7143 IU/d) plus 1000 mg/d calcium; or (4) vitamin D3 placebo plus calcium placebo for 8 weeks. Anthropometric measurements and blood pressure were assessed at study baseline and after 8 weeks of intervention.. A greater reduction in body mass index was observed in calcium plus vitamin D group than other groups (p = 0.03). Comparison of changes in waist circumference among 4 groups revealed no significant difference in crude model (p = 0.21) and when the effect of confounders was taken into account (p = 0.08). Calcium supplementation resulted in a significant reduction in hip circumference compared to other groups (p <0.001). Systolic blood pressure significantly decreased in the calcium plus vitamin D group compared to placebo (-7.3 ± 8.7 mmHg vs 0.5 ± 8.2 mmHg; p = 0.001). However, calcium and vitamin D supplementation had no significant effects on diastolic blood pressure.. Calcium-vitamin D3 cosupplementation can have beneficial effect on body mass index (BMI), hip circumference, and systolic blood pressure in vitamin D-insufficient type 2 diabetics.

Topics: Adult; Anthropometry; Blood Pressure; Body Mass Index; Body Weights and Measures; Calcium, Dietary; Cholecalciferol; Diabetes Mellitus, Type 2; Dietary Supplements; Disease Management; Female; Hip; Humans; Male; Middle Aged; Obesity; Vitamin D Deficiency; Vitamins

At this time, good quality randomized clinical trials assessing the effects of vitamin D supplementation on cardiometabolic outcomes are lacking in the international literature.. To fill this gap, the Working Group on Vitamin D and Cardiorenal Disorders established jointly by the Italian Society of Hypertension (SIIA) and the Forum in Bone and Mineral Research conceived the HYPODD study (HYPOvitaminosis D and organ Damage).. HYPODD is a no-profit multicenter 12-month parallel-group double-blind placebo controlled randomized trial aiming to assess the effects of cholecalciferol supplementation on blood pressure control, antihypertensive drugs consumption and progression of target organ damage in patients with essential hypertension and 25-hydroxyvitamin D serum level lower than 20 ng/ml (vitamin D deficiency). HYPODD is coordinated by the European Society Excellence Center of Hypertension of Federico II University, Naples, and involves 12 academic institutions in Italy (Ancona, Milan, Padua, Perugia, Rome, Siena, Trieste, Turin, Udine, Varese, and Verona).. The HYPODD study has been registered at the Agenzia Italiana del Farmaco-Osservatorio sulla Sperimentazione Clinica del Farmaco (AIFA-OsSC) and EUDRACT sites (n° 2012-003514-14) and has been approved by the Ethical Committees of all the Centers involved in the study. The patients' recruitment is currently underway.

Topics: Antihypertensive Agents; Arterial Pressure; Biomarkers; Cholecalciferol; Clinical Protocols; Dietary Supplements; Disease Progression; Double-Blind Method; Humans; Hypertension; Italy; Patient Selection; Sample Size; Time Factors; Treatment Outcome; Vitamin D; Vitamin D Deficiency

The superiority of cholecalciferol (D3) over ergocalciferol (D2) in sustaining serum 25-hydroxy vitamin D (25OHD) levels is controversial. To compare D2 with D3 we performed a single-blind, placebo-controlled randomized trial spanning 11 weeks.. Healthy volunteers (n=33, aged 33.4±6 years) were divided into three groups (n=11, each): D2, D3 and placebo. Treatment started with a loading dose (100,000 IU) followed by 4800 IU/day (d) between d7 and d20 and follow-up until d77. Serum samples were obtained at baseline and at days 3, 7, 14, 21, 35, 49, 63 and 77.. Baseline 25OHD values in the D2 group were lower than those in the D3 and placebo groups (P<0.01). Placebo 25OHD levels never changed. As after the loading dose both D2 and D3 groups had reached similar 25OHD levels, we tested equivalence of the area under the concentration × time curve (AUC) between d7 and d77. The AUC was 28.6% higher for D3 compared with D2, and both were higher with respect to placebo. At d77, D2 25OHD levels were higher than those at baseline, but similar to placebo; both were lower than D3 (P<0.04). According to raw data, the elimination half-life of 25OHD was 84 and 111 days under D2 and D3 supplementation, respectively; after subtracting the placebo values, the corresponding figures were 33 and 82 days.. D2 and D3 were equally effective in elevating 25OHD levels after a loading dose. In the long term, D3 seems more appropriate for sustaining 25OHD, which could be relevant for classic and non-classic effects of vitamin D.

Topics: 25-Hydroxyvitamin D 2; Adult; Argentina; Calcifediol; Calcium; Cholecalciferol; Dietary Supplements; Ergocalciferols; Female; Follow-Up Studies; Half-Life; Hospitals, University; Hospitals, Urban; Humans; Kinetics; Male; Middle Aged; Models, Biological; Personnel, Hospital; Single-Blind Method; Vitamin D Deficiency; Young Adult

This study aimed to evaluate the effect of vitamin D3 megadose supplementation and influence of BsmI polymorphism in the VDR gene on the inflammatory profile and oxidative stress in elderly women with vitamin D deficiency.. A double blind, randomized, placebo-controlled trial was conducted with 40 elderly women (aged 68±6 years) diagnosed with vitamin D insufficiency (24.7±3.1 ng/mL). Participants were distributed into a supplementation group that received 200,000 IU of vitamin D3 (SG; n=20) and a placebo group (PG; n=20). Blood samples were collected at baseline and after intervention to analyse the 25(OH)D, parathyroid hormone, serum calcium, ultra-sensitive C-reactive protein (us-CRP), alpha 1-acid glycoprotein (AGP-A), total antioxidant capacity (TAC), and malondialdehyde (MDA) levels, as well as the renal and hepatic function, and genotyping was performed for BsmI polymorphism.. Four weeks after supplementation, elderly women in the SG group showed a significant increase in the serum concentration of 25(OH)D (25.29±2.8 to 31.48±6.0; p=0.0001), which was followed by increased TAC (65.25±15.66 to 71.83±10.71; p=0.03) and decreased serum PTH (46.32±13.2 to 35.45±11.0; p=0.009), us-CRP (0.38±0.3 to 0.19±0.1; p=0.007) and AGP-A levels (75.3±15.4 to 61.1±5.9; p=0.005). Changes in BP, ANAC and MDA were not observed. The 25(OH)D and PTH, us-CRP and AGP-A levels of participants with the BB/Bb genotype were more responsive to supplementation, but their other markers did not change.. Supplementation with a vitamin D3 megadose reduced inflammatory markers and increased the total antioxidant capacity in elderly women with vitamin D insufficiency. The 25(OH)D, PTH, us-CRP and AGP-A levels of elderly patients with the BB/Bb genotype were more responsive to supplementation compared with those with the bb genotype.

Topics: Aged; Biomarkers; C-Reactive Protein; Calcium; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Genotype; Humans; Inflammation; Middle Aged; Oxidative Stress; Parathyroid Hormone; Polymorphism, Genetic; Receptors, Calcitriol; Vitamin D; Vitamin D Deficiency

Supplementation of cholecalciferol 800 IU daily appears to be insufficient to raise vitamin D levels to >75 nmol/l in nursing home (NH) patients.. Our objective was to compare the efficacy of an individualized cholecalciferol loading dose (LD) regimen and a daily dose (DD) regimen of cholecalciferol 800 IU in reaching 25-OH vitamin D (25OHD) levels >75 nmol/l.. A total of 30 NH patients with 25OHD levels <50 nmol/l were included. Patients were randomized using the minimization method in the LD or DD group. The cholecalciferol LD, calculated with an algorithm based on serum 25OHD level and body weight, was administered in divided doses of 50,000 IU twice a week, followed by a monthly maintenance dose of either 50,000 or 25,000 IU. The DD regimen consisted of cholecalciferol 800 IU daily for 26 weeks. Serum 25OHD, calcium, creatinine, phosphate, and parathyroid hormone were measured, and 2-minute walking test, handgrip strength, and timed get up and go test were assessed at baseline (T 0), after 5 weeks (T 5), 12 weeks (T 12), and 26 weeks (T 26). The primary endpoint was the percentage of patients with 25OHD levels >75 nmol/l at T 5. Secondary endpoints were the proportion of patients with 25OHD levels >75 nmol/l at T 26, safety of LD regimen, and improvement of performance tests with normalization of vitamin D levels.. Median baseline 25OHD levels (interquartile range) were comparable between the 14 DD and 16 LD patients: 20.9 (15.9-29.6) and 21.7 (16.4-32.8) nmol/l, respectively. Levels of 25OHD >75 nmol/l at T 5 were reached in 79 % of the 14 LD patients, but in none of the 13 DD patients (p < 0.001). At T 26, 25OHD levels >75 nmol/l were reached in 83 % of the 12 LD patients and in 30 % of the ten DD patients (p < 0.05). Side effects or hypercalcemia were not observed. No improvement of performance tests was observed.. In NH patients with severe 25OHD deficiency, an individualized calculated cholecalciferol LD is likely to be superior to a DD of cholecalciferol 800 IU in terms of the ability to rapidly normalize vitamin D levels.

Topics: Aged; Aged, 80 and over; Algorithms; Body Weight; Cholecalciferol; Dietary Supplements; Endpoint Determination; Female; Hand Strength; Humans; Male; Nursing Homes; Patients; Precision Medicine; Reference Standards; Treatment Outcome; Vitamin D; Vitamin D Deficiency; Vitamins; Walking

To investigate if correction of hypovitaminosis D before initiation of Peg-interferon-alpha/ribavirin (PegIFN/RBV) therapy could improve the efficacy of PegIFN/RBV in previously null-responder patients with chronic genotype 1 or 4 hepatitis C virus (HCV) infection.. Genotype 1 or 4 HCV-infected patients with null response to previous PegIFN/RBV treatment and with hypovitaminosis D (< 30 ng/mL) prospectively received cholecalciferol 100000 IU per week for 4 wk [from week -4 (W-4) to W0], followed by 100000 IU per month in combination with PegIFN/RBV for 12 mo (from W0 to W48). The primary outcome was the rate of early virological response defined by an HCV RNA < 12 IU/mL after 12 wk PegIFN/RBV treatment.. A total of 32 patients were included, 19 (59%) and 13 (41%) patients were HCV genotype 1 and 4, respectively. The median baseline vitamin D level was 15 ng/mL (range: 7-28). In modified intention-to-treat analysis, 29 patients who received at least one dose of PegIFN/RBV were included in the analysis. All patients except one normalized their vitamin D serum levels. The rate of early virologic response was 0/29 (0%). The rate of HCV RNA < 12 IU/mL after 24 wk of PegIFN/RBV was 1/27 (4%). The safety profile was favorable.. Addition of vitamin D to PegIFN/RBV does not improve the rate of early virologic response in previously null-responders with chronic genotype 1 or 4 HCV infection.

Topics: Adult; Aged; Antiviral Agents; Biomarkers; Calcifediol; Cholecalciferol; Drug Therapy, Combination; Female; France; Genotype; Hepacivirus; Hepatitis C, Chronic; Humans; Intention to Treat Analysis; Interferon alpha-2; Interferon-alpha; Male; Middle Aged; Polyethylene Glycols; Prospective Studies; Recombinant Proteins; Ribavirin; RNA, Viral; Time Factors; Treatment Outcome; Viral Load; Vitamin D Deficiency; Vitamins

The objective of this study was to evaluate the relationship between 25(OH)D, Vitamin D Binding Protein (DBP), and free vitamin D in premature infants.. Thirty-two infants <32 weeks' gestation were randomized to two different levels of vitamin D3 supplementation (400 vs. 800 IU/day). 25(OH)D levels were measured by LC-MS/MS; DBP was measured by validated ELISA. Free vitamin D was calculated using molar ratios of 25(OH)D and DBP. The Wilcoxon signed rank test was used to compare DBP, free D and 25(OH)D levels; Spearman's correlation coefficients were used to assess correlations.. The mean gestational age at birth was 30.5 weeks; mean birth weight was 1405 g. Mean 25(OH)D levels at birth were 17.3 ng/mL; DBP levels were 297 mg/L, and estimated free vitamin D levels were 18.9. There was a statistically significant change in 25(OH)D levels after 8 weeks (24.6 vs. 39.1 ng/mL in the 400 vs. 800 group, respectively, p=0.02). DBP levels from birth to 8 weeks showed a statistically significant decrease (267 vs. 208, p=0.04). Estimated free 25(OH)D concentrations increased over the study period, from 18.9 at birth to 64.7 at 8 weeks of age (p=0.0001). Free vitamin D levels at birth were associated with global DEXA bone mineral content at discharge from the NICU (r=0.58, p=0.05).. Supplementation with vitamin D3 increased the free portion of the vitamin D metabolite, providing increased bioavailable substrate. Improved free vitamin D levels may improve measurable outcomes such as bone mineral content and deserve further evaluation.

Topics: Cholecalciferol; Dietary Supplements; Female; Humans; Infant; Infant, Newborn; Infant, Premature; Inpatients; Male; Vitamin D; Vitamin D Deficiency; Vitamin D-Binding Protein

Dosages of vitamin D necessary to prevent or treat vitamin D deficiency in children remain to be clarified.. To determine the effects of vitamin D3 1000 IU/d on serum 25-hydroxyvitamin D [25(OH)D], PTH, and markers of bone turnover (osteocalcin and collagen type 1 cross-linked C-telopeptide) in black children and white children, and to explore whether there is a threshold level of 25(OH)D associated with maximal suppression of serum PTH concentration.. Healthy 8- to 14-year-old Pittsburgh-area black (n = 84) and white (n = 73) children not receiving vitamin supplements, enrolled from October through March from 2008 through 2011, were randomized to vitamin D3 1000 IU or placebo daily for 6 months.. The mean baseline concentration of 25(OH)D was <20 ng/mL in both the vitamin D-supplemented group and the placebo group (19.8 ± 7.6 and 18.8 ± 6.9 ng/mL, respectively). The mean concentration was higher in the supplemented group than in the placebo group at 2 months (26.4 ± 8.1 vs 18.9 ± 8.1 ng/mL; P < .0001) and also at 6 months (26.7 ± 7.6 vs 22.4 ± 7.3; P = .003), after adjusting for baseline 25(OH)D, race, gender, pubertal status, dietary vitamin D intake, body mass index, and sunlight exposure. Increases were only significant in black children, when examined by race. The association between 25(OH)D and PTH concentrations was inverse and linear, without evidence of a plateau. Overall, vitamin D supplementation had no effect on PTH and bone turnover.. Vitamin D3 supplementation with 1000 IU/d in children with mean baseline 25(OH)D concentration <20 ng/mL effectively raised their mean 25(OH)D concentration to ≥20 ng/mL but failed to reach 30 ng/mL. Vitamin D supplementation had no effect on PTH concentrations.

Topics: Adolescent; Black or African American; Bone Density; Bone Development; Child; Cholecalciferol; Dietary Supplements; Dose-Response Relationship, Drug; Female; Humans; Male; Placebos; Vitamin D Deficiency; White People

Many people worldwide are vitamin D (VTD) deficient or insufficient, and there is still no consensus on the dose of VTD that should be administered to achieve a 25(OH)D concentration of 20 or 30 ng/mL. In this study, we aimed to determine an adapted supplementation of VTD able to quickly and safely increase the vitamin D status of healthy adults with low 25(OH)D. One hundred and fifty (150) subjects were randomized into three groups, each to receive, orally, a loading dose of 50,000, 100,000 or 200,000 IU of VTD3 at Week 0, followed by 25,000, 50,000 or 100,000 IU at Week 4 and Week 8. Whereas 25(OH)D baseline values were not different between groups (p = 0.42), a significant increase was observed at Week 12 (p < 0.0001) with a mean change from baseline of 7.72 ± 5.08, 13.3 ± 5.88 and 20.12 ± 7.79 ng/mL. A plateau was reached after eight weeks. No related adverse event was recorded. This study demonstrated a linear dose-response relationship with an increase in 25(OH)D levels proportional to the dose administered. In conclusion, a loading dose of 200,000 IU VTD3 followed by a monthly dose of 100,000 IU is the best dosing schedule to quickly and safely correct the VTD status.

Topics: Adolescent; Adult; Cholecalciferol; Dietary Supplements; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Vitamin D; Vitamin D Deficiency; Vitamins; Young Adult

To ascertain the frequency of correction of vitamin D deficiency (VDD) with single or multiple doses of oral (p.o.) and intramuscular (i.m.) administration of 2 high-dose preparations of vitamin D3 (VD3).. This was a prospective intervention study conducted in an ambulatory care setting. One hundred participants with VDD (25-hydroxy vitamin D [25-OHD] <20 ng/mL) were randomized to receive a dose of 600,000 or 200,000 IU of VD3 via a p.o. or i.m. route. The main outcome measure was serum 25-OHD levels at 2, 4, and 6 months after the intervention. The same dose was repeated in participants if 25-OHD remained <30 ng/mL at 2 and 4 months.. At 2 months, VDD was corrected in 93.8% of participants in Group 1 (600,000 IU i.m.); 83.3% in Group 2 (600,000 IU p.o.), 87.5% in Group 3 (200,000 IU i.m.), and 70.6% in Group 4 (200,000 IU p.o.). The mean changes from baseline in vitamin D levels at 2 months were 29.6 ± 13.7, 19.8 ± 12.3, 18.3 ± 10.6, and 13.7 ± 7.8 ng/mL in Groups 1, 2, 3, and 4, respectively. The mean levels remained significantly higher from baseline in all groups at all time points during the 6 months of observation. The mean 25-OHD level achieved in Group 1 was significantly higher than all other groups at 6 months.. Two months after the intervention, VDD was corrected in more than 70% of participants with a single dose of either 600,000 or 200,000 IU given p.o. or i.m.

Topics: Administration, Oral; Adult; Cholecalciferol; Dose-Response Relationship, Drug; Female; Hormone Replacement Therapy; Humans; Injections, Intramuscular; Male; Middle Aged; Pakistan; Treatment Outcome; Vitamin D Deficiency

Vitamin D supplementation is recommended for breastfed infants. Maternal supplementation beginning in gestation is a potential alternative, but its efficacy in maintaining infant 25-hydroxyvitamin D [25(OH)D] concentration after birth is unknown.. We determined the effect of 3 doses of maternal vitamin D supplementation beginning in gestation and continued in lactation on infant serum 25(OH)D and compared the prevalence of infant serum 25(OH)D cutoffs (>30, >40, >50, and >75 nmol/L) by dose at 8 wk of age.. Pregnant women (n = 226) were randomly allocated to receive 10, 25, or 50 μg vitamin D₃/d from 13 to 24 wk of gestation until 8 wk postpartum, with no infant supplementation. Mother and infant blood was collected at 8 wk postpartum.. At 8 wk postpartum, mean [nmol/L (95% CI)] infant 25(OH)D at 8 wk was higher in the 50-μg/d [75 (67, 83)] than in the 25-μg/d [52 (45, 58)] or 10-μg/d [45 (38, 52)] vitamin D groups (P < 0.05). Fewer infants born to mothers in the 50-μg/d group had a 25(OH)D concentration <30 nmol/L (indicative of deficiency) than infants in the 25- and 10-μg/d groups, respectively (2% compared with 16% and 43%; P < 0.05). Fewer than 15% of infants in the 10- or 25-μg/d groups achieved a 25(OH)D concentration >75 nmol/L compared with 44% in the 50-μg/d group (P < 0.05). Almost all infants (∼98%, n = 44) born to mothers in the 50-μg/d group achieved a 25(OH)D concentration >30 nmol/L. At 8 wk postpartum, mean maternal 25(OH)D concentration was higher in the 50-μg/d [88 (84, 91)] than in the 25-μg/d [78 (74, 81)] or 10-μg/d [69 (66, 73)] groups (P < 0.05).. Maternal supplementation beginning in gestation with 50 μg vitamin D₃/d protects 98% of unsupplemented breastfed infants against 25(OH)D deficiency (<30 nmol/L) to at least 8 wk, whereas 10 or 25 μg vitamin D/d protects only 57% and 84% of infants, respectively.

Topics: Adult; British Columbia; Calcifediol; Calcium; Child Development; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Fetal Blood; Humans; Hypercalcemia; Infant, Newborn; Intention to Treat Analysis; Lactation; Male; Maternal Nutritional Physiological Phenomena; Patient Compliance; Pregnancy; Pregnancy Complications; Prevalence; Vitamin D Deficiency

To determine the effect of two doses of intramuscular cholecalciferol on serial serum 25-hydroxy-vitamin-D levels and on pharmacodynamics endpoints: calcium, phosphate, parathyroid hormone, C-reactive protein, interleukin-6, and cathelicidin in critically ill adults.. Prospective randomized interventional study.. Tertiary, academic adult ICU.. Fifty critically ill adults with the systemic inflammatory response syndrome.. Patients were randomly allocated to receive a single intramuscular dose of either 150,000 IU (0.15 mU) or 300,000 IU (0.3 mU) cholecalciferol.. Pharmacokinetic, pharmacodynamic parameters, and outcome measures were collected over a 14-day period or until ICU discharge, whichever was earlier. Prior to randomization, 28 of 50 patients (56%) were classified as vitamin D deficient. By day 7 after randomization, 15 of 23 (65%) and 14 of 21 patients (67%) normalized vitamin D levels with 0.15 and 0.3 mU, respectively (p=0.01) and by day 14, 8 of 10 (80%) and 10 of 12 patients (83%) (p=0.004), respectively. Secondary hyperparathyroidism was manifested in 28% of patients at baseline. Parathyroid hormone levels decreased over the study period with patients achieving vitamin D sufficiency at day 7 having significantly lower parathyroid hormone levels (p<0.01). Inflammatory markers (C-reactive protein and interleukin-6) fell significantly over the study period. Greater increments in 25-hydroxy-vitamin-D were significantly associated with greater increments in cathelicidin at days 1 and 3 (p=0.04 and 0.004, respectively). Although in-hospital mortality rate did not differ between the groups, patients who did not mount a parathyroid hormone response to vitamin D deficiency had a higher mortality (35% vs 12%; p=0.05). No significant adverse effects were observed.. A single dose of either dose of intramuscular cholecalciferol corrected vitamin D deficiency in the majority of critically ill patients. Greater vitamin D increments were associated with early greater cathelicidin increases, suggesting a possible mechanism of vitamin D supplementation in inducing bactericidal pleiotropic effects.

Topics: Academic Medical Centers; Adult; Aged; Australia; Cholecalciferol; Critical Care; Critical Illness; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Hospital Mortality; Humans; Inflammation Mediators; Injections, Intramuscular; Intensive Care Units; Male; Middle Aged; Prospective Studies; Risk Assessment; Systemic Inflammatory Response Syndrome; Vitamin D Deficiency

Observational studies have suggested that 25-hydroxyvitamin D (25(OH)D) levels are associated with inflammatory markers. Most trials reporting significant associations between vitamin D intake and inflammatory markers used specific patient groups. Thus, we aimed to determine the effect of supplementary vitamin D using secondary data from a population-based, randomised, placebo-controlled, double-blind trial (Pilot D-Health trial 2010/0423). Participants were 60- to 84-year-old residents of one of the four eastern states of Australia. They were randomly selected from the electoral roll and were randomised to one of three trial arms: placebo (n 214), 750 μg (n 215) or 1500 μg (n 215) vitamin D3, each taken once per month for 12 months. Post-intervention blood samples for the analysis of C-reactive protein (CRP), IL-6, IL-10, leptin and adiponectin levels were available for 613 participants. Associations between intervention group and biomarker levels were evaluated using quantile regression. There were no statistically significant differences in distributions of CRP, leptin, adiponectin, leptin:adiponectin ratio or IL-10 levels between the placebo group and either supplemented group. The 75th percentile IL-6 level was 2·8 pg/ml higher (95 % CI 0·4, 5·8 pg/ml) in the 1500 μg group than in the placebo group (75th percentiles:11·0 v. 8·2 pg/ml), with a somewhat smaller, non-significant difference in 75th percentiles between the 750 μg and placebo groups. Despite large differences in serum 25(OH)D levels between the three groups after 12 months of supplementation, we found little evidence of an effect of vitamin D supplementation on cytokine or adipokine levels, with the possible exception of IL-6.

Topics: Adipokines; Adiponectin; Aged; Biomarkers; C-Reactive Protein; Cholecalciferol; Cytokines; Dietary Supplements; Double-Blind Method; Female; Humans; Inflammation; Interleukin-10; Interleukin-6; Leptin; Male; Middle Aged; Vitamin D; Vitamin D Deficiency; Vitamins

Experts debate optimal 25-hydroxyvitamin D (25[OH]D) levels for musculoskeletal health.. To compare the effects of placebo, low-dose cholecalciferol, and high-dose cholecalciferol on 1-year changes in total fractional calcium absorption, bone mineral density, Timed Up and Go and five sit-to-stand tests, and muscle mass in postmenopausal women with vitamin D insufficiency.. This randomized, double-blind, placebo-controlled clinical trial was conducted at a single center in Madison, Wisconsin, from May 1, 2010, through July 31, 2013, and the final visit was completed on August 8, 2014. A total of 230 postmenopausal women 75 years or younger with baseline 25(OH)D levels of 14 through 27 ng/mL and no osteoporosis were studied.. Three arms included daily white and twice monthly yellow placebo (n=76), daily 800 IU vitamin D3 and twice monthly yellow placebo (n=75), and daily white placebo and twice monthly 50,000 IU vitamin D3 (n=79). The high-dose vitamin D regimen achieved and maintained 25(OH)D levels≥30 ng/mL.. Outcome measures were 1-year change in total fractional calcium absorption using 2 stable isotopes, bone mineral density and muscle mass using dual energy x-ray absorptiometry, Timed Up and Go and five sit-to-stand tests, functional status (Health Assessment Questionnaire), and physical activity (Physical Activity Scale for the Elderly), with Benjamini-Hochberg correction of P values to control for the false discovery rate.. After baseline absorption was controlled for, calcium absorption increased 1% (10 mg/d) in the high-dose arm but decreased 2% in the low-dose arm (P = .005 vs high-dose arm) and 1.3% in the placebo arm (P = .03 vs high-dose arm). We found no between-arm changes in spine, mean total-hip, mean femoral neck, or total-body bone mineral density, trabecular bone score, muscle mass, and Timed Up and Go or five sit-to-stand test scores. Likewise, we found no between-arm differences for numbers of falls, number of fallers, physical activity, or functional status.. High-dose cholecalciferol therapy increased calcium absorption, but the effect was small and did not translate into beneficial effects on bone mineral density, muscle function, muscle mass, or falls. We found no data to support experts' recommendations to maintain serum 25(OH)D levels of 30 ng/mL or higher in postmenopausal women. Instead, we found that low- and high-dose cholecalciferol were equivalent to placebo in their effects on bone and muscle outcomes in this cohort of postmenopausal women with 25(OH)D levels less than 30 ng/mL.. clinicaltrials.gov Identifier: NCT00933244.

Topics: Absorptiometry, Photon; Aged; Bone Density; Bone Density Conservation Agents; Calcium Radioisotopes; Cholecalciferol; Dose-Response Relationship, Drug; Double-Blind Method; Drug Monitoring; Female; Humans; Middle Aged; Motor Activity; Physical Endurance; Postmenopause; Radiopharmaceuticals; Treatment Outcome; Vitamin D; Vitamin D Deficiency

Beyond its classical role in calcium homoeostasis and bone metabolism, vitamin D deficiency has been found to be associated with several diseases, including diabetes, non-alcoholic fatty liver disease, and even obesity itself. Importantly, there are limited data on therapeutic strategies for vitamin D deficiency in bariatric patients, and the procedure-specific guidelines may not be sufficient. To improve long-term outcomes, nutritional screening and appropriate supplementation to prevent nutrient deficiencies are urgently needed. Therefore, the aim of this study is to examine effects and safety of a forced dosing regimen of vitamin D versus conventional dose supplementation on vitamin D levels and other parameters in bariatric patients.. The study includes loading plus repeat dosing compared with repeated administration of vitamin D without a loading dose, according to guidelines, in a prospective, double-blind, randomized controlled trial. Up to a triple oral loading dose is given on day 1, then 2 and 4 weeks after surgery (100,000 IU dose each time), followed by an oral maintenance dose (3420 IU/day). The control group (n = 25) will receive placebo, followed by administration of a standard dose (3420 IU/day). We hypothesize that a significant increase in vitamin D levels will occur in patients in the treatment group (n = 25) by 24 weeks after surgery. Further measurements are aimed at evaluating changes in inflammation, bone turnover, insulin resistance, blood pressure, liver, mental health, and gut microbiota of patients undergoing omega-loop gastric bypass surgery. Furthermore, possible associations between concentrations of vitamin D, the involved enzymes, or vitamin D receptor in adipose and/or liver tissues will be determined.. To our knowledge, this trial is the first of its kind with this type of vitamin D supplementation in bariatric patients. Its major strength is the design and implementation of evaluation of influencing factors such as liver function, bone health, inflammation, insulin resistance, blood pressure, symptoms of depression, or microbiota. This alternative vitamin D dosing regimen has the potential to be a safe, fast, evidence-based treatment of vitamin D deficiency in bariatric patients. Owing to the increasing number of bariatric patients, it is also of interest to elucidate the link between obesity and vitamin D.. ClinicalTrials.gov identifier: NCT02092376 . Registered on 17 March 2014.

Topics: Administration, Oral; Biomarkers; Cholecalciferol; Clinical Protocols; Dietary Supplements; Double-Blind Method; Drug Administration Schedule; Female; Gastric Bypass; Humans; Male; Obesity; Postoperative Care; Prospective Studies; Research Design; Time Factors; Treatment Outcome; Vitamin D; Vitamin D Deficiency

Despite Australia's sunny climate, low vitamin D levels are increasingly prevalent. Sun exposure is limited by long working hours, an increase in time spent indoors, and sun protection practices, and there is limited dietary vitamin D fortification. While the importance of vitamin D for bone mineralization is well known, its role as a protective agent against chronic diseases, such as type 2 diabetes and cardiovascular disease, is less understood. Observational and limited intervention studies suggest that vitamin D might improve insulin sensitivity and secretion, mainly via its anti-inflammatory properties, thereby decreasing the risk of development and progression of type 2 diabetes. The primary aim of this trial is to investigate whether improved plasma concentrations of 25-hydroxyvitamin D (25(OH)D), obtained through vitamin D supplementation, will increase insulin sensitivity and insulin secretion. A secondary aim is to determine whether these relationships are mediated by a reduction in underlying subclinical inflammation associated with obesity.. Fifty overweight but otherwise healthy nondiabetic adults between 18 and 60 years old, with low vitamin D levels (25(OH)D < 50 nmol/l), will be randomly assigned to intervention or placebo. At baseline, participants will undergo a medical review and anthropometric measurements, including dual X-ray absorptiometry, an intravenous glucose tolerance test, muscle and fat biopsies, a hyperinsulinemic euglycemic clamp, and questionnaires assessing diet, physical activity, sun exposure, back and knee pain, and depression. The intervention group will receive a first dose of 100,000 IU followed by 4,000 IU vitamin D (cholecalciferol) daily, while the placebo group will receive apparently identical capsules, both for a period of 16 weeks. All measurements will be repeated at follow-up, with the primary outcome measure expressed as a change from baseline in insulin sensitivity and secretion for the intervention group compared with the placebo group. Secondary outcome measures will compare changes in anthropometry, cardiovascular risk factors, and inflammatory markers.. The trial will provide much needed clinical evidence on the impact of vitamin D supplementation on insulin resistance and secretion and its underlying mechanisms, which are relevant for the prevention and management of type 2 diabetes.. Clinicaltrials.gov ID: NCT02112721 .

Topics: Adolescent; Adult; Biomarkers; Cholecalciferol; Clinical Protocols; Diabetes Mellitus, Type 2; Dietary Supplements; Female; Glucose Clamp Technique; Glucose Tolerance Test; Humans; Inflammation Mediators; Insulin; Insulin Resistance; Male; Middle Aged; Overweight; Research Design; Surveys and Questionnaires; Time Factors; Treatment Outcome; Victoria; Vitamin D; Vitamin D Deficiency; Young Adult

HIV infection and antiretroviral therapy (ART) may create unique risk factors for vitamin D insufficiency, including alterations of vitamin D metabolism by ART. We prospectively compared demographic and clinical parameters between vitamin D sufficient and insufficient HIV-infected (HIV+) adults, and assessed changes in these parameters among insufficient participants following standardized vitamin D supplementation.. HIV+ adults (≥ 18 years old) with HIV-1 RNA <50 copies/mL on ART were enrolled. Vitamin D sufficiency and insufficiency were defined as 25-hydroxyvitamin D (25(OH)D) ≥ 30 or <30 ng/mL, respectively. Insufficient participants received open-label vitamin D3 50,000 IU twice weekly for 5 weeks, then 8000 IU twice weekly to complete 24 weeks. The primary endpoint was success or failure to achieve 25(OH)D ≥ 30 ng/mL at week 24.. Ninety-seven participants enrolled (34 vitamin D sufficient, 63 insufficient); 32% female, 47% non-White, median age 46 years, ART duration 5 years, CD4+ T lymphocyte count (CD4) 673 cells/mm(3). 25(OH)D repletion was 83% (95% CI 71%-90%) successful. 25(OH)D levels correlated with both CD4 (r = 0.44, p = 0.01) and time on protease inhibitor (r = -0.35, p = 0.01). After adjusting for age, sex, race, nadir CD4 and baseline 25(OH)D: 1) current use of efavirenz exposure was associated with a 21.1 ng/mL higher week 24 25(OH)D level (p = 0.007), 2) per year use of zidovudine was associated with 7.1 ng/mL reduction in week 24 serum 25(OH)D (p = 0.05) and 3) every 1 ng/mL 25(OH)D increase was associated with a 3.3 cell/mm(3) CD4 increase (p = 0.06).. Vitamin D3 supplementation was effective in repleting 25(OH)D levels after 24 weeks. Current efavirenz use was positively associated with post-repletion 25(OH)D levels, while greater time on zidovudine was associated with lower post-repletion 25(OH)D levels. The association between improved CD4 recovery and vitamin D repletion suggests a potential benefit of vitamin D supplementation on immunologic recovery during HIV treatment.. This trial is registered at The Brazilian Clinical Trials Registry (U1111-1165-2537).

Topics: Adult; Alkynes; Antiretroviral Therapy, Highly Active; Benzoxazines; Brazil; Cholecalciferol; Cyclopropanes; Dietary Supplements; Female; HIV Infections; Humans; Linear Models; Male; Middle Aged; Multivariate Analysis; Prospective Studies; Risk Factors; Socioeconomic Factors; Vitamin D Deficiency

This study aimed to investigate the effects of daily intake of vitamin D-fortified yogurt drink (doogh) on central obesity indicators in subjects with type 2 diabetes (T2D) and the possible modulation of this effect by vitamin D receptor (VDR) Cdx-2 genotypes. A total of sixty T2D subjects were randomly allocated to two groups to receive either plain doogh (PD; n 29, containing 170 mg Ca and no vitamin D/250 ml) or vitamin D3-fortified doogh (FD; n 31, containing 170 mg Ca and 12·5 μg/250 ml) twice a day for 12 weeks. 25-hydroxyvitamin D (25(OH)D), glycaemic as well as adiposity indicators were evaluated before and after the intervention. VDR-Cdx-2 genotypes in extended number of T2D subjects in the FD group (n 60) were determined as AA, GA and GG. After 12 weeks, in FD compared with PD, serum 25(OH)D increased (+35·4 v. -4·8 nmol/l; P<0·001) and mean changes of waist circumference (WC; -1·3 v. +1·6 cm; P=0·02), body fat mass (FM; -1·9 v. +0·60 %; P=0·008), truncal fat (TF; -1·1 v. 0·13 %; P=0·003) and visceral adipose tissue (-0·80 v. +0·37 AU; P<0·001) decreased significantly. Circulating 25(OH)D was raised only in the AA group (34·8 nmo/l in AA group v. -6·4 nmol/l in AG and -1·6 nmol/l in GG groups; P<0·001), which was accompanied by a significant decrease in changes of WC (P=0·004), FM% (P=0·01) and TF% (P<0·001) in the AA genotype. Daily intake of vitamin D-FD for 12 weeks improved the central obesity indices in T2D subjects, and the improvement was more pronounced in the carriers of the AA genotype of VDR-Cdx-2.

Topics: Adiposity; Adult; Blood Glucose; Body Mass Index; Body Weight; CDX2 Transcription Factor; Cholecalciferol; Diabetes Mellitus, Type 2; Dose-Response Relationship, Drug; Energy Intake; Female; Food, Fortified; Genotyping Techniques; Homeodomain Proteins; Humans; Male; Middle Aged; Nutrigenomics; Nutrition Assessment; Obesity, Abdominal; Patient Compliance; Polymorphism, Single Nucleotide; Randomized Controlled Trials as Topic; Receptors, Calcitriol; Single-Blind Method; Vitamin D Deficiency; Waist Circumference; Yogurt

The endothelium is important not only in regulating vascular tone but also in modulating inflammation. Patients with systemic lupus erythematosus (SLE) have deficits in these endothelial functions. Vitamin D is a nuclear hormone that regulates vascular endothelial nitric oxide synthase activity and expression. Many SLE patients have insufficient levels of vitamin D. The effect of this hormone on vascular endothelial function in SLE patients is not known. This study was designed to determine the effect size of repleting vitamin D levels on endothelial function in patients with SLE and vitamin D deficiency.. SLE patients with 25(OH) vitamin D (25(OH)D) levels <20 ng/mL were randomized to oral vitamin D3 (D3) doses that did or did not raise 25(OH)D levels to ≥32 ng/mL. Endothelial function was measured with flow-mediated dilation (FMD) before and after 16 weeks of vitamin D3 supplementation.. Half of those who achieved 25(OH)D levels of ≥32 ng/mL experienced increases in FMD, whereas none of those with continued low 25(OH)D levels did. Those with increases in FMD had significantly higher final 25(OH)D levels. Using the effect size from this study, future studies designed to test the effect of repleting 25(OH)D on FMD in vitamin D-deficient SLE patients will require 35 patients in each group.. These results suggest a potential role for vitamin D in SLE-related endothelial dysfunction and that an adaptive, multi-arm, treat-to-target, serum-level trial design may increase the efficiency and likelihood of success of such a study.

Topics: Administration, Oral; Adult; Cholecalciferol; Dietary Supplements; Endothelium; Female; Humans; Inflammation; Lupus Erythematosus, Systemic; Male; Middle Aged; Pilot Projects; Vascular Diseases; Vitamin D Deficiency

Vitamin D is well known for its function in calcium homeostasis and bone mineralisation, but is increasingly studied for its potential immunomodulatory properties. Vitamin D deficiency is a common problem in patients with COPD. Previous studies have not demonstrated a beneficial effect of vitamin D on exacerbation rate in COPD patients. However, subgroup analyses suggested protective effects in vitamin D deficient patients. Our objective is to assess the effect of vitamin D supplementation on exacerbation rate specifically in vitamin D deficient COPD patients.. We will perform a randomised, multi-center, double-blind, placebo-controlled intervention study. The study population consists of 240 COPD patients aged 40 years and older with vitamin D deficiency (25-hydroxyvitamin D concentration < 50 nmol/L). Participants will be recruited after an exacerbation and will be randomly allocated in a 1:1 ratio to receive vitamin D3 16800 IU or placebo orally once a week during 1 year. Participants will receive a diary card to register the incidence of exacerbations and changes in medication during the study period. Visits will be performed at baseline, at 6 months and at 12 months after randomisation. Participants will undergo spirometry, measurement of total lung capacity and assessment of maximal respiratory mouth pressure. Several physical performance and hand grip strength tests will be performed, questionnaires on quality of life and physical activity will be filled in, a nasal secretion sample and swab will be obtained and blood samples will be taken. The primary outcome will be exacerbation rate.. This study will be the first RCT aimed at the effects of vitamin D supplementation on exacerbation rate in vitamin D deficient COPD patients. Also, in contrast to earlier studies that used infrequent dosing regimens, our trial will study effects of a weekly dose of vitamin D supplementation. Secondly, the immunomodulatory effects of vitamin D on host immune response of COPD patients and underlying mechanisms will be studied. Finally, the effects on physical functioning will be examined.. This trial is registered in ClinicalTrials.gov, ID number NCT02122627 . Date of Registration April 2014.

Topics: Adult; Aged; Aged, 80 and over; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Hand Strength; Humans; Male; Middle Aged; Pulmonary Disease, Chronic Obstructive; Quality of Life; Respiratory Function Tests; Surveys and Questionnaires; Treatment Outcome; Vitamin D; Vitamin D Deficiency

Tuberculosis, including multidrug-resistant tuberculosis (MDR-TB), is a major global health problem. Individuals with tuberculosis disease commonly exhibit vitamin D deficiency, which may adversely affect immunity and the response to therapy.. We determined whether adjunctive high-dose vitamin D3 supplementation improves outcomes in individuals with pulmonary tuberculosis disease.. The study was a double-blind, randomized, placebo-controlled, intent-to-treat trial in 199 individuals with pulmonary tuberculosis disease in Tbilisi, Georgia. Subjects were randomly assigned to receive oral vitamin D3 [50,000 IUs (1.25 mg) thrice weekly for 8 wk and 50,000 IU every other week for 8 wk] or a placebo concomitant with standard first-line antituberculosis drugs. The primary outcome was the time for the conversion of a Mycobacterium tuberculosis (Mtb) sputum culture to negative.. Baseline characteristics between groups were similar. Most subjects (74%) were vitamin D deficient (plasma 25-hydroxyvitamin D [25(OH)D] concentration <50 nmol/L). With vitamin D3, plasma 25(OH)D concentrations peaked at ∼250 nmol/L by 8 wk and decreased to ∼125 nmol/L at week 16. Adverse events and plasma calcium concentrations were similar between groups. In 192 subjects with culture-confirmed tuberculosis, an adjusted efficacy analysis showed similar median culture-conversion times between vitamin D3 and placebo groups [29 and 27 d, respectively; HR: 0.86; 95% CI: 0.63, 1.18; P = 0.33). Eight-week culture-conversion rates were also similar (84.0% and 82.1% for vitamin D3 and placebo, respectively; P = 0.99).. A high-dose vitamin D3 regimen safely corrected vitamin D deficiency but did not improve the rate of sputum Mtb clearance over 16 wk in this pulmonary tuberculosis cohort. This trial was registered at clinicaltrials.gov at NCT00918086.

Topics: Adolescent; Adult; Antitubercular Agents; Calcifediol; Cholecalciferol; Cohort Studies; Dietary Supplements; Double-Blind Method; Female; Georgia (Republic); Humans; Intention to Treat Analysis; Longitudinal Studies; Male; Middle Aged; Mycobacterium tuberculosis; Patient Dropouts; Sputum; Tuberculosis, Pulmonary; Vitamin D Deficiency; Young Adult

Compare effectiveness of maternal vitamin D3 supplementation with 6400 IU per day alone to maternal and infant supplementation with 400 IU per day.. Exclusively lactating women living in Charleston, SC, or Rochester, NY, at 4 to 6 weeks postpartum were randomized to either 400, 2400, or 6400 IU vitamin D3/day for 6 months. Breastfeeding infants in 400 IU group received oral 400 IU vitamin D3/day; infants in 2400 and 6400 IU groups received 0 IU/day (placebo). Vitamin D deficiency was defined as 25-hydroxy-vitamin D (25(OH)D) <50 nmol/L. 2400 IU group ended in 2009 as greater infant deficiency occurred. Maternal serum vitamin D, 25(OH)D, calcium, and phosphorus concentrations and urinary calcium/creatinine ratios were measured at baseline then monthly, and infant blood parameters were measured at baseline and months 4 and 7.. Of the 334 mother-infant pairs in 400 IU and 6400 IU groups at enrollment, 216 (64.7%) were still breastfeeding at visit 1; 148 (44.3%) continued full breastfeeding to 4 months and 95 (28.4%) to 7 months. Vitamin D deficiency in breastfeeding infants was greatly affected by race. Compared with 400 IU vitamin D3 per day, 6400 IU/day safely and significantly increased maternal vitamin D and 25(OH)D from baseline (P < .0001). Compared with breastfeeding infant 25(OH)D in the 400 IU group receiving supplement, infants in the 6400 IU group whose mothers only received supplement did not differ.. Maternal vitamin D supplementation with 6400 IU/day safely supplies breast milk with adequate vitamin D to satisfy her nursing infant's requirement and offers an alternate strategy to direct infant supplementation.

Topics: Adolescent; Adult; Breast Feeding; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Infant; Lactation; Maternal Health; Middle Aged; Vitamin D Deficiency; Vitamins; Young Adult

There is an abnormal increase in TGF-β1 bioavailability in women with polycystic ovary syndrome (PCOS), which might play a role in the pathophysiology of this syndrome. Vitamin D (VD) supplementation improves various clinical manifestations of PCOS and decreases TGF-β1 levels in several diseases including myelofibrosis.. The objective of the study was to determine the effect of VD supplementation on TGF-β1 bioavailability in VD-deficient women with PCOS and assess whether changes in TGF-β1/soluble endoglin (sENG) levels correlate with an improvement in PCOS clinical manifestations.. This was a prospective, randomized, placebo-controlled trial.. The study was conducted at an academic-affiliated medical center.. Sixty-eight VD-deficient women with PCOS who were not pregnant or taking any exogenous hormones were recruited between October 2013 and January 2015.. Forty-five women received 50 000 IU of oral vitamin D3 and 23 women received oral placebo once weekly for 8 weeks.. Serum TGF-β1, sENG, lipid profile, testosterone, dehydroepiandrosterone sulfate, and insulin resistance were measured. The clinical parameters were evaluated before and 2 months after treatment.. The VD level significantly increased and normalized after VD supplementation (16.3 ± 0.9 [SEM] to 43.2 ± 2.4 ng/mL; P < .01), whereas it did not significantly change after placebo. After the VD supplementation, there was a significant decrease in the following: the interval between menstrual periods (80 ± 9 to 60 ± 6 d; P = .04), Ferriman-Gallwey score (9.8 ± 1.5 to 8.1 ± 1.5; P < .01), triglycerides (138 ± 22 to 117 ± 20 mg/dL; P = .03), and TGF-β1 to sENG ratio (6.7 ± 0.4 to 5.9 ± 0.4; P = .04). In addition, the ΔTGF-β1 to sENG ratio was positively correlated with Δtriglycerides (r = 0.59; P = .03).. VD supplementation in VD-deficient women with PCOS significantly decreases the bioavailability of TGF-β1, which correlates with an improvement in some abnormal clinical parameters associated with PCOS. This is a novel mechanism that could explain the beneficial effects of VD supplementation in women with PCOS. These findings may support new treatment modalities for PCOS, such as the development of anti-TGF-β drugs.

Topics: Adolescent; Adult; Antigens, CD; Biological Availability; Cholecalciferol; Dehydroepiandrosterone Sulfate; Endoglin; Female; Humans; Insulin Resistance; Lipids; Polycystic Ovary Syndrome; Prospective Studies; Receptors, Cell Surface; Socioeconomic Factors; Testosterone; Transforming Growth Factor beta1; Vitamin D; Vitamin D Deficiency; Vitamins; Young Adult

  To study the associations between serum 25-hydroxy-vitamin D (25(OH)D) levels, vitamin D administration and intraocular pressure (IOP)..   The design of the study included a nested case-control study and a randomized controlled intervention trial. In the first part, healthy Caucasians with high or low serum 25(OH)D levels were recruited from a population-based study. IOP of the right eye was measured by the use of a rebound tonometer. In the second part, those with low serum 25(OH)D levels were randomized to receive either capsules of vitamin D3 20,000 IU twice per week or placebo for 6 months before IOP was measured again..   Intraocular pressure in the 87 participants with low serum 25(OH)D levels (mean 40.1±12.9 nm) did not differ from IOP in the 42 participants with high serum 25(OH)D levels (mean 85.1±14.0 nm) (15.9±3.3 mmHg versus 15.6±3.1 mmHg, p= 0.56, independent t-test). After intervention, IOP decreased by -0.8± 2.1 mmHg (p = 0.017, paired t-test) in the vitamin D group (n= 39) and -0.8±2.5 mmHg (p= 0.059) in the placebo group (n= 39), but the change was not significantly different between the groups (p= 0.92, independent t-test)..   This study in healthy participants revealed no associations between serum 25(OH)D levels and IOP, and administration of vitamin D3 to participants with low levels of 25(OH)D did not affect IOP. These results do not support a role of vitamin D in the regulation of IOP.

Topics: Adult; Aged; Aged, 80 and over; Calcifediol; Capsules; Case-Control Studies; Cholecalciferol; Female; Humans; Intraocular Pressure; Luminescent Measurements; Male; Middle Aged; Tonometry, Ocular; Vitamin D Deficiency; Vitamins

There is limited information on the effects of vitamin D on serum 25 hydroxyvitamin D (25OHD) in young people and none on African Americans. The main objective of this trial was to measure the effect of different doses of vitamin D3 on serum 25OHD and serum parathyroid hormone (PTH) in young women with vitamin D insufficiency (serum 25OHD ≤ 20 ng/mL (50 nmol/L). A randomized double-blind placebo-controlled trial of vitamin D3 was conducted in young white and African American women, age 25 to 45 years. A total of 198 healthy white (60%) and African American (40%) women were randomly assigned to placebo, or to 400, 800, 1600, or 2400 IU of vitamin D3 daily. Calcium supplements were added to maintain a total calcium intake of 1000 to 1200 mg daily. The primary outcomes of the study were the final serum 25OHD and PTH levels at 12 months. The absolute increase in serum 25OHD with 400, 800, 1600, and 2400 IU of vitamin D daily was slightly greater in African American women than in white women. On the highest dose of 2400 IU/d, the mixed model predicted that mean 25OHD increased from baseline 12.4 ng/mL (95% confidence interval [CI], 9.2-15.7) to 43.2 ng/mL (95% CI, 38.2-48.1) in African American women and from 15.0 ng/mL (95% CI, 12.3-17.6) to 39.1 ng/mL (95% CI, 36.2-42.0) in white women. There was no significant effect of vitamin D dose on serum PTH in either race but there was a significant inverse relationship between final serum PTH and serum 25OHD. Serum 25OHD exceeded 20 ng/mL in 97.5% of whites on the 400 IU/d dose and between 800 and 1600 IU/d for African Americans. The recommended dietary allowance (RDA) suggested by the Institute of Medicine for young people is 600 IU daily. The increase in serum 25OHD after vitamin D supplementation was similar in young and old, and in white and African American women.

Topics: Adult; Black or African American; Calcium; Cholecalciferol; Double-Blind Method; Female; Humans; Middle Aged; Parathyroid Hormone; Vitamin D; Vitamin D Deficiency; White People

Growing evidence indicates that vitamin D receptor activation may have antiproteinuric effects. We aimed to evaluate whether vitamin D supplementation with daily cholecalciferol could reduce albuminuria in proteinuric chronic kidney disease (CKD) patients.. This 6-month prospective, controlled, intervention study enrolled 101 non-dialysis CKD patients with albuminuria. Patients with low 25(OH) vitamin D [25(OH)D] and high parathyroid hormone (PTH) levels (n = 50; 49%) received oral cholecalciferol (666 IU/day), whereas those without hyperparathyroidism (n = 51; 51%), independent of their vitamin D status, did not receive any cholecalciferol, and were considered as the control group.. Cholecalciferol administration led to a rise in mean 25(OH)D levels by 53.0 ± 41.6% (P < 0.001). Urinary albumin-to-creatinine ratio (uACR) decreased from (geometric mean with 95% confidence interval) 284 (189-425) to 167 mg/g (105-266) at 6 months (P < 0.001) in the cholecalciferol group, and there was no change in the control group. Reduction in a uACR was observed in the absence of significant changes in other factors, which could affect proteinuria, like weight, blood pressure (BP) levels or antihypertensive treatment. Six-month changes in 25(OH)D levels were significantly and inversely associated with that in the uACR (Pearson's R = -0.519; P = 0.036), after adjustment by age, sex, body mass index, BP, glomerular filtration rate and antiproteinuric treatment. The mean PTH decreased by -13.8 ± 20.3% (P = 0.039) only in treated patients, with a mild rise in phosphate and calcium-phosphate product [7.0 ± 14.7% (P = 0.002) and 7.2 ± 15.2% (P = 0.003), respectively].. In addition to improving hyperparathyroidism, vitamin D supplementation with daily cholecalciferol had a beneficial effect in decreasing albuminuria with potential effects on delaying the progression of CKD.

Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Albuminuria; Cholecalciferol; Dietary Supplements; Disease Progression; Female; Humans; Hyperparathyroidism; Male; Middle Aged; Parathyroid Hormone; Phosphates; Prospective Studies; Renal Insufficiency, Chronic; Vitamin D; Vitamin D Deficiency; Vitamins; Young Adult

A course of treatment with narrow-band ultraviolet B (NB-UVB) improves psoriasis and increases serum 25-hydroxyvitamin D (25(OH)D). In this study 12 patients with psoriasis who were supplemented with oral cholecalciferol, 20 µg daily, were given a course of NB-UVB and their response measured. At baseline, serum 25(OH)D was 74.14 ± 22.9 nmol/l. At the 9th exposure to NB-UVB 25(OH)D had increased by 13.2 nmol/l (95% confidence interval (95% CI) 7.2-18.4) and at the 18th exposure by 49.4 nmol/l (95% CI 35.9-64.6) above baseline. Psoriasis Area Severity Index score improved from 8.7 ± 3.5 to 4.5 ± 2.0 (p < 0.001). At baseline, psoriasis lesions showed low vitamin D metabolizing enzyme (CYP27A1, CYP27B1) and high human β-defensin-2 mRNA expression levels compared with those of the healthy subjects. In conclusion, NB-UVB treatment significantly increases serum 25(OH)D in patients with psoriasis who are taking oral vitamin D supplementation, and the concentrations remain far from the toxicity level. Healing psoriasis lesions show similar mRNA expression of vitamin D metabolizing enzymes, but higher antimicrobial peptide levels than NB-UVB-treated skin in healthy subjects.

Topics: 25-Hydroxyvitamin D3 1-alpha-Hydroxylase; Administration, Oral; Adult; beta-Defensins; Biopsy; Cholecalciferol; Cholestanetriol 26-Monooxygenase; Female; Humans; Male; Middle Aged; Psoriasis; Real-Time Polymerase Chain Reaction; RNA, Messenger; Skin; Ultraviolet Therapy; Vitamin D; Vitamin D Deficiency; Vitamins

Regulatory T cells (Tregs) play a central role in the maintenance of self-tolerance. Animal and in vitro studies suggest that vitamin D is involved in reducing the risk of autoimmunity by modulating Tregs.. In a double-blind, placebo controlled study in 60 healthy volunteers, we assessed the effect of a 12-week high-dose oral cholecalciferol supplementation (140,000 IU/month) on the number and function of CD4(pos)CD25(high)FoxP3(pos)CD127(dim) Tregs. We also assessed the clinical safety of the supplementation and the effect on the frequency of other immune cells such as monocytes, dendritic cells, natural killer cells, natural killer T cells, B cells and subgroups of T cells. We also tested the in vitro effect of cholecalciferol on Tregs in human cell cultures.. By using FACS analysis, ex vivo suppressive co-cultures and apoptosis assays, we were able to show that a cholecalciferol supplementation leads to significantly increased numbers of peripheral Tregs in vivo. Tregs function and the frequency of other immune cells remained unchanged, and no clinically relevant safety concerns were found. The in vitro exposure of human peripheral blood mononuclear cells to cholecalciferol also supported our in vivo findings.. Our results indicate a substantial effect of a supplementation with inactive vitamin D on the immune system of healthy humans in vivo and provide a rationale for future studies to investigate the immunomodulatory effects of vitamin D in autoimmune diseases.

Topics: Adjuvants, Immunologic; Adult; Apoptosis; Austria; Blood Cell Count; Calcifediol; CD4 Antigens; Cells, Cultured; Cholecalciferol; Coculture Techniques; Dietary Supplements; Double-Blind Method; Female; Forkhead Transcription Factors; Humans; Interleukin-2 Receptor alpha Subunit; Leukocytes, Mononuclear; Leukopoiesis; Male; T-Lymphocytes, Regulatory; Vitamin D Deficiency; Young Adult

To determine whether treatment of low serum vitamin D in pregnant women improves fetal growth indices.. In this open-label randomized clinical trial, 130 Iranian pregnant women (24-26 weeks of gestation) with vitamin D deficiency or insufficiency [25(OH)D <30ng/ml] were divided at random into an intervention group and a control group. The control group received 200mg calcium plus a multivitamin (containing vitamin D3 400U) each day, and the intervention group received 200mg calcium plus a multivitamin (containing vitamin D3 400U) each day, plus vitamin D3 (50,000U) each week for 8 weeks. At delivery, maternal and cord blood 25(OH)D levels, maternal weight gain, neonatal length, neonatal weight and neonatal head circumference were compared between two groups. Serum vitamin D was measured using enzyme-linked immunosorbent assay. A multivariate regression analysis was performed to examine the independent effect of maternal vitamin D level on fetal growth indices.. Mean (±standard deviation) length (intervention group: 49±1.6cm; control group: 48.2±1.7cm; p=0.001), head circumference (intervention group: 35.9±0.7cm; control group: 35.3±1.0cm; p=0.001) and weight (intervention group: 3429±351.9g; control group: 3258.8±328.2g; p=0.01) were higher in the intervention group compared with the control group. Mean maternal weight gain was higher in the intervention group compared with the control group (13.3±2.4kg vs 11.7±2.7kg; p=0.006). Multivariate regression analysis for maternal weight gain, neonatal length, neonatal weight and neonatal head circumference showed an independent correlation with maternal vitamin D level.. Treatment of low serum vitamin D during pregnancy improves fetal growth indices and maternal weight gain.

Topics: Adult; Birth Weight; Body Height; Calcium; Cholecalciferol; Female; Fetal Development; Humans; Infant, Newborn; Iran; Multivariate Analysis; Pregnancy; Pregnancy Complications; Regression Analysis; Treatment Outcome; Vitamin D Deficiency; Vitamins; Weight Gain; Young Adult

Epidemiologic studies have shown that low vitamin D levels are associated with reduced insulin sensitivity and increased risk of developing type 2 diabetes mellitus (T2DM). However, there is little evidence that vitamin D supplementation improves glucose intolerance. We evaluated the glucose-lowering effect of vitamin D in Korean T2DM subjects. We enrolled 158 T2DM patients who had stable glycemic control [hemoglobin A1c (HbA1c) <8.5%] and vitamin D levels less than 20 ng/mL. The participants were randomized into two groups: Placebo (100 mg daily of elemental calcium administered twice a day) or Vitamin D (1000 IU daily of cholecalciferol combined with 100 mg of elemental calcium administered twice a day). We compared outdoor physical activity, glycemic control, homeostasis model of assessment - insulin resistance (HOMA-IR), and parathyroid hormone (PTH), during the 24-week intervention. We analyzed the data of 129 participants (placebo =65, vitamin D =64) who completely followed the protocol. Outdoor physical activity and oral anti-diabetic drugs did not differ between the groups. While there were significant differences in the vitamin D levels (15.6 ± 7.1 ng/mL vs 30.2 ± 10.8 ng/mL, P<0.001) and change in PTH levels (1.4 ± 15.3 pg/mL vs -5.5 ± 9.8 pg/mL, P=0.003) between the placebo and vitamin D groups, there were no differences in HbA1c (7.27 ± 0.87% vs 7.40 ± 0.90%) (P=0.415) and HOMA-IR. Serum calcium and kidney function results showed that the vitamin D supplementation was safe. While vitamin D supplementation is safe and effective in the attainment of vitamin D sufficiency, it had no effect on long-term glycemic control for T2DM in our study.

Topics: Adult; Aged; Blood Glucose; Calcium; Calcium, Dietary; Cholecalciferol; Diabetes Mellitus, Type 2; Double-Blind Method; Female; Glycated Hemoglobin; Humans; Insulin Resistance; Male; Middle Aged; Parathyroid Hormone; Republic of Korea; Vitamin D Deficiency

Hypovitaminosis D, especially during cold seasons, is quite prevalent among primary school children in Tehran. The present study aimed to compare the efficacy of calcium-vitamin D-fortified-milk, -orange juice and supplement in primary school children.. Children aged 9-12 years from both sexes were randomly assigned to one of six groups to receive plain milk, fortified milk, plain orange juice, fortified orange juice, supplement or placebo. Both fortified-milk and -juice contained 100 IU of vitamin D and 500 mg of calcium per 200 mL package, whereas supplement contained 200 IU of vitamin D and 500 mg of calcium. The duration of intervention was 12 weeks, from November 2008 to March 2009.. A total of 410 children completed the study. Regression analysis with adjustment for both sex and initial values of 25(OH)D revealed that consumption of either supplement, fortified orange juice or fortified milk resulted in a 20.8 nm [confidence interval (CI) = 17.4-23.9], 9.9 nm (CI = 7.4-12.3) or 6.9 nm (CI = 3.3-10.5) increase in circulating 25(OH)D compared to the related control groups. However, changes in serum osteocalcin and intact parathyroid hormone in the supplement group did not differ from those of fortified milk or plain milk. The increment of osteocalcin in both plain milk and fortified milk was more than in fortified orange juice, although the difference was statistically insignificant.. Despite having double amount of vitamin D and being more effective in raising serum 25(OH)D, supplementation did not confer additional benefit in terms of osteocalcin and intact parathyroid hormone compared to either fortified or plain milk.

Topics: Animals; Beverages; Biomarkers; Bone and Bones; Calcium, Dietary; Child; Cholecalciferol; Citrus sinensis; Dietary Supplements; Female; Food Preferences; Food, Fortified; Humans; Male; Milk; Nutritional Status; Osteocalcin; Parathyroid Hormone; Trace Elements; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D deficiency (serum 25-hydroxyvitamin D < 50 nm) has been associated with the onset of immunological diseases including atopic dermatitis (AD), cutaneous or systemic lupus erythematosus and allergic asthma. In this study, we assessed whether oral vitamin D (cholecalciferol) supplementation leads to a systemic modulation of the phenotype of circulating lymphocyte populations and whether a defined serum 25-hydroxyvitamin D (25(OH)D) concentration can be related to the effects on lymphocytes. Cholecalciferol was administered in a dose-escalation setting to vitamin D-deficient individuals from 2000 up to 8000 IU daily for 12 weeks. Individuals without cholecalciferol intake served as controls. Peripheral B cells and T cells were examined by multicolour flow cytometric analysis. The mean serum 25(OH)D concentrations increased upon cholecalciferol intake up to 159 ± 28.7 nm, and remained low in the control group 30.0 ± 12.5 nm. Following cholecalciferol intake, the frequencies of circulating CD38 expressing B cells were significantly increased and IFN-γ+ , and/or IL-17+ CD4+ T helper cells were decreased. These data were identified to correlate with the serum 25(OH)D levels by applying two different analysis approaches (ROC and a nonlinear regression analysis). Our data indicate that increasing 25(OH)D serum concentrations are associated with an increased expression of CD38 on B cells and a decreased T-cell-dependent proinflammatory cytokine production. The therapeutical role of our findings in systemic immunological diseases should be explored in the future by further controlled clinical studies.

Topics: Administration, Oral; Adolescent; ADP-ribosyl Cyclase 1; Adult; B-Lymphocyte Subsets; Calcifediol; Cholecalciferol; Female; Humans; Immunophenotyping; Interferon-gamma; Interleukin-17; Male; Membrane Glycoproteins; Middle Aged; ROC Curve; Seasons; Th17 Cells; Vitamin D Deficiency; Young Adult

This study aims to investigate the efficacy and safety of oral fixed-dose combination of strontium ranelate 2  g/vitamin D₃ 1000  IU daily vs strontium ranelate 2  g daily for correcting vitamin D insufficiency in osteoporosis.. A 6-month international, randomized, double-blind, parallel-group, phase 3 study.. A total of 518 men and postmenopausal women aged ≥50 years with primary osteoporosis (T-score ≤-2.5 s.d.) and serum 25-hydroxyvitamin D (25(OH)D) >22.5 nmol/l were included. Patients were allocated to strontium ranelate 2 g/vitamin D₃ 1000  IU daily (n=413) or strontium ranelate 2 g daily (n=105). The participants received calcium 1 g daily. The primary endpoint was serum 25(OH)D at last post-baseline evaluation during 3 months.. Both groups were comparable at baseline. Mean baseline of 25(OH)D was 44.1 ± 14.6 nmol/l. After 3 months, the percentage of patients with 25(OH)D ≥50 nmol/l was higher with strontium ranelate/vitamin D₃ vs strontium ranelate (84 vs 44%, P<0.001; adjusted between-group odds ratio=6.7; 95% CI, 4.2-10.9). The efficacy of the fixed-dose combination on 25(OH)D was maintained at 6 months (86 vs 40%, P<0.001). Mean 25(OH)D was 65.1 and 49.5 nmol/l, respectively, after 3 months and 66.9 and 45.4 nmol/l after 6 months. Physical performance improved in both groups. Falls were 17 and 20% in the strontium ranelate/vitamin D₃ and strontium ranelate groups respectively. Parathyroid hormone levels were inversely correlated with 25(OH)D. No clinically relevant differences in safety were observed.. This study confirms the efficacy and safety of fixed-dose combination of strontium ranelate 2 g/vitamin D₃ 1000 IU for correction of vitamin D insufficiency in osteoporotic patients.

Topics: Aged; Cholecalciferol; Female; Humans; Male; Middle Aged; Osteoporosis; Osteoporosis, Postmenopausal; Strontium; Thiophenes; Vitamin D; Vitamin D Deficiency

African Americans have a disproportionate burden of inflammation-associated chronic diseases such as cancer and lower circulating levels of 25-hydroxyvitamin D [25(OH)D]. The effect of vitamin D3 (cholecalciferol) supplementation on inflammatory markers is uncertain. We conducted a randomized, double-blind, placebo-controlled trial of supplemental oral vitamin D (placebo, 1,000, 2,000, or 4,000 IU/day of vitamin D3 orally for 3 months) in 328 African Americans (median age, 51 years) of public housing communities in Boston, MA, who were enrolled over three consecutive winter periods (2007-2010). Change from 0 to 3 months of plasma levels of 25(OH)D, high-sensitivity C-reactive protein (CRP), interleukin (IL)-6, IL-10, and soluble TNF-α receptor type 2 (sTNF-R2) in 292 (89%) participants were measured. Overall, no statistically significant changes in CRP, IL-6, IL-10, and sTNF-R2 were observed after the vitamin D supplementation period. Baseline CRP was significantly inversely associated with the baseline 25(OH)D level (P < 0.001) in unadjusted and adjusted models. An interaction between baseline 25(OH)D and vitamin D supplementation was observed for outcome change in log CRP (month 3-month 0; P for interaction = 0.04). Within an unselected population of African Americans, short-term exposure to vitamin D supplementation produced no change in circulating inflammatory markers. This study confirms the strong independent association of CRP with 25(OH)D status even after adjusting for body mass index. Future studies of longer supplemental vitamin D3 duration are necessary to examine the complex influence of vitamin D3 on CRP and other chronic inflammatory cytokines for possible reduction of cancer health disparities in African Americans.

Topics: Adult; Biomarkers; Black or African American; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Inflammation; Inflammation Mediators; Male; Middle Aged; Placebos; Vitamin D Deficiency

The maximal calcium absorption in response to vitamin D has been proposed as a biomarker for vitamin D sufficiency.. The objective was to determine whether there is a threshold beyond which increasing doses of vitamin D, or concentrations of serum 25-hydroxyvitamin D [25(OH)D], no longer increase calcium absorption.. This was a placebo-controlled, dose-response, randomized, double-blind study of the effect of vitamin D on calcium absorption in healthy postmenopausal women. Seventy-six healthy postmenopausal women were randomly assigned to placebo or 800 IU (20 μg), 2000 IU (50 μg), or 4000 IU (100 μg) vitamin D₃ for 8 wk. The technique of dual isotopes of stable calcium was used with a calcium carrier to measure calcium absorption at baseline and after 8 wk.. Seventy-one women with a mean ± SD age of 58.8 ± 4.9 y completed the study. The mean calcium intake was 1142 ± 509 mg/d and serum 25(OH)D was 63 ± 14 nmol/L at baseline. A statistically significant linear trend of an increase in calcium absorption adjusted for age and body mass index with increasing vitamin D₃ dose or serum 25(OH)D concentration was observed. A 6.7% absolute increase in calcium absorption was found in the highest vitamin D₃ group (100 μg). No evidence of nonlinearity was observed in the dose-response curve.. No evidence of a threshold of calcium absorption was found with a serum 25(OH)D range from 40 to 130 nmol/L. Calcium absorption in this range is not a useful biomarker to determine nutritional recommendations for vitamin D.

Topics: Biomarkers; Bone Density Conservation Agents; Calcifediol; Calcium; Calcium Isotopes; Calcium, Dietary; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Follow-Up Studies; Humans; Intestinal Absorption; Middle Aged; New York; Nutritional Requirements; Osteoporosis, Postmenopausal; Postmenopause; Seasons; Vitamin D Deficiency

To determine the vitamin D dose necessary to achieve serum 25-hydroxyvitamin D (25(OH)D) concentration ≥ 20 ng/mL during infancy.. A randomized, double-blind, placebo-controlled trial in New Zealand. Pregnant mothers, from 27 weeks' gestation to birth, and then their infants, from birth to age 6 months, were randomly assigned to 1 of 3 mother/infant groups: placebo/placebo, vitamin D3 1000/400 IU, or vitamin D3 2000/800 IU. Serum 25(OH)D and calcium concentrations were measured at enrollment, 36 weeks' gestation, in cord blood, and in infants at 2, 4, and 6 months of age.. Two-hundred-and-sixty pregnant women were randomized. At enrollment, the proportions with serum 25(OH)D ≥ 20 ng/mL for placebo, lower-dose, and higher-dose groups were 54%, 64%, and 55%, respectively. The proportion with 25(OH)D ≥ 20 ng/mL was larger in both intervention groups at 36 weeks' gestation (50%, 91%, 89%, P < .001). In comparison with placebo, the proportion of infants with 25(OH)D ≥ 20 ng/mL was larger in both intervention groups to age 4 months: cord blood (22%, 72%, 71%, P < .001), 2 months (50%, 82%, 92%, P < .001), and 4 months (66%, 87%, 87%, P = .004), but only in the higher-dose group at age 6 months (74%, 82%, 89%, P = .07; higher dose versus placebo P = .03, lower dose versus placebo P = .21).. Daily vitamin D supplementation during pregnancy and then infancy with 1000/400 IU or 2000/800 IU increases the proportion of infants with 25(OH)D ≥ 20 ng/mL, with the higher dose sustaining this increase for longer.

Topics: Adult; Biomarkers; Cholecalciferol; Dietary Supplements; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Infant; Intention to Treat Analysis; Linear Models; Male; Medication Adherence; Pregnancy; Prenatal Care; Prenatal Exposure Delayed Effects; Prenatal Nutritional Physiological Phenomena; Vitamin D; Vitamin D Deficiency; Vitamins

Association studies have suggested that lower circulating 25-hydroxyvitamin D [25(OH)D] in African Americans may partially underlie higher rates of cardiovascular disease and cancer in this population. Nonetheless, the relation between vitamin D supplementation and 25(OH)D concentrations in African Americans remains undefined.. Our primary objective was to determine the dose-response relation between vitamin D and plasma 25(OH)D.. A total of 328 African Americans in Boston, MA, were enrolled over 3 winters from 2007 to 2010 and randomly assigned to receive a placebo or 1000, 2000, or 4000 IU vitamin D₃/d for 3 mo. Subjects completed sociodemographic and dietary questionnaires, and plasma samples were drawn at baseline and 3 and 6 mo.. Median plasma 25(OH)D concentrations at baseline were 15.1, 16.2, 13.9, and 15.7 ng/mL for subjects randomly assigned to receive the placebo or 1000, 2000, or 4000 IU/d, respectively (P = 0.63). The median plasma 25(OH)D concentration at 3 mo differed significantly between supplementation arms at 13.7, 29.7, 34.8, and 45.9 ng/mL, respectively (P < 0.001). An estimated 1640 IU vitamin D₃/d was needed to raise the plasma 25(OH)D concentration to ≥ 20 ng/mL in ≥ 97.5% of participants, whereas a dose of 4000 IU/d was needed to achieve concentrations ≥ 33 ng/mL in ≥ 80% of subjects. No significant hypercalcemia was seen in a subset of participants.. Within African Americans, an estimated 1640 IU vitamin D₃/d was required to achieve concentrations of plasma 25(OH)D recommended by the Institute of Medicine, whereas 4000 IU/d was needed to reach concentrations predicted to reduce cancer and cardiovascular disease risk in prospective observational studies. These results may be helpful for informing future trials of disease prevention.

Topics: Adult; Aged; Aged, 80 and over; Black or African American; Boston; Calcifediol; Cardiovascular Diseases; Cholecalciferol; Cohort Studies; Dietary Supplements; Double-Blind Method; Female; Humans; Intention to Treat Analysis; Lost to Follow-Up; Male; Middle Aged; Neoplasms; Patient Dropouts; Risk Factors; Seasons; Vitamin D Deficiency

Summary A high incidence of 25OH vitamin D deficiency has been observed in HIV-infected subjects. The objective of this study was to evaluate the effect of cholecalciferol administration on serum 25OH vitamin D levels in HIV-infected patients. This prospective cohort study included 153 HIV-positive subjects; 47 were treated with 300,000 IU intramuscular cholecalciferol, 67 with 25,000 IU oral cholecalciferol monthly, while the remaining 39 did not receive any treatment. The group treated orally had an increase of serum 25OH vitamin D concentration, changing from 15.7 ± 12.2 ng/mL to 27.4 ± 11.6 ng/mL after 10 months (T10). The group treated with intramuscular supplementation had an improvement, changing from 18.5 ± 10.5 ng/mL to 32.9.0 ± 12.2 ng/mL at T10. One-way repeated measures analysis of variance indicated a significant difference for 25OH vitamin D variation (p = 0.002) among the three groups. A significant effect of time (p < 0.001) and group × time interaction (p < 0.001) was found: at T10, 25OH vitamin D values were significantly higher in the oral and intramuscular groups with respect to the control group. Our findings showed that the supplementation with cholecalciferol in patients with HIV-infection improved 25OH vitamin D serum levels, and suggest that the two types of administration are equivalent, but are insufficient for severe forms of hypovitaminosis.

Topics: Administration, Oral; Adult; Analysis of Variance; Anti-HIV Agents; Cholecalciferol; Dietary Supplements; Female; HIV Infections; Humans; Injections, Intramuscular; Italy; Male; Middle Aged; Prevalence; Prospective Studies; Socioeconomic Factors; Treatment Outcome; Vitamin D; Vitamin D Deficiency; Vitamins

To compare the effect of 800 vs 400 IU of daily oral vitamin D3 on the prevalence of vitamin D deficiency (VDD) at 40 weeks' postmenstrual age (PMA) in preterm infants of 28 to 34 weeks' gestation.. In this randomized double-blind trial, we allocated eligible infants to receive either 800 or 400 IU of vitamin D3 per day (n = 48 in both groups). Primary outcome was VDD (serum 25-hydroxyvitamin D levels <20 ng/mL) at 40 weeks' PMA. Secondary outcomes were VDD, bone mineral content, and bone mineral density at 3 months' corrected age (CA).. Prevalence of VDD in the 800-IU group was significantly lower than in the 400-IU group at 40 weeks (38.1% vs. 66.7%; relative risk: 0.57; 95% confidence interval: 0.37-0.88) and at 3 months' CA (12.5% vs. 35%; relative risk: 0.36; 95% confidence interval: 0.14-0.90). One infant (2.4%) in the 800-IU group had vitamin D excess (100-150 ng/mL). Bone mineral content (mean ± SD: 79.6 ± 16.8 vs. 84.7 ± 20.7 g; P = .27) and bone mineral density (0.152 ± 0.019 vs. 0.158 ± 0.021 g/cm2; P = .26) were not different between the 2 groups.. Daily supplementation with 800 IU of vitamin D reduces the prevalence of VDD at 40 weeks' PMA and at 3 months' CA in preterm infants without showing any improvement in bone mineralization. However, there is a possibility that this dose may occasionally result in vitamin D excess.

Topics: Administration, Oral; Adult; Cholecalciferol; Dietary Supplements; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Infant, Newborn; Infant, Premature; Male; Vitamin D Deficiency; Young Adult

Vitamin D deficiency is associated with obesity; whether repletion supports weight loss and changes obesity-related biomarkers is unknown.. We compared 12 mo of vitamin D3 supplementation with placebo on weight, body composition, insulin, and C-reactive protein (CRP) in postmenopausal women in a weight-loss intervention.. A total of 218 overweight/obese women (50-75 y of age) with serum 25-hydroxyvitamin D [25(OH)D] ≥10 ng/mL but <32 ng/mL were randomly assigned to weight loss + 2000 IU oral vitamin D3/d or weight loss + daily placebo. The weight-loss intervention included a reduced-calorie diet (10% weight loss goal) and 225 min/wk of moderate-to-vigorous aerobic activity. Mean 12-mo changes in weight, body composition, serum insulin, CRP, and 25(OH)D were compared between groups (intent-to-treat) by using generalized estimating equations.. A total of 86% of participants completed the 12-mo measurements. The mean (95% CI) change in 25(OH)D was 13.6 (11.6, 15.4) ng/mL in the vitamin D3 arm compared with -1.3 (-2.6, -0.3) ng/mL in the placebo arm (P < 0.0001). Changes in weight [-7.1 (-8.7, -5.7) compared with -7.4 (-8.1, -5.4) kg], body mass index (in kg/m(2): both -2.8), waist circumference [-4.9 (-6.7, -2.9) compared with -4.5 (-5.6, -2.6) cm], percentage body fat [-4.1 (-4.9, -2.9) compared with -3.5 (-4.5, -2.5)], trunk fat [-4.1 (-4.7, -3.0) compared with -3.7 (-4.3, -2.9) kg], insulin [-2.5 (-3.4, -1.7) compared with -2.4 (-3.3, -1.4) μU/mL], and CRP [-0.9 (-1.2, -0.6) compared with -0.79 (-0.9, -0.4) mg/L] [corrected] were similar between groups (all P > 0.05). Compared with women who achieved 25(OH)D <32 ng/mL, women randomly assigned to vitamin D who became replete (ie, 25(OH)D ≥32 ng/mL) lost more weight [-8.8 (-11.1, -6.9) compared with -5.6 (-7.2, -5.0) kg; P = 0.05], waist circumference [-6.6 (-9.3, -4.3) compared with -2.5 (-4.6, -2.0) cm; P = 0.02], and percentage body fat [-4.7 (-6.1, -3.5) compared with -2.6 (-3.9, -2.2); P = 0.04]. Among women with complete pill counts (97% adherence), the mean decrease in CRP was 1.18 mg/mL (46%) in the vitamin D arm compared with 0.46 mg/mL (25%) in the placebo arm (P = 0.03).. Vitamin D3 supplementation during weight loss did not increase weight loss or associated factors compared with placebo; however, women who became replete experienced greater improvements. This trial was registered at clinicaltrials.gov as NCT01240213.

Topics: Aged; Body Composition; Body Mass Index; Body Weight; C-Reactive Protein; Cholecalciferol; Diet; Dietary Supplements; Double-Blind Method; Energy Intake; Exercise; Female; Humans; Insulin; Linear Models; Middle Aged; Obesity; Patient Compliance; Postmenopause; Vitamin D Deficiency; Waist Circumference; Weight Loss

the possible therapeutic role of vitamin D in different kind of diseases explains the growing interest in this vitamin due to its pleiotropic effects. This short report shows preliminary results of prevalence of hypovitaminosis D in a group of patients and proposes a oral supplement therapy effective in correcting hypovitaminosis in a short time, without side effects.. 243 patients (aged 26-93; 67 males) were enrolled at this study. We evaluated plasma levels of 25-hydroxyvitamin D [25(OH)D] with the following cut-off values: <10 ng/ml or <0-25 nmol/L (deficient), 10-30 ng/ml or 25-75 nmol/L 30-50 (insufficient) and > 30 ng/ml or > 50 nmol/L (normal). The first 73 patients with hypovitaminosis D received at baseline 25,000 IU (Cholecalciferol) per os twice a month (Tp.A). The next patients (Tp.B) at baseline received a loading dose of 50,000 IU once a week for 8 weeks, followed by a maintenance dose of 25,000 IU twice a month.. hypovitaminosis D is a widespread condition (i.e., 82.3%) not only in elderly (75.6% of 75 patients aged <65 yrs and 86.5% of 168 subjects aged >65 yrs). Preliminary results at 6 months show that Tp.B is more effective in correcting hypovitaminosis D (baseline 14.4 ± 5.3 ng/ml; 24 wk 43.3 ± 14.7 ng/ml; p<0.0001).. hypovitaminosis D is an important public health problem. We believe it is important to quickly achieve normal Vit. D plasma values in order to produce pleiotropic effects.

Topics: Administration, Oral; Adult; Age Distribution; Aged; Aged, 80 and over; Aging; Cholecalciferol; Dietary Supplements; Female; Humans; Male; Middle Aged; Prevalence; Rome; Vitamin D; Vitamin D Deficiency

There are several published reports on the prevalence of low vitamin D levels in otherwise healthy Indian population. Vitamin D deficiency has shown variable effect on muscle performance and strength but there is paucity of data on the effect of vitamin D deficiency on muscle energy metabolism. The present study was proposed to investigate the influence of severe vitamin D deficiency on high-energy metabolite levels in resting skeletal muscle and thereafter, monitor the response after vitamin D supplementation using ³¹P magnetic resonance spectroscopy (MRS). Study was conducted on 19 otherwise healthy subjects but with low serum 25(OH)D levels (<5 ng/ml). Subjects were supplemented with cholecalciferol at a dose of 60,000 IU/week for 12 weeks. MRS measurements of inorganic phosphate (Pi), phosphocreatine (PCr), phosphodiester (PDE) and ATP of the calf muscle were taken pre- and post-vitamin D supplementation. The study revealed significantly increased PCr/Pi ratio and decreased [Pi] and PDE/ATP ratio with raised serum 25(OH)D levels after 12 weeks of supplementation. The study indicates that serum 25(OH)D level plays an important role in improving the skeletal muscle energy metabolism and vitamin D deficiency might be one of the primary reasons for prevalence of low PCr/Pi ratio and high PDE values in normal Indian population as reported earlier. The findings of this preliminary study are highly encouraging and warrant further in-depth research, involving larger number of subjects of different age groups, regions and socio-economic sections of the society to further strengthen a correlation between vitamin D levels and muscle energy metabolism.

Topics: Adenosine Triphosphate; Adolescent; Adult; Calcifediol; Cholecalciferol; Dietary Supplements; Energy Metabolism; Female; Humans; Hyperparathyroidism, Secondary; India; Magnetic Resonance Imaging; Male; Muscle, Skeletal; Phosphocreatine; Phosphoric Diester Hydrolases; Phosphorus Isotopes; Pilot Projects; Severity of Illness Index; Vitamin D Deficiency; Whole Body Imaging; Young Adult

As a result of research suggesting increased health risk with low serum 25-hydroxycholecalciferol (25(OH)D), health care providers are measuring it frequently. Providers and patients are faced with treatment choices when low status is identified.. To compare the safety and efficacy of three vitamin D3 dietary supplements with different delivery matrices.. A 12-week, parallel group, single-masked, clinical trial was conducted in Seattle, Washington and Kailua Kona, Hawaii. Sixty-six healthy adults with (25(OH)D) <33 ng/mL were randomly assigned to take one of three D3 supplements, ie, a chewable tablet (TAB), an oil-emulsified drop (DROP), or an encapsulated powder (CAP) at a label-claimed dose of 10,000 IU/day. Actual D3 content was assessed by a third party and the results adjusted based on the actual D3 content administered. Mean change in 25(OH)D/mcg D3 administered; difference in the proportion of D3 insufficient participants (ie, 25(OH)D ≤30 ng/mL) reaching sufficiency (ie, 25(OH)D ≥30 ng/mL); and mean change in serum 1, 25-dihydroxycholecalciferol were measured.. In two of the three products tested, the measured vitamin D3 content varied considerably from the label-claimed dose. Differences in 25(OH)D/mcg D3 administered were significantly different between groups (P = .04; n = 55). Pairwise comparisons demonstrated DROP resulted in a greater increase than TAB (P < .05) but not than CAP. TAB was not different from CAP. The proportions reaching sufficiency were: 100% (TAB and CAP) and 80% (DROP) (P = .03 between groups; n = 55). 1, 25-Dihydroxycholecalciferol did not change significantly in any group.. Oil-emulsified vitamin D3 supplements resulted in a greater mean change in serum 25(OH)D concentration, but fewer patients reaching vitamin D sufficiency, than chewable or encapsulated supplements.

Topics: Adolescent; Adult; Aged; Cholecalciferol; Dietary Supplements; Dosage Forms; Dose-Response Relationship, Drug; Drug Administration Routes; Female; Humans; Male; Middle Aged; Treatment Outcome; Vitamin D Deficiency; Young Adult

Interactions between calcium and vitamin D may have implications for the regulation of serum 25-hydroxyvitamin D [25(OH)D] and its catabolism and, consequently, the vitamin D dietary requirement.. We investigated whether different calcium intakes influenced serum 25(OH)D and indexes of vitamin D activation and catabolism during winter and in the context of both adequate and inadequate vitamin D intakes.. A 15-wk winter-based, randomized, placebo-controlled, double-blind vitamin D₃ intervention (20 μg/d) study was carried out in free-living men and women aged ≥50 y (n = 125) who were stratified according to calcium intakes [moderate-low (<700 mg/d) or high (>1000 mg/d) intake]. The serum 25(OH)D concentration was the primary outcome, and serum calcium, parathyroid hormone (PTH), 1,25-dihydroxyvitamin D [1,25(OH)₂D], 24,25-dihydroxyvitamin D [24,25(OH)₂D], the ratio of 24,25(OH)₂D to 25(OH)D, vitamin D-binding protein, and free 25(OH)D were exploratory outcomes.. A repeated-measures ANOVA showed there was no significant (P = 0.2) time × vitamin D treatment × calcium intake grouping interaction effect on the mean serum 25(OH)D concentration over the 15-wk intervention period. Serum 25(OH)D concentrations increased (P ≤ 0.005) and decreased (P ≤ 0.002) in vitamin D₃ and placebo groups, respectively, and were of similar magnitudes in subjects with calcium intakes <700 mg/d (and even <550 mg/d) compared with >1000 mg/d. The response of serum PTH, 1,25(OH)₂D, 24,25(OH)₂D, the ratio of 24,25(OH)₂D to 25(OH)D, and free 25(OH)D significantly differed in vitamin D₃ and placebo groups but not by calcium intake grouping.. We found no evidence of a vitamin D sparing effect of high calcium intake, which has been referred to by some authors as "vitamin D economy." Thus, recent dietary vitamin D requirement estimates will cover the vitamin D needs of even those individuals who have inadequate calcium intakes.

Topics: 24,25-Dihydroxyvitamin D 3; 25-Hydroxyvitamin D 2; Aged; Aged, 80 and over; Aging; Calcifediol; Calcitriol; Calcium; Calcium, Dietary; Cholecalciferol; Dietary Supplements; Double-Blind Method; Ergocalciferols; Female; Humans; Ireland; Male; Middle Aged; Nutritional Requirements; Seasons; Vitamin D Deficiency

Vitamin D deficiency, defined by the total serum 25-hydroxyvitamin D [25(OH)D] level, is common and more prevalent among Blacks than whites. Vitamin D-binding protein (DBP) levels vary with race and may modulate "bioavailable" levels of 25(OH)D.. To determine the effect of DBP levels on the functional response to vitamin D.. A randomized, placebo-controlled trial of vitamin D repletion for 2 mo, which took place at an outpatient research unit. Participants included 150 vitamin D-deficient (25(OH)D <20 ng/mL) adults. Participants were randomly assigned to receive either 50,000 IU of vitamin D3 or placebo weekly for 8 weeks. This is a post-hoc analysis using DBP, 25(OH)D, PTH, and calcium levels.. Blacks had lower total 25(OH)D (12 vs 15 ng/mL, P < .001) and DBP levels (119 vs 234 μg/mL, P < .001) than non-Blacks. DBP levels were similar before and after vitamin D3 or placebo treatment (r = 0.98, P < .001). Baseline total 25(OH)D levels were a significant determinant of baseline PTH levels (P < .001). The change in total 25(OH)D was associated with the change in PTH (P < 0.001) and calcium levels (P < .05). In contrast, DBP levels were not a determinant of baseline PTH (P = .57) nor significantly related to changes in either PTH (P = .53) or calcium levels (P = .88).. DBP levels are stable in Blacks and non-Blacks, and do not change with correction of vitamin D deficiency. Even for individuals with total 25(OH)D levels < 20 ng/mL, Blacks have significantly lower DBP levels than non-Blacks. However, within this range of total 25(OH)D, DBP levels do not influence the effect of vitamin D repletion on PTH or calcium levels.

Topics: Adult; Calcium; Cholecalciferol; Dietary Supplements; Female; Humans; Male; Middle Aged; Parathyroid Hormone; Vitamin D; Vitamin D Deficiency; Vitamin D-Binding Protein

Vitamin D supplementation during pregnancy is a well-accepted recommendation worldwide; however, the debate about the correct dose is ongoing. We aimed to compare daily doses of 600, 1,200, and 2,000 IU in this randomized, controlled study.. The study group consisted of 91 pregnant women aged 16-42 years admitted to Kocaeli Maternity and Children Hospital between April 2011 and April 2012. The participants were randomly divided into 3 groups. 600, 1,200, and 2,000 IU/day of vitamin D was supplemented to group 1 (control group, n = 31), group 2 (n = 31), and group 3 (n = 32), respectively. Serum calcium, 25-hydroxyvitamin D (25OHD), and the calcium/creatinine ratio in spot urine samples were measured in the follow-up period. The serum calcium and 25OHD levels of the mothers' infants were measured as well.. The frequency of vitamin D sufficiency after supplementation was 80% in group 3 and it was significantly higher than in groups 1 (42%) and 2 (39%) (p = 0.03). The frequency of vitamin D sufficiency in the infants of the participants was 91% in group 3 and it was significantly higher than in groups 1 (36%) and 2 (52%) (p = 0.006).. At least 2,000 IU/day of vitamin D is needed to ensure adequate vitamin D status in pregnancy and early infancy.

Topics: Adult; Calcium; Cholecalciferol; Creatinine; Dietary Supplements; Female; Humans; Infant, Newborn; Pregnancy; Turkey; Vitamin D; Vitamin D Deficiency

Vitamin D (vit-D) is essential for bone health, although many osteoporosis patients have low levels of 25-hydroxy-vit-D [25(OH)D]. This randomized, open-label study compared the effects of once weekly alendronate 70 mg containing 5600 IU vit-D₃ (ALN/D5600) to alendronate 70 mg without additional vit-D (ALN) on the percent of patients with vit-D insufficiency [25(OH)D <15 ng/mL, primary endpoint] and serum parathyroid hormone (PTH, secondary endpoint) levels in postmenopausal, osteoporotic Korean women. Neuromuscular function was also measured. A total of 268 subjects were randomized. Overall, 35% of patients had vit-D insufficiency at baseline. After 16-weeks, there were fewer patients with vit-D insufficiency in the ALN/D5600 group (1.47%) than in the ALN group (41.67%) (p<0.001). Patients receiving ALN/D5600 compared with ALN were at a significantly decreased risk of vit-D insufficiency [odds ratio=0.02, 95% confidence interval (CI) 0.00-0.08]. In the ALN/D5600 group, significant increases in serum 25(OH)D were observed at weeks 8 (9.60 ng/mL) and 16 (11.41 ng/mL), where as a significant decrease was recorded in the ALN group at week 16 (-1.61 ng/mL). By multiple regression analysis, major determinants of increases in serum 25(OH)D were ALN/D5600 administration, seasonal variation, and baseline 25(OH)D. The least squares mean percent change from baseline in serum PTH in the ALN/D5600 group (8.17%) was lower than that in the ALN group (29.98%) (p=0.0091). There was no significant difference between treatment groups in neuromuscular function. Overall safety was similar between groups. In conclusion, the administration of 5600 IU vit-D in the ALN/D5600 group improved vit-D status and reduced the magnitude of PTH increase without significant side-effects after 16 weeks in Korean osteoporotic patients.

Topics: Adult; Aged; Alendronate; Cholecalciferol; Female; Humans; Middle Aged; Osteoporosis, Postmenopausal; Vitamin D Deficiency

Vitamin D deficiency in pregnancy is associated with an increased risk of gestational diabetes mellitus (GDM) and neonatal vitamin D deficiency. We conducted a double-blind, randomized controlled trial of low-dose (LD) versus high-dose (HD) vitamin D supplementation to investigate the effects of vitamin D supplementation on glucose metabolism during pregnancy.. Women with plasma 25-hydroxyvitamin D (25OHD) levels <32 ng/mL before 20 weeks' gestation were randomized to oral vitamin D3 at 5,000 IU daily (HD) (n = 89) or the recommended pregnancy dose of 400 IU daily (LD) (n = 90) until delivery. The primary end point was maternal glucose levels on oral glucose tolerance test (OGTT) at 26-28 weeks' gestation. Secondary end points included neonatal 25OHD, obstetric and other neonatal outcomes, and maternal homeostasis model assessment of insulin resistance. Analysis was by intention to treat.. There was no difference in maternal glucose levels on OGTT. Twelve LD women (13%) developed GDM versus seven (8%) HD women (P = 0.25). Neonatal cord 25OHD was higher in HD offspring (46 ± 11 vs. 29 ± 12 ng/mL, P < 0.001), and deficiency was more common in LD offspring (24 vs. 10%, P = 0.06). Post hoc analysis in LD women showed an inverse relationship between pretreatment 25OHD and both fasting and 2-h blood glucose level on OGTT (both P < 0.001). Baseline 25OHD remained an independent predictor after multiple regression analysis.. HD vitamin D supplementation commencing at a mean of 14 weeks' gestation does not improve glucose levels in pregnancy. However, in women with baseline levels <32 ng/mL, 5,000 IU per day was well tolerated and highly effective at preventing neonatal vitamin D deficiency.

Topics: Adult; Cholecalciferol; Diabetes, Gestational; Dietary Supplements; Dose-Response Relationship, Drug; Double-Blind Method; Fasting; Female; Glucose; Glucose Tolerance Test; Humans; Insulin Resistance; Pregnancy; Pregnancy Complications; Vitamin D; Vitamin D Deficiency; Young Adult

Low plasma vitamin D levels have been associated with heart failure (HF). This research attempts to explain the role of vitamin D supplementation on myocardial function in elderly patients with HF.. Twenty-three chronic HF patients were randomized in a small parallel group, double-blind, placebo-controlled trial. All patients, with a mean age of 74 years and vitamin D levels <30 ng/mL, received 800,000 IU (4000 IU/daily) of cholecalciferol or placebo for 6 months. The outcomes measured at baseline and after 6 months were ejection fraction (EF) and other echocardiography parameters, carboxyterminal propeptide of procollagen type I (PIP), natriuretic peptides, lipid profile, renin, parathyroid hormone, blood pressure, and body mass index (BMI). In 13 patients under active treatment for 6 months, mean plasma 25-hydroxy vitamin D concentrations (15.51 vs. -1.40 ng/mL, p < 0.001) and plasma calcium (from 9.3 to 9.6 mmol/L, p < 0.05) increased significantly. However, other biomarkers of bone metabolism did not differ between the treatment and placebo groups. EF increased significantly in the intervention group (6.71 vs. -4.3%; p < 0.001), and the serum concentration of PIP increased only in the placebo group after 6 months (1140.98 vs. -145 mcg/L; p < 0.05). Systolic blood pressure was lower after 6 months of cholecalciferol treatment (from 129.6 to 122.7 mm Hg, p < 0.05). No significant variations were observed for other parameters.. Six months of vitamin D supplementation significantly improves EF in elderly patients with HF and vitamin D deficiency.

Topics: Aged; Aged, 80 and over; Biomarkers; Blood Pressure; Body Mass Index; Calcium; Cholecalciferol; Collagen Type I; Dietary Supplements; Double-Blind Method; Female; Heart Failure; Humans; Male; Middle Aged; Parathyroid Hormone; Renin; Treatment Outcome; Vitamin D; Vitamin D Deficiency

Fundamental knowledge gaps in relation to the 3 epimer of 25-hydroxycholecalciferol [3-epi-25(OH)D₃] limit our understanding of its relevance for vitamin D nutrition and health. The aims of this study were to characterize the 3-epi-25(OH)D₃ concentrations in a nationally representative sample of adults and explore its determinants. We also used data from a recent randomized controlled trial (RCT) of supplemental cholecalciferol (vitamin D₃) conducted in winter in older adults to directly test the impact of changes in vitamin D status on serum 3-epi-25(OH)D3 concentrations. Serum 25-hydroxycholecalciferol [25(OH)D₃] and 3-epi-25(OH)D₃ concentrations (via LC-tandem mass spectrometry) from our vitamin D₃ RCT in adults (aged ≥50 y) and data on dietary, lifestyle, and biochemical characteristics of participants of the recent National Adult Nutrition Survey in Ireland (aged 18-84 y; n = 1122) were used in the present work. In the subsample of participants who had serum 3-epi-25(OH)D₃ concentrations greater than the limit of quantification (n = 1082; 96.4%), the mean, 10th, 50th (median), and 90th percentile concentrations were 2.50, 1.05, 2.18, and 4.30 nmol/L, respectively, whereas the maximum 3-epi-25(OH)D₃ concentration was 15.0 nmol/L. A regression model [explaining 29.9% of the variability in serum 3-epi-25(OH)D₃] showed that age >50 y, vitamin D supplement use, dietary vitamin D, meat intake, season of blood sampling, and sun exposure habits were significant positive determinants, whereas increasing waist circumference and serum 25-hydroxyergocalciferol concentration were significant negative determinants. The RCT data showed that mean serum 25(OH)D₃ and 3-epi-25(OH)D₃ concentrations increased (49.3% and 42.1%, respectively) and decreased (-28.0% and -29.1%, respectively) significantly (P < 0.0001) with vitamin D₃ (20 μg/d) and placebo supplementation, respectively, over 15 wk of winter. In conclusion, we provide data on serum 3-epi-25(OH)D₃ in a nationally representative sample of adults. Our combined observational and RCT data might suggest that both dietary supply and dermal synthesis of vitamin D₃ contribute to serum 3-epi-25(OH)D₃ concentration.

Topics: 25-Hydroxyvitamin D 2; Adult; Aged; Aged, 80 and over; Calcifediol; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Ireland; Male; Meat; Middle Aged; Nutrition Surveys; Prevalence; Seasons; Severity of Illness Index; Skin; Stereoisomerism; Sunlight; Vitamin D Deficiency

In asthma and other diseases, vitamin D insufficiency is associated with adverse outcomes. It is not known if supplementing inhaled corticosteroids with oral vitamin D3 improves outcomes in patients with asthma and vitamin D insufficiency.. To evaluate if vitamin D supplementation would improve the clinical efficacy of inhaled corticosteroids in patients with symptomatic asthma and lower vitamin D levels.. The VIDA (Vitamin D Add-on Therapy Enhances Corticosteroid Responsiveness in Asthma) randomized, double-blind, parallel, placebo-controlled trial studying adult patients with symptomatic asthma and a serum 25-hydroxyvitamin D level of less than 30 ng/mL was conducted across 9 academic US medical centers in the National Heart, Lung, and Blood Institute's AsthmaNet network, with enrollment starting in April 2011 and follow-up complete by January 2014. After a run-in period that included treatment with an inhaled corticosteroid, 408 patients were randomized.. Oral vitamin D3 (100,000 IU once, then 4000 IU/d for 28 weeks; n = 201) or placebo (n = 207) was added to inhaled ciclesonide (320 µg/d). If asthma control was achieved after 12 weeks, ciclesonide was tapered to 160 µg/d for 8 weeks, then to 80 µg/d for 8 weeks if asthma control was maintained.. The primary outcome was time to first asthma treatment failure (a composite outcome of decline in lung function and increases in use of β-agonists, systemic corticosteroids, and health care).. Treatment with vitamin D3 did not alter the rate of first treatment failure during 28 weeks (28% [95% CI, 21%-34%] with vitamin D3 vs 29% [95% CI, 23%-35%] with placebo; adjusted hazard ratio, 0.9 [95% CI, 0.6-1.3]). Of 14 prespecified secondary outcomes, 9 were analyzed, including asthma exacerbation; of those 9, the only statistically significant outcome was a small difference in the overall dose of ciclesonide required to maintain asthma control (111.3 µg/d [95% CI, 102.2-120.4 µg/d] in the vitamin D3 group vs 126.2 µg/d [95% CI, 117.2-135.3 µg/d] in the placebo group; difference of 14.9 µg/d [95% CI, 2.1-27.7 µg/d]).. Vitamin D3 did not reduce the rate of first treatment failure or exacerbation in adults with persistent asthma and vitamin D insufficiency. These findings do not support a strategy of therapeutic vitamin D3 supplementation in patients with symptomatic asthma.. clinicaltrials.gov Identifier: NCT01248065.

Topics: Administration, Inhalation; Administration, Oral; Adrenal Cortex Hormones; Adult; Anti-Asthmatic Agents; Asthma; Cholecalciferol; Dose-Response Relationship, Drug; Double-Blind Method; Female; Glucocorticoids; Humans; Lung; Male; Middle Aged; Pregnenediones; Treatment Failure; Vitamin D Deficiency; Vitamins

Low serum 25-hydroxyvitamin D [25(OH)D] concentrations have been associated with insulin resistance, the metabolic syndrome, and type 2 diabetes. Because many non-Western immigrants in the Netherlands are vitamin D deficient, obese, and at high risk of diabetes, vitamin D supplementation may contribute to prevent diabetes and insulin resistance.. We examined the effect of vitamin D supplementation on insulin sensitivity and β cell function in overweight, vitamin D-deficient, non-Western immigrants at high risk of diabetes.. The study was a 16-wk, randomized, placebo-controlled trial. A total of 130 non-Western immigrants with prediabetes (fasting glucose concentration >5.5 mmol/L or random glucose concentration from 7.8 to 11.1 mmol/L) and vitamin D deficiency (serum 25[OH]D concentration <50 nmol/L) were randomly assigned after stratification by sex to receive either cholecalciferol (1200 IU/d) or a placebo for 16 wk. All participants received 500 mg Ca/d as calcium carbonate. The primary outcome was the difference in the area under the curve of insulin and glucose after a 75-g oral-glucose-tolerance test after 4 mo of treatment. Secondary outcomes were insulin-sensitivity variables, β cell-function variables, and metabolic syndrome.. Mean serum 25(OH)D concentrations increased significantly in the vitamin D compared with placebo groups. After 4 mo of therapy, the mean between-group difference was 38 nmol/L (95% CI: 32.1, 43.9 nmol/L; P < 0.001). There was no significant effect on insulin sensitivity and β cell function. In a post hoc analysis, when patients with diabetes at baseline were excluded, a significant increase in the insulinogenic index was observed in participants who obtained a 25(OH)D concentration ≥60 nmol/L (P = 0.040).. Vitamin D supplementation in non-Western vitamin D-deficient immigrants with prediabetes did not improve insulin sensitivity or β cell function or change the incidence of metabolic syndrome. However, after the exclusion of diabetic subjects, an improvement in the insulinogenic index was observed in participants who obtained a 25(OH)D concentration ≥60 nmol/L. This trial was registered at trialregister.nl as NTR1827.

Topics: Adult; Aged; Blood Glucose; Body Mass Index; Cholecalciferol; Dietary Supplements; Dose-Response Relationship, Drug; Double-Blind Method; Emigrants and Immigrants; Female; Follow-Up Studies; Glucose Tolerance Test; Humans; Insulin; Insulin Resistance; Insulin-Secreting Cells; Male; Middle Aged; Netherlands; Obesity; Overweight; Prediabetic State; Prevalence; Risk Factors; Treatment Outcome; Vitamin D; Vitamin D Deficiency; Young Adult

There is current interest in the maternal-fetal effects of antenatal vitamin D supplementation, yet little data regarding vitamin D's role in neonatal calcium homeostasis. We determined to assess the effect of high-dose antenatal vitamin D supplementation on fetal and neonatal calcium concentrations.. In a double-blinded, placebo-controlled trial in Bangladesh, 160 pregnant women were randomized to oral vitamin D3 (35,000 IU/wk) or placebo from 26 to 29 wk of gestation.. Total serum calcium (Ca) was higher in cord blood of those supplemented vs. placebo (2.66 ± 0.1 vs. 2.61 ± 0.2 mmol/l; P = 0.04), but the difference in albumin-adjusted calcium was not statistically significant. Change in Ca concentration from birth to day 3 of life was attenuated by vitamin D (-0.10 ± 0.17) compared with placebo (-0.22 ± 0.18 mmol/l; P = 0.02). Maternal 25-hydroxyvitamin D (25(OH)D) (P = 0.04) and cord 25(OH)D (P < 0.01) were associated with day 3 infant Ca, suggesting that the effect of supplementation was mediated by change in maternal-infant vitamin D status. Six infants in each of the supplemented and placebo groups had transient hypercalcemia/hypercalcuria; in all the hypercalcemia/hypercalcuria was asymptomatic, spontaneously resolved, and unassociated with nephrocalcinosis at 1 mo of life.. High-dose antenatal third-trimester vitamin D supplementation attenuated the early postnatal calcium nadir, without increasing the risk of postnatal hypercalcemia.

Topics: Administration, Oral; Biomarkers; Calcium; Cholecalciferol; Dietary Supplements; Double-Blind Method; Drug Administration Schedule; Female; Fetal Blood; Fetus; Gestational Age; Homeostasis; Humans; Hypercalcemia; Hypercalciuria; India; Infant, Newborn; Pregnancy; Pregnancy Trimester, Third; Prenatal Care; Prevalence; Time Factors; Treatment Outcome; Vitamin D; Vitamin D Deficiency

In observational studies, low serum 25-hydroxyvitamin D [25(OH)D] concentrations have been associated with insulin resistance and other risk factors for cardiovascular disease.. We present 1-year data from an ongoing 5-year trial in 511 individuals with impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) randomly assigned to 20,000 IU/week vitamin D3 or placebo. An oral glucose tolerance test was performed at baseline and after 1 year.. Mean baseline serum 25(OH)D was 59.9 nmol/L and 61.1 nmol/L in the vitamin D and placebo groups, respectively, and increased by 45.8 nmol/L and 3.4 nmol/L, respectively. With adjustment for baseline concentrations, no differences in measures of glucose metabolism, insulin secretion or sensitivity, blood pressure, or hs-CRP were found after 1 year. There was a slight, but significant decrease in total and LDL cholesterol in the vitamin D group compared with the placebo group, but as there was also a decrease in HDL cholesterol, the change in the total/HDL cholesterol ratio did not differ significantly. Only analyzing subjects with 25(OH)D <50 nmol/L did not change the results.. This study shows that vitamin D supplementation does not improve glycemic indices, blood pressure, or lipid status in subjects with IFG and/or IGT.

Topics: 25-Hydroxyvitamin D 2; Adult; Aged; Aged, 80 and over; Blood Pressure; Calcifediol; Cholecalciferol; Diabetes Mellitus, Type 2; Diabetic Angiopathies; Dietary Supplements; Double-Blind Method; Female; Glucose Intolerance; Glucose Tolerance Test; Humans; Insulin; Insulin Resistance; Lipids; Male; Middle Aged; Prediabetic State; Risk Factors; Vitamin D; Vitamin D Deficiency; Vitamins; Young Adult

Vitamin D₃, its biologically most active metabolite 1α,25-dihydroxyvitamin D₃ (1,25(OH)₂D₃), and the vitamin D receptor (VDR) are important for adipose tissue biology.. We extrapolated genomic VDR association loci in adipocytes from 55 conserved genome-wide VDR-binding sites in nonfat tissues. Taking the genes DUSP10, TRAK1, NRIP1, and THBD as examples, we confirmed the predicted VDR binding sites upstream of their transcription start sites and showed rapid mRNA up-regulation of all four genes in SGBS human pre-adipocytes. Using adipose tissue biopsy samples from 47 participants of a 5-month vitamin D₃ intervention study, we demonstrated that all four primary VDR target genes can serve as biomarkers for the vitamin D₃ responsiveness of human individuals. Changes in DUSP10 gene expression appear to be the most comprehensive marker, while THBD mRNA changes characterized a rather different group of study participants.. We present a new approach to predict vitamin D target genes based on conserved genomic VDR-binding sites. Using human adipocytes as examples, we show that such ubiquitous VDR target genes can be used as markers for the individual's response to a supplementation with vitamin D₃.

Topics: Adaptor Proteins, Signal Transducing; Adaptor Proteins, Vesicular Transport; Adipose Tissue; Aged; Biomarkers; Calcitriol; Cell Line; Cells, Cultured; Cholecalciferol; Conserved Sequence; Dietary Supplements; Dual-Specificity Phosphatases; Finland; Humans; Male; Mitogen-Activated Protein Kinase Phosphatases; Nuclear Proteins; Nuclear Receptor Interacting Protein 1; Receptors, Calcitriol; RNA, Messenger; Seasons; Thrombomodulin; Up-Regulation; Vitamin D Deficiency; Vitamin D Response Element

Vitamin D insufficiency is common in subjects with type 2 diabetes. Observational studies suggest that vitamin D plays a role in the pathogenesis of type 2 diabetes. However, results of intervention studies have been inconsistent. We investigated the effects of improving vitamin D status on insulin sensitivity, insulin secretion, and inflammatory markers in patients with type 2 diabetes.. A double blind, randomized, placebo controlled trial was conducted. Sixteen patients with type 2 diabetes and hypovitaminosis D were recruited. Eight patients received colecalciferol and (280 μg daily for 2 weeks, 140 μg daily for 10 weeks) and 8 patients received identical placebo tablets for 12 weeks. Before and after intervention, patients underwent IVGTT, hyperinsulinemic euglycemic clamp, assessment of baseline high-frequency insulin pulsatility, glucose-entrained insulin pulsatility, DXA scans, 24-hour-ambulatory blood pressure monitorings, and fasting blood samples.. Serum-25(OH) vitamin D and serum-1,25(OH)₂ vitamin D increased significantly after 12 weeks in the intervention group (p=0.01, p=0.004). Serum-25(OH) vitamin D was also significantly higher in the vitamin D group compared to the placebo group (p=0.02) after intervention. Although no significant changes in insulin sensitivity, inflammation, blood pressure, lipid profile, or HbA1c were found, we observed borderline (p between 0.05 and 0.10) improvements of insulin secretion, in terms of c-peptide levels, first phase incremental AUC insulin and insulin secretory burst mass.. Improvement in vitamin D status does not improve insulin resistance, blood pressure, inflammation or HbA1c, but might increase insulin secretion in patients with established type 2 diabetes.

Topics: Aged; Biomarkers; C-Peptide; Calcifediol; Calcitriol; Cholecalciferol; Denmark; Diabetes Mellitus, Type 2; Dietary Supplements; Double-Blind Method; Female; Humans; Inflammation Mediators; Insulin; Insulin Resistance; Insulin Secretion; Insulin-Secreting Cells; Kinetics; Male; Middle Aged; Seasons; Severity of Illness Index; Vitamin D Deficiency

The recommended dose of vitamin D supplementation of 400 IU/day might be inadequate to treat obese children with vitamin D insufficiency. Therefore, we tested the efficacy and tolerability of a high loading dose vitamin D3 supplementation of 25,000 IU weekly in multiethnic obese children, 8-18 years of age, with vitamin D insufficiency/deficiency.. Fasting blood samples were drawn for the assessment of vitamin D. Vitamin D-insufficient/-deficient children (<50 nmol/l) were supplemented, using a high loading dose of 25,000 IU weekly, and measured again 9 weeks later. Vitamin D supplementation was considered effective and tolerable when an increase to vitamin D sufficiency (25(OH)D >50 nmol/l) was reached in >75% without side effects nor reaching toxic levels.. In total, 109 children (mean ± SD age 11.1 ± 3.0, 34.2% boys, 90.8% obese) received vitamin D supplementation. In 84.4% of the children, the vitamin D status improved from insufficiency/deficiency (<50 nmol/l) to sufficiency (≥50 nmol/l). The majority of children that did not reach vitamin D sufficiency reported non-compliance. No side effects were reported, and the highest level reached was far below the threshold for toxicity.. A high loading dose vitamin D3 supplementation is effective and well-tolerated in our cohort of multiethnic obese children with vitamin D insufficiency/deficiency.

Topics: Child; Cholecalciferol; Female; Humans; Male; Obesity; Retrospective Studies; Vitamin D Deficiency; Vitamins

Adequate serum 25-hydroxyvitamin D concentrations, [25(OH)D], are required for optimal bone health, and low levels are associated with chronic diseases.. We investigated whether 41 candidate single nucleotide polymorphisms (SNPs) in vitamin D and calcium pathway genes (GC, DHCR7, CYP2R1, CYP27B1, CYP24A1, VDR, and CASR) are associated with [25(OH)D] or modify the increase in [25(OH)D] from vitamin D3 supplementation.. Baseline and year 1 [25(OH)D] measurements from a randomized controlled trial conducted at 11 clinical centers in the United States.. A total of 1787 healthy non-Hispanic white participants aged 45-75 years.. Vitamin D3 (1000 IU/d), calcium carbonate (1200 mg/d elemental), both, or placebo.. Genotype main effects and interactions with vitamin D3 treatment estimated using multiple linear regression.. The baseline serum [25(OH)D] was 25.4 ± 8.7 ng/mL (mean ± SD). Associations with baseline levels were discovered for SNPs in CYP24A1 (rs2209314, rs2762939) and confirmed for SNPs in GC and CYP2R1. After 1 year, [25(OH)D] increased on average by 6.1 ± 8.9 ng/mL on vitamin D3 treatment and decreased by 1.1 ± 8.4 ng/mL on placebo. The increase in [25(OH)D] due to vitamin D3 supplementation was modified by genotypes at rs10766197 near CYP2R1, rs6013897 near CYP24A1, and rs7968585 near VDR.. The increase in [25(OH)D] attributable to vitamin D3 supplementation may vary according to common genetic differences in vitamin D 25-hydroxylase (CYP2R1), 24-hydroxylase (CYP24A1), and the vitamin D receptor (VDR) genes. These findings have implications for achieving optimal vitamin D status and potentially for vitamin D-related health outcomes.

Topics: Aged; Calcium Carbonate; Cholecalciferol; Cholestanetriol 26-Monooxygenase; Cytochrome P450 Family 2; Drug Resistance; Female; Genetic Variation; Genotype; Humans; Linear Models; Male; Middle Aged; Polymorphism, Single Nucleotide; Receptors, Calcitriol; Treatment Outcome; Vitamin D; Vitamin D Deficiency; Vitamin D3 24-Hydroxylase

Vitamin D has regulatory effects on innate immunity. In the present study, we aimed to assess the effect of prenatal vitamin D₃ (vitD₃) supplementation on neonatal innate immunity in a randomised, placebo-controlled trial by evaluating cathelicidin (LL-37) expression and the killing capacity of macrophages. Healthy pregnant women (n 129) attending a clinic in Dhaka were randomised to receive either a weekly oral dose of 0·875 mg vitD₃ or placebo starting from 26 weeks of gestation up to delivery. Serum, plasma and monocyte-derived macrophages (MDM) were obtained from the cord blood. 25-Hydroxyvitamin D (25(OH)D) concentration was measured in serum. MDM were stimulated with or without Toll-like-receptor 4 ligand (TLR4L). Innate immune function was assessed by measuring LL-37 peptide levels in the culture supernatant of MDM by ELISA, LL-37 transcript levels by quantitative PCR, and ex vivo bactericidal capacity of MDM. VitD₃ supplementation did not increase LL-37 peptide levels in plasma or in the extracellular fluid of macrophages with or without TLR4L induction. However, stimulated intracellular LL-37 expression (ratio of stimulated:unstimulated MDM) was significantly reduced in the vitamin D group v. placebo (P=0·02). Multivariate-adjusted analyses showed that intracellular LL-37 peptide concentration from stimulated MDM was inversely associated with 25(OH)D concentration in serum (P=0·03). TLR4L stimulation increased the bactericidal capacity of MDM compared with the unstimulated ones (P=0·01); however, there was no difference in killing capacity between the two groups. A weekly dose of 0·875 mg vitD₃ to healthy pregnant women suppressed the intracellular LL-37 peptide stores of activated macrophages, but did not significantly affect the ex vivo bactericidal capacity of cord blood MDM.

Topics: Adolescent; Adult; Antimicrobial Cationic Peptides; Bangladesh; Cathelicidins; Cells, Cultured; Cholecalciferol; Cohort Studies; Dietary Supplements; Female; Fetal Blood; Humans; Immunity, Innate; Immunologic Factors; Macrophage Activation; Macrophages; Maternal Nutritional Physiological Phenomena; Phagocytosis; Pregnancy; Pregnancy Complications; Pregnancy Trimester, Third; Vitamin D Deficiency; Young Adult

The prevalence of vitamin D inadequacy is high in obese individuals. Determining the response of serum 25-hydroxyvitamin D (25[OH]D) to vitamin D3 supplementation in obese and nonobese individuals may lead to concurrent recommendations for optimal vitamin D intake in these populations. The objective of this study was to determine the dose response of vitamin D3 in subjects with a body mass index ≥35 kg/m2.. Randomized, double-blind, placebo-controlled study. This study is an extension of our previous study of vitamin D dosing in healthy adults. After an assessment of baseline 25(OH)D levels, participants were randomized to a vitamin D supplementation arm (100 μg daily if baseline 25[OH]D was <50 nmol/L, or 50 μg daily if baseline 25[OH]D was ≥50 nmol/L) or placebo arm. Subjects with baseline 25(OH)D level ≥80 nmol/L were excluded from the study. Two months following randomization, a repeat 25(OH)D measurement was done.. Final analysis included 25 subjects (14 placebo, 11 active). At 2 months, serum 25(OH)D concentration increased to a mean of 75 nmol/L in the active group. Mean slope (i.e., vitamin D3 response), defined as 25(OH) D change/baseline dose, was 0.398 nmol/L/μg/day.. The dose response of vitamin D3 (slope) in obese subjects was significantly lower (P<.03) at 0.398 nmol/L/μg/day compared to the slope in the previous study of healthy subjects (0.66 nmol/L/μg/day). These results suggest that obese individuals may require 40% higher vitamin D intake than nonobese individuals to attain the same serum 25(OH)D concentration.

Topics: Cholecalciferol; Dietary Supplements; Double-Blind Method; Humans; Obesity; Vitamin D; Vitamin D Deficiency

Based on the growing evidence of risk reduction from fresh fruit and vegetable consumption and an inverse relationship between serum 25-hydroxyvitamin D (25OHD) and the risk of type 2 diabetes (T2D), we determined the benefits of regularly consuming vitamin D-enriched mushrooms in a prediabetic cohort. Exposing edible mushrooms to ultraviolet B (UVB) light increases vitamin D2 (D2) and raises serum 25OHD2 in healthy young adults; however, their benefit to deficient prediabetics and glucose metabolism remains untested.. Forty-three prediabetic, D-deficient adults (25OHD≤20 ng/ml), BMI>25 were randomized to four groups consuming daily entrées containing 100 g fresh sliced cooked mushrooms prepared by a chef for 16 weeks. Two groups were fed UVB-treated mushrooms initially containing: 600 IU D2 or 4000 IU D2; each one also received one capsule of placebo daily. Two control groups were fed untreated mushrooms and D3 dietary supplements at two label doses: 600 IU D3 and 4000 IU D3. D2 and D3 content were analyzed in mushrooms, before and after cooking and in over-the-counter supplements.. After 16 weeks, both D2-UVB-mushroom entrée doses, which were significantly lower after cooking, produced modest or no increases in 25OHD2 or total 25OHD relative to the positive control subjects who actually consumed about 1242 and 7320 IU per day of D3 (higher than stated on the label).. Unanticipated D2 cooking loss from fresh UVB mushrooms and probable low absorption and/or hydroxylation may explain the smaller increase in 25OHD2 in our prediabetic overweight/obese cohort compared with past findings in younger, healthy subjects. Moreover, no dose or vitamin D source was associated with modifying T2D risk factors.

Topics: Adult; Agaricales; Aged; Aged, 80 and over; Biological Availability; Cholecalciferol; Cooking; Diabetes Mellitus, Type 2; Dietary Supplements; Ergocalciferols; Female; Humans; Insulin Resistance; Male; Middle Aged; Prediabetic State; Ultraviolet Rays; Vitamin D Deficiency

Elevated concentrations of fibroblast growth factor 23 (FGF23) are postulated to promote 25-hydroxyvitamin D (25[OH]D) insufficiency in CKD by stimulating 24-hydroxylation of this metabolite, leading to its subsequent degradation; however, prospective human studies testing this relationship are lacking.. An open-label prospective study was conducted from October 2010 through July 2012 to compare the effect of 8 weeks of oral cholecalciferol therapy (50,000 IU twice weekly) on the production of 24,25(OH)2D3 in vitamin D-insufficient patients with CKD (n=15) and controls with normal kidney function (n=15). Vitamin D metabolites were comprehensively profiled at baseline and after treatment, along with FGF23 and other mineral metabolism parameters.. Vitamin D3 and 25(OH)D3 concentrations increased equivalently in the CKD and control groups following cholecalciferol treatment (median D3 change, 8.6 ng/ml [interquartile range, 3.9-25.6 ng/ml] for controls versus 12.6 ng/ml [6.9-41.2 ng/ml] for CKD [P=0.15]; 25(OH)D3 change, 39.2 ng/ml [30.9-47.2 ng/ml] for controls versus 39.9 ng/ml [31.5-44.1 ng/ml] for CKD [P=0.58]). Likewise, the absolute increase in 1α,25(OH)2D3 was similar between CKD participants and controls (change, 111.2 pg/ml [64.3-141.6 pg/ml] for controls versus 101.1 pg/ml [74.2-123.1 pg/ml] for CKD; P=0.38). Baseline and post-treatment 24,25(OH)2D3 concentrations were lower in the CKD group; moreover, the absolute increase in 24,25(OH)2D3 after therapy was markedly smaller in patients with CKD (change, 2.8 ng/ml [2.3-3.5 ng/ml] for controls versus 1.2 ng/ml [0.6-1.9 ng/ml] for patients with CKD; P<0.001). Furthermore, higher baseline FGF23 concentrations were associated with smaller increments in 24,25(OH)2D3 for individuals with CKD; this association was negated after adjustment for eGFR by multivariate analysis.. Patients with CKD exhibit an altered ability to increase serum 24,25(OH)2D3 after cholecalciferol therapy, suggesting decreased 24-hydroxylase activity in CKD. The observed relationship between baseline FGF23 and increments in 24,25(OH)2D3 further refutes the idea that FGF23 directly contributes to 25(OH)D insufficiency in CKD through stimulation of 24-hydroxylase activity.

Topics: 24,25-Dihydroxyvitamin D 3; Adult; Aged; Bone Density Conservation Agents; Calcifediol; Calcitriol; Case-Control Studies; Cholecalciferol; Female; Fibroblast Growth Factor-23; Fibroblast Growth Factors; Glomerular Filtration Rate; Humans; Kidney Failure, Chronic; Male; Middle Aged; Prospective Studies; Vitamin D Deficiency

Recent epidemiological studies revealed a striking inverse relationship between vitamin D levels, glucose intolerance/insulin resistance (IR), and cardiovascular disease. However, few interventional studies have evaluated the effect of vitamin D supplementation on cardiovascular risk, such as IR and arterial stiffness, in diabetes. We investigated the role of vitamin D supplementation on cardiovascular risk in type 2 diabetes patients, including metabolic parameters, IR, and arterial stiffness.. We enrolled patients who were taking antidiabetic medications or managed their diabetes using lifestyle changes. We excluded patients who were taking vitamin D or calcium supplements. We randomized participants into the vitamin D group (cholecalciferol 2,000 IU/day + calcium 200 mg/day, n = 40) or the placebo group (calcium 200 mg/day, n = 41). We compared their IR (homeostasis model of assessment [HOMA]-IR) and arterial stiffness (brachial-ankle pulse wave velocity and radial augmentation index) before and after 24 weeks of intervention.. The baseline characteristics of the two groups were similar. A total of 62 participants (placebo, 30; vitamin D, 32) completed the study protocol. At the end of the study period, the 25-hydroxyvitamin D [25(OH)D] levels were significantly higher in the vitamin D group than in the placebo group (35.4 ± 8.5 ng/mL vs. 18.4 ± 7.3 ng/mL, p < 0.001). There was no difference in HOMA-IR or changes in arterial stiffness (placebo, 21, vitamin D, 24) between the groups.. Our data suggest that high-dose vitamin D supplementation might be effective in terms of elevating 25(OH)D levels. However, we identified no beneficial effects on cardiovascular risk in type 2 diabetes, including IR and arterial stiffness.

Topics: Calcium, Dietary; Cholecalciferol; Diabetes Mellitus, Type 2; Double-Blind Method; Female; Humans; Insulin Resistance; Male; Middle Aged; Prospective Studies; Vascular Stiffness; Vitamin D; Vitamin D Deficiency

Low vitamin D status is linked to increased mortality and morbidity in patients who are critically ill. It is unknown if this association is causal.. To investigate whether a vitamin D3 treatment regimen intended to restore and maintain normal vitamin D status over 6 months is of health benefit for patients in ICUs.. A randomized double-blind, placebo-controlled, single-center trial, conducted from May 2010 through September 2012 at 5 ICUs that included a medical and surgical population of 492 critically ill adult white patients with vitamin D deficiency (≤20 ng/mL) assigned to receive either vitamin D3 (n = 249) or a placebo (n = 243).. Vitamin D3 or placebo was given orally or via nasogastric tube once at a dose of 540,000 IU followed by monthly maintenance doses of 90,000 IU for 5 months.. The primary outcome was hospital length of stay. Secondary outcomes included, among others, length of ICU stay, the percentage of patients with 25-hydroxyvitamin D levels higher than 30 ng/mL at day 7, hospital mortality, and 6-month mortality. A predefined severe vitamin D deficiency (≤12 ng/mL) subgroup analysis was specified before data unblinding and analysis.. A total of 475 patients were included in the final analysis (237 in the vitamin D3 group and 238 in the placebo group). The median (IQR) length of hospital stay was not significantly different between groups (20.1 days [IQR, 11.1-33.3] for vitamin D3 vs 19.3 days [IQR, 11.1-34.9] for placebo; P = .98). Hospital mortality and 6-month mortality were also not significantly different (hospital mortality: 28.3% [95% CI, 22.6%-34.5%] for vitamin D3 vs 35.3% [95% CI, 29.2%-41.7%] for placebo; hazard ratio [HR], 0.81 [95% CI, 0.58-1.11]; P = .18; 6-month mortality: 35.0% [95% CI, 29.0%-41.5%] for vitamin D3 vs 42.9% [95% CI, 36.5%-49.4%] for placebo; HR, 0.78 [95% CI, 0.58-1.04]; P = .09). For the severe vitamin D deficiency subgroup analysis (n = 200), length of hospital stay was not significantly different between the 2 study groups: 20.1 days (IQR, 12.9-39.1) for vitamin D3 vs 19.0 days (IQR, 11.6-33.8) for placebo. Hospital mortality was significantly lower with 28 deaths among 98 patients (28.6% [95% CI, 19.9%-38.6%]) for vitamin D3 compared with 47 deaths among 102 patients (46.1% [95% CI, 36.2%-56.2%]) for placebo (HR, 0.56 [95% CI, 0.35-0.90], P for interaction = .04), but not 6-month mortality (34.7% [95% CI, 25.4%-45.0%] for vitamin D3 vs 50.0% [95% CI, 39.9%-60.1%] for placebo; HR, 0.60 [95% CI, 0.39-0.93], P for interaction = .12).. Among critically ill patients with vitamin D deficiency, administration of high-dose vitamin D3 compared with placebo did not reduce hospital length of stay, hospital mortality, or 6-month mortality. Lower hospital mortality was observed in the severe vitamin D deficiency subgroup, but this finding should be considered hypothesis generating and requires further study.. clinicaltrials.gov Identifier: NCT01130181.

Topics: Aged; Cholecalciferol; Critical Illness; Double-Blind Method; Female; Hospital Mortality; Humans; Intensive Care Units; Length of Stay; Male; Middle Aged; Vitamin D Deficiency; Vitamins

To examine whether combined vitamin D and calcium supplementation improves insulin sensitivity, insulin secretion, β-cell function, inflammation and metabolic markers.. 6-month randomized, placebo-controlled trial.. Ninety-five adults with serum 25-hydroxyvitamin D [25(OH)D] ≤55 nmol/L at risk of type 2 diabetes (with prediabetes or an AUSDRISK score ≥15) were randomized. Analyses included participants who completed the baseline and final visits (treatment n = 35; placebo n = 45).. Daily calcium carbonate (1,200 mg) and cholecalciferol [2,000-6,000 IU to target 25(OH)D >75 nmol/L] or matching placebos for 6 months.. Insulin sensitivity (HOMA2%S, Matsuda index), insulin secretion (insulinogenic index, area under the curve (AUC) for C-peptide) and β-cell function (Matsuda index x AUC for C-peptide) derived from a 75 g 2-h OGTT; anthropometry; blood pressure; lipid profile; hs-CRP; TNF-α; IL-6; adiponectin; total and undercarboxylated osteocalcin.. Participants were middle-aged adults (mean age 54 years; 69% Europid) at risk of type 2 diabetes (48% with prediabetes). Compliance was >80% for calcium and vitamin D. Mean serum 25(OH)D concentration increased from 48 to 95 nmol/L in the treatment group (91% achieved >75 nmol/L), but remained unchanged in controls. There were no significant changes in insulin sensitivity, insulin secretion and β-cell function, or in inflammatory and metabolic markers between or within the groups, before or after adjustment for potential confounders including waist circumference and season of recruitment. In a post hoc analysis restricted to participants with prediabetes, a significant beneficial effect of vitamin D and calcium supplementation on insulin sensitivity (HOMA%S and Matsuda) was observed.. Daily vitamin D and calcium supplementation for 6 months may not change OGTT-derived measures of insulin sensitivity, insulin secretion and β-cell function in multi-ethnic adults with low vitamin D status at risk of type 2 diabetes. However, in participants with prediabetes, supplementation with vitamin D and calcium may improve insulin sensitivity.. Australian New Zealand Clinical Trials Registry ACTRN12609000043235.

Topics: Adiponectin; Adult; Aged; Blood Glucose; C-Peptide; C-Reactive Protein; Calcium, Dietary; Cholecalciferol; Diabetes Mellitus, Type 2; Dietary Supplements; Female; Humans; Insulin; Insulin Resistance; Insulin-Secreting Cells; Interleukin-6; Male; Middle Aged; Osteocalcin; Pilot Projects; Prediabetic State; Tumor Necrosis Factor-alpha; Vitamin D Deficiency

In addition to their effects on bone health, high doses of cholecalciferol may have beneficial non-classic effects including the reduction of incidence of type 2 diabetes mellitus, cardiovascular disease, and cancer. These pleiotropic effects have been documented in observational and experimental studies or in small intervention trials. Vitamin D insufficiency is a frequent finding in renal transplant recipients (RTRs), and this population is at risk of the previously cited complications.. The VITALE study is a prospective, multicentre, double-blind, randomized, controlled trial with two parallel groups that will include a total of 640 RTRs. RTRs with vitamin D insufficiency, defined as circulating 25-hydroxyvitamin D levels of less than 30 ng/ml (or 75 nmol/l), will be randomized between 12 and 48 months after transplantation to blinded groups to receive vitamin D3 (cholecalciferol) either at high or low dose (respectively, 100,000 UI or 12,000 UI every 2 weeks for 2 months then monthly for 22 months) with a follow-up of 2 years. The primary objective of the study is to evaluate the benefit/risk ratio of high-dose versus low-dose cholecalciferol on a composite endpoint consisting of de novo diabetes mellitus; major cardiovascular events; de novo cancer; and patient death. Secondary endpoints will include blood pressure (BP) control; echocardiography findings; the incidences of infection and acute rejection episodes; renal allograft function using estimated glomerular filtration rate; proteinuria; graft survival; bone mineral density; the incidence of fractures; and biological relevant parameters of mineral metabolism.. We previously reported that the intensive cholecalciferol treatment (100 000 IU every 2 weeks for 2 months) was safe in RTR. Using a pharmacokinetic approach, we showed that cholecalciferol 100,000 IU monthly should maintain serum 25-hydroxyvitamin D at above 30 ng/ml but below 80 ng/ml after renal transplantation. Taken together, these results are reassuring regarding the safety of the cholecalciferol doses that will be used in the VITALE study. Analysis of data collected during the VITALE study will demonstrate whether high or low-dose cholecalciferol is beneficial in RTRs with vitamin D insufficiency.. ClinicalTrials.gov Identifier: NCT01431430.

Topics: Biomarkers; Cholecalciferol; Clinical Protocols; Dietary Supplements; Double-Blind Method; Drug Administration Schedule; Humans; Kidney Transplantation; Paris; Postoperative Complications; Prospective Studies; Research Design; Time Factors; Treatment Outcome; Vitamin D; Vitamin D Deficiency

Chronic kidney disease (CKD) is associated with increased concentration of intracellular calcium, which is pathological and may lead to irreversible damage of cell functions and structures. The aim of our study was to investigate the impact of 6 months vitamin D(3) supplementation (14 000 IU/week) on free cytosolic calcium concentration ([Ca(2+)](i)) and on the plasma membrane calcium ATPase (PMCA) activity of patients with CKD stage 2-3. PMCA activity of patients was also compared to that of healthy volunteers. Vitamin D(3) supplementation of CKD patients resulted in the decrease of [Ca(2+)](i) (119.79+/-5.87 nmol/l vs. 105.36+/-3.59 nmol/l, n=14, P<0.001), whereas PMCA activity of CKD patients (38.75+/-22.89 nmol P(i)/mg/h) remained unchanged after vitamin D(3) supplementation (40.96+/-17.74 nmol P(i)/mg/h, n=14). PMCA activity of early stage CKD patients before supplementation of vitamin D(3), was reduced by 34 % (42.01+/-20.64 nmol P(i)/mg/h) in comparison to healthy volunteers (63.68+/-20.32 nmol P(i)/mg/h, n=28, P<0.001). These results indicate that vitamin D(3) supplementation had a lowering effect on [Ca(2+)](i) and negligible effect on PMCA activity in CKD patients.

Topics: Adult; Aged; Calcium; Case-Control Studies; Cholecalciferol; Dietary Supplements; Healthy Volunteers; Humans; Middle Aged; Plasma Membrane Calcium-Transporting ATPases; Renal Insufficiency, Chronic; Vitamin D Deficiency

Obese adolescents are at a greater risk of vitamin D deficiency because vitamin D is thought to be sequestered by excess adipose tissue. Poor vitamin D status has been associated with a higher prevalence of the metabolic syndrome, type 2 diabetes, or both in adults and adolescents.. The objective was to determine in obese adolescents the efficacy and safety of 4000 IU vitamin D3/d and whether subsequent increased circulating concentrations of 25-hydroxyvitamin D [25(OH)D] are associated with improved markers of insulin sensitivity and resistance and reduced inflammation.. Obese adolescent patients [n = 35; mean ± SD age: 14.1 ± 2.8 y; BMI (in kg/m(2)): 39.8 ± 6.1; 25(OH)D: 19.6 ± 7.1 ng/mL] were recruited from the University of Missouri Adolescent Diabetes and Obesity Clinic and were randomly assigned to receive either vitamin D3 (4000 IU/d) or placebo as part of their standard care. Anthropometric measurements, inflammatory markers (IL-6, TNF-α, C-reactive protein), adipokines (leptin, adiponectin), fasting glucose, fasting insulin, and HOMA-IR values were measured at baseline and at 2 follow-up visits (3 and 6 mo).. After 6 mo, there were no significant differences in BMI, serum inflammatory markers, or plasma glucose concentrations between groups. Participants supplemented with vitamin D3 had increases in serum 25(OH)D concentrations (19.5 compared with 2.8 ng/mL for placebo; P < 0.001), fasting insulin (-6.5 compared with +1.2 μU/mL for placebo; P = 0.026), HOMA-IR (-1.363 compared with +0.27 for placebo; P = 0.033), and leptin-to-adiponectin ratio (-1.41 compared with +0.10 for placebo; P = 0.045). Inflammatory markers remained unchanged.. The correction of poor vitamin D status through dietary supplementation may be an effective addition to the standard treatment of obesity and its associated insulin resistance. This trial was registered at clinicaltrials.gov as NCT00994396.

Topics: Adipokines; Adiponectin; Adolescent; Blood Glucose; Body Mass Index; Child; Cholecalciferol; Dietary Supplements; Female; Humans; Inflammation Mediators; Insulin; Insulin Resistance; Leptin; Male; Obesity; Treatment Outcome; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D deficiency is a major public health problem, needing immediate attention. We studied the effect of vitamin D fortification of milk in school children. Our results show that fortification of milk is safe and effective strategy to deal with widespread vitamin D deficiency.. Vitamin D deficiency among school children and adolescents is a well-documented major public health problem, needing immediate attention. To assess the effect of vitamin D fortified milk on serum 25 hydroxy vitamin D [S.25(OH)D] levels, we carried out a prospective double-blind randomized control trial in apparently healthy school children, aged 10-14 years.. Of 776 subjects recruited out of 796 who consented, 713 (boys-300; girls-413) completed the study. Subjects were randomized into three groups. Group A (n = 237) received 200 ml of unfortified milk per day while group B (n = 243) and group C (n = 233) received 200 ml of milk fortified with 600 IU (15 μg) and 1,000 IU (25 μg) of vitamin D per day for 12 weeks. Serum calcium, phosphate, alkaline phosphatase, S.25(OH)D, and urinary calcium/creatinine ratio were estimated at baseline and after supplementation.. Hypovitaminosis D [25(OH)D < 20 ng/ml] was observed in 92.3 % subjects with mean S.25(OH)D level of 11.69 ± 5.36 ng/ml. There was no significant difference in S.25(OH)D levels among the three groups at baseline. The mean percentage change in S.25(OH)D level in groups B (137.97 %) and C (177.29 %.) were significantly greater than group A (-5.25 %). The percentage of subjects having S.25(OH)D levels >20 ng/ml following supplementation were 5.9 % in group A, 69.95 % in group B, and 81.11 % in group C in comparison to 6.32 %, 4.9 % and 12 %, respectively, at baseline.. Fortification of milk with vitamin D is an effective and safe strategy in improving S.25(OH)D levels in children aged 10-14 years.

Topics: Adolescent; Animals; Child; Cholecalciferol; Double-Blind Method; Female; Food, Fortified; Humans; India; Male; Milk; Prospective Studies; Treatment Outcome; Vitamin D; Vitamin D Deficiency

Observational studies suggest that calciferol supplementation may improve laboratory and patient-level outcomes of hemodialysis patients with reduced 25-hydroxyvitamin D [25(OH)D] levels. This randomized controlled trial examined effects of cholecalciferol supplementation in patients on hemodialysis.. Sixty patients with 25(OH)D levels ≤24 ng/ml (≤60 nmol/L) were randomized to receive 50,000 IU oral cholecalciferol or placebo, once weekly for 8 weeks and then monthly for 4 months. At baseline (autumn 2011) and 6 months, testing evaluated muscle strength, functional capacity, laboratory parameters, pulse wave velocity (PWV), and health-related quality of life (HRQOL) using the Kidney Disease Quality of Life-36 survey.. Patients were well matched by treatment allocation. Median age was 62 years (range, 20-86), 52% were women, 55% had a history of diabetes, and mean serum 25(OH)D was 17±5 ng/ml (43±13 nmol/L). Patients were assessed over 6 months by repeated-measures ANOVA. Patients allocated to cholecalciferol had significantly higher values of 25(OH)D (P<0.001), 1,25-dihydroxyvitamin D (P=0.04), and tartrate-resistant acid phosphatase-5b) (P=0.04) and a greater reduction in phosphorus values (P=0.03) than placebo-treated patients Values of serum calcium, intact parathyroid hormone, and episodes of hypercalcemia and hyperphosphatemia did not differ significantly between the groups. No significant differences were detected in muscle strength, functional capacity, PWV, or HRQOL.. In this randomized controlled trial, patients supplemented with cholecalciferol had higher 25(OH)D, 1,25-dihydroxyvitamin D, and tartrate-resistant acid phosphatase-5b levels, without increased calcium or phosphorus values. However, no effects were detected in muscle strength, functional capacity, PWV, or HRQOL.

Topics: Adult; Aged; Aged, 80 and over; Analysis of Variance; Biomarkers; Biomechanical Phenomena; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Health Status; Humans; Kidney Diseases; Male; Middle Aged; Muscle Strength; New South Wales; Pulse Wave Analysis; Quality of Life; Range of Motion, Articular; Renal Dialysis; Surveys and Questionnaires; Time Factors; Treatment Outcome; Vascular Stiffness; Vitamin D; Vitamin D Deficiency; Vitamins; Young Adult

Although there have been numerous observations of vitamin D deficiency and its links to chronic diseases, no studies have reported on how vitamin D status and vitamin D3 supplementation affects broad gene expression in humans. The objective of this study was to determine the effect of vitamin D status and subsequent vitamin D supplementation on broad gene expression in healthy adults. (Trial registration: ClinicalTrials.gov NCT01696409).. A randomized, double-blind, single center pilot trial was conducted for comparing vitamin D supplementation with either 400 IUs (n = 3) or 2000 IUs (n = 5) vitamin D3 daily for 2 months on broad gene expression in the white blood cells collected from 8 healthy adults in the winter. Microarrays of the 16 buffy coats from eight subjects passed the quality control filters and normalized with the RMA method. Vitamin D3 supplementation that improved serum 25-hydroxyvitamin D concentrations was associated with at least a 1.5 fold alteration in the expression of 291 genes. There was a significant difference in the expression of 66 genes between subjects at baseline with vitamin D deficiency (25(OH)D<20 ng/ml) and subjects with a 25(OH)D>20 ng/ml. After vitamin D3 supplementation gene expression of these 66 genes was similar for both groups. Seventeen vitamin D-regulated genes with new candidate vitamin D response elements including TRIM27, CD83, COPB2, YRNA and CETN3 which have been shown to be important for transcriptional regulation, immune function, response to stress and DNA repair were identified.. Our data suggest that any improvement in vitamin D status will significantly affect expression of genes that have a wide variety of biologic functions of more than 160 pathways linked to cancer, autoimmune disorders and cardiovascular disease with have been associated with vitamin D deficiency. This study reveals for the first time molecular finger prints that help explain the nonskeletal health benefits of vitamin D.. ClinicalTrials.gov NCT01696409.

Topics: Adult; Cholecalciferol; Dose-Response Relationship, Drug; Double-Blind Method; Female; Gene Expression; Humans; Leukocytes; Male; Oligonucleotide Array Sequence Analysis; Vitamin D; Vitamin D Deficiency; Vitamin D Response Element; Young Adult

It is not known whether genetic variation in the vitamin D binding protein (DBP) influences 25-hydroxyvitamin D levels [25(OH)D] after vitamin D supplementation. We aimed to investigate the changes of total 25(OH)D, 25(OH)D₃ and 25(OH)D₂ in a Thai cohort, according to type of vitamin D supplement (vitamin D₃ or D₂) and DBP genotype, after receiving vitamin D₃ or D₂ for 3 months.. Thirty-nine healthy subjects completed the study. All subjects received 400  IU of either vitamin D₃ or D₂, plus a calcium supplement, every day for 3 months. Total serum 25(OH)D, 25(OH)D₃ and 25(OH)D₂ were measured by LC-MS/MS. Individual genotyping of rs4588 in the DBP gene was performed using real-time PCR.. Vitamin D₃ supplementation of 400  IU/d increased 25(OH)D₃ significantly (+16.2 ± 4.2 nmol/L, p <0.001). Vitamin D₂ (400 IU/d) caused increased 25(OH)D₂ levels (+22.0 ± 2.11 nmol/L, p <0.001), together with a decrease of 25(OH)D₃ (-14.2 ± 2.0 nmol/L, p <0.001). At 3 month, subjects in vitamin D3 group tended to have higher total 25(OH)D levels than those in vitamin D₂ (67.8 ± 3.9 vs. 61.0 ± 3.0 nmol/L; p = 0.08). Subjects were then classified into two subgroups: homozygous for the DBP rs4588 C allele (CC), and the rest (CA or AA). With D₃ supplementation, subjects with CA or AA alleles had significantly less increase in 25(OH)D₃ and total 25(OH)D when compared with those with the CC allele. However, no difference was found when the supplement was vitamin D₂.. Genetic variation in DBP (rs4588 SNP) influences responsiveness to vitamin D₃ but not vitamin D₂.

Topics: Adolescent; Adult; Aged; Calcium, Dietary; Cholecalciferol; Chromatography, Liquid; Dietary Supplements; Ergocalciferols; Female; Follow-Up Studies; Genotype; Humans; Male; Middle Aged; Polymorphism, Single Nucleotide; Tandem Mass Spectrometry; Vitamin D Deficiency; Vitamin D-Binding Protein; Young Adult

Vitamin D deficiency is prevalent in chronic pancreatitis (CP), but the optimal route and dose of vitamin D supplementation are unknown. We evaluated the relative efficacy of two different doses of intramuscular (i.m.) vitamin D(3) in patients with CP and vitamin D insufficiency. In a double-blind randomized study, 40 patients with tropical calcific pancreatitis with serum 25-hydroxyvitamin D (25OHD) <75 nmol/L (mean 27.0 ± 14.5 nmol/L, <50 nmol/L in 90 %) were divided into three groups. Groups 1 and 2 received 600,000 IU (15,000 μg) and 300,000 IU (7,500 μg) i.m. cholecalciferol, respectively, while group 3 received i.m. saline. All groups received 1 g calcium and 500 IU (12.5 μg) vitamin D(3) orally daily and were studied for 9 months. The primary outcome was the proportion of patients with vitamin D sufficiency (25OHD >75 nmol/L) at 6 months. Vitamin D sufficiency was significantly different in the three groups (85, 29, and 0 % in groups 1, 2, and 3, respectively; p < 0.001). Mean 25OHD remained >75 nmol/L in months 1-6 in group 1 but reached a lower level (50-75 nmol/L) at these time points in group 2. At 6 months, serum alkaline phosphatase decreased significantly only in group 1 (230 ± 73 vs 165 ± 39 IU/L, p = 0.004). No patient in any group developed hypervitaminosis D or hypercalcemia. In conclusion, in patients with CP, a single i.m. injection of 600,000 IU was more effective at achieving vitamin D sufficiency over 6 months compared with 300,000 IU vitamin D(3). (Clinical Trials.gov number NCT00956839).

Topics: Adult; Bone Density Conservation Agents; Calcinosis; Cholecalciferol; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Male; Pancreatitis, Chronic; Prospective Studies; Vitamin D Deficiency

Low levels of 25-hydroxyvitamin D (25OHD) are associated with increased bone turnover and risk of fractures. Plasma 25OHD is inversely related to body mass index, and vitamin D deficiency is common in obesity. We aimed to determine whether vitamin D supplementation affects bone turnover and bone mineral density (BMD) in obese subjects. Fifty-two healthy obese men and women aged 18-50 years with plasma 25OHD levels below 50 nmol/L were randomized to 7,000 IU of cholecalciferol daily or placebo for 26 weeks. We measured plasma levels of 25OHD, parathyroid hormone (PTH), and markers of bone turnover, as well as BMD at the hip, spine, forearm, and whole body. Compared with placebo, treatment with cholecalciferol increased mean plasma 25OHD from 35 to 110 nmol/L (p < 0.00001) and significantly decreased PTH (p < 0.05). BMD increased significantly at the forearm by 1.6 ± 0.7 % (p = 0.03). The bone resorption marker C-terminal telopetide of type 1 collagen (CTX) decreased borderline significantly in the cholecalciferol group compared with the placebo group (p = 0.07). Changes in plasma 25OHD correlated inversely with changes in plasma levels of bone-specific alkaline phosphatase (r = -0.38, p = 0.01) and CTX (r = -0.33, p = 0.03). Changes in CTX correlated inversely with changes in spine BMD (r = -0.45, p = 0.04). Increasing circulating 25OHD levels by cholecalciferol treatment is of importance to bone health in young obese subjects as increased levels of 25OHD are associated with a decrease in both PTH and bone turnover and with an increase in BMD at the forearm.

Topics: Adolescent; Adult; Bone Density; Calcium; Cholecalciferol; Female; Humans; Male; Middle Aged; Obesity; Parathyroid Hormone; Vitamin D; Vitamin D Deficiency; Vitamins

There are several studies in which a correlation between maternal vitamin D deficiency and serum mineral disorders in the mother and the newborn has been reported. The present randomised clinical trial was designed to investigate the effect of vitamin D administration on maternal and fetal Ca and vitamin D status. The trial was carried out on 160 pregnant women. Vitamin D-deficient (25-hydroxyvitamin D (25(OH)D) < 30 ng/ml) pregnant women were recruited at 26-28 weeks of pregnancy. In the control group, a multivitamin supplement containing 400 IU vitamin D3/d was given. Patients in the treatment group were treated with 50 000 IU vitamin D3 weekly for a total duration of 8 weeks. At delivery, maternal and fetal Ca and 25(OH)D levels in both groups were compared. In total, 81 % of pregnant women were vitamin D deficient. At the time of delivery, Ca and vitamin D levels were higher in the treatment group compared with the control group (92 (SD 3) v. 85 (SD 4) mg/l, respectively, P= 0·001 for serum Ca; 47·8 (SD 11·1) v. 15·9 (SD 6·6) ng/ml, respectively, P< 0·001 for vitamin D). At the time of delivery, 32·7 % of women in the control group had hypocalcaemia, while no hypocalcaemic case was detected in the vitamin D-treated group. Mean neonatal serum 25(OH)D was higher in the treatment group compared with the control group (27·7 (SD 5·2) v.10·9 (SD 4·4) ng/ml, respectively, P< 0·01). The neonatal Ca level in the treatment group was significantly higher than that of the control group (99 (SD 3) v. 91 (SD 3) mg/l, respectively, P< 0·001). The administration of vitamin D to pregnant women with vitamin D deficiency improves both maternal and neonatal Ca levels.

Topics: Adult; Calcium; Cholecalciferol; Dietary Supplements; Female; Fetus; Humans; Hypocalcemia; Infant, Newborn; Pregnancy; Pregnancy Complications; Prevalence; Vitamin D; Vitamin D Deficiency; Young Adult

Nutritional prevention of bone deterioration with fortified foods seems particularly suitable in institutionalized elderly women at risk of vitamin D deficiency, secondary hyperparathyroidism, increased bone resorption, and osteoporotic fracture.. The objective was to evaluate whether fortification of yogurts with vitamin D and calcium exerts an additional lowering effect on serum PTH and bone resorption markers as compared with isocaloric and isoprotein dairy products in elderly women.. A randomized double-blind controlled-trial, 56-day intervention was conducted in institutionalized women (mean age 85.5 years) consuming 2 125-g servings of either vitamin D- and calcium-fortified yogurt (FY) at supplemental levels of 10 μg/d vitamin D₃ and 800 mg/d calcium or nonfortified control yogurt (CY) providing 280 mg/d calcium.. The endpoints were serum changes from baseline (day 0) to day 28 and day 56 in 25-hydroxyvitamin-D (25OHD), PTH, and bone resorption markers tartrate-resistant acid phosphatase isoform-5b (TRAP5b), the primary outcome, and carboxyl-terminal cross-linked telopeptide of type I collagen (CTX).. At day 56, serum 25OHD increased (mean ± SEM) by 25.3 ± 1.8 vs 5.2 ± 2.5 nmol/L in FY (n = 29) and CY (n = 27), respectively (P < .0001). The corresponding changes in PTH were -28.6% ± 7.2% vs -8.0% ± 4.3% (P = .0003); in TRAP5b, -21.9% ± 4.3% vs 3.0% ± 3.2% (P < .0001); and in CTX, -11.0% ± 9.7% vs -3.0% ± 4.1% (P = .0146), in FY and CY, respectively. At day 28, these differences were less pronounced but already significant for 25OHD, PTH, and TRAP5b.. This study in institutionalized elderly at high risk for osteoporotic fracture suggests that fortification of dairy products with vitamin D₃ and calcium provides a greater prevention of accelerated bone resorption as compared with nonfortified equivalent foods.

Topics: Acid Phosphatase; Aged, 80 and over; Biomarkers; Bone Density Conservation Agents; Bone Resorption; Calcium, Dietary; Cholecalciferol; Collagen Type I; Double-Blind Method; Female; Food, Fortified; France; Homes for the Aged; Humans; Hyperparathyroidism, Secondary; Isoenzymes; Nursing Homes; Osteoporosis, Postmenopausal; Osteoporotic Fractures; Parathyroid Hormone; Peptides; Risk; Tartrate-Resistant Acid Phosphatase; Vitamin D Deficiency; Yogurt

We previously showed that a single high dose of oral (po) cholecalciferol (D₃) sharply increases serum 25-hydroxyvitamin D [25(OH)D].. We evaluated the long-term bioavailability and metabolism of a single po or intramuscular (im) high dose of ergocalciferol (D₂) or D₃.. This was a prospective intervention study.. The study was conducted in an ambulatory care setting.. Participants were 24 subjects with hypovitaminosis D.. A single dose of 600,000 IU of po or im D₂ or D₃ was administered.. Serum 25(OH)D and 1,25-dihydroxyvitamin D [1,25(OH)₂D] were measured at baseline and at days 30, 60, 90, and 120 by RIA. Serum 1,25(OH)₂D₂, 1,25-dihydroxyvitamin D₃ [1,25(OH)₂D₃], 24,25-hydroxyvitamin D₂ [24,25(OH)D₂], and 24,25-hydroxyvitamin D₃ [24,25(OH)D₃] were measured by liquid chromatography-tandem mass spectrometry in a subgroup of patients receiving the po formulations.. The areas under the curve of 25(OH)D after D₃ were significantly higher than those after D₂ (P < .0001). Serum 25(OH)D basal difference significantly increased at day 30 with po D₂ and D₃ (P < .01 and P < .0001) and up to day 90 with po D₃ (P < .01). The im formulations produced a slow increased, and values peaked at day 120 relative to the other time points (P < .0001). We found a decrease in 1,25(OH)₂D at day 30 (P < .05) and up to day 120 (P < .001) and an increase in 1,25(OH)₂D₂ at day 30 (P < .01) and up to day 120 (P < .01) after po D₂. Oral D₂ and D₃ produced increases in 24,25(OH)D₂ and 24,25(OH)D₃, respectively, at day 30 (P < .001).. A po dose of 600,000 IU of D₂ or D₃ is initially more effective in increasing serum 25(OH)D than the equivalent im dose and is rapidly metabolized. Our RIA assay for 1,25(OH)₂D may not recognize 1,25(OH)₂D₂.

Topics: 24,25-Dihydroxyvitamin D 3; 25-Hydroxyvitamin D 2; Administration, Oral; Aged; Biological Availability; Biotransformation; Calcifediol; Cholecalciferol; Chromatography, High Pressure Liquid; Ergocalciferols; Female; Humans; Injections, Intramuscular; Male; Middle Aged; Radioimmunoassay; Reproducibility of Results; Spectrometry, Mass, Electrospray Ionization; Tandem Mass Spectrometry; Vitamin D Deficiency

We previously showed that oral cholecalciferol and ergocalciferol have comparable effects in decreasing circulating parathyroid hormone (PTH), despite a greater increase in total serum 25-hydroxyvitamin D (25OHD) concentration with cholecalciferol supplementation. However, the effects of cholecalciferol and ergocalciferol on total serum 1,25-dihydroxyvitamin D (1,25(OH)2D), vitamin D-binding protein (DBP), free 25OHD and free 1,25(OH)2D concentrations have not been previously studied. We randomized 95 hip fracture patients (aged 83±8 years) with vitamin D deficiency (serum 25OHD <50 nmol/L) to oral supplementation with either cholecalciferol 1000 IU/day (n=47) or ergocalciferol 1000 IU/day (n=48) for three months. All were given matching placebos of the alternative treatment to maintain blinding. We measured serum 25OHD (high-pressure liquid chromatography), 1,25(OH)2D (Diasorin radioimmunoassay), DBP (immunonephelometry), ionized calcium (Bayer 800 ion-selective electrode) and albumin (bromocresol green) concentrations before and after treatment. We calculated free and bioavailable concentrations of the vitamin D metabolites using albumin and DBP, and calculated free vitamin D metabolite indices as the ratios between the molar concentrations of the vitamin D metabolites and DBP. Seventy participants (74%) completed the study with paired samples for analysis. Total serum 1,25(OH)2D did not change significantly with either treatment (p>0.05, post-treatment vs baseline). Both treatments were associated with comparable increases in DBP (cholecalciferol: +18%, ergocalciferol: +16%, p=0.32 between groups), albumin (cholecalciferol: +31%, ergocalciferol: +21%, p=0.29 between groups) and calculated free 25OHD (cholecalciferol: +46%, ergocalciferol: +36%, p=0.08), with comparable decreases in free 1,25(OH)2D (cholecalciferol: -17%, ergocalciferol: -19%, p=0.32 between groups). In the treatment-adherent subgroup the increase in ionized calcium was marginally greater with cholecalciferol compared with ergocalciferol (cholecalciferol: +8%, ergocalciferol: +5%, p=0.03 between groups). There were no significant differences between the treatments in their effects on the calculated bioavailable concentrations or free indices of the vitamin D metabolites (p>0.05 between groups). In vitamin D-deficient hip fracture patients, oral supplementation with cholecalciferol and ergocalciferol had no effect on total serum 1,25(OH)2D, and comparable effects on DBP and free vitamin

Topics: Aged; Aged, 80 and over; Cholecalciferol; Ergocalciferols; Female; Hip Fractures; Humans; Male; Vitamin D; Vitamin D Deficiency

Vitamin D deficiency is considered as a risk factor in cardiometabolic disorders, including cardiovascular diseases, hypertension and Type 2 diabetes mellitus. We have investigated the effect of vitamin D3 supplementation on glucose homeostasis in healthy overweight and obese women.. In a double-blind randomized placebo-controlled clinical trial, 77 healthy overweight or obese women (mean age 38 ± 8 years; BMI 29.9 ± 4.2 kg/m(2)) were randomly assigned to the vitamin D3 group (25 μg/day as cholecalciferol tablets) or the placebo group. Selected anthropometric indices, glucose, insulin, HbA(1c) and homeostasis model assessment of insulin resistance at baseline and after 12 weeks were measured. Dietary intakes using 24-h food recall and food frequency questionnaires were assessed. Physical activity was assessed by the International Physical Activity Questionnaire. Adjusted mean differences were calculated using analysis of covariance. Correlation coefficients were calculated by Pearson's analysis.. Mean fasting blood glucose concentrations declined in the vitamin D3 and placebo groups (-0.28 ± 0.4 vs. -0.65 ± 0.4 mmol/l, P < 0.001) and the mean percentage of HbA(1c) was decreased (-13 ± 18 vs. -19 ± 17 mmol/l, P = 0.06) in both groups, respectively. Mean 25-hydroxyvitamin D concentrations increased in the vitamin D3 and placebo groups (38.2 ± 32 vs. 4.6 ± 14 nmol/l, P < 0.001), respectively. There was a significant correlation between HbA(1c) and 25-hydroxyvitamin D concentrations (r = -0.271; P = 0.018).. The results indicate that the vitamin D3 supplement of 25 μg/day had no beneficial effect on glycaemic indices in healthy overweight or obese women.

Topics: Adult; Blood Glucose; Body Mass Index; Cholecalciferol; Diet Records; Dietary Supplements; Double-Blind Method; Eating; Exercise; Female; Homeostasis; Humans; Insulin Resistance; Male; Obesity; Surveys and Questionnaires; Treatment Outcome; Vitamin D Deficiency; Vitamins

Many chronic heart failure (CHF) patients have low vitamin D (VitD) and high plasma renin activity (PRA), which are both associated with poor prognosis. Vitamin D may inhibit renin transcription and lower PRA. We investigated whether vitamin D3 (VitD3) supplementation lowers PRA in CHF patients.. We conducted a single-center, open-label, blinded end point trial in 101 stable CHF patients with reduced left ventricular ejection fraction. Patients were randomized to 6 weeks of 2,000 IU oral VitD3 daily or control. At baseline, mean age was 64 ± 10 years, 93% male, left ventricular ejection fraction 35% ± 8%, and 56% had VitD deficiency. The geometric mean (95% CI) of 25-hydroxyvitamin D3 increased from 48 nmol/L (43-54) at baseline to 80 nmol/L (75-87) after 6 weeks in the VitD3 treatment group and decreased from 47 nmol/L (42-53) to 44 nmol/L (39-49) in the control group (P < .001). The primary outcome PRA decreased from 6.5 ng/mL per hour (3.8-11.2) to 5.2 ng/mL per hour (2.9-9.5) in the VitD3 treatment group and increased from 4.9 ng/mL per hour (2.9-8.5) to 7.3 ng/mL per hour (4.5-11.8) in the control group (P = .002). This was paralleled by a larger decrease in plasma renin concentration in the VitD3 treatment group compared to control (P = .020). No significant changes were observed in secondary outcome parameters, including N-terminal pro-B-type natriuretic peptide natriuretic peptide and fibrosis markers.. Most CHF patients had VitD deficiency and high PRA levels. Six weeks of supplementation with 2,000 IU VitD3 increased 25-hydroxyvitamin D3 levels and decreased PRA and plasma renin concentration.

Topics: Aged; Cholecalciferol; Chronic Disease; Female; Heart Failure; Humans; Male; Middle Aged; Renin; Single-Blind Method; Vitamin D Deficiency; Vitamins

To estimate the effects of prenatal vitamin D supplementation on infant growth in Dhaka, Bangladesh.. Longitudinal follow-up of infants born at term or late preterm (≥34 weeks) to participants in a randomized double-blind trial of maternal third-trimester vitamin D3 (35 000 IU/wk; vitamin D ) vs placebo. Anthropometry was performed at birth, 1, 2, 4, 6, 9, and 12 months of age. The primary analysis (n = 145 overall; n = 134 at 1 year) was a comparison of mean length-for-age z-score (LAZ) based on World Health Organization standards.. LAZ was similar between groups at birth, but 0.44 (95% CI, 0.06-0.82) higher in vitamin D vs placebo at 1 year, corresponding to a sex-adjusted increase of 1.1 cm (95% CI, 0.06-2.0). Mean change in LAZ from birth to 1 month was significantly greater in vitamin D (0.53 per month) vs placebo (0.19 per month; P = .004); but there was no significant divergence thereafter. In longitudinal (repeated-measures) analysis, average LAZ during infancy was 0.41 higher in vitamin D vs placebo (95% CI, 0.11-0.71, P = .01). Stunting was less common in vitamin D (17% of infants were ever stunted) vs placebo (31%; P = .049). Other anthropometric indices were similar between groups.. Maternal vitamin D3 supplementation (35 000 IU/wk) during the third trimester of pregnancy enhanced early postnatal linear growth in a cohort of infants in Bangladesh.

Topics: Bangladesh; Child Development; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Follow-Up Studies; Growth; Humans; Infant; Infant, Newborn; Longitudinal Studies; Male; Pregnancy; Pregnancy Complications; Pregnancy Trimester, Third; Vitamin D Deficiency; Vitamins

Guidelines have suggested that obese adults need 2 to 3 times more vitamin D than lean adults to treat vitamin D deficiency, but few studies have evaluated the vitamin D dose response in obese subjects.. The purpose of this study was to characterize the pharmacokinetics of 25-hydroxyvitamin D [25(OH)D] response to 3 different doses of vitamin D₃ (cholecalciferol) in a group of obese subjects and to quantify the 25(OH)D dose-response relationship. DESIGN, SETTING, INTERVENTION, PATIENTS: This was a randomized, single-blind study of 3 doses of oral vitamin D₃ (1000, 5000, or 10,000 IU) given daily to 67 obese subjects for 21 weeks during the winter months.. Serum 25(OH)D levels were measured at baseline and after vitamin D replacement, and 25(OH)D pharmacokinetic parameters were determined, fitting the 25(OH)D concentrations to an exponential model.. Mean measured increments in 25(OH)D at week 21 were 12.4 ± 9.7 ng/mL in the 1000 IU/d group, 27.8 ± 10.2 ng/mL in the 5000 IU/d group, and 48.1 ± 19.6 ng/mL in the 10,000 IU/d group. Steady-state increments computed from the model were 20.6 ± 17.1, 35.2 ± 14.6, and 51.3 ± 22.0 ng/mL, respectively. There were no hypercalcuria or hypercalcemia events during the study.. Our data show that in obese people, the 25(OH)D response to vitamin D₃ is directly related to dose and body size with ∼2.5 IU/kg required for every unit increment in 25(OH)D (nanograms per milliliter).

Topics: Adult; Body Mass Index; Calcifediol; Calcium; Cholecalciferol; Cohort Studies; Dietary Supplements; Female; Humans; Kinetics; Male; Middle Aged; Models, Biological; Nebraska; Obesity; Parathyroid Hormone; Recommended Dietary Allowances; Seasons; Single-Blind Method; Vitamin D Deficiency

The randomised, double blind intervention trial 'Optimising Vitamin D Status in Older People' (VDOP) will test the effect of three oral dosages of vitamin D given for one year on bone mineral density (BMD) and biochemical markers of vitamin D metabolism, bone turnover and safety in older people. VDOP is funded by Arthritis Research UK, supported through Newcastle University and MRC Human Nutrition Research and sponsored by the Newcastle upon Tyne Hospitals NHS Foundation Trust.a. Vitamin D insufficiency is common in older people and may lead to secondary hyperparathyroidism, bone loss, impairment of muscle function and increased risk of falls and fractures. Vitamin D supplementation trials have yielded conflicting results with regard to decreasing rates of bone loss, falls and fractures and the optimal plasma concentration of 25 hydroxy vitamin D (25OHD) for skeletal health remains unclear.. Older (≥70 years) community dwelling men and women are recruited through General Practices in Northern England and 375 participants are randomised to take 12,000 international units (IU), 24,000 IU or 48,000 IU of vitamin D3 orally each month for one year starting in the winter or early spring. Hip BMD and anthropometry are measured at baseline and 12 months. Fasting blood samples are collected at baseline and three-month intervals for the measurement of plasma 25OHD, parathyroid hormone (PTH), biochemical markers of bone turnover and biochemistry to assess the dose-response and safety of supplementation. Questionnaire data include falls, fractures, quality of life, adverse events and outcomes, compliance, dietary calcium intake and sunshine exposure.. This is the first integrated vitamin D supplementation trial in older men and women using a range of doses given at monthly intervals to assess BMD, plasma 25OHD, PTH and biochemical markers of bone turnover and safety, quality of life and physical performance. We aim to investigate the vitamin D supplementation and plasma 25OHD concentration required to maintain bone health and to develop a set of biochemical markers that reflects the effect of vitamin D on bone. This will aid future studies investigating the effect of vitamin D supplementation on fracture risk.#ISRCTN 35648481 (assigned 16 August 2012), EudraCT 2011-004890-10.

Topics: Administration, Oral; Age Factors; Aged; Biomarkers; Bone and Bones; Bone Density; Bone Remodeling; Cholecalciferol; Dietary Supplements; Dose-Response Relationship, Drug; Double-Blind Method; England; Female; Humans; Male; Research Design; Surveys and Questionnaires; Time Factors; Treatment Outcome; Vitamin D Deficiency; Vitamins

Changes in serum vitamin D metabolites and calcium absorption with varying doses of oral vitamin D₃ in healthy children are unknown.. Our objective was to examine the dose-response effects of supplemental vitamin D₃ on serum vitamin D metabolites and calcium absorption in children living at two U.S. latitudes.. Black and white children (n = 323) participated in a multisite (U.S. latitudes 34° N and 40° N), triple-masked trial. Children were randomized to receive oral vitamin D₃ (0, 400, 1000, 2000, and 4000 IU/d) and were sampled over 12 weeks in winter. Serum 25-hydroxyvitamin D (25(OH)D) and 1,25-dihydroxyvitamin D (1,25(OH)₂D) were measured using RIA and intact PTH (iPTH) by immunoradiometric assay. Fractional calcium absorption was determined from an oral stable isotope ⁴⁴Ca (5 mg) in a 150-mg calcium meal. Nonlinear and linear regression models were fit for vitamin D metabolites, iPTH, and calcium absorption.. The mean baseline 25(OH)D value for the entire sample was 70.0 nmol/L. Increases in 25(OH)D depended on dose with 12-week changes ranging from -10 nmol/L for placebo to 76 nmol/L for 4000 IU. Larger 25(OH)D gains were observed for whites vs blacks at the highest dose (P < .01). Gains for 1,25(OH)₂D were not significant (P = .07), and decreases in iPTH were not dose-dependent. There was no dose effect of vitamin D on fractional calcium absorption when adjusted for pill compliance, race, sex, or baseline 25(OH)D.. Large increases in serum 25(OH)D with vitamin D₃ supplementation did not increase calcium absorption in healthy children living at 2 different latitudes. Supplementation with 400 IU/d was sufficient to maintain wintertime 25(OH)D concentrations in healthy black, but not white, children.

Topics: Adolescent; Black or African American; Calcifediol; Calcitriol; Calcium, Dietary; Child; Child Development; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Georgia; Humans; Indiana; Intestinal Absorption; Male; Models, Biological; Parathyroid Hormone; Seasons; Sunlight; Vitamin D Deficiency; White People

Studies examining whether vitamin D supplementation increases muscle mass or muscle-specific vitamin D receptor (VDR) concentration are lacking.. Our objective was to determine whether vitamin D₃ 4000 IU/d alters muscle fiber cross-sectional area (FCSA) and intramyonuclear VDR concentration over 4 months.. This was a randomized, double-blind, placebo-controlled study in a single center.. Participants were 21 mobility-limited women (aged ≥ 65 years) with serum 25-hydroxyvitamin D (25OHD) levels of 22.5 to 60 nmol/L.. Baseline and 4-month FCSA and intramyonuclear VDR were measured from vastus lateralis muscle cross-sections probed for muscle fiber type (I/IIa/IIx) and VDR using immunofluorescence.. At baseline, mean (±SD) age was 78 ± 5 years; body mass index was 27 ± 5 kg/m², 25OHD was 46.3 ± 9.5 nmol/L, and a short physical performance battery score was 7.95 ± 1.57 out of 12. At 4 months, 25OHD level was 52.5 ± 17.1 (placebo) vs 80.0 ± 11.5 nmol/L (vitamin D [VD]; P < .01), and change in 25OHD level was strongly associated with percent change in intramyonuclear VDR concentration-independent of group (r = 0.87, P < .001). By treatment group, percent change in intramyonuclear VDR concentration was 7.8% ± 18.2% (placebo) vs 29.7% ± 11.7% (VD; P = .03) with a more pronounced group difference in type II vs I fibers. Percent change in total (type I/II) FCSA was -7.4% ± 18.9% (placebo) vs 10.6% ± 20.0% (VD; P = .048).. Vitamin D₃ supplementation increased intramyonuclear VDR concentration by 30% and increased muscle fiber size by 10% in older, mobility-limited, vitamin D-insufficient women. Further work is needed to determine whether the observed effect of vitamin D on fiber size is mediated by the VDR and to identify which signaling pathways are involved.

Topics: Aged; Aged, 80 and over; Aging; Anatomy, Cross-Sectional; Calcifediol; Cholecalciferol; Cohort Studies; Dietary Supplements; Double-Blind Method; Female; Geriatric Assessment; Humans; Mobility Limitation; Muscle Development; Muscle Fibers, Fast-Twitch; Muscle Fibers, Slow-Twitch; Muscle Strength; Pilot Projects; Quadriceps Muscle; Receptors, Calcitriol; Up-Regulation; Vitamin D Deficiency

We conducted a single-arm clinical trial in institutionalized seniors, on the effects of high-dose vitamin D3-fortified bread daily intake (clinicaltrials.gov registration NCT00789503).. At 1 and 3 years after the dietary fortification was stopped, serum 25-hydroxyvitamin D (25(OH)D), parathyroid hormone (PTH) and bone mineral density were measured in 23 of the original study subjects, aged 60-82 years who had consumed bread buns (100 g) fortified with 320 mg elemental calcium and 125 μg (5,000 IU) vitamin D3 daily for one year.. At the end of the 1-year supplementation phase (receiving vitamin D3 fortified bread daily), mean (SD) serum 25(OH)D was 127.3 ± 37.8 nmol/L (baseline for this follow-up). At 1-year follow-up, the serum 25(OH)D was 64.9 ± 24.8 nmol/L (p = 0.001, vs. baseline); and at 3-year follow-up it was 28.0 ± 15.0 nmol/L (p = 0.001 vs. baseline). Serum PTH was 18.8 ± 15.6 pg/ml at baseline while at Year 3 it was 48.4 ± 18.4 pg/ml (p = 0.001 vs. baseline). Lumbar spine BMD did not change from baseline to Year 3. However, by Year 3, hip BMD had decreased (0.927 ± 0.130 g/cm² vs. 0.907 ± 0.121 g/cm², p = 0.024).. Vitamin D nutritional status exhibits a long half-life in the body, and a true steady-state plateau may not even be reached 1 year after a discontinuation in dose. Furthermore, once the need for vitamin D has been established, based on a low baseline serum 25(OH)D concentrations, the appropriate action is to maintain corrective vitamin D supplementation over the long term.

Topics: Absorptiometry, Photon; Aged; Aged, 80 and over; Aging; Bone Density; Bread; Calcifediol; Calcium, Dietary; Cholecalciferol; Follow-Up Studies; Food, Fortified; Hip Joint; Homes for the Aged; Humans; Lumbar Vertebrae; Middle Aged; Nursing Homes; Osteoporosis; Parathyroid Hormone; Recurrence; Romania; Vitamin D Deficiency

To our knowledge, there is no study that has examined the effects of vitamin D supplementation on metabolic status in gestational diabetes mellitus (GDM).. This study was designed to assess the effects of vitamin D supplementation on metabolic profiles, high-sensitivity C-reactive protein, and biomarkers of oxidative stress in pregnant women with GDM.. This randomized, double-blind, placebo-controlled clinical trial was conducted in 54 women with GDM. Subjects were randomly assigned to receive either vitamin D supplements or placebo. Individuals in the vitamin D group (n = 27) received capsules containing 50,000 IU vitamin D₃ 2 times during the study (at baseline and at day 21 of the intervention) and those in the placebo group (n = 27) received 2 placebos at the same times. Fasting blood samples were collected at baseline and after 6 wk of the intervention to quantify relevant variables.. Cholecalciferol supplementation resulted in increased serum 25-hydroxyvitamin D concentrations compared with placebo (+18.5 ± 20.4 compared with +0.5 ± 6.1 ng/mL; P < 0.001). Furthermore, intake of vitamin D supplements led to a significant decrease in concentrations of fasting plasma glucose (-17.1 ± 14.8 compared with -0.9 ± 16.6 mg/dL; P < 0.001) and serum insulin (-3.08 ± 6.62 compared with +1.34 ± 6.51 μIU/mL; P = 0.01) and homeostasis model of assessment-insulin resistance (-1.28 ± 1.41 compared with +0.34 ± 1.79; P < 0.001) and a significant increase in the Quantitative Insulin Sensitivity Check Index (+0.03 ± 0.03 compared with -0.001 ± 0.02; P = 0.003) compared with placebo. A significant reduction in concentrations of total (-11.0 ± 23.5 compared with +9.5 ± 36.5 mg/dL; P = 0.01) and low-density lipoprotein (LDL) (-10.8 ± 22.4 compared with +10.4 ± 28.0 mg/dL; P = 0.003) cholesterol was also seen after vitamin D supplementation.. Vitamin D supplementation in pregnant women with GDM had beneficial effects on glycemia and total and LDL-cholesterol concentrations but did not affect inflammation and oxidative stress. This trial was registered at www.irct.ir as IRCT201305115623N7.

Topics: Adult; Biomarkers; C-Reactive Protein; Calcifediol; Cholecalciferol; Diabetes, Gestational; Dietary Supplements; Double-Blind Method; Female; Humans; Hypercholesterolemia; Hyperinsulinism; Insulin Resistance; Intention to Treat Analysis; Iran; Lost to Follow-Up; Oxidative Stress; Pregnancy; Pregnancy Complications; Vitamin D Deficiency

To determine whether a single monthly supplement is as effective as a daily maternal supplement in increasing breast milk vitamin D to achieve vitamin D sufficiency in their infants.. Forty mothers with exclusively breast-fed infants were randomized to receive oral cholecalciferol (vitamin D3) 5000 IU/d for 28 days or 150,000 IU once. Maternal serum, breast milk, and urine were collected on days 0, 1, 3, 7, 14, and 28; infant serum was obtained on days 0 and 28. Enrollment occurred between January 7, 2011, and July 29, 2011.. In mothers given daily cholecalciferol, concentrations of serum and breast milk cholecalciferol attained steady levels of 18 and 8 ng/mL, respectively, from day 3 through 28. In mothers given the single dose, serum and breast milk cholecalciferol peaked at 160 and 40 ng/mL, respectively, at day 1 before rapidly declining. Maternal milk and serum cholecalciferol concentrations were related (r=0.87). Infant mean serum 25-hydroxyvitamin D concentration increased from 17±13 to 39±6 ng/mL in the single-dose group and from 16±12 to 39±12 ng/mL in the daily-dose group (P=.88). All infants achieved serum 25-hydroxyvitamin D concentrations of more than 20 ng/mL.. Either single-dose or daily-dose cholecalciferol supplementation of mothers provided breast milk concentrations that result in vitamin D sufficiency in breast-fed infants.. clinicaltrials.gov NCT01240265.

Topics: Adult; Breast Feeding; Cholecalciferol; Dietary Supplements; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Humans; Infant; Infant, Newborn; Lactation; Male; Milk, Human; Mothers; Time Factors; Treatment Outcome; Vitamin D Deficiency; Vitamins

To investigate the effect of Vitamin D3 on physical performance in patients with HF.. HF is associated with functional decline and frailty. Vitamin D deficiency is associated with loss of muscle strength and poor outcomes in patients with HF.. Sixty-four patients participated in a 6-month parallel design double blind RCT to test the hypothesis that oral vitamin D3 would improve physical performance. Vitamin D3 50,000 IU or placebo was given weekly; all received daily calcium. Patients were included regardless of EF and 25OHD ≤ 37.5 ng/ml. The primary outcome was peak VO2, and secondary outcomes were the 6MW, TGUG and knee isokinetic muscle strength. Between group comparisons were made using ANCOVA models that adjust for baseline measures.. Patients were age 65.9 ± 10.4 years old, 48% women, 64% African American, EF 37.6±13.9, 36% NYHA III, the remainder NYHA II. At baseline the vitamin D group 25OHD was 19.1 ± 9.3 ng/ml and increased to 61.7 ± 20.3 ng/ml; in the placebo group baseline 25OHD was 17.8 ± 9.0 ng/ml and decreased to 17.4 ± 9.8 ng/ml at 6 months (between groups p<0.001). There was no significant change from baseline to 6 months in peak VO2, 6MW, TGUG or isokinetic muscle strength.. Vitamin D3 did not improve physical performance for patients with HF despite a robust increase in serum 25OHD. Vitamin D repletion in patients with HF should conform to standard adult guidelines for vitamin D supplementation.

Topics: Aged; Cholecalciferol; Double-Blind Method; Exercise Test; Exercise Tolerance; Female; Heart Failure; Humans; Male; Muscle Strength; Muscle, Skeletal; Vitamin D Deficiency; Vitamins

Treatment of vitamin D deficiency for 3 months with oral cholecalciferol 5,000 IU daily was more effective than 2,000 IU daily in achieving optimal serum 25-hydroxyvitamin D (25OHD) concentrations. Optimal 25OHD serum level calculated to be 63.8 nmol/L. All parameters of muscle strength improved following administration of cholecalciferol for 3 months.. The aim of this study was to determine the optimal dose of cholecalciferol required to achieve target serum 25OHD level ≥ 75 nmol/L and its relationship to both bone turnover and muscle strength.. Thirty deficient patients (serum 25OHD ≤ 50 nmol/L) were randomly assigned into two groups-i.e. 2,000 and 5,000 IU/day. Data were collected at baseline, at 2 and 3 months post-therapy: (a) clinical demographics, (b) dietary calcium recall, (c) physical tests of muscle function and (d) biochemistry. Statistical analysis used paired student t test and analysis of variance. Regression analysis was used to determine relationship between serum 25OHD and parathyroid hormone (PTH).. Twenty-six (87%) patients completed 3 months of therapy. The percent increase in serum 25OHD (compared to baseline) was 82.7% in 2,000-IU group and 219.5% in 5,000-IU group. All participants (100%) achieved a serum 25OHD concentration >50 nmol/L; only 5 subjects (45.4%) in 2,000-IU group compared to 14 subjects (93.3%) in 5,000-IU group achieved final 25OHD concentration ≥ 75 nmol/L (p < 0.01). In the regression analysis, the reflexion point at which the PTH level increased above the normal range was calculated to be 63.8 nmol/L 25OHD. All parameters of muscle strength showed trends in improvements following the administration of both the 2,000 and 5,000 IU doses. No patient reported untoward side effects and no patient developed hypercalcaemia.. Treatment for 3 months with oral cholecalciferol 5,000 IU daily may be more effective than 2,000 IU daily in achieving optimal serum 25OHD concentrations in vitamin D-deficient patients.

Topics: Administration, Oral; Adult; Bone Density Conservation Agents; Bone Remodeling; Cholecalciferol; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Muscle Strength; Muscle, Skeletal; Parathyroid Hormone; Treatment Outcome; Vitamin D; Vitamin D Deficiency

We evaluated the effectiveness of supplementation with high dose of oral vitamin D3 to correct vitamin D insufficiency. We have shown that one or two oral bolus of 300,000 IU of vitamin D3 can correct vitamin D insufficiency in 50% of patients and that the patients who benefited more from supplementation were those with the lowest baseline levels.. Adherence with daily oral supplements of vitamin D3 is suboptimal. We evaluated the effectiveness of a single high dose of oral vitamin D3 (300,000 IU) to correct vitamin D insufficiency in a rheumatologic population.. Over 1 month, 292 patients had levels of 25-OH vitamin D determined. Results were classified as: deficiency <10 ng/ml, insufficiency ≥10 to 30 ng/ml, and normal ≥30 ng/ml. We added a category using the IOM recommended cut-off of 20 ng/ml. Patients with deficient or normal levels were excluded, as well as patients already supplemented with vitamin D3. Selected patients (141) with vitamin D insufficiency (18.5 ng/ml (10.2-29.1) received a prescription for 300,000 IU of oral vitamin D3 and were asked to return after 3 (M3) and 6 months (M6). Patients still insufficient at M3 received a second prescription for 300,000 IU of oral vitamin D3. Relation between changes in 25-OH vitamin D between M3 and M0 and baseline values were assessed.. Patients (124) had a blood test at M3. Two (2%) had deficiency (8.1 ng/ml (7.5-8.7)) and 50 (40%) normal results (36.7 ng/ml (30.5-5.5)). Seventy-two (58%) were insufficient (23.6 ng/ml (13.8-29.8)) and received a second prescription for 300,000 IU of oral vitamin D3. Of the 50/124 patients who had normal results at M3 and did not receive a second prescription, 36 (72%) had a test at M6. Seventeen (47%) had normal results (34.8 ng/ml (30.3-42.8)) and 19 (53%) were insufficient (25.6 ng/ml (15.2-29.9)). Of the 72/124 patients who receive a second prescription, 54 (75%) had a test at M6. Twenty-eight (52%) had insufficiency (23.2 ng/ml (12.8-28.7)) and 26 (48%) had normal results (33.8 ng/ml (30.0-43.7)). At M3, 84% patients achieved a 25-OH vitamin D level >20 ng/ml. The lowest the baseline value, the highest the change after 3 months (negative relation with a correlation coefficient r = -0.3, p = 0.0007).. We have shown that one or two oral bolus of 300,000 IU of vitamin D3 can correct vitamin D insufficiency in 50% of patients.

Topics: Administration, Oral; Adolescent; Adult; Aged; Aged, 80 and over; Calcifediol; Cholecalciferol; Dietary Supplements; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Treatment Outcome; Vitamin D Deficiency; Young Adult

Vitamin D, parathyroid hormone levels and calcium absorption was assessed before and after cholecalciferol using Strontium as a surrogate. Increase in 25OHD, lowering of iPTH with no effect on Sr absorption was seen, suggesting the possibility that maximal Ca absorption had already been achieved in these volunteers.. This paper discusses the determination of calcium (Ca) absorption, using strontium (Sr) as a surrogate, before and after a single IM injection of vitamin D(3) (600,000 IU).. Baseline serum 25-hydroxyvitamin D (25OHD), Sr, Ca, P, and intact parathyroid hormone (iPTH) were determined in 53 fasting volunteers, followed by administrating (PO) 0.03 mM (4.8 mg/kg) SrCl(2) and collecting blood at 0.5, 1 and 4 h to determine the absorption (AUC(0 → t )) of Sr. Following the initial absorption test, volunteers received a single IM injection of 600,000 IU vitamin D(3). Two months later, the fasting serum and the Sr absorption test were repeated, as described above.. The IM injection of vitamin D(3) caused a significant increase in fasting 25OHD (from 43.5 ± 19 to 66.1 ± 19.1 nmol/L (p < 0.001)) and a trend toward lower serum iPTH (from 59.8 ± 27.8 to 53 ± 31 ng/L). Fasting serum Ca and P remained unchanged. A higher 25OHD level failed (p = 0.32) to translate into a higher rate of Sr absorption. AUC(0 → 4 h) were almost identical before and after the IM injection of vitamin D(3).. A single vitamin D(3) injection of 600,000 IU significantly increase mean 25OHD concentration and tended to lower iPTH concentrations in volunteers with initially low 25OHD status, suggesting to utilize this simple form of treatment to improve vitamin D status and to have a possible biological effect on Ca homeostasis. However, we found no obvious effect on Sr absorption, suggesting the possibility that maximal vitamin D-dependent Ca absorption had already been achieved in these volunteers at a lower vitamin D status.

Topics: Adolescent; Adult; Biomarkers; Calcium, Dietary; Cholecalciferol; Dietary Supplements; Female; Humans; Injections, Intramuscular; Intestinal Absorption; Male; Parathyroid Hormone; Strontium; Vitamin D; Vitamin D Deficiency; Young Adult

Vitamin D deficiency is a worldwide health problem. Usual supplements are inadequate for prevention of hypovitaminosis D, and much higher doses are needed for its treatment. This study was designed to compare the efficacy and practicality of high-dose intramuscular and oral cholecalciferol in treatment of hypovitaminosis D and to evaluate durability of the effect of each remedy.. Ninety-two patients with hypovitaminosis D [serum 25(OH) D level < 75 nmol/l] were enrolled in a randomised clinical trial. Participants were randomly assigned to receive 300 000 IU cholecalciferol, either intramuscularly as a single injection or orally in six divided doses during 3 months period. Serum 25(OH) D level was measured at baseline and at 3 and 6 months.. Both treatment regimens significantly increased the serum 25(OH)D level. Delta change in serum 25(OH) D level from baseline (presented as mean ± SEM) at month 3 was significantly higher in oral than injection group (90 ± 11·2 and 58·8 ± 8·9 nmol/l, respectively, P = 0·03); but was similar at 6th month intervention (52·1 ± 7·6 and 62·2 ± 6·7 nmol/l, respectively, P = 0·32). There was a marginally significant trend in favour of oral group in the proportion of cases attained vitamin D adequacy at 6th month (P = 0·06); but still 15% of all patients remained at < 50 nmol/l.. Both regimens were considerably effective, safe and practical in treating hypovitaminosis D. Although we revealed superiority of oral route, at least at early short time, the way of treatment may depend on the patient's choice, compliance and availability of various forms of the drug in any regions.

Topics: Administration, Oral; Cholecalciferol; Drug Administration Schedule; Female; Humans; Injections, Intramuscular; Male; Middle Aged; Vitamin D; Vitamin D Deficiency

Optimal vitamin D status is known to have beneficial health effects and vitamin D supplements are commonly used. It has been suggested that vitamin D supplementation may increase blood lead in children and adults with previous lead exposure. The objective was to determine the safety regarding lead toxicity during 12 weeks of high-dose vitamin D3 supplementation in children and young adults with human immunodeficiency virus (HIV).. Subjects with HIV (8-24 years) were randomized to vitamin D3 supplementation of 4000 or 7000 IU/day and followed at 6 and 12 weeks for changes in serum 25-hydroxy vitamin D (25D) and whole-blood lead concentration. This was a secondary analysis of a larger study of vitamin D3 supplementation in children and adolescents with HIV.. In 44 subjects (75% African American), the baseline mean ± standard deviation serum 25D was 48.3±18.6 nmol/L. Fifty percent of subjects had baseline serum 25D <50.0 nmol/L. Serum 25D increased significantly with D3 supplementation during the 12 weeks. No subject had a whole-blood lead >5.0 μg/dL at baseline or during subsequent visits. Whole-blood lead and 25D were not correlated at baseline, and were negatively correlated after 12 weeks of supplementation (P=0.014). Whole-blood lead did not differ between those receiving 4000 and 7000 IU of vitamin D3.. High-dose vitamin D3 supplementation and the concomitant increased serum 25D did not result in increased whole-blood lead concentration in this sample of children and young adults living in a northeastern urban city.

Topics: Adolescent; Adult; Calcifediol; Child; Cholecalciferol; Dietary Supplements; Female; HIV Infections; Humans; Lead; Lead Poisoning; Longitudinal Studies; Male; Nutritional Status; Philadelphia; Vitamin D Deficiency; Young Adult

Public health recommendations do not distinguish between vitamin D2 and vitamin D3, yet disagreement exists on whether these two forms should be considered equivalent. The objective of the present study was to evaluate the effect of a daily physiological dose of vitamin D2 or vitamin D3 on 25-hydroxyvitamin D (25(OH)D) status over the winter months in healthy adults living in Dunedin, New Zealand (latitude 46°S). Participants aged 18-50 years were randomly assigned to 25 μg (1000 IU) vitamin D3 (n 32), 25 μg (1000 IU) vitamin D2 (n 31) or placebo (n 32) daily for 25 weeks beginning at the end of summer. A per-protocol approach, which included ≥ 90 % supplement compliance, was used for all analyses. Serum 25-hydroxyvitamin D3 (25(OH)D3), 25-hydroxyvitamin D2 (25(OH)D2) and parathyroid hormone (PTH) were measured at baseline and at 4, 8, 13 and 25 weeks. Geometric mean total serum 25(OH)D concentrations (sum of 25(OH)D2 and 25(OH)D3) at baseline was 80 nmol/l. After 25 weeks, participants randomised to D2 and placebo had a significant reduction in serum 25(OH)D3 concentrations over the winter months compared with vitamin D3-supplemented participants (both P< 0.001). Supplementation with vitamin D2 increased serum 25(OH)D2 but produced a 9 (95 % CI 1, 17) nmol/l greater decline in the 25(OH)D3 metabolite compared with placebo (P< 0.036). Overall, total serum 25(OH)D concentrations were 21 (95 % CI 14, 30) nmol/l lower in participants receiving vitamin D2 compared with those receiving D3 (P< 0.001), among whom total serum 25(OH)D concentrations remained unchanged. No intervention-related changes in PTH were observed. Daily supplementation of vitamin D3 was more effective than D2; however, the functional consequence of the differing metabolic response warrants further investigation.

Topics: Adolescent; Adult; Cholecalciferol; Dietary Supplements; Double-Blind Method; Ergocalciferols; Female; Humans; Male; Middle Aged; New Zealand; Nutritional Status; Placebos; Seasons; Vitamin D; Vitamin D Deficiency

Systemic lupus erythematosus (SLE) is a chronic multisystem inflammatory autoimmune disease. Vitamin D has potent immunomodulatory properties that support its use in the treatment of autoimmune conditions, including SLE. We assessed vitamin D status in patients with SLE and determined alterations in inflammatory and hemostatic markers and disease activity before and after vitamin D supplementation.. Patients with SLE (n = 267) were randomized 2:1 to receive either oral cholecalciferol 2000 IU/day or placebo for 12 months. Outcome measures included assessment of alterations in levels of proinflammatory cytokines and hemostatic markers, and improvement in disease activity before and after 12 months of supplementation. Disease activity was measured by the SLE Disease Activity Index. Vitamin D levels were measured by Liaison immunoassay (normal 30-100 ng/ml). Serum levels between 10 and 30 ng/ml were classified as vitamin D insufficiency and levels < 10 ng/ml as vitamin D deficiency.. The mean 25(OH)D level at baseline was 19.8 ng/ml in patients compared to 28.7 ng/ml in controls. The overall prevalence of suboptimal and deficient 25(OH)D serum levels among patients with SLE at baseline was 69% and 39%, respectively. Lower 25(OH)D levels correlated significantly with higher SLE disease activity. At 12 months of therapy, there was a significant improvement in levels of inflammatory and hemostatic markers as well as disease activity in the treatment group compared to the placebo group.. Vitamin D supplementation in patients with SLE is recommended because increased vitamin D levels seem to ameliorate inflammatory and hemostatic markers and show a tendency toward subsequent clinical improvement. Clinical Trial Registry NCT01425775.

Topics: Adult; Biomarkers; Cholecalciferol; Cytokines; Double-Blind Method; Female; Humans; Inflammation; Lupus Erythematosus, Systemic; Male; Middle Aged; Severity of Illness Index; Treatment Outcome; Vitamin D; Vitamin D Deficiency

The biological equivalency of ergocalciferol (D2) and cholecalciferol (D3) has been debated; several comparisons have appeared in the adult literature but are scarce in pediatrics. The objective of this study was to compare increases in plasma 25-hydroxyvitamin D [25(OH)D] concentrations and attainment of 50 and 75 mol/L status cutoffs following 3 mo of daily supplementation with D2 compared with D3. Healthy, breast-fed, 1-mo-old infants (n = 52) received 10 μg (400 ic) of either D2 or D3 daily. At 1 and 4 mo of age, plasma 25-hydroxyergocalciferol and 25-hydroxycholecalciferol concentrations were determined by liquid chromatography tandem MS (LC-MS/MS) and total 25(OH)D by chemiluminescent immunoassay (DiaSorin Liaison). Data were analyzed using t tests and χ² by intent to treat. A total of 23% of infants were deficient (≤24.9 nmol/L) at baseline and 2% at follow-up on the basis of LC-MS/MS. At 4 mo, 96% were breastfed and there were no differences in compliance, breastfeeding rates, or sun exposure among groups. The change in total 25(OH)D measured by LC-MS/MS did not differ between the D2 (17.6 ± 26.7 nmol/L) and D3 (22.2 ± 20.2 nmol/L) groups. In the combined groups, the baseline plasma 25(OH)D concentration was inversely related to the change in total 25(OH)D (r = -0.52; P < 0.001). Overall, 86% of infants met the 50 nmol/L cutoff at follow-up; however, fewer infants in the D2 group (75%) met this level compared with the D3 group (96%) (P < 0.05). Similar results were obtained by immunoassay. In conclusion, the increase in the 25(OH)D concentration among the D2 and D3 groups did not differ, suggesting daily intake of either isoform is acceptable for infants <4 mo.

Topics: 25-Hydroxyvitamin D 2; Adult; Breast Feeding; Calcifediol; Cholecalciferol; Chromatography, High Pressure Liquid; Dietary Supplements; Ergocalciferols; Female; Follow-Up Studies; Humans; Immunoassay; Infant; Intention to Treat Analysis; Male; Patient Compliance; Quebec; Remission Induction; Tandem Mass Spectrometry; Vitamin D Deficiency

The role of cholecalciferol supplementation in end-stage renal disease (ESRD) patients has been questioned. The objective of this randomized double-blinded study is to assess whether cholecalciferol therapy can increase serum 25-hydroxyvitamin D [25(OH)D] levels in haemodialysed patients and the safety implications of this therapy on certain biological parameters and vascular calcifications score.. Forty-three haemodialysis patients were randomized to receive placebo or cholecalciferol (25,000 IU) therapy every 2 weeks. The biological parameters, serum calcium, phosphorus, 25(OH)D and parathormone (PTH) levels, were monitored monthly for 12 consecutive months. Vascular calcifications were assessed by lateral X-ray radiography.. At baseline, the mean serum 25(OH)D levels were low and similar in both groups. Thirty patients (16 treated and 14 placebo) completed the study: 11 patients died (5 placebo and 6 treated), 1 patient dropped out and 1 patient was transplanted (both from the placebo group). After 1 year, the percentage of 25(OH)D deficient patients was significantly lower in the treated group. None of the patients developed hypercalcaemia. The PTH levels tended to increase over the study period under placebo and to decrease in the cholecalciferol group. The median changes in PTH levels from baseline to 1 year were statistically different between the two groups [+80 (-58 to 153) and -115 (-192 to 81) under placebo and cholecalciferol treatment, respectively, P=0.02].The calcification scores increased equivalently in both groups (+2.3 per year).. Cholecalciferol is effective and safe, and does not negatively affect calcium, phosphorus, PTH levels and vascular calcifications. Additional studies are needed to compare the impacts of nutritional and active vitamin D agents on vascular calcification and mortality.

Topics: Aged; Bone Density Conservation Agents; Calcium; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Glomerular Filtration Rate; Humans; Kidney Failure, Chronic; Male; Parathyroid Hormone; Phosphorus; Renal Dialysis; Vascular Calcification; Vitamin D; Vitamin D Deficiency

Serum 25-hydroxyvitamin D (25OHD) is lower in women with darker skin color. Is it due to lower skin production, lower absorption, or different metabolism of vitamin D?. The objective of the study was to measure the effect of vitamin D3 on serum 25OHD and serum PTH in older African American women with vitamin D insufficiency and the serum 25OHD 20 ng/mL or less (<50 nmol/L). The results can be used to estimate the Recommended Dietary Allowance (RDA).. This was a randomized, double-blind placebo trial at Creighton University Medical Center and Indiana University Medical Center.. Participants were 110 healthy older African American women.. The intervention consisted of participants randomly assigned to placebo, vitamin D3 400, 800, 1600, 2400, 3200, 4000, or 4800 IU daily; calcium supplements were given to maintain total calcium intake of 1200-1400 mg/d.. Change in serum 25OHD and serum PTH levels at 12 months was measured.. Mean baseline serum 25OHD was 13 ng/mL (33 nmol/L). On 4800 IU, serum 25OHD averaged 50 ng/mL (125 nmol/L) compared with 47 ng/mL (117 nmol/L) in Caucasian women. Serum PTH at 12 months decreased significantly (P = .008) when related to serum 25OHD but not dose. Hypercalcemia occurred in 7% and hypercalciuria in 15%. Events were unrelated to vitamin D dose.. Vitamin D3 800 IU increased serum 25OHD greater than 20 ng/mL (>50 nmol/L) in 97.5% of the African American women just as it did in the Caucasian women, and therefore, the RDA is the same for both groups. Because absorption and metabolism of oral vitamin D absorption is similar in both groups, lower levels of serum 25OHD in African Americans must be due to lower production of vitamin D in skin.

Topics: Aged; Aged, 80 and over; Aging; Black or African American; Calcium, Dietary; Cholecalciferol; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Middle Aged; Parathyroid Hormone; Placebos; Prospective Studies; Vitamin D; Vitamin D Deficiency; Vitamins; White People

Suboptimal mitochondrial function has been implicated in several disorders in which fatigue is a prominent feature. Vitamin D deficiency is a well-recognized cause of fatigue and myopathy. The aim of this study was to examine the effects of cholecalciferol therapy on skeletal mitochondrial oxidative function in symptomatic, vitamin D-deficient individuals.. This longitudinal study assessed mitochondrial oxidative phosphorylation in the gastrosoleus compartment using phosphorus-31 magnetic resonance spectroscopy measurements of phosphocreatine recovery kinetics in 12 symptomatic, severely vitamin D-deficient subjects before and after treatment with cholecalciferol. All subjects had serum assays before and after cholecalciferol therapy to document serum 25-hydroxyvitamin D (25OHD) and bone profiles. Fifteen healthy controls also underwent (31)P-magnetic resonance spectroscopy and serum 25OHD assessment.. The phosphocreatine recovery half-time (τ1/2PCr) was significantly reduced after cholecalciferol therapy in the subjects indicating an improvement in maximal oxidative phosphorylation (34.44 ± 8.18 sec to 27.84 ± 9.54 sec, P < .001). This was associated with an improvement in mean serum 25OHD levels (8.8 ± 4.2 nmol/L to 113.8 ± 51.5 nmol/L, P < .001). There was no difference in phosphate metabolites at rest. A linear regression model showed that decreasing serum 25OHD levels was associated with increasing τ1/2PCr (r = -0.41, P = .009). All patients reported an improvement in fatigue after cholecalciferol therapy.. Cholecalciferol therapy augments muscle mitochondrial maximal oxidative phosphorylation after exercise in symptomatic, vitamin D-deficient individuals. This finding suggests that changes in mitochondrial oxidative phosphorylation in skeletal muscle could at least be partly responsible for the fatigue experienced by these patients. For the first time, we demonstrate a link between vitamin D and the mitochondria in human skeletal muscle.

Topics: Adolescent; Adult; Cholecalciferol; Fatigue; Female; Humans; Longitudinal Studies; Magnetic Resonance Spectroscopy; Male; Middle Aged; Mitochondria; Muscle Cramp; Muscle, Skeletal; Oxidative Phosphorylation; Phosphocreatine; Phosphorus Isotopes; Treatment Outcome; Vitamin D Deficiency; Vitamins; Young Adult

There is increasing epidemiological evidence linking sub-optimal vitamin D status with overweight and obesity. Although increasing BMI and adiposity have also been negatively associated with the change in vitamin D status following supplementation, results have been equivocal. The aim of this randomised, placebo-controlled study was to investigate the associations between anthropometric measures of adiposity and the wintertime serum 25-hydroxycholecalciferol (25(OH)D) response to 15 μg cholecalciferol per d in healthy young and older Irish adults. A total of 110 young adults (20-40 years) and 102 older adults ( ≥ 64 years) completed the 22-week intervention with >85 % compliance. The change in 25(OH)D from baseline was calculated. Anthropometric measures of adiposity taken at baseline included height, weight and waist circumference (WC), along with skinfold thickness measurements to estimate fat mass (FM). FM was subsequently expressed as FM (kg), FM (%), FM index (FMI (FM kg/height m2)) and as a percentage ratio to fat-free mass (FFM). In older adults, vitamin D status was inversely associated with BMI (kg/m2), WC (cm), FM (kg and %), FMI (kg/m2) and FM:FFM (%) at baseline (r - 0·33, - 0·36, - 0·33, - 0·30, - 0·33 and - 0·27, respectively, all P values < 0·01). BMI in older adults was also negatively associated with the change in 25(OH)D following supplementation (β - 1·27, CI - 2·37, - 0·16, P = 0·026); however, no such associations were apparent in younger adults. Results suggest that adiposity may need to be taken into account when determining an adequate wintertime dietary vitamin D intake for healthy older adults residing at higher latitudes.

Topics: Adipose Tissue; Adiposity; Adult; Age Factors; Aged; Body Mass Index; Body Size; Calcifediol; Cholecalciferol; Cross-Sectional Studies; Dietary Supplements; Female; Humans; Ireland; Male; Middle Aged; Nutritional Status; Patient Compliance; Seasons; Vitamin D Deficiency; Young Adult

The goal of this study was to examine the effects of a single oral dose of 300,000 international units of either ergocalciferol (D₂) or cholecalciferol (D₃) on the plasma levels of 25-hydroxyvitamin D in patients with alcoholic liver cirrhosis.. Inclusion criteria for this study were diagnosis of alcoholic liver cirrhosis and plasma levels of 25-hydroxyvitamin D less than 25 nmol/l. At baseline, patients were divided into Child-Pugh groups A, B, or C and were given one oral dose of 300,000 international units of ergocalciferol (D₂ group, N=23) or cholecalciferol (D₃ group, N=13). Plasma concentrations of 25(OH) vitamin D and vitamin D-binding protein were measured on days 0, 7, 30, and 90.. On days 7 and 30, patients from the D₃ group had higher vitamin D levels than patients from the D₂ group (P<0.05). On day 7, vitamin D levels were found to correlate with Child-Pugh scores from patients in the D₃ group. For patients in the D₂ group, there was a positive correlation between vitamin D and vitamin D-binding protein as indicated by the area under the concentration versus time curves (Spearmen's ρ=0.64 P<0.001).. In patients with alcoholic liver cirrhosis, a single oral megadose of cholecalciferol was more effective than ergocalciferol in the treatment of vitamin D deficiency. Severe liver disease and low levels of vitamin D-binding protein were predictors for poor treatment outcomes.

Topics: Administration, Oral; Cholecalciferol; Drug Administration Schedule; Ergocalciferols; Female; Humans; Liver Cirrhosis, Alcoholic; Male; Prognosis; Severity of Illness Index; Treatment Outcome; Vitamin D; Vitamin D Deficiency; Vitamin D-Binding Protein

We aimed to assess the safety and efficacy of high-dose intermittent vitamin D supplementation in adolescents. Twenty-two healthy adolescents with serum 25 hydroxy-vitamin D (25-OHD) of 12.5-50 nmol/l were randomised to receive 300,000 IU or 150,000 IU of vitamin D3, or placebo orally 6-monthly for 1 year. At 12 months, the average vitamin D levels for the 300,000 IU, 150,000 IU and placebo groups were 63.0, 41.1 and 35.8 nmol/l, respectively, (P=0.004 for difference between 300 000 IU group and placebo after adjustment for age, sex and seasonal variation). At 12 months, one participant receiving 300,000 IU was mildly deficient (25-OHD 49 nmol/l), whereas five out of six (83%) in the placebo and four out of seven participants (57%) in the 150,000 IU group remained deficient. There were no adverse events. Compliance was high. This suggests that 300,000 IU vitamin D3 orally 6-monthly may safely and effectively correct vitamin D deficiency in adolescents.

Topics: Administration, Oral; Adolescent; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Male; Patient Compliance; Pilot Projects; Seasons; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D deficiency is highly prevalent among hemodialysis patients, but little data exist in support of an optimal repletion regimen.. The objective was to ascertain the efficacy of weekly very-high-dose cholecalciferol (vitamin D(3)) in correcting vitamin D insufficiency and deficiency in patients with stage 5D chronic kidney disease.. We conducted a prospective, double-blind, randomized controlled pilot study that compared placebo with very high doses of oral cholecalciferol for 3 wk (200,000 IU/wk) in hemodialysis patients. We examined the rate of correction of vitamin D insufficiency or deficiency and the effect of treatment on markers of mineral metabolism and routine laboratory variables.. Twenty-seven subjects received placebo, and 25 received cholecalciferol. The majority (94%) of subjects had serum 25-hydroxyvitamin D [25(OH)D] concentrations <30 ng/mL. Study groups were similar with respect to baseline clinical characteristics, with the exception of hemoglobin concentrations, which were lower in the cholecalciferol-treated group (P < 0.04). At follow-up, 90.5% of subjects treated with cholecalciferol achieved serum 25(OH)D concentrations ≥30 ng/mL in contrast to 13.6% of the placebo group. There were no significant changes in serum calcium, phosphate, or intact parathyroid hormone during the study.. Short-term, high-dose oral cholecalciferol treatment of vitamin D deficiency in hemodialysis patients appears to be effective and with no evidence of toxic effects. This trial was registered at clinicaltrials.gov as NCT00912782.

Topics: Adult; Aged; Cholecalciferol; Double-Blind Method; Drug Administration Schedule; Female; Hemoglobins; Humans; Male; Middle Aged; Pilot Projects; Prospective Studies; Renal Dialysis; Renal Insufficiency, Chronic; Vitamin D; Vitamin D Deficiency

Skeletal abnormalities have been reported in HIV-infected children and adolescents. Although the etiology is not well understood, vitamin D deficiency may be involved.. The study objective was to evaluate the effect of vitamin D and calcium supplementation on bone mass accrual in HIV-infected youth.. Perinatally HIV-infected children were randomly assigned to receive vitamin D (100,000 IU cholecalciferol given every 2 mo) and calcium (1 g/d) (supplemented group) or double placebo (placebo group) for 2 y. The total-body bone mineral content (TBBMC), total-body bone mineral density (TBBMD), spine bone mineral content (SBMC), and spine bone mineral density (SBMD) were assessed by using dual-energy X-ray absorptiometry at baseline and at 2 annual follow-up visits.. Fifty-nine participants, aged 6-16 y, were randomly assigned to either the supplemented (n = 30) or the placebo (n = 29) group. At enrollment, supplemented and placebo groups did not differ with respect to age, sex, dietary intakes of vitamin D and calcium, mean baseline serum 25-hydroxyvitamin D [25(OH)D] concentration, TBBMC, TBBMD, SBMC, or SBMD. Significant increases in serum 25(OH)D were observed in the supplemented group but not in the placebo group. TBBMC, TBBMD, SBMC, and SBMD increased significantly at 1 and 2 y in both groups. No between-group differences were observed at any time before or after adjustment for stage of sexual maturation by mixed linear model analysis.. One gram of calcium per day and oral cholecalciferol at a dosage of 100,000 IU every 2 mo administered to HIV-infected children and adolescents did not affect bone mass accrual despite significant increases in serum 25(OH)D concentrations. This trial was registered at clinicaltrials.gov as NCT00724178.

Topics: Absorptiometry, Photon; Adolescent; Bone and Bones; Bone Density; Calcium, Dietary; Child; Cholecalciferol; Dietary Supplements; Female; Follow-Up Studies; HIV Infections; Humans; Male; Surveys and Questionnaires; Vitamin D Deficiency

Vitamin D deficiency is often treated or prevented by high intermittent doses of vitamin D to achieve a better treatment adherence, but treatment outcomes were contradictory, and even a transient increase in fracture and fall risk was reported.. The objective of the study was to investigate the short-term effects on bone turnover markers of a single bolus of vitamin D₃.. Twelve elderly subjects (eight women, four men; mean age 76 ± 3 yr) were given a single oral bolus of 600,000 IU vitamin D₃. Blood samples were taken at baseline and 1, 3, 7, 14, 30, 60, and 90 d after vitamin D₃ administration. Twenty-four subjects served as controls.. Changes in serum levels of 25-hydroxyvitamin D (25OHD), 1,25-dihydroxyvitamin D, PTH, C-terminal-telopeptides of type I collagen, cross-linked N-telopeptide of type I collagen (sNTX), osteocalcin, and bone-specific alkaline phosphatase.. No relevant changes in 25OHD and bone turnover markers were observed in the controls. In treated subjects, serum 25OHD attained a peak increment to 67.1 ± 17.1 ng/ml (P < 0.001) at d 3. Subsequently it slowly decreased to 35.2 ± 5.8 ng/ml (P <0.01 vs. a baseline value of 21.7 ± 5.6 ng/ml). Mean serum PTH concentration decreased by 25-50% and serum 1,25-dihydroxyvitamin D rose by 25-50%. Serum CTX and sNTX rose significantly at d 1 (P < 0.01), they attained a peak increment greater than 50% at d 3, and they subsequently decreased almost back to baseline values at d 90. Serum osteocalcin slightly rose within the first 3 d and then declined by d 60. No changes were observed in serum bone-specific alkaline phosphatase.. Our results indicate that the use of large doses of vitamin D may be associated with acute increases in C-terminal-telopeptides of type I collagen and sNTX, which may explain the negative clinical results obtained by using intermittent high doses of vitamin D to treat or prevent vitamin D deficiency.

Topics: Administration, Oral; Aged; Biomarkers; Biotransformation; Bone and Bones; Bone Density Conservation Agents; Calcifediol; Calcitriol; Cholecalciferol; Collagen Type I; Female; Humans; Male; Osteocalcin; Osteoporosis; Parathyroid Hormone; Peptides; Phosphopeptides; Procollagen; Vitamin D Deficiency

MAVIDOS is a randomised, double-blind, placebo-controlled trial (ISRCTN82927713, registered 2008 Apr 11), funded by Arthritis Research UK, MRC, Bupa Foundation and NIHR.. Osteoporosis is a major public health problem as a result of associated fragility fractures. Skeletal strength increases from birth to a peak in early adulthood. This peak predicts osteoporosis risk in later life. Vitamin D insufficiency in pregnancy is common (31% in a recent Southampton cohort) and predicts reduced bone mass in the offspring. In this study we aim to test whether offspring of mothers supplemented with vitamin D in pregnancy have higher bone mass at birth than those whose mothers were not supplemented.. Women have their vitamin D status assessed after ultrasound scanning in the twelfth week of pregnancy at 3 trial centres (Southampton, Sheffield, Oxford). Women with circulating 25(OH)-vitamin D levels 25-100 nmol/l are randomised in a double-blind design to either oral vitamin D supplement (1000 IU cholecalciferol/day, n = 477) or placebo at 14 weeks (n = 477). Questionnaire data include parity, sunlight exposure, dietary information, and cigarette and alcohol consumption. At 19 and 34 weeks maternal anthropometry is assessed and blood samples taken to measure 25(OH)-vitamin D, PTH and biochemistry. At delivery venous umbilical cord blood is collected, together with umbilical cord and placental tissue. The babies undergo DXA assessment of bone mass within the first 14 days after birth, with the primary outcome being whole body bone mineral content adjusted for gestational age and age. Children are then followed up with yearly assessment of health, diet, physical activity and anthropometric measures, with repeat assessment of bone mass by DXA at age 4 years.. As far as we are aware, this randomised trial is one of the first ever tests of the early life origins hypothesis in human participants and has the potential to inform public health policy regarding vitamin D supplementation in pregnancy. It will also provide a valuable resource in which to study the influence of maternal vitamin D status on other childhood outcomes such as glucose tolerance, blood pressure, cardiovascular function, IQ and immunology.

Topics: Absorptiometry, Photon; Administration, Oral; Age Factors; Biomarkers; Bone and Bones; Bone Density; Child, Preschool; Cholecalciferol; Dietary Supplements; Double-Blind Method; England; Female; Gestational Age; Humans; Infant; Infant, Newborn; Osteoporosis; Pregnancy; Pregnancy Complications; Research Design; Treatment Outcome; Vitamin D; Vitamin D Deficiency

Evidence indicates that vitamin D deficiency contributes to CVD. We investigated the effect of vitamin D3 supplementation on cardiovascular risk factors in women. Healthy premenopausal overweight and obese women (n 77; mean age 38 (sd 8·1) years) were randomly allocated to the vitamin D (25 μg/d as cholecalciferol) or the placebo group in a double-blind manner for 12 weeks. Blood pressure, serum lipoproteins, apolipoproteins and anthropometric parameters were recorded. Dietary intake was recorded using 24 h food recall and FFQ. Physical activity was assessed by the International Physical Activity Questionnaire. Mean total cholesterol concentrations increased in the vitamin D group (0·08 (sd 0·56) mmol/l) but declined in the placebo group (0·47 (sd 0·58) mmol/l), and a significant effect was observed (P ≤ 0·001). In the vitamin D group, mean HDL-cholesterol concentration increased, whereas it decreased in the placebo group (0·07 (sd 0·2) v. - 0·03 (sd 0·2) mmol/l; P = 0·037). Mean apoA-I concentration increased in the vitamin D group, although it decreased in the placebo group (0·04 (sd 0·39) v. - 0·25 (sd 0·2) g/l; P ≤ 0·001). Mean LDL-cholesterol:apoB-100 ratio augmented in the vitamin D group, while this ratio declined in the placebo group (0·11 (sd 0·6) v. - 0·19 (sd 0·3); P = 0·014). Body fat mass was significantly decreased in the vitamin D group more than the placebo group ( - 2·7 (sd 2) v. - 0·4 (sd 2) kg; P ≤ 0·001). The findings showed that supplementation with vitamin D3 can significantly improve HDL-cholesterol, apoA-I concentrations and LDL-cholesterol:apoB-100 ratio, which remained significant in the multivariate model including anthropometric, dietary and physical activity measures.

Topics: Adolescent; Adult; Cardiovascular Diseases; Cholecalciferol; Female; Humans; Lipids; Lipoproteins; Middle Aged; Overweight; Risk Factors; Vitamin D Deficiency; Young Adult

We wanted to evaluate the cutaneous synthesis of 25OHD and cholecalciferol after one whole-body exposure to ultraviolet radiation type B (UVB) in a randomized setup. Healthy volunteers were randomized to one whole-body exposure in a commercial tanning bed with UVB emission (UVB/UVA ratio 1.8-2.0%) or an identical placebo tanning bed without UVB. The output in the 280-320 nm range was 450 µW/cm². Blood samples were analyzed for 25OHD and cholecalciferol at baseline and during 7 days after treatment. We included 20 volunteers, 11 to UVB and 9 to placebo treatment. During the first 6 h, no significant differences in 25OHD between the groups were found. At the end of the study, we found a mean increase of 25OHD in the UVB group of 4.5 nmol/l (SD 7 nmol/l) compared to a decline of -1.2 nmol/l (SD 7 nmol/l) in the placebo group (p = 0.1). A linear mixed model yielded an increase of 25OHD in the UVB group of 1.0 nmol/l per 24 h (p < 0.01). For cholecalciferol, we found a near significant increase of 1 pmol/l per hour in the UVB group compared to the placebo group during the first 6 h (p = 0.052). One tanning bed session had significant, but modest impact on the level of 25OHD during 7 days after exposure to UVB.

Topics: 25-Hydroxyvitamin D 2; Adult; Beauty Culture; Calcifediol; Cholecalciferol; Denmark; Double-Blind Method; Guidelines as Topic; Humans; Kinetics; Middle Aged; Skin; Ultraviolet Rays; Vitamin D Deficiency; White People; Whole-Body Irradiation

Vitamin D insufficiency [serum 25-hydroxyvitamin D (25OHD) concentration less than 20 ng/ml] is prevalent among children with inflammatory bowel disease (IBD), and its treatment has not been studied.. The aim of this study was to compare the efficacy and safety of three vitamin D repletion regimens.. We conducted a randomized, controlled clinical trial from November 2007 to June 2010 at the Clinical and Translational Study Unit of Children's Hospital Boston. The study was not blinded to participants and investigators.. Eligibility criteria included diagnosis of IBD, age 5-21, and serum 25OHD concentration below 20 ng/ml. Seventy-one patients enrolled, 61 completed the trial, and two withdrew due to adverse events.. Patients received orally for 6 wk: vitamin D(2), 2,000 IU daily (arm A, control); vitamin D(3), 2,000 IU daily (arm B); vitamin D(2), 50,000 IU weekly (arm C); and an age-appropriate calcium supplement.. We measured the change in serum 25OHD concentration (Δ25OHD) (ng/ml). Secondary outcomes included change in serum intact PTH concentration (ΔPTH) (pg/ml) and the adverse event occurrence rate.. After 6 wk, Δ25OHD ± se was: 9.3 ± 1.8 (arm A); 16.4 ± 2.0 (arm B); 25.4 ± 2.5 (arm C); P (A vs. C) = 0.0004; P (A vs. B) = 0.03. ΔPTH ± SE was -5.6 ± 5.5 (arm A); -0.1 ± 4.2 (arm B); -4.4 ± 3.9 (arm C); P = 0.57. No participant experienced hypercalcemia or hyperphosphatemia, and the prevalence of hypercalciuria did not differ among arms at follow-up.. Oral doses of 2,000 IU vitamin D(3) daily and 50,000 IU vitamin D(2) weekly for 6 wk are superior to 2,000 IU vitamin D(2) daily for 6 wk in raising serum 25OHD concentration and are well-tolerated among children and adolescents with IBD. The change in serum PTH concentration did not differ among arms.

Topics: Adolescent; Calcium; Child; Cholecalciferol; Dose-Response Relationship, Drug; Ergocalciferols; Female; Follow-Up Studies; Humans; Inflammatory Bowel Diseases; Male; Parathyroid Hormone; Patient Compliance; Treatment Outcome; Vitamin D; Vitamin D Deficiency; Vitamins; Young Adult

Insulin resistance is one of the most common features of polycystic ovary syndrome (PCOS). Some studies suggest that vitamin D deficiency may have a role in insulin resistance; thus, the aim of the current study was to determine the effect of vitamin D supplementation on insulin resistance in women with PCOS and a vitamin D deficiency. We hypothesized that vitamin D supplementation would lower the glucose level and insulin resistance in women with PCOS and a vitamin D deficiency. The current study was a randomized, placebo-controlled, double-blinded trial with 50 women with PCOS and a vitamin D deficiency, 20 to 40 years old, assigned to receive 3 oral treatments consisting of 50,000 IU of vitamin D₃ or a placebo (1 every 20 days) for 2 months (vitamin D, n = 24; placebo, n = 26). The fasting blood glucose, insulin, 25-hydroxyvitamin D, and parathyroid hormone levels, as well as the homeostasis model assessment of insulin resistance and quantitative insulin sensitivity check index were measured at baseline and after treatment. In the vitamin D group, the serum level of 25-hydroxyvitamin D increased (6.9 ± 2.8 to 23.4 ± 6.1 ng/mL, P < .0001), and the parathyroid hormone level decreased (70.02 ± 43.04 to 50.33 ± 21.99 μ IU/mL, P = .02). There were no significant changes in the placebo group. There was a significant increase in insulin secretion in the vitamin D group (P = .01), but this was not significant compared with the placebo group. The fasting serum insulin and glucose levels and the insulin sensitivity and homeostasis model assessment of insulin resistance did not change significantly by the end of the study. We were not able to demonstrate the effect of vitamin D supplementation on insulin sensitivity and insulin resistance in women with PCOS and vitamin D deficiency.

Topics: Adult; Blood Glucose; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Insulin; Insulin Resistance; Insulin Secretion; Parathyroid Hormone; Polycystic Ovary Syndrome; Vitamin D; Vitamin D Deficiency; Vitamins; Young Adult

Vitamin D deficiency may increase the risk for type 2 diabetes. African Americans tend to have poor vitamin D status and increased risk of diabetes, but effects of vitamin D supplementation on components of diabetes risk have not been tested in this group. This study was conducted to determine whether vitamin D supplementation improves insulin secretion, insulin sensitivity and glycaemia in African Americans with prediabetes or early diabetes.. In this randomized, placebo-controlled trial, we examined the effect of 4000 IU/day vitamin D(3,) on glycaemia and contributing measures including insulin secretion, insulin sensitivity and the disposition index over 12 weeks in 89 overweight or obese African Americans with prediabetes or early diabetes. Outcome measures were derived from oral glucose tolerance testing.. Mean plasma 25-hydroxyvitamin D was about 40 nmol/l in the placebo and vitamin D groups at baseline and increased to 81 nmol/l with supplementation. Insulin sensitivity decreased by 4% in the vitamin D group compared with a 12% increase in the placebo group (p = 0.034). Insulin secretion increased by 12% in the vitamin D group compared with a 2% increase in the placebo group (p = 0.024), but changes in the disposition index were similar across groups. There was no effect of supplementation on post-load glucose or other measures of glycaemia.. Supplementation with 4000 IU/day vitamin D(3) successfully corrected vitamin D insufficiency and had divergent effects on insulin secretion and sensitivity with no overall effect on disposition index or glycaemia. In this study, vitamin D supplementation for 3 months did not change the pathophysiology of prediabetes in overweight and obese African Americans.

Topics: Black or African American; Blood Glucose; Cholecalciferol; Diabetes Mellitus, Type 2; Dietary Supplements; Female; Humans; Insulin; Insulin Resistance; Insulin Secretion; Male; Middle Aged; Obesity; Overweight; Prediabetic State; Vitamin D; Vitamin D Deficiency; Vitamins

We investigated the effect of vitamin D on hematological indices, blood pressure (BP) and heart rate (HR) in children with vitamin D deficiency before and after treatment. Vitamin D deficiency does not have a significant effect on red blood cell count and indices, total and differential white blood cell count, or on BP and HR. A mega-dose vitamin D therapy did not have a significant effect on all these parameters in children.

Topics: Blood Pressure; Child; Cholecalciferol; Dose-Response Relationship, Drug; Erythrocyte Indices; Female; Heart Rate; Humans; Male; Treatment Outcome; Vitamin D Deficiency; Vitamins

Vitamin D deficiency and obesity are associated with increased tissue renin-angiotensin system (RAS) activity.. The objective of the study was to evaluate whether vitamin D(3) therapy in obesity reduces tissue-RAS activity, as indicated by an increase in tissue sensitivity to angiotensin II (AngII).. Participants included obese subjects with hypertension and 25-hydroxyvitamin D less than 25 ng/ml.. Subjects were studied before and after 1 month of vitamin D(3) 15,000 IU/d, while in dietary sodium balance, and off all interfering medications. Fourteen subjects successfully completed all study procedures.. The study was conducted at a clinical research center.. At each study visit, tissue sensitivity to AngII was assessed by measuring renal plasma flow (RPF), mean arterial pressure (MAP), and adrenal secretion of aldosterone during an infusion of AngII. Subjects were then given captopril, and a second AngII infusion to evaluate the effect of captopril on tissue-RAS activity.. Vitamin D(3) therapy increased 25-hydroxyvitamin D (18 to 52 ng/ml) and basal RPF (+5%) and lowered supine MAP (-3%) (all P < 0.01). There was a greater decline in RPF and higher stimulation of aldosterone with AngII infusion after vitamin D(3) therapy (both P < 0.05). As anticipated, captopril increased the renal-vascular, MAP, and adrenal sensitivity to AngII, but this effect was much smaller after vitamin D(3) therapy, indicating that vitamin D(3) therapy corrected the tissue sensitivity to AngII akin to captopril.. Vitamin D(3) therapy in obese hypertensives modified RPF, MAP, and tissue sensitivity to AngII similar to converting enzyme inhibition. Whether chronic vitamin D(3) therapy abrogates the development of diseases associated with excess RAS activity warrants investigation.

Topics: Adult; Angiotensin II; Angiotensin-Converting Enzyme Inhibitors; Antihypertensive Agents; Captopril; Cholecalciferol; Drug Resistance; Drug Synergism; Female; Humans; Hypertension; Male; Middle Aged; Obesity; Renal Plasma Flow; Vitamin D Deficiency

The relative potency of 25-hydroxyvitamin D3 to vitamin D3 needs to be better defined so that food-composition tables can better reflect the true vitamin D nutritive value of certain foods.. We performed a randomized, controlled intervention study in apparently healthy, free-living adults to investigate whether the intake of 25-hydroxyvitamin D3 is 5 times more potent in raising serum 25-hydroxyvitamin D [25(OH)D] during winter compared with an equivalent amount of vitamin D3.. A randomized, placebo-controlled, double-blind intervention study was conducted in adults aged ≥50 y (n = 56) who consumed a placebo, 20 μg vitamin D3, or 7 or 20 μg 25-hydroxyvitamin D3 daily throughout 10 wk of winter. Serum 25(OH)D was measured by using an enzyme-linked immunoassay, and serum albumin-corrected calcium (S-Ca) was assessed colorimetrically at the baseline, midpoint, and endpoint of the study.. The mean (±SD) increases (per microgram of vitamin D compound) in serum 25(OH)D concentrations over baseline after 10 wk of supplementation were 0.96 ± 0.62, 4.02 ± 1.27, and 4.77 ± 1.04 nmol · L(-1) · μg intake(-1) for the 20-μg vitamin D3/d and 7- and 20-μg 25-hydroxyvitamin D3/d groups, respectively. A comparison of the 7- and 20-μg 25-hydroxyvitamin D3/d groups with the 20-μg vitamin D3/d group yielded conversion factors of 4.2 and 5, respectively. There was no effect of treatment on S-Ca concentrations and no incidence of hypercalcemia (S-Ca >2.6 nmol/L).. Each microgram of orally consumed 25-hydroxyvitamin D3 was about 5 times more effective in raising serum 25(OH)D in older adults in winter than an equivalent amount of vitamin D3. This conversion factor could be used in food-compositional tables for relevant foods. This study was registered at clinicaltrials.gov as NCT01398202.

Topics: Administration, Oral; Calcifediol; Calcium; Cholecalciferol; Diet; Dietary Supplements; Double-Blind Method; Female; Humans; Male; Middle Aged; Seasons; Sunlight; Vitamin D; Vitamin D Deficiency; Vitamins

To evaluate and compare the effects and safety of high dose intramuscular (IM) or oral cholecalciferol on 25-hydroxyvitamin D [25(OH)D] levels, muscle strength and physical performance in vitamin D deficient/insufficient elderly.. Randomized prospective study.. 116 ambulatory individuals aged 65 years or older living in a nursing home were evaluated. Eligible patients with 25(OH)D levels <30 ng/ml (n=66) were randomized to IM or Oral groups according to the administration route of 600,000 IU cholecalciferol. Demographic and descriptive data were collected. Biochemical response was measured at baseline, 6th and 12th weeks. Muscle strength was measured from quadriceps by using a hand-held dynamometer and physical performance was evaluated by short physical performance battery (SPPB) at the beginning and 12th week.. Among the screened ambulatory elderly only 5.2% (n=6) had adequate vitamin D levels. 37.1% (n=43) were vitamin D deficient and 57.7% (n=67) were insufficient. After administration of one megadose of vitamin D, mean serum 25(OH)D levels increased significantly at 6th week (32.72±9.0 ng/ml) and at 12th week (52.34±14.2 ng/ml) compared with baseline (11.76±7.6 ng/ml) in IM group (p<0.0001). In Oral group levels were 47.57±12.7 ng/ml, 42.94±13.4 ng/ml and 14.87±6.9 ng/ml, respectively (p<0.0001). At 12th week the increase in IM group was significantly higher than Oral group (p=0.003). At the end of the study period, serum 25(OH)D levels were ≥30 ng/ml in all patients in IM group and in 83.3% of the patients in the Oral group. Quadriceps muscle strength and SPPB total score increased significantly in both groups and SPPB balance subscale score increased only in IM group. Six patients (9.6%) developed hypercalciuria, no significant adverse events were observed.. In vitamin D deficient/insufficient elderly, a single megadose of cholecalciferol increased vitamin D levels significantly and the majority of the patients reached optimal levels. Although both administration routes are effective and appear to be safe, IM application is more effective in increasing 25(OH)D levels and balance performance.

Topics: Administration, Oral; Aged; Aged, 80 and over; Cholecalciferol; Drug Administration Schedule; Female; Humans; Hypercalciuria; Injections, Intramuscular; Male; Muscle Strength; Physical Fitness; Postural Balance; Prevalence; Prospective Studies; Quadriceps Muscle; Treatment Outcome; Vitamin D; Vitamin D Deficiency

Uncertainty remains regarding the efficacy of low intakes of ergocalciferol (vitamin D2 or D2) and cholecalciferol (vitamin D3 or D3) provided in food to increase serum 25-hydroxy-vitamin D (25-OH-D) metabolite concentrations when UV-B exposure is low. We recruited 40 healthy men and women into a double-blind, parallel design, randomized controlled trial. Participants received placebo or 1 of 4 experimental treatments (D2 or D3 at 5 or 10 μg/d) supplied as a malted milk drink for 4 wk during a period of minimal UV-B exposure in the UK. The primary outcome was a change in serum 25-OH-D2 and 25-OH-D3 concentrations measured by ultra-performance liquid chromatography tandem MS. The secondary outcomes were changes in concentrations of plasma parathyroid hormone and serum calcium (Ca(2+)). Baseline concentrations (geometric mean ± SD) of 25-OH-D2, 25-OH-D3, and total 25-OH-D were 3 ± 4, 32 ± 22, and 37 ± 22 nmol/L, respectively. Both D2- and D3-fortified drinks resulted in dose-dependent increases (P < 0.001) in their respective 25-OH metabolites that did not significantly differ in size. Increments from baseline compared with the placebo group following 5 and 10 μg/d of D2 were (mean ± SEM) 9.4 ± 2.5 and 17.8 ± 2.4 nmol/L for 25-OH-D2 and following 5 and 10 μg/d of D3 were 15.1 ± 4.7 and 22.9 ± 4.6 nmol/L for 25-OH-D3, respectively. There was no difference between D2 and D3 groups in the incremental AUC of their respective metabolites. These findings suggest that D2 and D3 are equipotent in increasing 25-OH-D in healthy men and women with negligible UV-B exposure.

Topics: 25-Hydroxyvitamin D 2; Adult; Animals; Area Under Curve; Calcifediol; Calcium; Cholecalciferol; Chromatography, High Pressure Liquid; Diet; Dose-Response Relationship, Drug; Double-Blind Method; Ergocalciferols; Female; Food, Fortified; Humans; Male; Mass Spectrometry; Milk; Parathyroid Hormone; Ultraviolet Rays; United Kingdom; Vitamin D; Vitamin D Deficiency; Vitamins; Young Adult

It is known that narrowband ultraviolet B (NB-UVB) radiation and oral vitamin D(3) supplementation can both improve serum levels of vitamin D, expressed as 25-hydroxyvitamin D(3) [25(OH)D(3) ]. However, surprisingly few studies have compared the effects of the two interventions in treating vitamin D deficiency.. To compare the effect of NB-UVB exposure with oral vitamin D(3) supplementation on vitamin D levels in patients with vitamin D deficiency.. Seventy-three participants with vitamin D deficiency [25(OH)D(3) ≤ 25 nmol L(-1) ] were consecutively enrolled from February 2010 to May 2011, avoiding the summer period (June to September). The participants were randomized into two groups, one receiving full body NB-UVB exposure three times per week, the other receiving 1600 IU (40 μg) oral vitamin D(3) per day together with 1,000 mg calcium. Thirty-two participants completed the 6-week study period, 16 in each group. In both groups blood samples were obtained at baseline and after 3 and 6 weeks.. We found a significantly greater increase in 25(OH)D(3) levels (mean) in the NB-UVB treated group (from 19·2 to 75 nmol L(-1) ) compared with the oral vitamin D(3) treated group (from 23·3 to 60·6 nmol L(-1) ) after 6 weeks of treatment (P = 0·02), accompanied by a significant decrease in parathyroid hormone for the whole group (from 5·3 to 4·2 pmol L(-1) , P = 0·028).. Full body NB-UVB three times per week is more effective in treating vitamin D deficiency than prescription of a daily oral intake of 1600 IU (40 μg) vitamin D(3) .

Topics: Administration, Oral; Adult; Cholecalciferol; Dietary Supplements; Female; Humans; Male; Treatment Outcome; Ultraviolet Therapy; Vitamin D; Vitamin D Deficiency; Vitamins

Myasthenia gravis (MG) is a chronic autoimmune neuromuscular disorder. Vitamin D has important roles both in the autoimmune response and in skeletal muscles. We determined the levels of 25-hydroxy vitamin D [25(OH)D] in patients with MG and in healthy subjects to determine whether vitamin D deficiency is present in MG and whether vitamin D supplementation has beneficial effects on fatigue.. Plasma levels of 25(OH)D were analyzed in 33 patients with MG (22 males; mean age, 58 years) and in 50 healthy age- and sex-matched blood donors, without vitamin D3 medication. MG composite (MGC) score assessed fatigue. Thirteen patients with MG without previous vitamin D3 supplementation were started on vitamin D3 supplementation (cholecalciferol) 800 IU/day, with a follow-up examination after 2.5-10 months (mean, 6 months).. Patients with MG without pre-existing vitamin D3 supplementation (N = 16) had a mean MGC of 4.5 and lower plasma 25(OH)D levels (mean, 51 ± 19 nM) than healthy controls (69 ± 21 nM) (P = 0.017). Seventeen patients had pre-existing vitamin D3 supplementation, because of corticosteroid treatment, and their mean 25(OH)D was 79 ± 22 nM and mean MGC was 5.5. In the 13 patients who received cholecalciferol, 25(OH)D was overall increased at follow-up with 22% (P = 0.033) and MGC score improved by 38% (P = 0.05).. Plasma 25(OH)D levels are significantly lower in patients with MG compared with healthy controls. As vitamin D has beneficial effects on the autoimmune response and on fatigue score in patients with MG, we suggest monitoring this parameter in patients with MG and supplementation with vitamin D3 when 25(OH)D levels are low.

Topics: Adult; Aged; Cholecalciferol; Dietary Supplements; Fatigue; Female; Humans; Male; Middle Aged; Myasthenia Gravis; Pilot Projects; Vitamin D; Vitamin D Deficiency

The equivalence of cholecalciferol (D3) and ergocalciferol (D2) as well as their corresponding doses and administration route remain controversial to date. The aim of this study was to compare the effectiveness of daily supplementation with 800 IU of D2 (drops) and D3 (pills) on 25-hydroxivitamin D (25OHD) levels (= 30 ng/ml). Twenty-one ambulatory postmenopausal women from Buenos Aires City with a mean (X ± SD) age of 77.1 ± 6.8 years were included. The participants were randomly assigned to one of the following groups: GD2 (n = 13): 800 IU (drops) and GD3 (n = 8): 800 IU (pills). Serum 25OHD levels were measured (RIA-DIASORIN) at baseline, and at 7, 28 and 45 days. Nineteen out of twenty one women showed deficient levels of 25OHD at baseline (< 20 ng/ml): GD2: 14.0 ± 4.8 ng/ml and GD3: 13.2 ± 4.9 ng/ml (NS). Whereas only GD3 exhibited an increase (≈ 25%) at 7 days, both groups showed a significant increase at the end of the study. However, neither attained adequate 25OHD levels (GD2: 17.4 ± 5.5 vs. GD3:22.9 ± 4.6 ng/ml; p < 0.001). Administration of 800 IU of vitamin D3 during 45 days was more effective than D2 in increasing 25OHD, but both failed to achieve adequate levels of 25OHD (= 30 ng/ml). but neither succeeded in achieving adequate levels of 25OHD (= 30 ng/ml).

Topics: Administration, Oral; Aged; Argentina; Calcium; Cholecalciferol; Dietary Supplements; Ergocalciferols; Female; Humans; Sunlight; Treatment Outcome; Vitamin D Deficiency

To assess effects of vitamin D and Calcium (Ca) on hormonal and metabolic milieu of polycystic ovary syndrome (PCOS).. Single arm open label trial.. Twelve overweight and vitamin D deficient women with PCOS underwent a 2 hour oral glucose tolerance testing at baseline and following 3-month supplementation with vitamin D (daily dose of 3533 IU, increased to 8533 IU after the first five participants) and 530 mg elemental Ca daily.. Blood pressure (BP), plasma glucose, insulin, total testosterone (T) androstenedione (A), sex hormone binding globulin, lifestyle parameters were assessed at baseline and following 3-month intervention. Insulin resistance (IR) and area under the curve for glucose and insulin were computed; paired analyses were conducted.. Improved serum 25OHD (p < 0.001) and reductions in total T (p = 0.036) and A (p = 0.090) levels were noted following 3-month supplementation, compared to baseline. Significant lowering in BP parameters was seen in participants with baseline BP ≥ 120/80 mmHg (n = 8) and in those with baseline serum 25OHD ≤20 ng/ml (n = 9). Parameters of glucose homeostasis and IR remained unchanged (p > 0.05).. Androgen and BP profiles improved followed three month intervention, suggesting therapeutic implications of vitamin D and Ca in overweight and vitamin D deficient women with PCOS.

Topics: 25-Hydroxyvitamin D 2; Adult; Body Mass Index; Calcifediol; Calcium, Dietary; Cholecalciferol; Cohort Studies; Dietary Supplements; Ergocalciferols; Female; Humans; Hyperandrogenism; Hypertension; Overweight; Patient Dropouts; Pilot Projects; Polycystic Ovary Syndrome; Testosterone Congeners; Vitamin D Deficiency; Young Adult

To compare depressive symptoms in participants with low and high serum 25-hydroxyvitamin D (25(OH)D) levels and to examine whether supplementation with vitamin D(3) would improve symptoms in those with low serum 25(OH)D levels.. Participants with low 25(OH)D levels were randomised to either placebo or 40 000 IU vitamin D(3) per week for 6 months. Individuals with high serum 25(OH)D levels were used as nested controls. Depressive symptoms were evaluated with the Beck Depression Inventory, Hospital Anxiety and Depression Scale, Seasonal Pattern Assessment Scale and Montgomery-Åsberg Depression Rating Scale. The study was registered at ClinicalTrials.gov (NCT00960232).. Participants with low 25(OH)D levels (n = 230) at baseline were more depressed (P<0.05) than participants with high 25(OH)D levels (n = 114). In the intervention study no significant effect of high-dose vitamin D was found on depressive symptom scores when compared with placebo.. Low levels of serum 25(OH)D are associated with depressive symptoms, but no effect was found with vitamin D supplementation.

Topics: Adult; Aged; Case-Control Studies; Cholecalciferol; Depressive Disorder; Dietary Supplements; Female; Humans; Male; Middle Aged; Vitamin D; Vitamin D Deficiency; Vitamins

Hypovitaminosis D is common in chronic kidney disease (CKD). Effects of 25-hydroxyvitamin D replenishment in CKD are not well described.. An 8-week randomized, placebo-controlled, double-blind parallel intervention study was conducted in haemodialysis (HD) and non-HD CKD patients. Treatment consisted of 40,000 IU of cholecalciferol orally per week. Plasma 25-hydroxyvitamin D (25-OHD), plasma 1,25-dihydroxyvitamin D (1,25-diOHD), plasma parathyroid hormone (PTH), serum phosphate, ionized serum calcium and serum fibroblast growth factor 23 (FGF-23) were analysed. We also investigated biomarkers related to cardiovascular disease (plasma D-dimer, plasma fibrinogen, plasma von Willebrand factor antigen and activity, plasma interleukin 6, plasma C-reactive protein, blood pressure, aortic augmentation index, aortic pulse wave velocity and 24-h urinary protein loss). Objective and subjective health variables were assessed (muscle function tests, visual analogue scores and Health Assessment Questionnaire).. Fifty-two CKD patients with 25-OHD <50 nmol/L at screening were included. Cholecalciferol supplementation led to a significant increase to a median of 155 nmol/L 25-OHD (interquartile range 137-173 nmol/L) in treated patients (n = 25, P < 0.001). In non-HD patients, we saw a significant increase in 1,25-diOHD (n = 13, P < 0.01) and a lowering of PTH (n = 13, P < 0.001). This was not observed in HD patients. Cholecalciferol supplementation caused a significant increase in serum calcium and FGF-23.. 25-OHD replenishment was effectively obtained with the employed cholecalciferol dosing. In non-HD patients, it had favourable effects on 1,25-diOHD and PTH. Vitamin D-supplemented patients must be monitored for hypercalcaemia. The present study could not identify significant pleiotropic effects of 25-OHD replenishment.

Topics: Aged; Biomarkers; Calcification, Physiologic; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Fibroblast Growth Factor-23; Glomerular Filtration Rate; Humans; Male; Middle Aged; Muscles; Prognosis; Renal Insufficiency, Chronic; Vitamin D Deficiency; Vitamins

Apart from its role in bone metabolism, vitamin D may also influence cardiovascular disease. The objective of this study was: (1) to determine the effect of a single, oral, high-dose vitamin D supplementation on endothelial function and arterial stiffness in patients with peripheral arterial disease (PAD) and (2) to investigate the impact of this supplementation on coagulation and inflammation parameters.. In this double-blind, placebo-controlled, interventional pilot study, we screened 76 Caucasian patients with PAD for vitamin D deficiency. Sixty-two were randomised to receive a single, oral supplementation of 100,000 IU vitamin D3 or placebo. At baseline and after 1 month, we measured serum vitamin D and parathormone levels, and surrogate parameters for cardiovascular disease.. Sixty-five of 76 patients (86%) had low 25-hydroxyvitamin D levels (<30 ng ml(-1)); of those, 62 agreed to participate in the study. At baseline, only parathormone was related to vitamin D. In supplemented patients, vitamin D levels increased from 16.3 ± 6.7 to 24.3 ± 6.2 ng ml(-1) (P < 0.001), with wide variations between single patients; in the placebo group vitamin levels did not change. Seasonal factors accounted for a decrease of vitamin D levels by 8 ng ml(-1) between summer and winter. After 1 month, none of the measured parameters was influenced by vitamin substitution.. In this pilot study, most patients with PAD were vitamin D deficient. Vitamin D supplementation increased serum 25-hydroxyvitamin D without influencing endothelial function, arterial stiffness, coagulation and inflammation parameters, although the study was underpowered for definite conclusions.

Topics: Administration, Oral; Aged; Aged, 80 and over; Biomarkers; Blood Coagulation; Cholecalciferol; Dietary Supplements; Double-Blind Method; Endothelium, Vascular; Female; Hemodynamics; Humans; Inflammation Mediators; Linear Models; Male; Middle Aged; Parathyroid Hormone; Peripheral Arterial Disease; Pilot Projects; Seasons; Switzerland; Time Factors; Treatment Outcome; Vascular Stiffness; Vitamin D; Vitamin D Deficiency

Vitamin D deficiency contributes to secondary hyperparathyroidism, which occurs early in chronic kidney disease (CKD).. We aimed to determine whether high-dose cholecalciferol supplementation for 1 y in early CKD is sufficient to maintain optimal vitamin D status (serum 25-hydroxyvitamin D [25(OH)D] concentration ≥30 ng/mL) and decrease serum parathyroid hormone (PTH). A secondary aim was to determine the effect of cholecalciferol on blood pressure and serum fibroblast growth factor-23 (FGF23).. This was a double-blind, randomized, placebo-controlled trial. Forty-six subjects with early CKD (stages 2-3) were supplemented with oral cholecalciferol (vitamin D group; 50,000 IU/wk for 12 wk followed by 50,000 IU every other week for 40 wk) or a matching placebo for 1 y.. By 12 wk, serum 25(OH)D increased in the vitamin D group only [baseline (mean ± SD): 26.7 ± 6.8 to 42.8 ± 16.9 ng/mL; P < 0.05] and remained elevated at 1 y (group-by-time interaction: P < 0.001). PTH decreased from baseline only in the vitamin D group (baseline: 89.1 ± 49.3 to 70.1 ± 24.8 pg/mL; P = 0.01) at 12 wk, but values were not significantly different from baseline at 1 y (75.4 ± 29.5 pg/mL; P = 0.16; group-by-time interaction: P = 0.09). Group differences were more pronounced in participants with secondary hyperparathyroidism (group-by-time interaction: P = 0.004). Blood pressure and FGF23 did not change in either group.. After 1 y, this oral cholecalciferol regimen was safe and sufficient to maintain serum 25(OH)D concentrations and prevent vitamin D insufficiency in early CKD. Furthermore, serum PTH improved after cholecalciferol treatment, particularly in patients who had secondary hyperparathyroidism.

Topics: Aged; Calcifediol; Cholecalciferol; Diet; Dietary Supplements; Double-Blind Method; Female; Fibroblast Growth Factor-23; Georgia; Hospitals, Veterans; Humans; Hyperparathyroidism; Hyperparathyroidism, Secondary; Intention to Treat Analysis; Male; Middle Aged; Parathyroid Hormone; Pilot Projects; Prevalence; Renal Insufficiency, Chronic; Severity of Illness Index; Vitamin D Deficiency

Low 25-hydroxy-vitamin D (25(OH)D) levels are inversely related to blood pressure (BP) and have been associated with incident hypertension. In people living at northern latitudes diminished cholecalciferol synthesis in the winter increases the risk of vitamin D deficiency. We wanted to test the hypothesis that daily cholecalciferol supplementation in the winter lowers BP in patients with hypertension.. We investigated the effect of 75 µg (3,000 IU) cholecalciferol per day in a randomized, placebo-controlled, double-blind study in 130 hypertensive patients residing in Denmark (56º N). Ambulatory BP (24-h BP) and arterial stiffness were measured before and after 20 weeks of treatment, that took place between October and March.. A total of 112 patients (mean age 61 ± 10) with a baseline p-25(OH)D of 23 ± 10 ng/ml completed the study. Compared with placebo, a nonsignificant 3/1 mm Hg (P = 0.26/0.18) reduction was found in 24-h BP. In patients with vitamin D insufficiency (<32 ng/ml) at baseline (n = 92), 24-h BP decreased by 4/3 mm Hg (P = 0.05/0.01). Central BP (CBP) estimated by applanation tonometry and calibrated with a standardized office BP was reduced by 7/2 mm Hg (P = 0.007/0.15) vs. placebo. No differences in carotid-femoral pulse wave velocity (PWV) or central augmentation index (AIx) were found between treatment arms.. Cholecalciferol supplementation, by a dose that effectively increased vitamin D levels, did not reduce 24-h BP, although central systolic BP decreased significantly. In a post-hoc subgroup analysis of 92 subjects with baseline p-25(OH)D levels <32 ng/ml, significant decreases in 24-h systolic and diastolic BP occurred during cholecalciferol supplementation.

Topics: Aged; Blood Pressure; Cholecalciferol; Denmark; Double-Blind Method; Female; Humans; Hypertension; Male; Middle Aged; Seasons; Vascular Stiffness; Vitamin D Deficiency

Vitamin D is often recommended for use with calcium supplements to increase absorption. There are no systematic studies of vitamin D on calcium absorption that indicate what dose should be recommended.. Our objective was to study the effect of increasing doses of vitamin D3 on calcium absorption.. We conducted a randomized double-blind placebo-controlled trial at Creighton University Medical Center, Omaha, NE.. Participants included 163 postmenopausal Caucasian women with vitamin D insufficiency, defined as a serum 25-hydroxyvitamin D (25OHD) below 20 ng/ml (50 nmol/liter).. Participants were randomized to receive one of the vitamin D3 doses, 400, 800, 1600, 2400, 3200, 4000, or 4800 IU/d, or placebo for 1 yr. Calcium intake was increased to 1200-1400 mg daily by giving daily calcium citrate.. We evaluated the change in calcium absorption on vitamin D.. Mean serum 25OHD increased from baseline 15.6 ng/ml (39 nmol/liter) to 46.5 ng/ml (112 nmol/liter) in subjects randomized to the highest dose of vitamin D (4800 IU). Calcium absorption was more significantly related to serum 25OHD (R2=0.50; P=0.001) than dose (R2=0.47; P=0.033). Calcium absorption of a 100-mg dose increased from 52-58% (6 mg) over a serum 25OHD range of 20-66 ng/ml (50-165 nmol/liter).. There was no evidence of a threshold for reduced calcium absorption in the serum 25OHD range of 10-66 ng/ml (25-165 nmol/liter). The increase in absorbed calcium of 6% on high doses of vitamin D is so small that the same amount could be obtained from half a glass of milk (100 ml) or 100 mg elemental calcium. The results challenge assumptions about the value of adding vitamin D to increase calcium absorption except when serum 25OHD is very low that is less than 10 ng/ml (25 nmol/liter).

Topics: Aged; Aged, 80 and over; Calcium Citrate; Cholecalciferol; Dose-Response Relationship, Drug; Double-Blind Method; Drug Interactions; Female; Follow-Up Studies; Food Additives; Humans; Intestinal Absorption; Middle Aged; Postmenopause; Treatment Outcome; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D deficiency is a common health complication in patients with chronic kidney disease and can be treated with an abundance of classical and advanced pharmaceutics. However, the impact of bundling in dialysis clinics limits the use of the most optimal therapeutics and desired efficacy targets in end-stage renal disease patients. To address this issue, we investigated the benefits of adding a cost-effective antioxidant and vitamin D nutraceutical (MV-ONE, Nephrian Inc.) to patient regiments. This nutraceutical was used in an attempt to replete vitamin D levels and decrease inflammation that dialysis patients experience. Additionally, we investigated the potential of this therapy to reduce the need for erythropoietin-stimulating agents. Results indicate MV-ONE caused: (1) increases in 25-OH vitamin D (p = 0.0058), (2) decreases in ESA dose (p = 0.0475), and (3) no change in C-reactive protein (p = 0.3290). Overall, this suggests the addition of MV-ONE does benefit the vitamin D deficiency and anemia observed in ESRD patients.

Topics: Anemia; Antioxidants; C-Reactive Protein; Cholecalciferol; Cost-Benefit Analysis; Dietary Supplements; Drug Combinations; gamma-Tocopherol; Hematinics; Humans; Kidney Failure, Chronic; Renal Dialysis; Thioctic Acid; Vitamin D; Vitamin D Deficiency; Vitamins

Guidelines in Finland recommend 10 μg of vitamin D3 daily for all infants. Recent observations suggest that this may be insufficient to maintain optimal serum 25-hydroxyvitamin D (S-25-OHD).. The aim of the study was to evaluate effects of various vitamin D doses and determine a dose ensuring S-25-OHD of at least 80 nmol/liter in infants without signs of vitamin D excess.. We conducted a randomized double-blind intervention study. Cord blood was obtained at birth for S-25-OHD; 113 infants were randomized to receive vitamin D3 10, 30, or 40 μg/d from age 2 wk to 3 months.. An investigator-initiated study was performed in a single maternity hospital in Helsinki, Finland.. S-25-OHD, calcium homeostasis, and skeletal characteristics were evaluated with peripheral quantitative computed tomography at age 3 months.. Baseline S-25-OHD was similar in all three groups (median, 53 nmol/liter). At 3 months, the mean S-25-OHD values were 88, 124, and 153 nmol/liter, and the minimum values were 46, 57, and 86 nmol/liter in the groups receiving 10, 30, and 40 μg (ANOVA; P < 0.001). No hypercalcemia occurred; plasma calcium, serum PTH, and urine calcium excretion was similar between the groups. Peripheral quantitative computed tomography showed a trend toward larger tibial total bone and cortical bone area with higher vitamin D doses.. Vitamin D3 supplementation with up to 40 μg/d from age 2 wk to 3 months was safe and caused no hypercalcemia or hypercalciuria. The 40-μg dose maintained S-25-OHD above 80 nmol/liter in all infants. More extensive and longer intervention studies are necessary to assess long-term effects.

Topics: Cholecalciferol; Dietary Supplements; Dose-Response Relationship, Drug; Double-Blind Method; Female; Fetal Blood; Finland; Humans; Infant; Infant, Newborn; Male; Treatment Outcome; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D deficiency and insufficiency occur frequently in youth with HIV infection, particularly among those receiving the antiretroviral drug efavirenz. Optimal vitamin D dosing for treatment is unclear.. Our objective was to evaluate safety and measure change in 25-hydroxyvitamin D (25-OHD) concentration from baseline to study wk 4 and 12 during treatment with vitamin D(3), 50,000 IU monthly.. We conducted a randomized double-blind, placebo-controlled multicenter trial of HIV-infected youth ages 18-24 yr, with viral load below 5000 copies/ml, on stable antiretroviral therapy.. INTERVENTION included vitamin D(3), 50,000 IU (n = 102), or matching placebo (n = 101) administered in three directly observed oral doses at monthly intervals.. At baseline, mean (sd) age was 20.9 (2.0) yr; 37% were female and 52% African-American, and 54% were vitamin D deficient/insufficient (25-OHD < 20 ng/ml), with no randomized group differences. Of evaluable participants vitamin D deficient/insufficient at baseline who were administered vitamin D, 43 of 46 (93%) had sufficient 25-OHD by wk 12. Vitamin D supplementation increased 25-OHD serum concentration from a baseline of 21.9 (13.3) to 35.9 (19.1) ng/ml at wk 12 (P < 0.001) with no change for placebo. Although use of the antiretroviral efavirenz was associated with lower baseline 25-OHD concentration, efavirenz did not diminish the response to vitamin D supplementation. There was no treatment-related toxicity.. Supplementation with vitamin D(3) 50,000 IU monthly for three doses was safe. Increases in 25-OHD occurred in treated participants regardless of antiretroviral regimen.

Topics: Adolescent; Cholecalciferol; Double-Blind Method; Female; HIV Infections; HIV-1; Humans; Male; Treatment Outcome; Vitamin D; Vitamin D Deficiency; Vitamins; Young Adult

Vitamin D concentrations are linked to body composition indices, particularly body fat mass. Relationships between hypovitaminosis D and obesity, described by both BMI and waist circumference, have been mentioned. We have investigated the effect of a 12-week vitamin D3 supplementation on anthropometric indices in healthy overweight and obese women.. In a double-blind, randomized, placebo-controlled, parallel-group trial, seventy-seven participants (age 38 ± 8.1 years, BMI 29.8 ± 4.1 kg/m²) were randomly allocated into two groups: vitamin D (25 μg per day as cholecalciferol) and placebo (25 μg per day as lactose) for 12 weeks. Body weight, height, waist, hip, fat mass, 25(OH) D, iPTH, and dietary intakes were measured before and after the intervention.. Serum 25(OH)D significantly increased in the vitamin D group compared to the placebo group (38.2 ± 32.7 nmol/L vs. 4.6 ± 14.8 nmol/L; P<0.001) and serum iPTH concentrations were decreased by vitamin D3 supplementation (-0.26 ± 0.57 pmol/L vs. 0.27 ± 0.56 pmol/L; P<0.001). Supplementation with vitamin D3 caused a statistically significant decrease in body fat mass in the vitamin D group compared to the placebo group (-2.7 ± 2.1 kg vs. -0.47 ± 2.1 kg; P<0.001). However, body weight and waist circumference did not change significantly in both groups. A significant reverse correlation between changes in serum 25(OH) D concentrations and body fat mass was observed (r = -0.319, P = 0.005).. Among healthy overweight and obese women, increasing 25(OH) D concentrations by vitamin D3 supplementation led to body fat mass reduction.

Topics: 25-Hydroxyvitamin D 2; Adiposity; Adult; Body Mass Index; Calcifediol; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Iran; Middle Aged; Obesity; Overweight; Parathyroid Hormone; Patient Compliance; Patient Dropouts; Time Factors; Vitamin D Deficiency

Systemic lupus erythematosus (SLE) is a T and B cell-dependent autoimmune disease characterized by the appearance of autoantibodies, a global regulatory T cells (Tregs) depletion and an increase in Th17 cells. Recent studies have shown the multifaceted immunomodulatory effects of vitamin D, notably the expansion of Tregs and the decrease of Th1 and Th17 cells. A significant correlation between higher disease activity and lower serum 25-hydroxyvitamin D levels [25(OH)D] was also shown.. In this prospective study, we evaluated the safety and the immunological effects of vitamin D supplementation (100,000 IU of cholecalciferol per week for 4 weeks, followed by 100,000 IU of cholecalciferol per month for 6 months.) in 20 SLE patients with hypovitaminosis D.. Serum 25(OH)D levels dramatically increased under vitamin D supplementation from 18.7±6.7 at day 0 to 51.4±14.1 (p<0.001) at 2 months and 41.5±10.1 ng/mL (p<0.001) at 6 months. Vitamin D was well tolerated and induced a preferential increase of naïve CD4+ T cells, an increase of regulatory T cells and a decrease of effector Th1 and Th17 cells. Vitamin D also induced a decrease of memory B cells and anti-DNA antibodies. No modification of the prednisone dosage or initiation of new immunosuppressant agents was needed in all patients. We did not observe SLE flare during the 6 months follow-up period.. This preliminary study suggests the beneficial role of vitamin D in SLE patients and needs to be confirmed in randomized controlled trials.

Topics: Adult; Antibodies, Anti-Idiotypic; B-Lymphocytes; Cholecalciferol; Comorbidity; Dietary Supplements; DNA; Dose-Response Relationship, Drug; Female; Follow-Up Studies; Homeostasis; Humans; Longitudinal Studies; Lupus Erythematosus, Systemic; Prospective Studies; T-Lymphocytes; T-Lymphocytes, Regulatory; Th1 Cells; Th17 Cells; Vitamin D; Vitamin D Deficiency

Vitamin D(3) has been called the "sunshine" vitamin since the formation of vitamin D is mediated by exposure to sunlight. Vitamin D(3) is linked to many health benefits, however serum levels of vitamin D(3) have been decreasing over the last few decades and the lower levels of vitamin D(3) may have consequences on normal physiology. We investigated the association between serum 25-hydroxyvitamin D (25(OH)D) levels and stratum corneum conductance as well as the effect of topical application of cholecalciferol (vitamin D(3)) on dry skin. Eighty three subjects were recruited and blood serum levels and skin conductance measurements were taken after a one week washout. A correlation was observed between vitamin D levels and skin moisture content, individuals with lower levels of vitamin D had lower average skin moisture. Subsequently, a 3-week split leg, randomized, vehicle controlled clinical study was conducted on a subset of 61 of the above individuals who were identified with non-sufficient vitamin D serum levels. Topical supplementation with cholecalciferol significantly increased measurements of skin moisturization and resulted in improvements in subjective clinical grading of dry skin. Taken together our finding suggest a relationship between serum vitamin D(3) (25(OH)D) levels and hydration of the stratum corneum and further demonstrate the skin moisture benefit from topical application of vitamin D(3).

Topics: Adolescent; Adult; Black or African American; Cholecalciferol; Dietary Supplements; Epidermis; Female; Humans; Middle Aged; Skin; Skin Diseases; Sunlight; Vitamin D Deficiency; White People; Young Adult

Vitamin D deficiency is highly prevalent in obese children, and obese children tend to respond poorly to vitamin D supplementation. The objective of the study was to compare the response to vitamin D(3) supplementation (2,000 IU once daily for 12 weeks) between obese and non-obese Caucasian adolescents.. The study design was open label non-randomized. It was carried out at a single center. Eighteen obese adolescents (aged 12-18 years) and the same number of age-, gender- and season-matched non-obese adolescents received vitamin D(3) (2,000 IU/day) orally for 12 weeks. Total serum 25-hydroxyvitamin D [25(OH)D], parathyroid hormone, calcium and phosphorus were measured at baseline and at the end of the 12-week period.. The mean baseline 25(OH)D level was higher in the non-obese compared to the obese subjects (mean 28.9 vs. 25.2 ng/ml; p = 0.029). The increment in 25(OH)D levels following vitamin D supplementation was significantly lower in the obese adolescents (mean change 5.8 vs. 9.8 ng/ml; p = 0.019).. Higher doses of vitamin D are required to treat vitamin D deficiency in obese adolescents compared to their non-obese peers.

Topics: Adolescent; Body Mass Index; Child; Cholecalciferol; Dietary Supplements; Female; Humans; Ideal Body Weight; Male; Medication Adherence; Obesity; Prevalence; Seasons; Vitamin D Deficiency; White People

Improvements in antenatal vitamin D status may have maternal-infant health benefits. To inform the design of prenatal vitamin D3 trials, we conducted a pharmacokinetic study of single-dose vitamin D3 supplementation in women of reproductive age.. A single oral vitamin D3 dose (70,000 IU) was administered to 34 non-pregnant and 27 pregnant women (27 to 30 weeks gestation) enrolled in Dhaka, Bangladesh (23°N). The primary pharmacokinetic outcome measure was the change in serum 25-hydroxyvitamin D concentration over time, estimated using model-independent pharmacokinetic parameters.. Baseline mean serum 25-hydroxyvitamin D concentration was 54 nmol/L (95% CI 47, 62) in non-pregnant participants and 39 nmol/L (95% CI 34, 45) in pregnant women. Mean peak rise in serum 25-hydroxyvitamin D concentration above baseline was similar in non-pregnant and pregnant women (28 nmol/L and 32 nmol/L, respectively). However, the rate of rise was slightly slower in pregnant women (i.e., lower 25-hydroxyvitamin D on day 2 and higher 25-hydroxyvitamin D on day 21 versus non-pregnant participants). Overall, average 25-hydroxyvitamin D concentration was 19 nmol/L above baseline during the first month. Supplementation did not induce hypercalcemia, and there were no supplement-related adverse events.. The response to a single 70,000 IU dose of vitamin D3 was similar in pregnant and non-pregnant women in Dhaka and consistent with previous studies in non-pregnant adults. These preliminary data support the further investigation of antenatal vitamin D3 regimens involving doses of ≤70,000 IU in regions where maternal-infant vitamin D deficiency is common.

Topics: Adolescent; Adult; Bangladesh; Calcium; Cholecalciferol; Creatinine; Dietary Supplements; Dose-Response Relationship, Drug; Female; Follow-Up Studies; Humans; Hypercalcemia; Pregnancy; Serum Albumin; Specimen Handling; Treatment Outcome; Vitamin D Deficiency; Young Adult

We recorded the manifestations of severe vitamin D deficiency (VDD) in 40 adolescents before and 3 and 6 months after treatment with a mega dose of cholecalciferol (10 000 IU kg(-1), max 600 000 IU). Significant improvement of symptoms related to VDD was reported in 34/40. Three months after the injection, serus calcium, phosphate, alkaline phosphatase and parathormone were normal in all adolescents with VDD with 25-hydroxyvitamin D (25OHD) level = or >20 ng ml(-1). After 6 months, the majority had 25OHD level <20 ng ml(-1). Two patterns of radiological changes have been recorded with complete healing achieved in all patients after a year of therapy. A mega dose of cholecalciferol is an effective therapy for treatment of VDD in adolescents for 3 months but not for 6 months. Radiographs of the ends of long bones are still valuable tool for diagnosis and follow-up of these patients.

Topics: Adolescent; Alkaline Phosphatase; Arthralgia; Back Pain; Biomarkers; Bone Density Conservation Agents; Calcium; Cholecalciferol; Female; Humans; Injections, Intramuscular; Knee; Male; Muscle Weakness; Parathyroid Hormone; Phosphorus; Prospective Studies; Qatar; Radiography; Risk Assessment; Risk Factors; Severity of Illness Index; Treatment Outcome; Vitamin D Deficiency; Walking; Wrist

Vitamin D insufficiency is a risk for both skeletal and nonskeletal health. However, some ambiguity remains about threshold serum 25(OH)D for vitamin D insufficiency. To determine the threshold serum 25(OH)D to maintain normal calcium availability without elevation in serum parathyroid hormone (PTH) among Japanese subjects with various calcium intakes, we conducted a multicenter prospective open-labeled study. We recruited 107 ambulatory subjects without disorders affecting vitamin D metabolism to whom oral vitamin D₃ 800 IU/day for 4 weeks or 1,200 IU/day for 8 weeks was given. Serum 25(OH)D, PTH, calcium, phosphate, and magnesium were measured before and after vitamin D₃ supplementation. Calcium intake was assessed by questionnaires. When all the data were combined, serum 25(OH)D was negatively correlated with PTH. The cubic spline curve between serum 25(OH)D and PTH indicated PTH reached its plateau between 35 and 40 pg/ml at 25(OH)D between 25 and 30 ng/ml. Vitamin D₃ supplementation increased serum 25(OH)D and decreased PTH. Change in PTH correlated positively with baseline serum 25(OH)D. From the regression analyses, baseline serum 25(OH)D above 28 ng/ml corresponded to the threshold level without reduction in PTH after vitamin D₃ supplementation. In multivariate regression analyses, age but not calcium intake was a significant determinant of PTH. We concluded that a serum 25(OH)D level of 28 ng/ml was identified as a threshold for vitamin D insufficiency necessary to stabilize PTH to optimal levels.

Topics: Adult; Aged; Aged, 80 and over; Cholecalciferol; Female; Humans; Male; Middle Aged; Osteoporosis; Parathyroid Hormone; Prospective Studies; Vitamin D; Vitamin D Deficiency

Low habitual dietary calcium intake and vitamin D deficiency are common among Indian children. Using 'laddoo', an Indian snack, as a vehicle for administering calcium and vitamin D supplements, a randomized double-blind controlled trial was conducted for 12 months to assess its efficacy on total body less head (TBLH) bone mineral content (BMC) in underprivileged toddlers.. A total of 60 toddlers (mean age 2.7±0.52 years, boys=31) were randomized to two groups, (i) study group receiving one calcium fortified laddoo (cereal-legume snack) containing 405 mg calcium per day and (ii) control receiving a non-fortified laddoo, containing 156 mg of indigenous calcium. Both groups also received a laddoo fortified with 30,000 IU of vitamin D(3) per month. Outcome measures included TBLH bone area (BA) and TBLH BMC by GE-Lunar DPX Pro Pencil Beam Dual-Energy X-ray absorptiometry.. At baseline, mean energy, protein and calcium intakes were 71, 72 and 47% of Indian Recommended Dietary allowances. In all, 87 and 83% toddlers were hypocalcaemia and vitamin D deficient, respectively. Mean TBLH BMC was 289.5±45.8 g. Post supplementation, mean TBLH BMC of study group showed a significantly greater (P<0.01) increase of 35% as against 28% in controls and the difference remained significant after adjusting for vitamin D status, calcium intake, height and TBLH BA.. Daily supplementation with calcium fortified laddoo, and monthly vitamin D supplement resulted in a significant increase in TBLH BMC of underprivileged toddlers. We believe that such strategies have the potential of addressing nutritional problems in developing countries.

Topics: Absorptiometry, Photon; Administration, Oral; Bone Density; Calcium; Child, Preschool; Cholecalciferol; Cities; Developing Countries; Diet; Double-Blind Method; Female; Food, Fortified; Humans; India; Male; Pilot Projects; Poverty; Vitamin D Deficiency

Epidemiological studies have shown that low vitamin D status results in impaired immune function and is associated with the prevalence of autoimmune and inflammatory conditions. Vitamin D supplementation has been shown to reduce circulating concentrations of inflammatory markers in such conditions. However, the possible beneficial effect of vitamin D supplementation in the general population, particularly for those individuals living at high latitudes where hypovitaminosis D is common during wintertime, remains unclear. The aim of this study was to assess the effect of vitamin D supplementation using doses of 5, 10, and 15 μg/d cholecalciferol (D3) compared with placebo on cytokine concentrations throughout winter in apparently healthy younger (aged 20-40 y) and older (aged ≥64 y) adults. A total of 211 younger and 202 older adults completed the 22-wk intervention (from October to March) with >85% compliance. Serum concentrations of 25-hydroxycholecalciferol [25(OH)D3], high sensitivity C-reactive protein, IL-6, IL-10, soluble CD40 ligand, TGFβ, TNFα, and fibrinogen were measured using ELISA. 25(OH)D3 concentrations significantly decreased in the placebo and 5 and 10/d μg D3 groups in the younger cohort and in the placebo group in the older cohort. Whereas 15 μg/d D3 supplementation maintained 25(OH)D3 concentrations in the younger cohort (baseline, 75.9 nmol/L; postintervention, 69.0 nmol/L) and significantly increased concentrations in the older cohort (baseline, 55.1 nmol/L; postintervention, 73.9 nmol/L), it had no significant effect on cytokine concentrations (ANCOVA, P > 0.05). The long-term effects of low vitamin D status remain to be elucidated and optimization of vitamin D status in otherwise healthy individuals may potentially have lasting beneficial effects on the immune system.

Topics: Acute-Phase Proteins; Adult; Aged; Aged, 80 and over; Aging; Biomarkers; Calcifediol; Cholecalciferol; Cohort Studies; Cytokines; Dietary Supplements; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Male; Medication Adherence; Middle Aged; Nutritional Status; Seasons; Vitamin D Deficiency; Young Adult

Knowledge gaps have contributed to considerable variation (between 0 and 15 μg/d) in international dietary recommendations for vitamin D in adolescents.. We aimed to establish the distribution of dietary vitamin D required to maintain serum 25-hydroxyvitamin D [25(OH)D] concentrations above several proposed cutoffs (25, 37.5, 40, and 50 nmol/L) during wintertime in adolescent white girls.. Data (baseline and 6 mo) from 2 randomized, placebo-controlled, double-blind, 12-mo intervention studies in Danish (55°N) and Finnish (60°N) girls (n = 144; mean age: 11.3 y; mean vitamin D intake: 3.7 μg/d) at vitamin D(3) supplementation amounts of 0, 5, and 10 μg/d were used. Serum 25(OH)D was measured with an HPLC assay in a centralized laboratory.. Clear dose-related increments (P < 0.0001) in serum 25(OH)D with increasing supplemental vitamin D(3) were observed. The slope of the relation between vitamin D intake and serum 25(OH)D at the end of winter was 2.43 nmol ⋅ L(-1) ⋅ μg intake(-1), and no difference in the slopes between Finnish and Danish girls was observed. The vitamin D intakes that maintained serum 25(OH)D concentrations at >25, >37.5, and >50 nmol/L in 97.5% of the sample were 8.3, 13.5, and 18.6 μg/d, respectively, whereas an intake of 6.3 μg/d maintained a serum 25(OH)D concentration >40 nmol/L in 50% of the sample.. The vitamin D intakes required to ensure that adequate vitamin D status [defined variably as serum 25(OH)D >25 and >50 nmol/L] is maintained during winter in the vast majority (>97.5%) of adolescent girls (mean age: 11.3 y) at northern latitudes (>55°N) are 8.3 and 18.6 μg/d, respectively. This trial was registered at clinicaltrials.gov as NCT00267540.

Topics: Adolescent; Calcifediol; Child; Cholecalciferol; Denmark; Diet; Dietary Supplements; Double-Blind Method; Female; Finland; Humans; Models, Biological; Nutrition Policy; Nutritional Requirements; Nutritional Status; Seasons; Surveys and Questionnaires; Vitamin D Deficiency; White People

To determine the prevalence of hypovitaminosis D (serum 25-hydroxyvitamin D<32 ng/mL; HVD) in a population of elderly veterans and conduct a preliminary assessment of the efficacy of supplementation with cholecalciferol in correcting HVD.. Randomized, double-blind, placebo-controlled clinical trial.. Geriatric clinic at the Bruce W. Carter Veterans Affairs Medical Center, Miami, Florida.. Veterans aged 70 and older.. Oral cholecalciferol 2,000 IU daily or placebo for 6 months.. Serum calcium, 25-hydroxyvitamin D, parathyroid hormone, and 24-hour urinary calcium.. Of the 34 participants who completed the study, 62% had HVD at baseline. In the treatment group, mean serum 25-hydroxyvitamin D level rose from 28.4±7.9 ng/mL at baseline to 42.7±10.5 ng/mL at the end of the trial, but levels remained less than 32 ng/mL in three of 17 (18%) of the participants. In the placebo group, the baseline level of 27.7±8.3 ng/mL remained unchanged (28.8±8.7 ng/mL). Supplementation did not alter serum or urinary calcium levels and did not result in any adverse events.. These initial observations suggest that, in older veterans, cholecalciferol 2,000 IU daily for 6 months is generally safe and corrects HVD in most but not all individuals.

Topics: Administration, Oral; Aged; Calcium; Cholecalciferol; Dietary Supplements; Dose-Response Relationship, Drug; Double-Blind Method; Female; Florida; Follow-Up Studies; Humans; Male; Parathyroid Hormone; Pilot Projects; Prevalence; Treatment Outcome; Veterans; Vitamin D; Vitamin D Deficiency; Vitamins

A growing body of evidence has linked vitamin D deficiency to increased risk of cardiovascular disease. Vitamin D deficiency is also more common in African Americans for whom an increased cardiovascular disease risk exists. This study sought to test the hypothesis that 16 weeks of 60,000 IU monthly supplementation of oral vitamin D(3) would improve flow-mediated dilation (FMD) in African Americans, whereas no change would be observed in the placebo group.. A randomized, double-blind, placebo-controlled clinical trial was conducted. Fifty-seven African-American adults were randomly assigned to either the placebo group or vitamin D group.. Following 16 weeks of placebo (n = 23; mean age 31 ± 2 years) or 60,000 IU monthly oral vitamin D(3) (n = 22; mean age 29 ± 2 years), serum concentrations of 25-hydroxyvitamin D (25(OH)D) increased from 38.2 ± 3.0 to 48.7 ± 3.2 nmol/l and 34.3 ± 2.2 to 100.9 ± 6.6 nmol/l, respectively. No changes in serum parathyroid hormone (PTH), serum calcium, or urine calcium/creatinine were observed following either treatment. Following 16 weeks of treatment, significant improvements in FMD were only observed in the vitamin D group (1.8 ± 1.3%), whereas the placebo group had no change (-1.3 ± 0.6%). Similarly, the vitamin D group exhibited an increase in absolute change in diameter (0.005 ± 0.004 cm) and FMD/shear (0.08 ± 0.04 %/s(-1), area under the curve (AUC) × 10(3)) following treatment, whereas no change (-0.005 ± 0.002 cm and -0.02 ± 0.02 %/s(-1), AUC, respectively) was observed following placebo.. Supplementation of 60,000 IU monthly oral vitamin D(3) (~2,000 IU/day) for 16 weeks is effective at improving vascular endothelial function in African-American adults.

Topics: Adult; Black or African American; Cholecalciferol; Dietary Supplements; Double-Blind Method; Endothelium, Vascular; Female; Humans; Male; Overweight; Vasodilation; Vitamin D; Vitamin D Deficiency

Vitamin D deficiency is encountered frequently in critically ill patients and might be harmful. Current nutrition guidelines recommend very low vitamin D doses. The objective of this trial was to evaluate the safety and efficacy of a single oral high-dose vitamin D3 supplementation in an intensive care setting over a one-week observation period.. This was a randomized, double-blind, placebo-controlled pilot study in a medical ICU at a tertiary care university center in Graz, Austria. Twenty-five patients (mean age 62 ± 16 yrs) with vitamin D deficiency [25-hydroxyvitamin D (25(OH)D) ≤ 20 ng/ml] and an expected stay in the ICU >48 hours were included and randomly received either 540,000 IU (corresponding to 13.5 mg) of cholecalciferol (VITD) dissolved in 45 ml herbal oil or matched placebo (PBO) orally or via feeding tube.. The mean serum 25(OH)D increase in the intervention group was 25 ng/ml (range 1-47 ng/ml). The highest 25(OH)D level reached was 64 ng/ml, while two patients showed a small (7 ng/ml) or no response (1 ng/ml). Hypercalcemia or hypercalciuria did not occur in any patient. From day 0 to day 7, total serum calcium levels increased by 0.10 (PBO) and 0.15 mmol/L (VITD; P < 0.05 for both), while ionized calcium levels increased by 0.11 (PBO) and 0.05 mmol/L (VITD; P < 0.05 for both). Parathyroid hormone levels decreased by 19 and 28 pg/ml (PBO and VITD, ns) over the seven days, while 1,25(OH)D showed a transient significant increase in the VITD group only.. This pilot study shows that a single oral ultra-high dose of cholecalciferol corrects vitamin D deficiency within 2 days in most patients without causing adverse effects like hypercalcemia or hypercalciuria. Further research is needed to confirm our results and establish whether vitamin D supplementation can affect the clinical outcome of vitamin D deficient critically ill patients. EUDRACT NUMBER: 2009-012080-34 GERMAN CLINICAL TRIALS REGISTER (DRKS): DRKS00000750.

Topics: Administration, Oral; Aged; Cholecalciferol; Critical Care; Critical Illness; Dietary Supplements; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Male; Middle Aged; Pilot Projects; Time Factors; Treatment Outcome; Vitamin D Deficiency; Vitamins

Vitamin D insufficiency is common in patients with osteoporosis. We conducted a randomized trial comparing alendronate 70 mg combined with vitamin D(3) 5,600 IU in a single tablet (ALN/D5600, n = 257) with standard care chosen by the patients' personal physicians (n = 258) in patients with postmenopausal osteoporosis (BMD T score ≤2.5 or ≤1.5 and a prior fragility fracture) who had vitamin D insufficiency (serum 25[OH]D values 8-20 ng/ml) and who were at risk of falls. Virtually all patients randomized to standard care received bisphosphonate therapy, and in approximately 70% of cases this was combined with vitamin D supplements. However, only 24% took ≥800 IU/day of supplemental vitamin D. At 6 months the proportion of patients with vitamin D insufficiency was 8.6% in the ALN/D5600 group compared with 31.0% in the standard care group (P < 0.001). Those in the ALN/D5600 group also had a greater reduction in urinary NTX/creatinine ratio (-57% vs. -46%, P < 0.001) and bone-specific alkaline phosphatase (-47% vs. -40%, P < 0.001). In the ALN/5600 group, by 12 months the increase in BMD was greater at the lumbar spine (4.9% vs. 3.9%, P = 0.047) and the total hip (2.2% vs. 1.4%, P = 0.035), significantly fewer patients were vitamin D-insufficient (11.3% vs. 36.9%, P < 0.001), and bone turnover marker (BTM) results were similar to those at 6 months. There was no difference between groups in those who experienced falls or fractures, and adverse events were similar. Based on the finding that ALN/D5600 was more effective than standard care at correcting vitamin D insufficiency, increasing BMD, and reducing BTMs in this patient group, greater attention needs to be directed toward optimizing the treatment of osteoporosis and correcting vitamin D deficiency in postmenopausal women.

Topics: Accidental Falls; Aged; Aged, 80 and over; Alendronate; Algorithms; Bone Density; Bone Density Conservation Agents; Cholecalciferol; Diphosphonates; Drug Combinations; Female; Humans; Osteoporosis, Postmenopausal; Postmenopause; Standard of Care; Vitamin D Deficiency

Epidemiological evidence supports a relationship between vitamin D and mental well-being, although evidence from large-scale placebo-controlled intervention trials is lacking.. To examine if vitamin D supplementation has a beneficial effect on mood in community-dwelling older women; if a single annual large dose of vitamin D has a role in the prevention of depressive symptoms; and if there is an association between serum 25-hydroxyvitamin D levels and mental health.. A double-blind, randomised, placebo-controlled trial of women aged 70 or older (the Vital D Study: ISRCTN83409867 and ACTR12605000658617). Participants were randomly assigned to receive 500 000 IU vitamin D(3) (cholecalciferol) orally or placebo every autumn/winter for 3-5 consecutive years. The tools utilised at various time points were the General Health Questionnaire, the 12-item Short Form Health Survey, the Patient Global Impression-Improvement scale and the WHO Well-Being Index. Serum 25-hydroxyvitamin D levels were measured in a subset of 102 participants.. In this non-clinical population, no significant differences between the vitamin D and placebo groups were detected in any of the measured outcomes of mental health. Serum 25-hydroxyvitamin D levels in the vitamin D group were 41% higher than the placebo group 12 months following their annual dose. Despite this difference, scores from the questionnaires did not differ. Furthermore, there was no interaction between those on antidepressant/anxiety medication at baseline and the treatment groups.. The lack of improvement in indices of mental well-being in the vitamin D group does not support the hypothesis that an annual high dose of vitamin D(3) is a practical intervention to prevent depressive symptoms in older community-dwelling women.

Topics: Aged; Aged, 80 and over; Anxiety; Cholecalciferol; Data Interpretation, Statistical; Depression; Double-Blind Method; Female; Fractures, Bone; Health Status; Humans; Intention to Treat Analysis; Mental Health; Middle Aged; Osteoporosis; Outcome Assessment, Health Care; Placebos; Risk Factors; Time Factors; Vitamin D; Vitamin D Deficiency; Vitamins

Lack of adherence with vitamin D supplementation is still a risk factor for rickets. In a randomized cross-over design, infants received 400 IU cholecalciferol by dropper (1 mL syrup) or filmstrip. Infant and parent preference scores and adherence were then compared. Forty-three parents of healthy infants preferred the filmstrip (85.4% of parents; 95% confidence interval of 70.1%-93.9%; p < 0.001), a result that was corroborated by higher infant and parental scores and compliance. Ease of administration of supplements with improved acceptance may improve adherence.

Topics: Administration, Oral; Cholecalciferol; Cross-Over Studies; Dietary Supplements; Dosage Forms; Humans; Infant, Newborn; Patient Compliance; Vitamin D Deficiency

Women with polycystic ovary syndrome (PCOS) frequently suffer from metabolic disturbances, in particular from insulin resistance. Accumulating evidence suggests that vitamin D deficiency may contribute to the development of insulin resistance. Hence, we aimed to examine the effect of vitamin D supplementation on metabolic and endocrine parameters in PCOS women.. Fifty-seven PCOS women were included in the study. PCOS women received 20,000 IU cholecalciferol weekly for 24 weeks. Anthropometric measures, oral glucose tolerance test, and blood analyses of endocrine parameters were performed at baseline and after 12 weeks (V2) and 24 weeks (V3).. Forty-six PCOS women finished the study. 25-hydroxyvitamin D [25(OH)D] levels significantly increased from 28.0±11.0 ng/ml at baseline to 51.3±17.3 and 52.4±21.5 at V2 and V3, respectively (p<0.001). We observed a significant decrease of fasting and stimulated glucose (V3, p<0.05) and C-peptide levels (V2 and 3, p<0.001) after vitamin D treatment. Moreover, triglyceride and estradiol levels significantly decreased at V3 (p=0.001) and V2 (p=0.022), respectively, whereas total cholesterol (V2, p=0.008) and LDL cholesterol levels (V2, p=0.005; V3, p=0.026) significantly increased after vitamin D treatment. There were no changes in androgens. At V2, 14 out of 46 PCOS women previously affected by menstrual disturbances (30.4%) reported improvement of menstrual frequency; at V3, 23 out of 46 women (50.0%), who were oligo- or amenorrheic at baseline reported improvement.. Our results suggest that vitamin D treatment might improve glucose metabolism and menstrual frequency in PCOS women. Further randomized controlled trails are warranted to confirm our findings.

Topics: Administration, Oral; Adolescent; Adult; Blood Glucose; C-Peptide; Cholecalciferol; Cholesterol; Cholesterol, LDL; Female; Humans; Menstruation; Menstruation Disturbances; Pilot Projects; Polycystic Ovary Syndrome; Prospective Studies; Vitamin D Deficiency

Recent studies have demonstrated the immunomodulatory properties of vitamin D, and vitamin D deficiency may be a risk factor for the development of MS. The risk of developing MS has, in fact, been associated with rising latitudes, past exposure to sun and serum vitamin D status. Serum 25-hydroxyvitamin D [25(OH)D] levels have also been associated with relapses and disability progression. The identification of risk factors, such as vitamin D deficiency, in MS may provide an opportunity to improve current treatment strategies, through combination therapy with established MS treatments. Accordingly, vitamin D may play a role in MS therapy. Small clinical studies of vitamin D supplementation in patients with MS have reported positive immunomodulatory effects, reduced relapse rates and a reduction in the number of gadolinium-enhancing lesions. However, large randomized clinical trials of vitamin D supplementation in patients with MS are lacking. SOLAR (Supplementation of VigantOL(®) oil versus placebo as Add-on in patients with relapsing-remitting multiple sclerosis receiving Rebif(®) treatment) is a 96-week, three-arm, multicenter, double-blind, randomized, placebo-controlled, Phase II trial (NCT01285401). SOLAR will evaluate the efficacy of vitamin D(3) as add-on therapy to subcutaneous interferon beta-1a in patients with RRMS. Recruitment began in February 2011 and is aimed to take place over 1 calendar year due to the potential influence of seasonal differences in 25(OH)D levels.

Topics: Adolescent; Adult; Cholecalciferol; Dietary Supplements; Double-Blind Method; Drug Synergism; Female; Humans; Interferon beta-1a; Interferon-beta; Male; Middle Aged; Multiple Sclerosis, Relapsing-Remitting; Vitamin D Deficiency; Young Adult

There remains uncertainty regarding the appropriate therapeutic management of hip fracture patients. The primary aim of our study was to examine whether large loading doses in addition to daily vitamin D offered any advantage over a simple daily low-dose vitamin D regimen for increasing vitamin D levels.. In this randomized controlled study, patients over age 50 with an acute fragility hip fracture were enrolled from two hospital sites in Ontario, Canada. Participants were randomized to one of three loading dose groups: placebo; 50,000 IU vitamin D2; or 100,000 IU D2. Following a placebo/loading dose, all patients received a daily tablet of 1,000 IU vitamin D3 for 90 days. Serum 25-hydroxy vitamin D (25-OHD) was measured at baseline, discharge from acute care (approximately 4-weeks), and 3-months.. Sixty-five patients were enrolled in the study (44% male). An immediate rise in 25-OHD occurred in the 100,000 group, however there were no significant differences in 25-OHD between the placebo, 50,000 and 100,000 loading dose groups after 4-weeks (69.3, 84.5, 75.6 nmol/L, p = 0.15) and 3-months (86.7, 84.2, 73.3 nmol/L, p = 0.09), respectively. At the end of the study, approximately 75% of the placebo and 50,000 groups had reached the target therapeutic range (75 nmol/L), and 44% of the 100,000 group.. In correcting vitamin D insufficiency/deficiency in elderly patients with hip fracture, our findings suggest that starting with a lower daily dose of Vitamin D3 achieved similar results as providing an additional large loading dose of Vitamin D2. At the end of the study, all three groups were equally effective in attaining improvement in 25-OHD levels. Given that a daily dose of 1,000 IU vitamin D3 (with or without a loading dose) resulted in at least 25% of patients having suboptimal vitamin D status, patients with acute hip fracture may benefit from a higher daily dose of vitamin D.. Clinical Trials # NCT00424619.

Topics: Acute Disease; Aged; Aged, 80 and over; Analysis of Variance; Biomarkers; Chi-Square Distribution; Cholecalciferol; Dietary Supplements; Double-Blind Method; Ergocalciferols; Female; Hip Fractures; Humans; Male; Medication Adherence; Ontario; Time Factors; Treatment Outcome; Vitamin D; Vitamin D Deficiency

Although Vitamin D is best known as a modulator of calcium homeostasis, it also has immune modulating potential. A protective effect of Vitamin D on Multiple Sclerosis (MS) is supported by the reduced risk associated with sun exposure and use of Vitamin D supplements. Moreover, high circulating levels of Vitamin D have been associated with lower risk of MS. To gain more insight into putative regulatory mechanisms of Vitamin D in MS pathogenesis, we studied 132 Hispanic patients with clinically definite MS, 58 with relapsing remitting MS (RR MS) during remission, 34 RR MS patients during relapse, and 40 primary progressive MS cases (PP MS). Sixty healthy individuals matched with respect to place of residence, race/ethnicity, age and gender served as controls. Levels of 25(OH) Vitamin D and 1,25(OH)(2) Vitamin D, measured by ELISA were significantly lower in RR MS patients than in controls. In addition, levels in patients suffering relapses were lower than during remissions. By contrast, PP MS patients showed similar values to controls. Proliferation of both freshly isolated CD4+ T cells and MBP-specific T cells was significantly inhibited by 1,25(OH)(2) Vitamin D. Moreover, activated Vitamin D enhanced the development of IL-10 producing cells, and reduced the number of IL-6 and IL-17 secreting cells. Notably, VDR expression was induced by 1,25(OH)(2) Vitamin D in both activated and resting cells. Interestingly, T cells were able to metabolize 25(OH) Vitamin D into biologically active 1,25(OH)(2) Vitamin D, since T cells express 1α-hydroxylase constitutively. Finally, 1,25(OH)(2) Vitamin D also increased the expression and biological activity of IDO, triggering significant increase in the number of CD4+CD25+ T regulatory cells. Collectively, these findings suggest that 1,25(OH)(2) VitaminD plays an important role in T cell homeostasis during the course of MS, suggesting correction of its deficiency may be useful during treatment of the disease.

Topics: Adult; Cholecalciferol; Cohort Studies; Comorbidity; Female; Homeostasis; Humans; Immunomodulation; Male; Middle Aged; Multiple Sclerosis, Chronic Progressive; Multiple Sclerosis, Relapsing-Remitting; Primary Cell Culture; T-Lymphocyte Subsets; Vitamin D Deficiency

Patients with chronic pancreatitis (CP) often develop fat malabsorption and are susceptible to hypovitaminosis D.. We wanted to evaluate the intestinal uptake of cholecalciferol in patients with CP and fat malabsorption.. We did a prospective placebo-controlled study including patients with verified CP and fat malabsorption. They were randomized to 10 weeks of (A) ultraviolet radiation B (UVB) 6 min weekly in a commercial tanning bed, (B) vitamin D supplement 1,520 IU/daily, or (C) placebo. The vitamin D metabolites 25-hydroxyvitamin D (25OHD) and 1,25-dihydroxyvitamin D (calcitriol) were quantified at the start and end of the study.. In total 30 patients were randomized and 27 completed the study. Compliance to tablets and tanning sessions was >80%. The changes in 25OHD levels in group B (32.3 nmol/l; 95% CI 15-50) were significantly greater than changes in group A (p < 0.001) and group C (p < 0.001). Changes in group A (1.1 nmol/l) did not differ from the placebo group (p = 0.9). Changes in calcitriol levels were identical between groups.. Daily vitamin D supplements increased 25OHD in patients with CP compared to placebo whereas weekly tanning bed sessions did not.

Topics: Administration, Oral; Adult; Aged; Cholecalciferol; Dietary Fats; Exocrine Pancreatic Insufficiency; Female; Humans; Intestinal Absorption; Male; Middle Aged; Pancreatitis, Chronic; Patient Compliance; Radiotherapy; Sunbathing; Ultraviolet Rays; Ultraviolet Therapy; Vitamin D Deficiency; Vitamins

Vitamin D deficiency is associated with an unfavorable metabolic profile in observational studies. The intention was to compare insulin sensitivity (the primary end point) and secretion and lipids in subjects with low and high serum 25(OH)D (25-hydroxyvitamin D) levels and to assess the effect of vitamin D supplementation on the same outcomes among the participants with low serum 25(OH)D levels.. Participants were recruited from a population-based study (the Tromsø Study) based on their serum 25(OH)D measurements. A 3-h hyperglycemic clamp was performed, and the participants with low serum 25(OH)D levels were thereafter randomized to receive capsules of 20,000 IU vitamin D(3) or identical-looking placebo twice weekly for 6 months. A final hyperglycemic clamp was then performed.. The 52 participants with high serum 25(OH)D levels (85.6 ± 13.5 nmol/L [mean ± SD]) had significantly higher insulin sensitivity index (ISI) and lower HbA(1c) and triglycerides (TGs) than the 108 participants with low serum 25(OH)D (40.3 ± 12.8 nmol/L), but the differences in ISI and TGs were not significant after adjustments. After supplementation, serum 25(OH)D was 142.7 ± 25.7 and 42.9 ± 17.3 nmol/L in 49 of 51 completing participants randomized to vitamin D and 45 of 53 randomized to placebo, respectively. At the end of the study, there were no statistically significant differences in the outcome variables between the two groups.. Vitamin D supplementation to apparently healthy subjects with insufficient serum 25(OH)D levels does not improve insulin sensitivity or secretion or serum lipid profile.

Topics: Adult; Aged; Calcifediol; Capsules; Carbohydrate Metabolism, Inborn Errors; Case-Control Studies; Cholecalciferol; Dietary Supplements; Female; Glucose Clamp Technique; Glycated Hemoglobin; Glycerol Kinase; Humans; Hyperglycemia; Hypoadrenocorticism, Familial; Insulin; Insulin Resistance; Insulin Secretion; Lipids; Male; Middle Aged; Triglycerides; Vitamin D Deficiency

In most developed countries overt vitamin D deficiency, characterized by rickets or osteomalacia, is now uncommon. However, subclinical vitamin D insufficiency is extremely common and may contribute to the development of skeletal and non-skeletal problems. Standard practice involves supplementation with a combination of vitamin D and calcium although the benefit of adding calcium to vitamin D supplements has not been fully established and may reduce adherence due to its bulky and chalky consistency.. To compare the effects of vitamin D alone versus vitamin D/calcium supplements on vitamin D levels, bone profile and parathyroid hormone level.. Older (> 65 years) female patients living in the community and long term care institutions.. Either 800 iu of vitamin D3 or a composite supplement of 800 iu vitamin D3 and 1000 mg calcium were given to patients in an open-labelled observational study. Serum 25-hydroxy-vitamin D, parathyroid hormone, calcium, phosphate and alkaline phosphatase levels were assessed at baseline and after 3 months of treatment.. Serum 25-hydroxy-vitamin D levels rose from baseline levels of 25 ± 16 to 79 ± 16 in those treated with vitamin D alone and from 35 ± 24 nmol/L to 70 ± 24 nmol/L in those treated with vitamin D and calcium. Serum PTH levels fell by similar amounts in both groups. In both community dwellers and institutionalised patients, those treated with vitamin D alone were at least as likely to achieve normalisation of serum vitamin D levels as those on combined calcium/vitamin D treatment.. Vitamin D alone appears as effective as combined calcium/vitamin D treatment in restoring serum vitamin D levels in older community dwelling and institutionalised patients. A prospective randomised trial would help confirm these findings.

Topics: Aged; Aged, 80 and over; Calcium; Cholecalciferol; Dietary Supplements; Drug Therapy, Combination; Female; Humans; Micronutrients; Parathyroid Hormone; Vitamin D; Vitamin D Deficiency

Daily dosing of vitamin D supplements may be difficult among older people. Infrequent administration of 'megadoses' controlled by health care personnel may overcome adherence problem. We compared the efficacy and safety of two oral dosages (800 IU daily or 97333 IU four monthly) of vitamin D(3) resulting in the equal annual dose of 292000 IU.. Randomized, double-blind, double-dummy parallel group comparison. Patients Forty women aged 69.3-78.8 years.. Vitamin D(3) 400 IU twice daily (D group) or vitamin D(3) oil 97333 IU every 4 months (4 M group) for 1 year. All received 1 g of calcium daily.. Serum 25-hydroxyvitamin D(3) [25(OH)D(3)] in relation to the target levels of 50-75 nmol/l, PTH, serum type I procollagen aminoterminal propeptide (PINP), serum and urine calcium, renal function.. A quantity of 25OHD(3) increased more in D group than in 4 M group (P < 0.0001). All participants in D group and 67% in 4 M group had 25(OH)D(3) above 50 nmol/l at 12 months; the target level of 75 nmol/l was reached by 47% and 28% respectively. PTH did not show any seasonal perturbation in either group. PINP declined and urinary calcium rose similarly in the study groups over time (P < 0.0001). Renal function did not worsen in either group.. In terms of serum 25(OH)D(3) concentrations, 800 IU daily was more efficient than a 97333 IU every 4 months. However, to increase adherence, the latter is still worth developing. Both treatments increased urinary excretion of calcium, but did not worsen renal function.

Topics: Aged; Calcium; Cholecalciferol; Double-Blind Method; Female; Humans; Kidney Function Tests; Parathyroid Hormone; Patient Compliance; Peptide Fragments; Procollagen; Vitamin D; Vitamin D Deficiency

Was to investigate the effect of treatment with an IM injection, a mega dose of vitamin D3 (10,000 IU/kg) on the clinical, biochemical and radiological parameters of 40 rachitic children with vitamin D deficiency (VDD) over a period of 3 months.. In this prospective study we evaluated the clinical, biochemical and radiological responses of an IM injection of cholecalciferol (10,000 IU/kg) for 3 months.. At presentation, the most frequent manifestations were enlarged wrist joints, hypotonia, irritability, cranial bossing, wide anterior fontanel, bow legs, delayed teething and walking and Harrison's sulcus with chest rosaries. Short stature (length SDS < -2) was recorded in 30% of patients. Craniotabes and hypocalcemic tetany were the least common presentations. In VDD children the most frequent biochemical abnormality was high alkaline phosphatase (ALP) (100%), followed by low phosphate (PO(4)) (75%) and low calcium (Ca) (12.5%). One month after treatment, serum Ca, PO(4) and 25(OH)D concentrations were normal. Three months after the injection, serum level of ALP and parathormone (PTH) decreased to normal. The majority of patients (87.5%) had serum 25(OH)D level >or= 20 ng/ml, but some (12.5%) had level <20 ng/ml. Hypercalcemia was not recorded in any patient during the 3-month-period. Significant cure of all symptoms and signs related to vitamin D deficiency had been achieved in all children. Leg bowing showed significant improvement in all patients but was still evident in one third. Complete healing of the radiological evidence of rickets was achieved in 95% of all children.. An IM injection of a mega dose of cholecalciferol is a safe and effective therapy for treatment of VDD rickets in infants and toddlers with normalization of all the biochemical parameters and healing of radiological manifestations. Measurement of serum 25(OH)D level is highly recommended in all short children with a clear need for a general vitamin D supplementation for all infants and young children in Qatar.

Topics: Alkaline Phosphatase; Bone Density Conservation Agents; Calcium; Cholecalciferol; Dose-Response Relationship, Drug; Female; Humans; Infant; Injections, Intramuscular; Male; Parathyroid Hormone; Phosphates; Prospective Studies; Qatar; Rickets; Treatment Outcome; Vitamin D; Vitamin D Deficiency; Vitamins

Low serum 25-hydroxyvitamin D (25(OH)D) has been shown to correlate with increased risk of type 2 diabetes. Small, observational studies suggest an action for vitamin D in improving insulin sensitivity and/or insulin secretion. The objective of the present study was to investigate the effect of improved vitamin D status on insulin resistance (IR), utilising randomised, controlled, double-blind intervention administering 100 microg (4000 IU) vitamin D(3) (n 42) or placebo (n 39) daily for 6 months to South Asian women, aged 23-68 years, living in Auckland, New Zealand. Subjects were insulin resistant - homeostasis model assessment 1 (HOMA1)>1.93 and had serum 25(OH)D concentration < 50 nmol/l. Exclusion criteria included diabetes medication and vitamin D supplementation >25 microg (1000 IU)/d. The HOMA2 computer model was used to calculate outcomes. Median (25th, 75th percentiles) serum 25(OH)D(3) increased significantly from 21 (11, 40) to 75 (55, 84) nmol/l with supplementation. Significant improvements were seen in insulin sensitivity and IR (P = 0.003 and 0.02, respectively), and fasting insulin decreased (P = 0.02) with supplementation compared with placebo. There was no change in C-peptide with supplementation. IR was most improved when endpoint serum 25(OH)D reached > or = 80 nmol/l. Secondary outcome variables (lipid profile and high sensitivity C-reactive protein) were not affected by supplementation. In conclusion, improving vitamin D status in insulin resistant women resulted in improved IR and sensitivity, but no change in insulin secretion. Optimal vitamin D concentrations for reducing IR were shown to be 80-119 nmol/l, providing further evidence for an increase in the recommended adequate levels. Registered Trial No. ACTRN12607000642482.

Topics: Adult; Asia; Asian People; C-Reactive Protein; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Insulin; Insulin Resistance; Insulin Secretion; Middle Aged; New Zealand; Nutritional Status; Vitamin D; Vitamin D Deficiency; Vitamins

Concentrations of 50 and 75 nmol/l are proposed as serum 25-hydroxyvitamin D (25(OH)D) target for older people from the view of bone health. We evaluated vitamin D status of elderly Finnish women in light of these definitions, its relationship to bone mineral density (BMD) and turnover, and improvement by summer sunshine.. Population-based study.. A total of 1604 ambulatory women aged 62-79 years were studied; 66% used vitamin D supplements. Serum 25(OH)D(3) was measured with HPLC before and after summer, and heel BMD in spring. In subgroups, serum parathyroid hormone (PTH) and type I procollagen aminoterminal propeptide (PINP) were analyzed.. In spring, 60.3% of the women had 25(OH)D(3)

Topics: Aged; Bone Density; Cholecalciferol; Female; Finland; Follow-Up Studies; Humans; Middle Aged; Seasons; Sunlight; Vitamin D; Vitamin D Deficiency

Vitamin D insufficiency was shown to be associated with adverse musculoskeletal and nonskeletal outcomes in numerous observational studies. However, some studies did not control for confounding factors such as age or seasonal variation of 25-hydroxyvitamin D [25(OH)D].. We sought to determine the effect of vitamin D status on health outcomes.. Healthy community-dwelling women (n = 1471) with a mean age of 74 y were followed in a 5-y trial of calcium supplementation. 25(OH)D was measured at baseline in all women. Skeletal and nonskeletal outcomes were evaluated according to seasonally adjusted vitamin D status at baseline.. Fifty percent of women had a seasonally adjusted 25(OH)D concentration <50 nmol/L. These women were significantly older, heavier, and less physically active and had more comorbidities than women with a seasonally adjusted 25(OH)D concentration > or =50 nmol/L. Women with a seasonally adjusted 25(OH)D concentration <50 nmol/L had an increased incidence of stroke and cardiovascular events that did not persist after adjustment for between-group differences in age or comorbidities. Women with a seasonally adjusted 25(OH)D concentration <50 nmol/L were not at increased risk of adverse consequences for any musculoskeletal outcome, including fracture, falls, bone density, or grip strength or any nonskeletal outcomes, including death, myocardial infarction, cancer, heart failure, diabetes, or adverse changes in blood pressure, weight, body composition, cholesterol, or glucose.. Vitamin D insufficiency is more common in older, frailer women. Community-dwelling older women with a seasonally adjusted 25(OH)D concentration <50 nmol/L were not at risk of adverse outcomes over 5 y after control for comorbidities. Randomized placebo-controlled trials are needed to determine whether vitamin D supplementation in individuals with vitamin D insufficiency influences health outcomes. This trial was registered at www.anzctr.org.au as ACTRN 012605000242628.

Topics: Aged; Aged, 80 and over; Blood Pressure; Bone Density; Calcium; Cholecalciferol; Dietary Supplements; Female; Fractures, Bone; Hand Strength; Health Status; Humans; Hydroxycholecalciferols; Incidence; Lipids; Middle Aged; Phosphates; Postmenopause; Vitamin D Deficiency

The optimal treatment of secondary hyperparathyroidism in chronic kidney disease (CKD) is unknown.. We conducted a randomized, blinded, 3-month trial in vitamin D-deficient CKD stage 3 and 4 patients with parathyroid hormone (PTH) values above the Kidney Disease Outcomes Quality Initiative target, comparing cholecalciferol (4000 IU/d x 1 month, then 2000 IU/d; n = 22) to doxercalciferol (1 microg/d; n = 25).. There was no difference in baseline demographics or lab tests, except a slightly higher estimated GFR (eGFR) in the doxercalciferol group. There was a significant increase in vitamin D level in the cholecalciferol group (14 +/- 6 to 37 +/- 10 ng/ml; P < 0.001) but no change in the doxercalciferol group. The PTH decreased by 27% +/- 34% in the doxercalciferol group (P = 0.002) and decreased by 10% +/- 31% in the cholecalciferol group (P = 0.16), but the difference between treatments was NS (P = 0.11). Similar results were found when absolute PTH change from baseline to end point was analyzed in a repeated-measures ANOVA model. The serum calcium and urine calcium excretions were not different. Additional non-mineral-related end points, albuminuria, and BP were evaluated, and although trends were present, this did not reach significance.. This prospective, randomized trial demonstrated a within-group reduction in PTH in the doxercalciferol-treated patients but no significant difference between the doxercalciferol and cholecalciferol patients. Larger, long-term studies are needed to demonstrate efficacy of mineral-related and non-mineral-related end points and safety.

Topics: Aged; Biomarkers; Calcium; Cholecalciferol; Chronic Disease; Ergocalciferols; Female; Humans; Hyperparathyroidism, Secondary; Kidney Diseases; Male; Middle Aged; Parathyroid Hormone; Prospective Studies; Single-Blind Method; Time Factors; Treatment Outcome; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D insufficiency, which is prevalent in older individuals, is associated with bone and muscle weakness and falls.. We examined the effects of a weekly dose of 8400 IU vitamin D(3) on postural stability, muscle strength, and safety.. In this double-blind trial, subjects aged > or =70 y with serum 25-hydroxyvitamin D [25(OH)D] concentrations < or =20 but > or =6 ng/mL were randomly assigned to receive a weekly dose of 8400 IU vitamin D(3) (n = 114) or a placebo (n = 112). Mediolateral body sway with eyes open (assessed with the AccuSway(PLUS) platform; Advanced Medical Technology Inc, Watertown, MA) was the primary endpoint. Secondary endpoints included the short physical performance battery (SPPB) and serum 25(OH)D concentrations. An analysis of covariance model was used for treatment comparisons. Safety and tolerability were monitored.. Serum 25(OH)D concentrations rose significantly (from 13.9 to 26.2 ng/mL, P < 0.001) in patients treated with 8400 IU vitamin D(3) but not in patients treated with the placebo. After 16 wk, neither mediolateral sway nor SPPB differed significantly between treatment groups. However, in the post hoc analysis of patients subgrouped by baseline sway (> or = 0.46 compared with <0.46 cm), treatment with 8400 IU vitamin D(3) significantly reduced sway compared with treatment with placebo (P = 0.047) in patients with elevated baseline sway but not in patients with normal baseline sway. Adverse experiences and incidences of hypercalcemia, hypercalciuria, and elevated creatinine were similar with both treatments. In patients treated with 8400 IU vitamin D(3), but not in placebo-treated patients, parathyroid hormone decreased significantly.. Weekly treatment with 8400 IU vitamin D(3) raised 25(OH)D concentrations in elderly, vitamin D-insufficient individuals. Treatment with 8400 IU vitamin D(3) did not reduce mediolateral sway significantly compared with treatment with placebo in this population, although in post hoc analysis, treatment with 8400 IU vitamin D(3) reduced sway in the subgroup of patients who had elevated sway at baseline. Weekly treatment with 8400 IU vitamin D(3) was well tolerated. This trial was registered at clinicaltrials.gov as NCT00242476.

Topics: Aged; Aged, 80 and over; Cholecalciferol; Dietary Supplements; Double-Blind Method; Drug Administration Schedule; Female; Humans; Male; Movement; Parathyroid Hormone; Postural Balance; Vitamin D; Vitamin D Deficiency; Vitamins

Optimal levels of 25-hydroxyvitamin D [25(OH)D] were investigated in premenopausal Chinese women. Parathyroid hormone (PTH) change at 3 months was associated with change in 25(OH)D but not with baseline levels, and PTH fell even when starting levels of 25(OH)D were >40 nmol/L, consistent with optimal values for 25(OH)D of ≥40 nmol/l.. The upper level of 25-hydroxyvitamin D [25(OH)D] which constitutes a long-term bone health risk by causing elevated PTH levels is uncertain. Although many studies have addressed this question using cross-sectional data, the present study is one of few employing a prospective approach to determine 25(OH)D levels required to minimize PTH.. Relationships among baseline values and 3-month changes (Δ) in PTH and 25(OH)D were assessed in 221 Chinese women, aged 28.0±4.4 years (mean±SD), taking part in a placebo-controlled dairy product intervention delivering 200 IU vitamin D(3)/day.. Baseline 25(OH)D was 34±11 nmol/L and was inversely related to baseline PTH (r=-0.18, P=0.007), with a plateau in PTH levels when 25(OH)D was >40 nmol/L. After 3 months intervention, PTH fell 11% and neither Δ25(OH)D nor ΔPTH differed between treatment and control groups. ΔPTH was inversely related to Δ25(OH)D (P<0.001) but not to baseline 25(OH)D. Similarly, ΔPTH differed between quartiles of Δ25(OH)D (P<0.001), but not between quartiles of baseline 25(OH)D and no interaction was observed between quartiles of baseline 25(OH)D and Δ25(OH)D. Even in the highest quartile of baseline 25(OH)D (>40 nmol/L), PTH fell 0.4±0.1 pmol/L (mean±SEM; P=0.008).. We conclude that vitamin D deficiency is common in young women in Hong Kong. The cross-sectional analysis indicates that optimal 25(OH)D is >40 nmol/L, and the longitudinal data is consistent with a higher optimal value which is not defined in this study's results.

Topics: Adult; Cholecalciferol; Dairy Products; Female; Follow-Up Studies; Food, Fortified; Humans; Parathyroid Hormone; Premenopause; Prospective Studies; Vitamin D; Vitamin D Deficiency; Young Adult

Low serum 25-hydroxyvitamin D (25(OH)D) levels are associated with risk factors for cardiovascular disease, and they also appear to predict later development of type 2 diabetes, cancer, and an increased mortality rate. These predictions are all based on a single 25(OH)D measurement, but so far there are no known reports on tracking of serum 25(OH)D levels. In the present Norwegian study, serum 25(OH)D levels were measured 1) in 2,668 subjects in the 1994 and 2008 Tromsø surveys and 2) every third month for 1 year in 94 subjects randomly assigned to placebo in a vitamin D intervention study. There was a marked seasonal variation in 25(OH)D, and, depending on the method of adjusting for season, the correlation coefficient between serum 25(OH)D measurements from 1994 and 2008 ranged from 0.42 to 0.52. In the 1-year intervention study, the correlation between baseline and 12-month values was 0.80. Apart from the effect of season, changes in weight, intake of vitamin D, and physical activity were related to change in serum 25(OH)D levels. Tracking of serum 25(OH)D appears similar to that for blood pressure and serum lipids, and it provides some support for the use of a single 25(OH)D measurement to predict future health outcomes.

Topics: Aged; Analysis of Variance; Chi-Square Distribution; Cholecalciferol; Drug Monitoring; Epidemiologic Studies; Female; Humans; Linear Models; Longitudinal Studies; Male; Middle Aged; Norway; Nutrition Assessment; Population Surveillance; Predictive Value of Tests; Risk Factors; Seasons; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D has been added to calcium-fortified orange juice. It is unknown whether vitamin D is as bioavailable from orange juice as it is from supplements.. The objective was to compare the bioavailability of vitamin D(2) and vitamin D(3) from orange juice with that from vitamin D(2) and vitamin D(3) supplements. A secondary aim was to determine which form of vitamin D is more bioavailable in orange juice.. A randomized, placebo-controlled, double-blind study was conducted in healthy adults aged 18-84 y (15-20/group) who received 1000 IU vitamin D(3), 1000 IU vitamin D(2), or placebo in orange juice or capsule for 11 wk at the end of winter.. A total of 64% of subjects began the study deficient in vitamin D (ie, 25-hydroxyvitamin D [25(OH)D]) concentrations <20 ng/mL). Analysis of the area under the curve showed no significant difference in serum 25(OH)D between subjects who consumed vitamin D-fortified orange juice and those who consumed vitamin D supplements (P = 0.084). No significant difference in serum 25(OH)D(3) was observed between subjects who consumed vitamin D(3)-fortified orange juice and vitamin D(3) capsules (P > 0.1). Similarly, no significant difference in serum 25(OH)D(2) was observed between subjects who consumed vitamin D(2)-fortified orange juice and vitamin D(2) capsules (P > 0.1). No significant overall difference in parathyroid hormone concentrations was observed between the groups (P = 0.82).. Vitamin D(2) and vitamin D(3) are equally bioavailable in orange juice and capsules.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Beverages; Biological Availability; Calcium; Cholecalciferol; Citrus sinensis; Dietary Supplements; Double-Blind Method; Ergocalciferols; Female; Food, Fortified; Fruit; Humans; Middle Aged; Parathyroid Hormone; Vitamin D Deficiency; Young Adult

Vitamin D deficiency is prevalent worldwide. Vitamin D supplementation has shown variable effect on skeletal muscle strength in the elderly with hypovitaminosis D. There is a paucity of similar data in young individuals.. To study the effect of cholecalciferol and calcium supplementation on muscle strength and energy metabolism in young individuals.. Forty healthy volunteers (24 M/16 F, mean age (SD) 31.5 ± 5.0 year) with hypovitaminosis D were randomized to either oral cholecalciferol (60,000 IU D3/week for 8 weeks followed by 60,000 IU/month for 4 months) with 1 g of elemental calcium daily or dual placebos for 6 months.. Handgrip and gastro-soleus dynamometry, pinch-grip strength, respiratory pressures, 6-min walk-test and muscle energy metabolism on (31) P magnetic resonance spectroscopy were assessed at baseline and after 6 months.. The mean serum 25(OH)D in the supplemented and placebo groups at baseline, two and 6 months were 25.4 ± 9.9, 94.5 ± 53.8 and 56.0 ± 17.0 nm, and 21.1 ± 9.4, 32.8 ± 14.4 and 29.7 ± 15.0 nm, respectively. The supplemented group gained a handgrip strength of 2.4 kg (95% C.I. = 1.2-3.6); gastro-soleus strength of 3.0 Nm (95% C.I. = 0.1-5.9) and walking distance of 15.9 m (95% C.I. = 6.3-25.5) over the placebo group after adjustment for age, gender and respective baseline parameters. Muscle energy parameters were comparable at 6 months.. Six months of cholecalciferol and calcium supplementation results in enhanced skeletal muscle strength and physical performance despite no change in muscle energy parameters. Cholecalciferol supplementation of 60,000 IU per month could not maintain 25(OH)D levels in the sufficient range.

Topics: Adult; Calcium, Dietary; Cholecalciferol; Double-Blind Method; Energy Metabolism; Female; Humans; India; Male; Muscle Strength; Muscle, Skeletal; Vitamin D; Vitamin D Deficiency

Low vitamin D status in women of childbearing age may have implications for health. Vitamin D status of New Zealanders (NZ), based on low serum 25-hydroxyvitamin D (25OHD) is suboptimal. Vitamin D status may be improved with supplements and/or fortified foods. Recently an Adequate Intake (AI) for Australia and NZ was set at 5 microg/d vitamin D. We aimed to determine the effect of daily consumption of milk powder fortified with 5 microg vitamin D3 on serum 25OHD concentration over 12 wks. 73 non-pregnant women (18 - 47 y) living in Dunedin, NZ (46 degrees S) were randomised to receive either unfortified (control) or fortified (5 microg vitamin D3) milk for 12 wks from January to April. Mean 25OHD was similar between groups at week 0 (control 74 vs 76 nmol/L) and fell significantly in both groups over the 12 weeks (control 53 nmol/L, fortified 65 nmol/L; p < 0.001). After 12 wks the fortified milk group had a serum 25OHD 19% (95% CI; 7, 32%) higher (10 nmol/L) than the control group after adjusting for baseline levels (p < 0.001). Daily consumption of fortified milk providing the current AI of 5 microg day vitamin D3 for 12 weeks resulted in higher 25OHD concentrations than control milk. This dose was not sufficient to prevent the seasonal decline in 25OHD. This study suggests an AI of 5 microg may be inadequate for New Zealanders to allow for seasonal changes in sunlight exposure, and is unlikely sufficient for other populations with low sunlight exposure.

Topics: 25-Hydroxyvitamin D 2; Adolescent; Adult; Animals; Calcifediol; Cholecalciferol; Double-Blind Method; Female; Food, Fortified; Humans; Middle Aged; Milk; New Zealand; Nutrition Policy; Nutritional Requirements; Nutritional Status; Nutritive Value; Seasons; Surveys and Questionnaires; Vitamin D Deficiency; Young Adult

To evaluate the bioavailability of vitamin D in capsules as compared with oily drops in nuns living in a closed community with very low sun exposure.. A randomized, 2 x 2 crossover, open clinical trial was conducted, with 18 nuns aged between 20 and 75 years. Samples were collected in the fasting state and at 4, 8, 12 and 24 hours following the administration of capsules and oily drops (both containing vitamin D3 66,000 UI plus vitamin A 13,200 UI) to determine serum 25 hydroxyvitamin D concentrations (25OHD), at baseline and 90 days after. The evaluation was based on the maximum concentration (Cmax) and area under the curve (AUC0-24).. The capsule formulation presented Cmax and AUC0-24, 5.78% and 0.76%, respectively, greater than the oily drops formulation.. Both formulations were within the limits for a bioequivalence study, namely C-90% for Cmax and AUC0-24, and the drugs were considered bioequivalent.

Topics: Adult; Aged; Area Under Curve; Biological Availability; Capsules; Cholecalciferol; Cross-Over Studies; Female; Humans; Middle Aged; Therapeutic Equivalency; Time Factors; Vitamin D; Vitamin D Deficiency; Young Adult

To compare the efficacy and safety of a 10-day, high-dose v a 3-month, continuous low-dose oral cholecalciferol course in a vitamin D deficient population. The primary end points were the change in serum 25-hydroxyvitamin D (25(OH)D) concentrations at 3 months and the development of hypercalcaemia and hypercalciuria.. Fifty-nine vitamin D deficient inpatients (serum 25(OH)D < or = 50 nmol/L) were enrolled in a prospective, randomised, open-label trial. Participants were randomly assigned to a high-dose regimen of cholecalciferol 50 000 IU daily for 10 days or a 3-month, continuous low-dose cholecalciferol regimen of 3000 IU daily for 30 days, followed by 1000 IU daily for 60 days. Both groups received calcium citrate 500 mg daily.. Twenty-six patients completed the study within 3 - or + 1 months. The mean increases in serum 25(OH)D were similar in both the high- and low-dose groups (to 55 v 51 nmol/L, respectively; P = 0.9). There was no significant difference in the proportion of subjects who attained serum 25(OH)D concentrations > 50 nmol/L between the high- and low-dose groups (9/10 v 13/14, respectively; P = 1.0). Hypercalciuria (urine calcium > 7.5 mmol/day) occurred in three patients (two low-dose, one high-dose), while renal impairment worsened in one patient. No patient developed hypercalcaemia (corrected calcium > 2.6 mmol/L), vitamin D toxicity (25(OH)D > 200 nmol/L) or nephrolithiasis during the study.. Both the 10-day, high-dose and the 3-month, low-dose cholecalciferol regimens effectively increased serum 25(OH)D to within the normal range. The high-dose regimen may be an effective and cheap alternative for patients with vitamin D deficiency.. Australian Clinical Trials Registry ACTRN 12607000338460.

Topics: Administration, Oral; Adult; Aged; Calcium; Cholecalciferol; Creatinine; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Prospective Studies; Vitamin D; Vitamin D Deficiency

To compare the effects on parathyroid hormone (PTH) and 25-hydroxy-vitamin D (25(OH)D) of two dosing regimens of cholecalciferol in women with secondary hyperparathyroidism (sHPTH) and hypovitaminosis D and to investigate variables affecting 25(OH)D response to cholecalciferol.. Randomized-controlled trial with 6-month follow-up.. Two osteoporosis centers in northern Italy.. Sixty community-dwelling women aged 65 and older with sHPTH and hypovitaminosis D, creatinine clearance greater than 65 mL/min and without diseases or drugs known to influence bone and vitamin D metabolism.. Cholecalciferol 300,000 IU every 3 months, once at baseline and once at 3 months (intermittent D(3) group) or cholecalciferol 1,000 IU/day (daily D(3) group).. Serum PTH, 25(OH)D, calcium, bone-specific alkaline phosphatase, β-C-terminal telopeptide of type I collagen, phosphate, 24-hour urinary calcium excretion.. The two groups had similar baseline characteristics. All participants had vitamin D deficiency [25(OH)D<20 ng/mL)], and 36 subjects (60%) had severe deficiency (<10 ng/mL), with no difference between the groups (severe deficiency: intermittent D(3) group, n=18; daily D(3) group, n=18). After 3 and 6 months, both groups had a significant increase in 25(OH)D and a reduction in PTH. Mean absolute increase ± standard deviation of 25(OH)D at 6 months was higher in the intermittent D(3) group (22.7±11.8 ng/mL) than in the daily D(3) group (13.7±6.7 ng/mL, P<.001), with a higher proportion of participants in the intermittent D(3) group reaching desirable serum concentration of 25(OH)D≥30 ng/mL (55% in the intermittent D(3) group vs 20% in the daily D(3) group, P<.001). Mean percentage decrease of PTH in the two groups was comparable, and at 6 months, a similar proportion of participants reached normal PTH values. 25(OH)D response to cholecalciferol showed a wide variability. In a logistic regression analysis, body mass index and type of treatment appeared to be significantly associated with normalization of 25(OH)D values.. Cholecalciferol 300,000 IU every 3 months was more effective than 1,000 IU daily in correcting vitamin D deficiency, although the two groups achieved similar effects on PTH at 6 months. Only 55% of the higher-dose intermittent group reached desirable concentrations of 25(OH)D, suggesting that yet-higher doses will be required for adequate vitamin D repletion.

Topics: Aged; Alkaline Phosphatase; Biomarkers; Calcium; Cholecalciferol; Collagen Type I; Dose-Response Relationship, Drug; Female; Humans; Hyperparathyroidism, Secondary; Parathyroid Hormone; Peptides; Phosphates; Vitamin D; Vitamin D Deficiency; Vitamins

Effects of vitamin D repletion in young people with low vitamin D status have not been investigated so far.. We evaluated the effect of a single massive dose of cholecalciferol on calcium metabolism at 3, 15, and 30 d, compared to baseline.. We conducted a prospective intervention study in an ambulatory care setting.. Forty-eight young subjects with vitamin D deficiency participated in the study.. A single oral dose of 600,000 IU of cholecalciferol was administered to each subject.. We evaluated serum changes of 25-hydroxyvitamin D [25(OH)D], 1,25-dihydroxyvitamin D, calcium, and PTH induced by a single load of cholecalciferol.. The 25(OH)D level was 15.8 ± 6.5 ng/ml at baseline and became 77.2 ± 30.5 ng/ml at 3 d (P < 0.001) and 62.4 ± 26.1 ng/ml at 30 d (P < 0.001). PTH levels concomitantly decreased from 53.0 ± 20.1 to 38.6 ± 17.2 pg/ml at 3 d and to 43.4 ± 14.0 pg/ml at 30 d (P < 0.001 for both). The trends were maintained in a subgroup followed up to 90 d (P < 0.001). Mean serum Ca and P significantly increased compared to baseline, whereas serum Mg decreased at 3 d. 1,25-Dihydroxyvitamin D significantly increased from 46.8 ± 18.9 to 97.8 ± 38.3 pg/ml at 3 d (P < 0.001) and to 59.5 ± 27.3 pg/ml at 60 d (P < 0.05).. A single oral dose of 600,000 IU of cholecalciferol rapidly enhances 25(OH)D and reduces PTH in young people with vitamin D deficiency.

Topics: Administration, Oral; Adult; Calcium; Cholecalciferol; Dose-Response Relationship, Drug; Female; Hormones; Humans; Male; Middle Aged; Parathyroid Hormone; Prospective Studies; Vitamin D; Vitamin D Deficiency; Young Adult

Controversies surround the actual requirements of vitamin D in adolescents. We aimed to assess the efficacy and safety of different doses of vitamin D in high schoolchildren of Taleghan (latitude 36.5°N) near Tehran.. In a randomized double-blind, placebo-controlled trial, 210 subjects, aged 14-20 years, 105 boys and 105 girls were assigned to three groups; group A (n=70) received 50 000 U oral cholecalciferol monthly (equal to 1600 U per day), group B (n=70), 50 000 U bimonthly (equal to 800 U/day) and group C (n=70), placebo. The study began in November 2007 and continued until April 2008. Serum 25(OH)D, parathyroid hormone (PTH), calcium (Ca) and bone markers were measured.. At baseline, girls had significantly lower concentrations of 25(OH)D than boys (19.25±16 vs 40.5±14 nmol/l). Mean 25(OH)D increased from 32±22 to 60±27.5 and 28.25±14.5 to 45.75±24 in groups A and B, respectively (P<0.001); however, it did not change over time in group C (29±18 vs 29±17.5). Increment of mean 25(OH)D was higher in group A than in group B (P<0.01). In all groups, girls had lower concentrations of 25(OH)D than boys (P<0.001). Serum Ca increased and PTH decreased in groups A and B (P<0.001). In group A, osteocalcin (OC) and bone-specific alkaline phosphatase increased (P<0.001), but in group B only OC increased (P<0.001). Urine C telopeptide and Ca did not change in all three groups; no case of hypercalcemia was observed.. Although monthly administration of 50 000 U vitamin D(3) increased serum 25(OH)D significantly, it was apparently not enough to correct vitamin D deficiency, especially in girls.

Topics: Administration, Oral; Adolescent; Adolescent Nutritional Physiological Phenomena; Biomarkers; Bone Density; Calcium; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Iran; Male; Parathyroid Hormone; Seasons; Vitamin D; Vitamin D Deficiency; Young Adult

To assess vitamin D status and the influences of race, sun exposure and dietary vitamin D intake on vitamin D levels, and to evaluate two vitamin D repletion regimens in extremely obese patients awaiting bariatric surgery.. A cross-sectional analysis of dietary vitamin D, sun exposure, PTH [intact (iPTH) and PTH(1-84)] and 25-hydroxyvitamin D (25OHD; differentiated 25OHD2 and 25OHD3) in 56 obese [body mass index (BMI) > 35 kg/m(2)] men and women (age 20-64 years). In a pilot clinical trial, 27 subjects with 25OHD levels < 62 nmol/l were randomized to receive ergocalciferol or cholecalciferol for 8 weeks.. Serum 25OHD was low (mean 45 +/- 22 nmol/l) and was inversely associated with BMI (r = -0.36, P < 0.01). Each BMI increase of 1 kg/m(2) was associated with a 1.3 nmol/l decrease in 25OHD (P < 0.01). BMI, sun exposure, African American race and PTH predicted 40% of the variance in 25OHD (P < 0.0001). Serum 25OHD significantly increased at 4 and 8 weeks in both treatment groups (P < 0.001), whereas PTH(1-84) declined significantly in subjects treated with cholecalciferol (P < 0.007) and tended to decrease following ergocalciferol (P < 0.09).. In severely obese individuals, those who are African American, have higher BMI and limited sunlight exposure are at greatest risk for vitamin D insufficiency. These demographic factors can help to identify at-risk patients who require vitamin D repletion prior to bariatric surgery. Commonly prescribed doses of ergocalciferol and cholecalciferol are effective in raising 25OHD. Further investigation is needed to evaluate whether these regimens have differential effects on PTH, and to determine the optimal regimen for vitamin D repletion in the extremely obese patient.

Topics: Adult; Aged; Bariatric Surgery; Bone Density Conservation Agents; Cholecalciferol; Cross-Sectional Studies; Ergocalciferols; Humans; Male; Middle Aged; Obesity; Pilot Projects; Risk Factors; Sunlight; Vitamin D Deficiency; Young Adult

We investigated whether osteoporosis therapy with alendronate in postmenopausal patients is equally effective in patients who are vitamin D insufficient as in those who are vitamin D sufficient. We found that vitamin D insufficiency is common among patients with low bone density but that vitamin D insufficiency did not impair response to alendronate.. Treatment of vitamin D deficiency leads to significant improvements in bone mineral density (BMD); however, whether insufficiency affects BMD's response to bisphosphonate therapy is unknown.. To determine whether vitamin D insufficiency at initiation of alendronate therapy for low BMD affects treatment efficacy, we used data from 1,000 postmenopausal women randomly selected from the vertebral fracture arm (n = 2,027) of the placebo-controlled Fracture Intervention Trial of alendronate. Participants were randomly assigned to placebo (50%) or alendronate therapy and most (83%) to calcium (500 mg/day) and cholecalciferol (250 IU/day). We measured serum 25-hydroxy vitamin D (25OHD) at enrollment, then categorized baseline vitamin D status according to 25OHD concentration (10 but 30 ng/ml = sufficient) and used linear regression to compare the effects of alendronate treatment among these categories.. At baseline, participants were vitamin D sufficient (14%), insufficient (83%), and deficient (2%). We found that BMD response to therapy at total hip or spine did not vary by vitamin D status at baseline (p for heterogeneity = 0.6). We determined that vitamin D insufficiency is common among participants with low BMD. However, vitamin D status at initiation of therapy does not affect BMD's response to alendronate, when it is coadministered with cholecalciferol and calcium.

Topics: Absorptiometry, Photon; Aged; Alendronate; Bone Density; Bone Density Conservation Agents; Calcium; Cholecalciferol; Female; Femur Neck; Hip Joint; Humans; Osteoporosis, Postmenopausal; Spine; Vitamin D; Vitamin D Deficiency

Vitamin D has been shown to be involved in the host immune response toward Mycobacterium tuberculosis.. To test whether vitamin D supplementation of patients with tuberculosis (TB) improved clinical outcome and reduced mortality.. We conducted a randomized, double-blind, placebo-controlled trial in TB clinics at a demographic surveillance site in Guinea-Bissau. We included 365 adult patients with TB starting antituberculosis treatment; 281 completed the 12-month follow-up. The intervention was 100,000 IU of cholecalciferol or placebo at inclusion and again 5 and 8 months after the start of treatment.. The primary outcome was reduction in a clinical severity score (TBscore) for all patients with pulmonary TB. The secondary outcome was 12-month mortality. No serious adverse effects were reported; mild hypercalcemia was rare and present in both arms. Reduction in TBscore and sputum smear conversion rates did not differ among patients treated with vitamin D or placebo. Overall mortality was 15% (54 of 365) at 1 year of follow-up and similar in both arms (30 of 187 for vitamin D treated and 24 of 178 for placebo; relative risk, 1.19 [0.58-1.95]). HIV infection was seen in 36% (131 of 359): 21% (76 of 359) HIV-1, 10% (36 of 359) HIV-2, and 5% (19 of 357) HIV-1+2.. Vitamin D does not improve clinical outcome among patients with TB and the trial showed no overall effect on mortality in patients with TB; it is possible that the dose used was insufficient. Clinical trial registered with www.controlled-trials.com/isrctn (ISRCTN35212132).

Topics: Adult; Antitubercular Agents; CD4 Lymphocyte Count; Cholecalciferol; Double-Blind Method; Drug Therapy, Combination; Female; Guinea-Bissau; HIV Infections; Humans; Male; Tuberculosis, Pulmonary; Vitamin D; Vitamin D Deficiency; Vitamins; Weight Gain

In older adults, a serum 25-hydroxyvitamin D [25(OH)D] concentration >75 nmol/L lowers the risk of fracture. An oral intake of 125 microg (5000 IU) vitamin D(3)/d may be required to achieve this target.. The objective was to characterize the safety and efficacy of fortifying bread with a biologically meaningful amount of vitamin D(3).. In a single-arm design, 45 nursing home residents consumed one bun daily that had been fortified with 125 microg (5000 IU) vitamin D(3) and 320 mg elemental calcium.. The initial mean (+/-SD) serum 25(OH)D concentration was 28.5 +/- 10.8 nmol/L. After 12 mo, the 25(OH)D concentration was 125.6 +/- 38.8 nmol/L, and it exceeded 74 nmol/L in 92% of the patients. At every 3-mo follow-up, serum parathyroid hormone was lower than at baseline (P = 0.001). No changes in serum calcium or cases of hypercalcemia were observed at the follow-up assessments. Both mean total urinary calcium and the mean urinary calcium-creatinine ratio increased from baseline at one follow-up time point (P < 0.05). Between baseline and the 12-mo visit, z scores for bone mineral density at the lumbar spine and the hip both increased significantly (P < 0.001).. Fortification of bread with much more vitamin D than used previously produced no evident adverse effects on sun-deprived nursing home residents and improved bone density measures. Fortification of bread with 5000 IU vitamin D(3)/d provided reasonable assurance that vitamin D-deficient older adults attained a serum 25(OH)D concentration greater than the desirable objective of >75 nmol/L. This trial was registered at (ClinicalTrials.gov) as: NCT00789503.

Topics: Aged; Aged, 80 and over; Aging; Bone Density; Bone Density Conservation Agents; Bread; Calcium; Calcium, Dietary; Cholecalciferol; Dose-Response Relationship, Drug; Female; Food, Fortified; Homes for the Aged; Humans; Male; Middle Aged; Nursing Homes; Nutrition Assessment; Nutritional Requirements; Parathyroid Hormone; Romania; Vitamin D; Vitamin D Deficiency

Older adults may be more prone to developing vitamin D deficiency than younger adults. Dietary requirements for vitamin D in older adults are based on limited evidence.. The objective was to establish the dietary intake of vitamin D required to maintain serum 25-hydroxyvitamin D [25(OH)D] concentrations above various cutoffs between 25 and 80 nmol/L during wintertime, which accounted for the effect of summer sunshine exposure and diet.. A randomized, placebo-controlled, double-blind, 22-wk intervention was conducted in men and women aged >/=64 y (n = 225) at supplemental levels of 0, 5, 10, and 15 microg vitamin D(3)/d from October 2007 to March 2008.. Clear dose-related increments (P < 0.0001) in serum 25(OH)D were observed with increasing supplemental vitamin D(3) intakes. The slope of the relation between total vitamin D intake and serum 25(OH)D was 1.97 nmol . L(-1) . microg intake(-1). The vitamin D intake that maintained serum 25(OH)D concentrations >25 nmol/L in 97.5% of the sample was 8.6 microg/d. Intakes were 7.9 and 11.4 microg/d in those who reported a minimum of 15 min daily summer sunshine exposure or less, respectively. The intakes required to maintain serum 25(OH)D concentrations of >37.5, >50, and >80 nmol/L in 97.5% of the sample were 17.2, 24.7, and 38.7 microg/d, respectively.. To ensure that the vitamin D requirement is met by the vast majority (>97.5%) of adults aged >/=64 y during winter, between 7.9 and 42.8 microg vitamin D/d is required, depending on summer sun exposure and the threshold of adequacy of 25(OH)D. This trial was registered at http://www.controlled-trials.com/ISRCTN20236112 as ISRCTN registration no. ISRCTN20236112.

Topics: Aged; Calcium; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Male; Nutritional Requirements; Parathyroid Hormone; Seasons; Sunlight; Vitamin D; Vitamin D Deficiency

The optimal treatment for correcting or preventing vitamin D insufficiency in cystic fibrosis (CF) patients has not been established.. The aim of the study was to assess the relative efficacy of three modes of vitamin D therapy: cholecalciferol (D3), ergocalciferol (D2), and UV light in raising or maintaining 25(OH)D levels above 30 ng/ml.. Thirty adult CF subjects with vitamin D insufficiency were randomized into one of three treatment arms: D3, D2, or UV light. Subjects randomized to D3 or D2 ingested 50,000 IU of vitamin D weekly, and those randomized to UV exposed their skin to UV light from a lamp five times a week. Serum was collected for 25(OH)D and PTH at baseline and at 12 wk.. Treatment with D3 and D2 raised 25(OH)D levels significantly, from a mean of 21.2 +/- 10.18 to 47.1 +/- 20.5 ng/ml (P < 0.001) and 24.4 +/- 10.3 to 32.7+/- 9.7 ng/ml (P = 0.01), with 100% and 60% reaching 25(OH)D levels above 30 ng/ml, respectively. Treatment with UV did not raise 25(OH)D levels significantly; however, only 55% of subjects were adherent with UV therapy.. This study demonstrates that CF subjects are able to achieve or maintain optimal vitamin D status (>30 ng/ml) with two oral regimens of either D3 or D2 treatment, the former being more efficacious. A confounding variable for this observation is the fact that the D3 and D2 capsules contained different carriers, powder-based vs. oil-based, respectively. UV therapy did not alter vitamin D status, possibly due to poor adherence to UV therapy.

Topics: Adolescent; Adult; Aged; Cholecalciferol; Cystic Fibrosis; Ergocalciferols; Female; Humans; Hydroxycholecalciferols; Male; Middle Aged; Parathyroid Hormone; Patient Compliance; Ultraviolet Therapy; Vitamin D Deficiency; Young Adult

To examine the association of symptoms with vitamin D deficiency and symptom response to cholecalciferol treatment in a randomized, double-blind, placebo-controlled trial.. Adult primary care patients in Duluth, Minnesota, were screened for vitamin D deficiency in February 2007. Participants completed questionnaires pertaining to a variety of symptoms, vitamin D intake, and selected medical conditions. Patients with mild to moderate vitamin D deficiency (25-hydroxyvitamin D [25(OH)D], 10-25 ng/mL) participated in a randomized controlled trial (RCT) of vitamin D replacement and its effect on symptoms. Participants were randomly assigned to receive 50 000 units of cholecalciferol (vitamin D3) weekly or placebo for 8 weeks. Patients with severe vitamin D deficiency (25[OH]D <10 ng/mL) were treated in an unblinded fashion, and symptoms were reevaluated post treatment.. A total of 610 patients underwent initial screening, and 100 patients with mild to moderate vitamin D deficiency participated in the RCT. Thirty-eight severely deficient patients were treated in an unblinded fashion. On initial screening, 46.2% of participants were deficient in vitamin D. Self-reported vitamin D supplementation, milk intake, celiac disease, gastric bypass, and chronic pancreatitis were predictive of vitamin D status. Severely deficient participants reported increased musculoskeletal symptoms, depression (including seasonal), and higher (worse) scores on a fibromyalgia assessment questionnaire. In the RCT, the treated group showed significant improvement in fibromyalgia assessment scores (P = 0.03), whereas the placebo-treated participants did not. Severely deficient patients did not show symptom improvement over the 8-week trial period or when followed up 1 year later.. Compared with participants in the placebo group, patients in the treatment group showed mild short-term improvement in the overall fibromyalgia impact score, but did not show significant improvement in most musculoskeletal symptoms or in activities of daily living.

Topics: Adult; Aged; Algorithms; Biomarkers, Pharmacological; Calcifediol; Cholecalciferol; Double-Blind Method; Female; Humans; Male; Middle Aged; Placebos; Prognosis; Risk Factors; Surveys and Questionnaires; Treatment Outcome; Vitamin D Deficiency

Hypovitaminosis D is common in both urban and rural Indians. The dose of vitamin D needed for the treatment of its deficiency during pregnancy is not clear. We conducted a study in rural Indians to evaluate the effect of cholecalciferol supplementation during routine antenatal visits on maternal 25 hydroxyvitamin D (25OHD) at delivery. Pregnant women received either no cholecalciferol (Group A) or 60 000 U (Group B) in the fifth month of gestation or 120 000 U each in the fifth and seventh gestational months (Group C). Serum 25OHD was measured at baseline (n=139) and at delivery (n=84). Median (interquartile range) 25OHD at baseline was low: 32.3 nmol/l (22.8-50.1 nmol/l). A significant increase in 25OHD at delivery was obtained only in group C: 40.1 nmol/l (26.9-58.4 nmol/l) at baseline vs 53.4 nmol/l (41.2-88.0 nmol/l) after delivery, P<0.001. Only 20% of participants in Group C achieved 25OHD at delivery >80 nmol/l, not significantly different from Group B. Cholecalciferol in doses of 120 000 U each in fifth and seventh gestational months was effective in raising 25OHD at delivery.

Topics: Cholecalciferol; Dietary Supplements; Dose-Response Relationship, Drug; Female; Humans; India; Pilot Projects; Pregnancy; Pregnancy Complications; Prenatal Care; Rural Health; Vitamin D; Vitamin D Deficiency

Vitamin D does not only regulate calcium homeostasis but also plays an important role as an immune modulator. It influences the immune system through the induction of immune shifts and regulatory cells resulting in immunologic tolerance. As such, vitamin D is thought to exert beneficial effects within the transplant setting, especially in kidney transplant recipients, considering the high prevalence of vitamin D deficiency in kidney transplant recipients.. The VITA-D study, a randomized, placebo-controlled, double-blind study with two parallel groups including a total of 200 kidney transplant recipients, is designed to investigate the immunomodulatory and renoprotective effects of cholecalciferol (vitamin D3) within the transplant setting. Kidney transplant recipients found to have vitamin D deficiency defined as 25-hydroxyvitamin D3 < 50 nmol per liter will be randomly assigned to receive either oral cholecalciferol therapy or placebo and will be followed for one year. Cholecalciferol will be administered at a dose of 6800 International Units daily over a time period of one year. The objective is to evaluate the influence of vitamin D3 substitution in vitamin D deficient kidney transplant recipients on the post-transplant outcome. As a primary endpoint glomerular filtration rate calculated with the MDRD formula (modification of diet in renal disease) one year after kidney transplantation will be evaluated. Incidence of acute rejection episodes, and the number and severity of infections (analyzed by means of C-reactive protein) within the first year after transplantation will be monitored as well. As a secondary endpoint the influence of vitamin D3 on bone mineral density within the first year post-transplant will be assessed. Three DXA analyses will be performed, one within the first four weeks post-transplant, one five months and one twelve months after kidney transplantation.

Topics: Administration, Oral; Cholecalciferol; Double-Blind Method; Glomerular Filtration Rate; Graft Rejection; Graft Survival; Humans; Immunologic Factors; Kidney Transplantation; Research Design; Risk Assessment; Time Factors; Treatment Outcome; Vitamin D Deficiency; Vitamins

Topics: Aged; Aged, 80 and over; Aging; Calcium; Cholecalciferol; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Female; Fractures, Spontaneous; Glucose Intolerance; Humans; Male; Metabolic Syndrome; Osteoporosis; Placebos; Risk Factors; Vitamin D Deficiency; Vitamins

There is growing evidence of the usefulness of vitamin D supplementation in dialysis patients who are most often vitamin D deficient. Due to the long half-life of vitamin D, there is much interest in administering it intermittently for long-term adherence. However, there are no data to indicate which dosage would be most efficient. Objective. The aim was to assess the long-term efficiency and safety of a monthly oral dose of cholecalciferol (100 000 IU) in vitamin D-deficient haemodialysis (HD) patients.. HD patients with a serum 25-hydroxyvitamin D (25(OH)D) level <75 nmol/L were enrolled in a 15-month prospective study. The exclusion criteria were as follows: use of any vitamin D derivatives, prescription of cinacalcet and bisphosphonates, uncontrolled hypercalcaemia (>2.55 mmol/L), hyperphosphataemia (>2 mmol/L) and severe secondary hyperparathyroidism (SHPT; serum PTH >600 pg/mL). Biological data were recorded in the following months: M-3, M0, M1, M3, M9 and M15. We aimed to maintain stable levels of the phosphate binder and oral and dialysate calcium during the course of the study.. Of the 250 patients screened, 161 were enrolled, and the results from 107 were recorded at the end of the study. Of these 107 patients, 56% were males, and the average age of the patient group was 66.4 +/- 15 years. Diabetics accounted for 36% of the total patients. The dialysis schedule ranged from 3 x 5 to 3 x 8 h, with a mean dialysate calcium concentration of 1.48 +/- 0.6 mmol/L. After 15 months, the mean serum 25(OH)D level increased from 32 +/- 13 to 105.8 +/- 27 nmol/L (P < 0.001) and plateaued after M3. Of the patients, 91% had a level higher than the target level (>75 nmol/L), while none had levels >200 nmol/L. The serum calcitriol (1,25(OH)(2)D) level increased from 13.7 +/- 14 to 45 +/- 13 pmol/L (P < 0.001) and plateaued after M9. The levels of serum PTH (median 295-190 pg/mL, P < 0.001), bone alkaline phosphatase (20.5 +/- 9-17.1 +/- 7 microg/L, P < 0.05) and beta-cross-laps (2.5 +/- 1-2.07 +/- 0.8 microg/L, P < 0.05) decreased significantly. No significant changes were observed in the values of the following: calcaemia, phosphataemia, blood pressure, serum albumin, haemoglobin and C-reactive protein.. Long-term monthly administration of oral cholecalciferol (100 000 IU) was a safe, effective, inexpensive and simple method for correcting vitamin D deficiency in almost 90% of the HD patients in this study and led to optimal compliance. The most evident consequences were a slight decrease in the levels of PTH and bone markers and an increase in the level of serum 1,25(OH)(2)D.

Topics: Administration, Oral; Aged; Cholecalciferol; Drug Administration Schedule; Female; Humans; Male; Prospective Studies; Renal Dialysis; Time Factors; Vitamin D Deficiency; Vitamins

Vitamin D insufficiency is commonly associated with hip fracture. However, the equipotency of ergocalciferol and cholecalciferol supplementation in this patient group has not been studied in a randomized trial using high-performance liquid chromatography (HPLC) measurement of serum 25-hydroxyvitamin D (25OHD). The objective of this study was to determine if ergocalciferol and cholecalciferol are equipotent therapies in vitamin D-insufficient hip fracture patients. Ninety five hip fracture inpatients with vitamin D insufficiency (25OHD<50 nmol/L) were randomized, double-blind, to treatment with ergocalciferol 1000 IU/day (n=48) or cholecalciferol 1000 IU/day (n=47) for three months. All participants were also given a placebo matching the alternative treatment to maintain blinding of treatment allocation. The primary endpoint was total serum 25OHD measured by HPLC. Secondary endpoints included 25OHD measured by radioimmunoassay (RIA), intact parathyroid hormone (iPTH), and bioactive (1-84) whole PTH (wPTH). Seventy patients (74%) completed the study with paired samples for analysis. Cholecalciferol supplementation resulted in a 31% greater increase in total HPLC-measured 25OHD (p=0.010) and 52% greater rise in RIA-measured 25OHD (p<0.001) than supplementation with an equivalent dose of ergocalciferol. Changes in iPTH and wPTH were not significantly different between calciferol treatments (p>0.05). In vitamin D-insufficient hip fracture patients, supplementation with cholecalciferol 1000 IU/day for three months was more effective in increasing serum 25OHD than an equivalent dose of ergocalciferol. However, the lack of difference in PTH lowering between calciferol treatments raises questions about the biological importance of this observation.

Topics: Aged, 80 and over; Bone Density Conservation Agents; Calcium; Cholecalciferol; Dietary Supplements; Ergocalciferols; Hip Fractures; Humans; Parathyroid Hormone; Patient Compliance; Vitamin D; Vitamin D Deficiency

To investigate the effects of a 6-month supplementation with calcium and cholecalciferol on biochemical parameters and muscle strength of institutionalized elderly.. This prospective, double-blind, placebo-controlled, randomized trial included Brazilian institutionalized people > or =60 years of age receiving a 6-month supplementation (December to May) of daily calcium plus monthly placebo (calcium/placebo group) or daily calcium plus oral cholecalciferol (150,000 IU once a month during the first 2 months, followed by 90,000 IU once a month for the last 4 months; calcium/vitamin D group). Fasting blood samples for 25(OH)D, PTH and calcium determination were collected (n = 56) and muscle tests were performed (n = 46) to measure the strength of hip flexors (SHF) and knee extensors (SKE) before (baseline) and after the 6-month intervention (6 months).. Due to seasonal variations, serum 25(OH)D significantly enhanced in both groups after treatment, but the calcium/vitamin D group had significantly higher 25 (OH)D levels than the calcium/placebo group (84 vs. 33%, respectively; p < 0.0001). No cases of hypercalcemia were observed. While the calcium/placebo group showed no improvement in SHF and SKE at 6 months (p = 0.93 and p = 0.61, respectively), SHF was increased in the calcium/vitamin D group by 16.4% (p = 0.0001) and SKE by 24.6% (p = 0.0007).. The suggested cholecalciferol supplementation was safe and efficient in enhancing 25(OH)D levels and lower limb muscle strength in the elderly, in the absence of any regular physical exercise practice.

Topics: Aged; Aged, 80 and over; Calcifediol; Calcium; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Homes for the Aged; Humans; Lower Extremity; Male; Middle Aged; Muscle Strength; Nursing Homes; Parathyroid Hormone; Phosphorus; Seasons; Surveys and Questionnaires; Vitamin D Deficiency

Approximately 50% of patients with stage 3 Chronic Kidney Disease are 25-hydroxyvitamin D insufficient, and this prevalence increases with falling glomerular filtration rate. Vitamin D is now recognised as having pleiotropic roles beyond bone and mineral homeostasis, with the vitamin D receptor and metabolising machinery identified in multiple tissues. Worryingly, recent observational data has highlighted an association between hypovitaminosis D and increased cardiovascular mortality, possibly mediated via vitamin D effects on insulin resistance and inflammation. The main hypothesis of this study is that oral Vitamin D supplementation will ameliorate insulin resistance in patients with Chronic Kidney Disease stage 3 when compared to placebo. Secondary hypotheses will test whether this is associated with decreased inflammation and bone/adipocyte-endocrine dysregulation.. This study is a single-centre, double-blinded, randomised, placebo-controlled trial. Inclusion criteria include; estimated glomerular filtration rate 30-59 ml/min/1.73 m(2); aged >or=18 on entry to study; and serum 25-hydroxyvitamin D levels <75 nmol/L. Patients will be randomised 1:1 to receive either oral cholecalciferol 2000IU/day or placebo for 6 months. The primary outcome will be an improvement in insulin sensitivity, measured by hyperinsulinaemic euglycaemic clamp. Secondary outcome measures will include serum parathyroid hormone, cytokines (Interleukin-1beta, Interleukin-6, Tumour Necrosis Factor alpha), adiponectin (total and High Molecular Weight), osteocalcin (carboxylated and under-carboxylated), peripheral blood mononuclear cell Nuclear Factor Kappa-B p65 binding activity, brachial artery reactivity, aortic pulse wave velocity and waveform analysis, and indirect calorimetry. All outcome measures will be performed at baseline and end of study.. To date, no randomised controlled trial has been performed in pre-dialysis CKD patients to study the correlation between vitamin D status with supplementation, insulin resistance and markers of adverse cardiovascular risk. We remain hopeful that cholecalciferol may be a safe intervention, with health benefits beyond those related to bone-mineral homeostasis.. Australian and New Zealand Clinical Trials Registry ACTRN12609000246280.

Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Bone Density Conservation Agents; Cholecalciferol; Double-Blind Method; Female; Humans; Inflammation; Insulin Resistance; Kidney Failure, Chronic; Male; Placebo Effect; Treatment Outcome; Vitamin D Deficiency; Young Adult

To study the adequate intake (AI) for vitamin D in the elderly, we have performed an intervention study with 800 IU/d of vitamin D(3) in the institutionalized elderly. Sixty-two institutionalized elderly were randomly assigned to two groups; receiving either supplements of 200 mg calcium plus 800 IU vitamin D(3)/d (Ca+VD group), or supplements of 200 mg calcium/d (Ca group) for 30 d in October. Serum concentrations of 25-hydroxyvitamin D (25OH-D), parathyroid hormone (PTH), and bone turnover markers were measured before and after intervention. Average dietary vitamin D intake during the intervention period was approximately 300 IU/d in both groups, exceeding the AI in Dietary Reference Intakes for Japanese 2005 of 200 IU/d. In both groups, mean serum 25OH-D level at baseline fell into the hypovitaminosis D range (9.7 ng/mL), despite apparently adequate vitamin D intake. Serum PTH level at baseline was within the reference range. Mean serum 25OH-D concentration significantly increased to 19.3 ng/mL in the Ca+VD group and to 11.1 ng/mL in the Ca group. Post intervention serum 25OH-D level was significantly higher in the Ca+VD group than in the Ca group (p<0.001). In 53 subjects (85.5%) who took more than 80% of their supplements for 30 d, serum PTH level in the Ca+VD group was significantly lower than in the Ca groups (p=0.05). Bone turnover markers were not significantly changed after intervention in either group. Daily supplementation of 800 IU vitamin D(3) was considered effective in the institutionalized elderly with minimal chance of sun exposure, but further studies with longer duration are necessary.

Topics: Aged; Aged, 80 and over; Bone and Bones; Calcium; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Institutionalization; Japan; Male; Nursing Homes; Nutritional Requirements; Parathyroid Hormone; Reference Values; Vitamin D; Vitamin D Deficiency

There is a need to increase the options for vitamin D fortification. We have developed a method to fortify hard cheese with vitamin D. Our aim was to characterize the bioavailability of vitamin D from fortified cheeses. Eighty adults were randomized to weekly servings of fortified cheddar cheese (DC) (34 g; n = 20); fortified low-fat cheese (DLF) (41 g; n = 10); liquid vitamin D supplement (1 mL), taken with food (DS+) (n = 20) or without food (DS-) (n = 10); placebo cheddar cheese (n = 10); or placebo supplement (n = 10). The treatments contained 28,000 IU cholecalciferol (vitamin D3), equivalent to 4000 IU (100 microg/d). The primary outcome was the comparison of vitamin D bioavailability, as measured by the serum 25-hydroxyvitamin D [25(OH)D] response, between fortified cheeses and supplement. In the placebo groups, initial 25(OH)D, 55.0 +/- 25.3 nmol/L, declined over the 8-wk winter protocol, to 50.7 +/- 24.2 nmol/L (P = 0.046). In the vitamin D-treated groups, the mean increases in 25(OH)D over 8 wk were: 65.3 +/- 24.1 (DC), 69.4 +/- 21.7 (DLF), 59.3 +/- 23.3 (DS+), and 59.3 +/- 19.6 nmol/L (DS-); these changes differed from the placebo groups (P < 0.0001) but not from one another (P = 0.62). Compared with baseline, serum parathyroid hormone decreased with both fortification (P = 0.003) and supplementation (P = 0.012). These data demonstrate that vitamin D is equally bioavailable from fortified hard cheeses and supplements, making cheese suitable for vitamin D fortification.

Topics: Adolescent; Adult; Biological Availability; Cheese; Cholecalciferol; Dietary Supplements; Female; Food, Fortified; Humans; Male; Vitamin D; Vitamin D Deficiency

Vitamin D has emerged as an important survival factor in patients with chronic kidney disease. Non-activated vitamin D may also have beneficial effects on bone, cardiovascular and immune functions. Cholecalciferol is the prevalent non-activated vitamin D in Europe, but there is no valid prospective data available about its use in haemodialysis patients. Thus, we initiated a prospective study to evaluate dosing, safety and tolerability of cholecalciferol supplementation in haemodialysis patients.. The prospective study included 64 haemodialysis patients. During replenishment phase patients received 20 000 IU cholecalciferol/week for 9 months. In the open maintenance phase (15 months), patients were randomized to a treated group (20 000 IU cholecalciferol/month) and an untreated group, which did not receive cholecalciferol.. Calcidiol [25(OH)D] deficiency (<37.5 nmol/l; <15 microg/l) was detected in 61/64 patients (95%). During the replenishment phase, calcidiol increased significantly from 16.65 +/- 9.6 to 79.48 +/- 27.15 nmol/l (6.66 +/- 3.84 microug/l to 31.79 +/- 10.86 microg/l) (P < 0.001). Recommended levels (>75 nmol/l; >30 microg/l; K/DOQI) were achieved in 57% of patients. Calcium increased from 2.28 +/- 0.17 to 2.37 +/- 0.19 mmol/l (9.1 +/- 0.69 mg/dl to 9.49 +/- 0.75 mg/dl) (P<0.01). Phosphorus, calcium-phosphorus product and parathyroid hormone showed no significant changes. Fifty-nine patients progressed to the maintenance phase. Analysis per protocol showed a significant drop of calcidiol in the treated [83.98 +/- 31.73 versus 78.5 +/- 38.75 nmol/l (33.59 +/- 12.69 versus 31.4 +/- 15.5 microg/l) (P < 0.001)] and untreated groups [86.35 +/- 40.75 versus 53.4 +/- 26.2 nmol/l (34.54 +/- 16.3 versus 21.36 +/- 10.48 microg/l) (P < 0.001)]. The comparison of the treated and the untreated groups showed no significant differences at the beginning of the maintenance phase: 83.98 +/- 31.73 versus 86.35 +/- 40.75 nmol/l (33.59 +/- 12.69 versus 34.54 +/- 16.3 microg/l). At the end they differed significantly: 78.5 +/- 38.75 versus 53.4 +/- 26.2 nmol/l (31.4 +/- 15.5 versus 21.36 +/- 10.48 microg/l) (P < 0.001).. Vitamin D deficiency is present in a majority of haemodialysis patients. Supplementation with cholecalciferol is safe, well tolerated and reasonable to replenish vitamin D stores in haemodialysis patients. However, only 57% of patients achieved recommended calcidiol levels, thus favouring additional dose-finding studies.

Topics: Calcifediol; Cholecalciferol; Drug Tolerance; Female; Humans; Kidney Failure, Chronic; Male; Prospective Studies; Renal Dialysis; Vitamin D Deficiency

Data on the efficacy and safety of long-term vitamin D supplementation in chronic kidney disease (CKD) are scarce. We assessed the effects of the 12-month vitamin D(3) treatment on mineral metabolism and calciotropic hormones in patients with CKD stages 2-4.. Eighty-seven patients (mean age 66 years, men/women 33/54) were randomized to cholecalciferol treatment with either 5,000 or 20,000 IU/week. Serum calcium, phosphate, 25(OH)D(3), 1,25(OH)(2)D(3), PTH and urinary mineral concentrations were obtained at baseline and after 4, 8 and 12 months.. The median serum mineral concentrations were normal and not changed throughout the study. The number of hypercalciuric patients slightly increased with higher dose, but no sustained rise in calciuria was present. Vitamin D insufficiency/deficiency was revealed in 72 (83%) patients at baseline and 37 (43%) at month 12. The 25(OH)D(3) levels increased more with higher dose; a rise in 1,25(OH)(2)D(3) was less impressive. The parathyroid hormone (PTH) concentrations were reduced, but the number of subjects with PTH below the lower limit for CKD stage 3 increased equally with both doses.. Vitamin D insufficiency/deficiency in CKD significantly improved after the 12-month cholecalciferol treatment, with higher dose being more effective and equally safe. Further studies of vitamin D(3) effects on bone metabolism are warranted.

Topics: Aged; Cholecalciferol; Chronic Disease; Dietary Supplements; Female; Hormones; Humans; Kidney Diseases; Male; Minerals; Vitamin D Deficiency

We designed a randomized, double-blind, controlled clinical trial to compare the effect of two regimens for administering cholecalciferol on the serum 25-hydroxycholecalciferol [25(OH)D] levels and in the reversion of secondary hyperparathyroidism in the elderly living in a low-income housing unit in the city of Porto Alegre, southern Brazil. We studied 28 individuals ranging in age from 65 to 102 years with serum parathyroid hormone (PTH) levels greater than 48 pg/ml and normal or reduced serum calcium levels. Subjects were randomized to receive oral cholecalciferol, as a single dose of 300 000 IU (group 1) or 800 IU (group 2) daily for 9 months. Both groups received 1250 mg calcium carbonate per day. Serum 25(OH)D and PTH levels were measured at baseline and after 1, 2, 3, 6, and 9 months. Serum 25(OH)D levels in group 1 were significantly higher than in group 2 during the study (P < 0.001). After 1 (P < 0.001) and 2 (P < 0.04) months of treatment, mean serum 25(OH)D levels were higher in group 1. The number of subjects who reached serum 25(OH)D levels >/=20 ng/dl was higher in group 1, after the first (P < 0.001) and third (P = 0.008) months. In the short term, a single 300 000 IU oral dose of vitamin D(3) was more effective than 800 IU per day to increase serum 25(OH)D levels in elderly persons, living in a low-income housing unit, who were taking 500 mg elementary calcium supplement per day.

Topics: Aged; Aged, 80 and over; Bone Density Conservation Agents; Brazil; Calcifediol; Calcium, Dietary; Cholecalciferol; Dietary Supplements; Double-Blind Method; Humans; Hyperparathyroidism, Secondary; Parathyroid Hormone; Poverty; Public Housing; Vitamin D; Vitamin D Deficiency

to evaluate the effects of vitamin D supplementation on parathyroid function and bone turnover in aged, chronically immobile patients.. a randomised double-blind controlled trial.. two hundred and eighteen long-term inpatients aged over 65 years.. the patients were randomised into treatment groups of I-III, each receiving 0 IU, 400 IU and 1200 IU cholecalciferol per day, respectively. In case of inadequate consumption of dairy products, patients received a daily calcium substitution of 500 mg.. plasma concentrations of 25-hydroxyvitamin D (25-OHD), intact parathyroid hormone (PTH), amino-terminal propeptide of type I procollagen (PINP), a marker of bone formation, and carboxy-terminal telopeptide of type I collagen (ICTP), a marker of bone resorption, were measured at baseline and after 6 months.. the patients (age 84.5 years) were chronically bedridden. The baseline 25-OHD was low (23 nmol/l), correlated inversely with PINP, and tended to associate inversely with PTH. The prevalence of vitamin D deficiency (VDD) (25-OHD < 50 nmol/l) was 98% and PTH was elevated in 23% of the patients. Vitamin D supplementation significantly increased 25-OHD concentrations (124% group II, 204% group III) and decreased PTH (-7% group II, -8% group III). PINP tended to decrease, but ICTP tended to increase, and only their ratio decreased significantly. The tendency of ICTP to increase was inconsistent. Changes in 25-OHD correlated inversely with those in PTH and PINP.. vitamin D supplementation has minor effects on PTH and bone turnover in chronically immobilised aged patients with VDD. Further comparative studies and meta-analyses are warranted to elucidate the confounding effects of different mobility levels on the benefits of vitamin D supplementation in patients with differing baseline PTH levels.

Topics: Aged; Aged, 80 and over; Bed Rest; Bone Density; Calcium; Cholecalciferol; Collagen Type I; Dose-Response Relationship, Drug; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Long-Term Care; Male; Parathyroid Hormone; Peptide Fragments; Peptides; Procollagen; Reference Values; Treatment Outcome; Vitamin D; Vitamin D Deficiency

Severe vitamin D deficiency is common among Muslim immigrants. The dose necessary to correct the deficiency and its consequence for bone health are not known for immigrants. The aim was to assess the effect of relatively low dosages of supplemental vitamin D on vitamin D and bone status in Pakistani immigrants. This 1-year-long randomised double-blinded placebo-controlled intervention with vitamin D3 (10 and 20 microg/d) included girls (10.1-14.7 years), women (18.1-52.7 years) and men (17.9-63.5 years) of Pakistani origin living in Denmark. The main endpoints were serum 25-hydroxyvitamin D (S-25OHD), parathyroid hormone, bone turnover markers and bone mass. The study showed that supplementation with 10 and 20 microg vitamin D3 per d increased S-25OHD concentrations similarly in vitamin D-deficient Pakistani women (4-fold), and that 10 microg increased S-25OHD concentrations 2-fold and 20 microg 3-fold in Pakistani men. S-25OHD concentrations increased at 6 months and were stable thereafter. Baseline S-25OHD concentrations tended to be lower in girls and women than in men; females achieved about 46 nmol/l and men 55 nmol/l after supplementation. Serum intact parathyroid hormone concentrations decreased at 6 months, but there was no significant effect of the intervention on bone turnover markers and dual-energy X-ray absorptiometry measurements of the whole body and lumbar spine.

Topics: Adolescent; Adult; Age Factors; Amino Acids; Bone and Bones; Bone Density; Child; Cholecalciferol; Denmark; Dose-Response Relationship, Drug; Double-Blind Method; Emigrants and Immigrants; Female; Humans; Male; Middle Aged; Osteocalcin; Pakistan; Parathyroid Hormone; Sex Factors; Vitamin D; Vitamin D Deficiency; Young Adult

Hypovitaminosis D is common in Asian Indians. Physicians often prescribe 1500 mug (60 000 IU) cholecalciferol per week for 8 weeks for vitamin D deficiency in India. Its efficacy to increase serum 25-hydroxy vitamin D (25(OH)D) over short (2 months) and long (1 year) term is not known. We supplemented a group of twenty-eight apparently healthy Asian Indians detected to have low serum 25(OH)D (mean 13.5 (sd 3.0) nmol/l) on screening during January-March 2005. Serum parathyroid hormone (PTH) level was supranormal in 30 % of them. Oral supplementation included 1500 mug cholecalciferol per week and 1g elemental Ca daily for 8 weeks. Serum 25(OH)D, total Ca, inorganic P and intact (i) PTH were reassessed in twenty-three subjects (twelve females and eleven males) who had follow up at both 8 weeks and 1 year. At 8 weeks the mean 25(OH)D levels increased to 82.4 (sd 20.7) nmol/l and serum PTH normalized in all. Twenty-two of the twenty-three subjects had 25(OH)D levels>49.9 nmol/l. At 1 year, though the mean 25(OH)D level of 24.7 (sd 10.9) nmol/l was significantly higher than the baseline, all subjects were 25(OH)D deficient. Five subjects with supranormal iPTH at baseline showed recurrence of biochemical hyperparathyroidism. Thus, with 8 weeks of cholecalciferol supplementation in Asian Indians with chronic hypovitaminosis D, mean serum 25(OH)D levels would be normalized and serum PTH value would be reduced to half. However, such quick supplementation would not maintain their 25(OH)D levels in the sufficient range for 1 year. For sustained improvement in 25(OH)D levels vitamin D supplementation has to be ongoing after the initial cholecalciferol loading.

Topics: Adult; Analysis of Variance; Asian People; Biomarkers; Calcium; Cholecalciferol; Chronic Disease; Dietary Supplements; Female; Follow-Up Studies; Humans; India; Male; Parathyroid Hormone; Phosphorus; Rickets; Time Factors; Vitamin D; Vitamin D Deficiency

There is much interest in dosing vitamin D intermittently for patient convenience and long-term adherence.. The objective was to characterize the time course and response of 25-hydroxyvitamin D (calcidiol) to a large oral dose of cholecalciferol.. One group (30 subjects) was supplemented with a single oral dose of 100,000 IU cholecalciferol. A second group (10 subjects) served as a control group to assess the seasonal change of calcidiol. Serum calcidiol concentrations were followed for 4 mo. The subjects were healthy with limited sun exposure (<10 h/wk) and milk consumption (<0.47 L daily). We excluded subjects with granulomatous conditions, liver disease, kidney disease, or diabetes and subjects taking anticonvulsants, barbiturates, or steroids.. Serum calcidiol rose promptly after cholecalciferol dosing from a mean (+/-SD) baseline of 27.1 +/- 7.7 ng/mL to a concentration maximum of 42.0 +/- 9.1 ng/mL. Seven percent of the supplemented cohort failed to achieve 32.1 ng/mL at any time point. The highest achieved concentration in any subject was 64.2 ng/mL. The control group had a nonsignificant change from baseline of -0.72 +/- 0.80 ng/mL during 4 mo.. Cholecalciferol (100,000 IU) is a safe, effective, and simple way to increase calcidiol concentrations. The dosing interval should be < or =2 mo to ensure continuous serum calcidiol concentrations above baseline. This trial was registered at www.clinicaltrials.gov as #NCT00473239.

Topics: Adult; Aged; Aged, 80 and over; Animals; Area Under Curve; Bone Density Conservation Agents; Cholecalciferol; Cohort Studies; Dietary Supplements; Dose-Response Relationship, Drug; Female; Humans; Male; Middle Aged; Milk; Patient Compliance; Radioimmunoassay; Seasons; Skin Pigmentation; Sunlight; Vitamin D; Vitamin D Deficiency; White People

Reports on the dose response to vitamin D are conflicting, and most data were derived from white men and women.. The objective was to determine the response of serum 25-hydroxyvitamin D [25(OH)D] to oral vitamin D(3) supplementation in an African American population.. Healthy black postmenopausal women (n = 208) participated in a vitamin D(3) supplementation trial for a period of 3 y. Analyses were done in the vitamin D supplementation arm (n = 104) to quantify the response in serum 25-hydroxyvitamin D concentrations at a steady state vitamin D input. The participants received 20 microg/d (800 IU) oral vitamin D(3) for the initial 2 y and 50 microg/d (2000 IU) for the third year.. Supplementation with 20 microg/d (800 IU/d) vitamin D(3) raised the mean serum 25(OH)D concentration from a baseline of 46.9 +/- 20.6 nmol/L to 71.4 +/- 21.5 nmol/L at 3 mo. The mean (+/-SD) concentration of serum 25(OH)D was 87.3 +/- 27.0 nmol/L 3 mo after supplementation increased to 50 microg/d (2000 IU/d). All participants achieved a serum 25(OH)D concentration >35 nmol/L, 95% achieved a concentration >50 nmol/L, but only 60% achieved a concentration >75 nmol/L. All patients had concentrations <153 nmol/L. On the basis of our findings, an algorithm for prescribing vitamin D so that patients reach optimal serum concentrations was developed. The algorithm suggests a dose of 70 microg (2800 IU/d) for those with a concentration >45 nmol/L and a dose of 100 microg (4000 IU/d) for those with a concentration <45 nmol/L.. Supplementation with 50 microg/d (2000 IU/d) oral vitamin D(3) is sufficient to raise serum 25-hydroxyvitamin D concentrations to >50 nmol/L in almost all postmenopausal African American women. However, higher doses were needed to achieve concentrations >75 nmol/L in many women in this population.

Topics: Algorithms; Black or African American; Calcium; Cholecalciferol; Cohort Studies; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Longitudinal Studies; Middle Aged; Parathyroid Hormone; Vitamin D; Vitamin D Deficiency

Topics: Cholecalciferol; Dietary Supplements; Humans; Infant; Patient Compliance; Switzerland; Taste; Vitamin D Deficiency

To assess the feasibility of administering an inexpensive preparation of vitamin D(3) 100 000 IU orally 3 monthly to aged-care residents.. Prospective, controlled open-label implementation trial.. Residential aged care, November 2003 to May 2004 (primary study).. 137 ambulant residents: 107 treated (mean age, 85 years; 79 were women), 30 untreated controls (mean age, 87 years; 22 were women).. Lactose microencapsulated vitamin D(3) 100 000 IU orally at baseline, then 3 monthly (three or more doses); untreated subjects were observed contemporaneously.. Serum levels of 25-hydroxyvitamin D [25(OH)D] at 6 months compared with baseline; acceptability of the program to residents and staff.. At baseline, 95% of residents assessed (n = 137) had serum 25(OH)D levels below the desirable range of 60-160 nmol/L. At 6 months, all treated residents (n = 98) achieved desired levels, with the mean (+/- SD) 25(OH)D level increasing from 36.4 +/- 12.6 nmol/L (range, 12-75 nmol/L) at baseline to 124.0 +/- 27.9 nmol/L (range, 68-244 nmol/L). In no resident did 25(OH)D approach toxic levels. The mean serum 25(OH)D level remained low in the control group (n = 27): 42.8 +/- 18.3 nmol/L (range, 18-98 nmol/L). The difference between the mean 25(OH)D levels of treatment and control groups at 6 months was 81.2 nmol/L (95% CI, 69.7-92.0 nmol/L). The cost of the supplement was $4 per resident per annum. Substudies showed mean trough serum 25(OH)D levels in the desired range at 3 months (n = 31), but below the desired range at 6 months (n = 50). Subjects given 3-monthly doses for up to 2 years maintained serum 25(OH)D levels within the desired range, with no trend toward undesirable accumulation (n = 11).. Vitamin D(3) 100 000 IU given orally 3 monthly is a practical, safe, effective and inexpensive way to meet the vitamin D(3) requirements of aged-care residents.

Topics: Administration, Oral; Aged; Aged, 80 and over; Cholecalciferol; Feasibility Studies; Female; Homes for the Aged; Humans; Male; Prospective Studies; Surveys and Questionnaires; Vitamin D; Vitamin D Deficiency

Vitamin D insufficiency poses a problem in many parts of the world, the elderly being an especially vulnerable group. This insufficiency results from an inadequate amount of sunshine and a low dietary intake of vitamin D. Typically, insufficiency is accompanied with high intact parathyroid hormone, (S-iPTH) concentrations.. We studied how serum 25-hydroxy vitamin D (S-25-OHD) concentrations respond to different doses of vitamin D3 supplementation. Secondly to determine the smallest efficient dose to maintain serum 25-OHD concentration above the insufficiency level. We also studied which dose would be efficient in decreasing S-iPTH concentration in these subjects.. Forty-nine 65- to 85-year-old women participated. The women were randomly assigned into one of four groups receiving 0 (placebo), 5, 10 or 20 microg of vitamin D3 daily for 12 weeks. Fasting morning blood was drawn at the beginning of the study, and thereafter every second week. Calciotropic variables were assessed from serum and urine samples.. The S-25-OHD concentration increased significantly (p < 0.001) in all supplemented groups [5 microg: by 10.9 (8.5) nmol/L, 10 microg: by 14.4 (6.9) nmol/L, 20 microg: by 23.7 (11.9) nmol/L], whereas it decreased in the placebo group by 8.3 (13.2) nmol/L. Equilibrium in S-25-OHD concentration was reached in all groups after 6 weeks of supplementation at 57.7 (8.9) nmol/L, 59.9 (8.9) nmol/L and 70.9 (8.9) nmol/L in the groups with increasing vitamin D supplementation. The dose-response to supplementation decreased with increasing vitamin D status at baseline, r = -0.513, p = 0.002. S-iPTH tended to decrease in those with highest dose response to supplementation.. A clear dose response was noted in S-25-OHD to different doses of vitamin D3. The recommended dietary intake of 15 microg is adequate to maintain the S-25-OHD concentration around 40-55 nmol/L during winter, but if the optimal S-25-OHD is higher than that even higher vitamin D intakes are needed. Interestingly, subjects with lower vitamin D status at baseline responded more efficiently to supplementation than those with more adequate status.

Topics: Aged; Aged, 80 and over; Cholecalciferol; Dose-Response Relationship, Drug; Female; Geriatric Assessment; Humans; Nutrition Assessment; Nutritional Requirements; Parathyroid Hormone; Seasons; Sunlight; Vitamin D; Vitamin D Deficiency; Vitamins

To evaluate the efficacy and safety of an annual intramuscular injection of cholecalciferol for vitamin D deficiency.. Prospective open-label study.. Five men and 45 women (mean age 66.3 years) with vitamin D deficiency who were given a single therapeutic intramuscular injection of 600 000 IU (15 mg) cholecalciferol (vitamin D(3)).. Serum levels of calcium, creatinine, 25-hydroxyvitamin D(3) (25OHD(3)) and parathyroid hormone, as well as early morning 2-hour urine calcium/creatinine excretion index. Specimens were collected at baseline and after 4 and 12 months of therapy. Data are reported as mean +/- 1 SD.. Vitamin D deficiency was severe (< 12.5 nmol/L) in one participant, moderate (12.5-24 nmol/L) in 14, and mild (25-49 nmol/L) in 35. Twenty-four participants (48%) had secondary hyperparathyroidism. Following intramuscular cholecalciferol injection, serum 25OHD(3) levels normalised in all participants and remained above 50 nmol/L throughout the study. Serum 25OHD(3) levels were significantly higher at 4 months (114 +/- 35 nmol/L), and 12 months (73 +/- 13 nmol/L) compared with baseline (32 +/- 8 nmol/L) (P < 0.001), increasing by an average of 128% over the 12 months. There was a corresponding decrease in serum parathyroid hormone levels at 4 months (6 +/- 3 pmol/L) and at 12 months (5.2 +/- 3 pmol/L), with a 30% decrease at 12 months from baseline (7.4 +/- 4 pmol/L) (P < 0.01). Primary hyperparathyroidism was unmasked in one participant at 4 months and mild hypercalcaemia (serum calcium, < 2.70 mmol/L) was noted in two participants (4%) at 12 months. Serum creatinine levels remained normal in all participants throughout the study, while increases in 2-hour urine calcium/creatinine excretion index were seen in 10 participants (20%) at 12 months, three of whom had had elevated values at baseline.. Once-yearly intramuscular cholecalciferol injection (600 000 IU) is effective therapy for vitamin D deficiency. While this therapy appears to be safe, the potential for developing hypercalciuria needs to be examined in a large randomised controlled trial.

Topics: Adult; Aged; Aged, 80 and over; Calcium; Cholecalciferol; Creatinine; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Humans; Hyperparathyroidism, Secondary; Injections, Intramuscular; Male; Middle Aged; Parathyroid Hormone; Prospective Studies; Treatment Outcome; Vitamin D; Vitamin D Deficiency

This article presents the results of an evaluation of the clinical and laboratory safety of a 1-year course of treatment with a combination calcium and vitamin D tablet in ambulatory women aged >65 years with vitamin D insufficiency.. In a multicenter, randomized, double-blind, placebo-controlled study conducted in France, women with a 25-hydroxyvitamin D level < or =12 ng/mL were randomized to receive either a combination tablet containing calcium carbonate 500 mg and vitamin D3 400 IU taken twice daily or a matching placebo tablet for 1 year. A complete clinical examination was performed at baseline and at 3, 6, 9, and 12 months of treatment; blood and urine samples were collected for laboratory analyses at the same time points. Safety was monitored based on adverse events recorded during the treatment period and on the results of laboratory tests, including measurement of creatinine and uric acid levels.. The study included 192 women (mean [SD] age, 74.6 [6.9] years; mean weight, 64.0 [12.5] kg), 95 in the calcium + vitamin D group and 97 in the placebo group. Fifty women (21/95 [22.1%] calcium + vitamin D, 29/96 [30.2%] placebo) were prematurely withdrawn from the study for various reasons, with no difference in withdrawals between groups. Treatment-related adverse events were reported in 21 (22.1%) and 23 (24.0%) women in the respective treatment groups. These events consisted mainly of metabolic disorders (9 [9.5%] and 10 [10.4%], respectively), particularly hypercalcemia (6 [6.3%] and 8 [8.3%]) and gastrointestinal disorders (9 [9.5%] and 8 [8.3%]). No major complications directly related to calcium and vitamin D supplementation occurred during the course of treatment. Although renal function was not altered, the group who received calcium + vitamin D had significantly elevated concentrations of serum uric acid compared with those who received placebo (52.3% vs 37.2%; P = 0.046) but not urinary uric acid.. In these ambulatory elderly women with vitamin D deficiency, supplementation with calcium + vitamin D appeared to be well tolerated over 1 year of treatment. No significant effects on creatinine clearance were observed. However, the proportion of women with elevated serum uric acid concentrations was significantly greater in those who received calcium + vitamin D compared with those who received placebo.

Topics: Aged; Bone Density Conservation Agents; Calcium; Calcium Carbonate; Cholecalciferol; Creatine; Dietary Supplements; Double-Blind Method; Drug Combinations; Female; Humans; Parathyroid Hormone; Treatment Outcome; Uric Acid; Vitamin D Deficiency

Scientific data pertaining to vitamin D supplementation during lactation are scarce. The daily recommended intake for vitamin D during lactation has been arbitrarily set at 400 IU/d (10 microg/d). This recommendation is irrelevant with respect to maintaining the nutritional vitamin D status of mothers and nursing infants, especially among darkly pigmented individuals. Our objective was to examine the effect of high-dose maternal vitamin D2 supplementation on the nutritional vitamin D status of mothers and nursing infants. Fully lactating women (n = 18) were enrolled at 1 mo after birth to 1 of 2 treatment arms, ie, 1600 IU vitamin D2 and 400 IU vitamin D3 (prenatal vitamin) or 3600 IU vitamin D2 and 400 IU vitamin D3, for a 3-mo study period. High-dose (1600 or 3600 IU/d) vitamin D2 supplementation for a period of 3 mo safely increased circulating 25-hydroxyvitamin D [25(OH)D] concentrations for both groups. The antirachitic activity of milk from mothers receiving 2000 IU/d vitamin D increased by 34.2 IU/L, on average, whereas the activity in the 4000 IU/d group increased by 94.2 IU/L. Nursing infant circulating 25(OH)D2 concentrations reflected maternal intake and the amount contained in the milk. With limited sun exposure, an intake of 400 IU/d vitamin D would not sustain circulating 25(OH)D concentrations and thus would supply only limited amounts of vitamin D to nursing infants in breast milk. A maternal intake of 2000 IU/d vitamin D would elevate circulating 25(OH)D concentrations for both mothers and nursing infants, albeit with limited capacity, especially with respect to nursing infants. A maternal intake of 4000 IU/d could achieve substantial progress toward improving both maternal and neonatal nutritional vitamin D status.

Topics: Adult; Cholecalciferol; Dietary Supplements; Dose-Response Relationship, Drug; Ergocalciferols; Female; Humans; Infant; Infant Nutritional Physiological Phenomena; Infant, Newborn; Lactation; Maternal Nutritional Physiological Phenomena; Milk, Human; Nutrition Policy; Nutritional Requirements; Vitamin D; Vitamin D Deficiency

The first part of this study consisted of an 18 month follow-up of the vitamin D status and parathyroid function in a group of 54 French male adolescents, aged from 13 to 16 years old and all pupils of a jockey training school. During the 18 month period four samplings were made, one every 6 months. The first was during September of the first year, the second and third during March and October of the second year, and the last in March of the third year. Therefore we had two main periods: summer and winter. The summer 25-hydroxyvitamin D (25(OH)D) concentrations were higher (71.6 +/- 19.9 and 52.4 +/- 16.5 nmol/l) than the winter ones (20.4 +/- 6.9 and 21.4 +/- 6.1 nmol/l). Conversely, the winter intact parathyroid hormone (iPTH) serum levels (4.18 +/- 1.18 and 4.11 +/- 1.35 pmol/l) were higher than the summer ones (2.44 +/- 0.82 and 2.71 +/- 0.71 pmol/l). At the two winter time points the 25(OH)D concentrations were lower than 25 nmol/l (10 ng/ml) in 72% (2nd year) and 68% (3rd year) of the adolescents. In the second part of the study we tried a vitamin D3 supplementation procedure designed to maintain the 25(OH)D and iPTH postsummer serum levels throughout the winter. Pairs of male adolescents matched for height, weight and Tanner pubertal stage were randomly assigned to either vitamin D3 supplementation (2.5 mg, i.e., 100,000 IU) administered orally at three specific periods (end of September, November and January) or no vitamin D3 treatment (control subjects). Blood was collected just before the first intake of vitamin D3 and 2 months after the last intake (March). The control subjects had blood drawn at the same time points. In the vitamin D3-treated subjects, the concentrations of 25 (OH)D (55.3 +/- 11.5 nmol/l) and of iPTH (3.09 +/- 1.16 pmol/l) in March and September (53.8 +/- 12.3 nmol/l and 2.75 +/- 1.26 pmol/l) were not significantly different. In the control subjects, March 25(OH)D levels (21.0 +/- nmol/l were low, with values below 25 nmol/l in 78% of subjects, and iPTH concentrations (3.97 +/- 1.08 pmol/l) were significantly (p<0.001) higher than in September (2.91 +/- 0.81 pmol/l). The constant vitamin D wintertime deficiency and wintertime rise in iPTH in adolescent French males throughout puberty has been demonstrated. In adolescents with low dairy calcium intakes, the vitamin D3 treatment was sufficient to maintain 25(OH)D concentrations at their summer levels throughout winter and to prevent an excessive wintertime rise in iPTH levels.

Topics: Adolescent; Biomarkers; Case-Control Studies; Cholecalciferol; Follow-Up Studies; Humans; Male; Parathyroid Hormone; Puberty; Seasons; Vitamin D; Vitamin D Deficiency

Recent studies have shown a high prevalence of calcium and vitamin D deficiencies in adolescents. The aim of this present study was to follow the changes in calcium status and 25 hydroxyvitamin D (25[OH]D) and parathyroid hormone (iPTH) levels during winter in preadolescents and adolescents from four university hospitals in northern France.. Two groups of teenagers and adolescents (range: 10-15 years) were followed from October 1996 to June 1997. They were given either 100,000 IU of vitamin D (treated group n = 33) or a placebo (control group n = 35) in October, January and April. Serum calcium, phosphate, 25(OH)D and iPTH levels were measured at inclusion and every three months thereafter.. At inclusion, plasma or serum 25(OH)D levels were < or = 10 ng/mL in 16 subjects and < 6 ng/mL in six. In control children, no significant change in 25(OH)D occurred during the study, while plasma or serum iPTH levels increased to 34 +/- 11 pg/mL. In the treated groups, 25(OH)D levels remained > 20 ng/mL in every subject; no hypercalcemia was observed; and the mean plasma or serum iPTH level was 25 +/- 14 pg/mL at the end of the study.. Teenagers presented with a high prevalence of biological vitamin D deficiency at the end of summer. The increase of iPTH during winter in the unsupplemented group suggests that this has secondary consequences on their calcium homeostasis unless they are supplemented with vitamin D. We advocate a sufficient calcium supply and a 100,000 IU vitamin D supplement given two or three times during winter to preadolescents and adolescents living in northern France.

Topics: Adolescent; Calcifediol; Calcium; Calcium, Dietary; Child; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Follow-Up Studies; France; Homeostasis; Humans; Male; Parathyroid Hormone; Phosphates; Placebos; Prevalence; Seasons; Vitamin D Deficiency

Supplementation of elderly institutionalized women with vitamin D and calcium decreased hip fractures and increased hip bone mineral density. Quantitative ultrasound (QUS) measurements can be performed in nursing homes, and easily repeated for follow-up. However, the effect of the correction of vitamin D deficiency on QUS parameters is not known. Therefore, 248 institutionalized women aged 62-98 years were included in a 2-year open controlled study. They were randomized into a treated group (n = 124), receiving 440 IU of vitamin D3 combined with 500 mg calcium (1250 mg calcium carbonate, Novartis) twice daily, and a control group (n = 124). One hundred and three women (42%), aged 84.5 +/- 7.5 years, completed the study: 50 in the treated group, 53 in the controls. QUS of the calcaneus, which measures BUA (broadband ultrasound attenuation) and SOS (speed of sound), and biochemical analysis were performed before and after 1 and 2 years of treatment. Only the results of the women with a complete follow-up were taken into account. Both groups had low initial mean serum 25-hydroxyvitamin D levels (11.9 +/- 1.2 and 11.7 +/- 1.2 micrograms/l; normal range 6.4-40.2 micrograms/l) and normal mean serum parathyroid hormone (PTH) levels (43.1 +/- 3.2 and 44.6 +/- 3.5 ng/l; normal range 10-70 ng/l, normal mean 31.8 +/- 2.3 ng/l). The treatment led to a correction of the metabolic disturbances, with an increase in 25-hydroxyvitamin D by 123% (p < 0.01) and a decrease in PTH by 18% (p < 0.05) and of alkaline phosphatase by 15% (p < 0.01). In the controls there was a worsening of the hypovitaminosis D, with a decrease of 25-hydroxyvitamin D by 51% (p < 0.01) and an increase in PTH by 51% (p < 0.01), while the serum calcium level decreased by only 2% (p < 0.01). After 2 years of treatment BUA increased significantly by 1.6% in the treated group (p < 0.05), and decreased by 2.3% in the controls (p < 0.01). Therefore, the difference in BUA between the treated subjects and the controls (3.9%) was significant after 2 years (p < 0.01). However, SOS decreased by the same amount in both groups (approximately 0.5%). In conclusion, BUA, but not SOS, reflected the positive effect on bone of supplementation with calcium and vitamin D3 in a population of elderly institutionalized women.

Topics: Aged; Aged, 80 and over; Bone and Bones; Bone Density; Calcium; Cholecalciferol; Female; Homes for the Aged; Humans; Hyperparathyroidism, Secondary; Institutionalization; Longitudinal Studies; Middle Aged; Ultrasonography; Vitamin D Deficiency

To assess markers of bone metabolism in two groups of inpatients with hypovitaminosis D and elevated PTH levels receiving two different vitamin D medications.. 26 patients with secondary hyperparathyroidism (2 degrees HP) were treated either with 800 IU cholecalciferol and 1000 mg calcium or 0.5 microgram calcitriol plus 500 mg calcium daily for 6 months. 25-OH-vitamin D3, 1,25-dihydroxy-vitamin D3, intact PTH, calcium and urinary N-telopeptides of bone collagen I were measured at baseline, 3 and 6 months.. PTH levels decreased earlier in the calcitriol group than in the cholecalciferol group. After six month no difference could be documented. Lowering of urinary N-telopeptides excretion was observed in both groups.. The use of both forms of vitamin D supplementation appears to be useful for patients with hypovitaminosis D, elevated PTH levels and high telopeptide excretion.

Topics: Administration, Oral; Aged; Aged, 80 and over; Calcitriol; Calcium; Cholecalciferol; Cohort Studies; Collagen; Collagen Type I; Female; Humans; Male; Parathyroid Hormone; Peptides; Time Factors; Vitamin D Deficiency

The objective of this study was to compare the effect of ultraviolet radiation (UV) and oral vitamin D3 on the vitamin D status and parathyroid hormone (PTH) concentration in elderly nursing home patients. The design of the study was a randomized clinical trial. The setting was a psychogeriatric nursing home. Subjects included 45 female psychogeriatric patients with a mean age of 85 years. Exclusion criteria were going outdoors more than once a week and the presence of actinic or cancer skin lesions. Intervention was random allocation of UV-B irradiation at half the minimal erythemal dose of the lower back, three times per week during 12 weeks (UV-B), or oral vitamin D3 400 IU/day during 12 weeks (VIT-D), or no treatment (CONTR). Main outcome measures were change in fasting serum levels of vitamin D metabolites at 0, 2, 4, 8, and 12 weeks in the treatment groups, compared with the control group. PTH(1-84) was measured at 0 and 12 weeks. Baseline serum 25-hydroxyvitamin D (25(OH)D) was lower than 30 nmol/l in 95% of the participants. It increased to a median value of around 60 nmol/l after 12 weeks both in the UV-B and VIT-D groups, whereas there was no change in the CONTR group. Serum 1,25-dihydroxyvitamin D increased significantly in the UV-B group. Serum calcium increased significantly in both treatment groups. Serum PTH decreased more than 30% in both treatment groups (p < 0.001), whereas there was no significant change in the control group. Irradiation with UV-B in the very elderly for a few minutes per day leads to adequate improvement of the vitamin D status. It is as effective as oral vitamin D3 in increasing serum 25(OH)D and suppressing secondary hyperparathyroidism.

Topics: Administration, Oral; Aged; Aged, 80 and over; Calcium; Cholecalciferol; Female; Humans; Hyperparathyroidism, Secondary; Netherlands; Nursing Homes; Parathyroid Hormone; Ultraviolet Rays; Vitamin D; Vitamin D Deficiency

Recently, 25 hydroxyvitamin D (25 OHD) blood concentrations measured in adolescents during or at the end of winter were found very low. A concomitant stimulation of parathyroid function was observed. The aim of the present study was to test the biological effects of a treatment with vitamin D3 during winter.. The effects of vitamin D3 supplementation (100,000 IU, twice, at the end of November and of January) were assessed in 24 male Caucasian adolescents (mean age +/- SD: 14 y 6 m +/- 9 m). They were pupils in a lad-jockeys training center located in the countryside near Chantilly (49 degrees northern latitude). Blood concentrations of 25 OHD, calcium and intact parathormone (PTH) were measured three times: before each oral intake of vitamin D3 and 2 months after the last intake (March). A group of 32 male adolescents (mean age +/- SD: 14 y 9 m +/- 6 m), pupils in the same center, receiving no vitamin D and sampled in November and in March, served as controls.. In March, mean concentrations of 25 OHD (8.36 +/- 2.73 micrograms/L) were very low in vitamin D-not supplemented adolescents since 34% had levels less than 6 micrograms/L. In March, PTH concentrations (40.5 +/- 12.2 ng/L) were significantly (P = 0.0001) higher than in November (28.8 +/- 9.9 ng/L). In boys receiving vitamin D3 25 OHD serum concentrations measured in January (17.5 +/- 3.2 micrograms/L) and in March (18.7 +/- 4.0 micrograms/L) remained at a level not very different from that measured in November (16.6 +/- 3.8 micrograms/L). During the same period, calcium and PTH concentrations (32.2 +/- 11.7 ng/L in November; 32.4 +/- 14.3 in January and 32.9 +/- 13.5 ng/L in March) remained at their basal level as well.. The observation that, after winter, a relatively large number of adolescents presented low concentrations of 25 OHD suggests that, during winter, usual dietary intakes and/or vitamin D stores are not sufficient to provide for their needs. Administration of two oral doses of 100,000 IU of vitamin D3 could maintain the vitamin D status at its initial level. The efficiency of such a prophylactic treatment is also assessed by its effect on parathyroid function.

Topics: Adolescent; Cholecalciferol; Cross-Sectional Studies; France; Humans; Incidence; Male; Seasons; Vitamin D Deficiency

Recent findings have shown that bisphosphonates had different effects on the urinary excretion of free and peptide-bound cross-links. Because of this discrepancy, we investigated the effects of another antiresorptive therapy, i.e. vitamin D (vitD) and calcium (Ca) supplementation (800 IU vit D3 and 1 g elemental calcium daily for 6 months) in elderly women (n = 21, age: 83.5 +/- 1.5 yr) with vitD insufficiency and secondary hyperparathyroidism (mean level 25 hydroxy vitamin D = 3.17 +/- 1.2 ng/mL, mean level of intact parathormone = 45.3 +/- 22.7 pg/mL) on the urinary excretion of free and peptide-bound cross-links. A group of free-living, healthy elderly women (n = 25, age: 76.6 +/- 3.1 yr) with a normal vitD status (mean level of 25 OH D = 23.4 +/- 8.9 ng/mL, intact parathormone = 30.2 +/- 11.2 pg/mL) was simultaneously studied. Bone resorption was assessed by total (T), free (F), peptidyl (P) hydroxylysylpyridinoline (HP) and lysylpyridinoline (LP) measured with high performance liquid chromatography, by F-LP determined with enzyme linked immunosorbent assay (iF-LP) and by the N- and C-terminal telopeptides of type I collagen (NTX and Cross-laps) before and after (3 and 6 months) therapy. Comparison of the two groups of elderly women at baseline showed that the urinary excretion of pyridinoline cross-links (T, F, and peptide-bound forms) and of telopeptide fragment of type I collagen were all increased in patients with a low vitD status. Highly significant differences were seen principally for T-HP, F-HP, and F-LP (P < 0.001). Correlation studies between each marker showed that the values of pyridinoline cross-links (T and peptide-bound forms) and of the telopeptide fragments of type I collagen correlated well, but the correlation was slightly less pronounced between free pyridinolines and the other markers. After treatment, the response to therapy was greatest for peptide-bound cross-links assessed by high performance liquid chromatography and for telopeptide fragments of type I collagen (percent change at 6 months: -21% for P-HP P < 0.05, -26% for P-LP P < 0.05, -31% for NTX P < 0.01, and -51% for CLaps P < 0.001). In contrast, free pyridinolines excretion (F-HP and F-LP) assessed by high performance liquid chromatography as well as by immunoassay remained unchanged at 3 and 6 months. Because marked and significant changes were seen with peptide-bound cross-links only and not with free forms, we conclude that vitD and Ca therapy has the same effects

Topics: Aged; Aged, 80 and over; Amino Acids; Biomarkers; Bone Resorption; Calcifediol; Calcium; Cholecalciferol; Chromatography, High Pressure Liquid; Collagen; Collagen Type I; Enzyme-Linked Immunosorbent Assay; Female; Humans; Hyperparathyroidism; Parathyroid Hormone; Peptides; Vitamin D Deficiency

A possible role for vitamin D deficiency in contributing to the winter increase in cardiovascular disease mortality was investigated by testing the effect of vitamin D supplementation on blood pressure and other cardiovascular risk factors during winter.. Randomised double-blind trial of vitamin D supplementation in winter.. Men and women, mean age 70 years (range 63-76) recruited from general practitioner age-sex registers in Cambridge (UK).. 95 people received a single oral dose of 2.5 mg cholecalciferol and 94 received the placebo at baseline interviews during December 1991. Follow-up assessment was 5 weeks later during January 1992.. Comparing follow-up with baseline assessment, serum 25-hydroxyvitamin D increased in the treated group and decreased slightly in the placebo group [mean (s.d.) change: 7.2 (+/- 3.8) vs -1.4 (+/- 1.1) ng/ml, P = 0.0001]; while parathyroid hormone decreased in the treated, and increased in the placebo, group [-0.27 (+/- 0.78) vs 0.13 (+/- 0.75) pmol/l, P = 0.0004]. However, the mean change in blood pressure was similar in both groups: systolic -5 (+/- 13) vs -5 (+/- 16) mmHg, P = 0.81; diastolic -1 (+/- 9) vs -1 (+/- 9), P = 0.92; as was the mean change in serum cholesterol [-0.07 (+/- 0.52) vs -0.05 (+/- 0.60) mmol/l, P = 0.81]. In contrast, the mean change in radial pulse was significantly decreased in the treated group compared with placebo [-2 (+/- 9) vs 1 (+/- 7) beats per min, P = 0.030].. The failure of vitamin D supplementation to change blood pressure or serum cholesterol suggests that the winter increase in these factors is not caused by decreased vitamin D levels.

Topics: Aged; Cardiovascular Diseases; Cholecalciferol; Double-Blind Method; Female; Follow-Up Studies; Humans; Male; Middle Aged; Risk Factors; Seasons; Vitamin D Deficiency

Supplementation with 800 IU of vitamin D and 1 g of calcium each day is recommended in institutionalized elderly subjects to prevent secondary hyperparathyroidism and its adverse skeletal effects. An original formulation (IDEOS) combining vitamin D and calcium has been developed for use in this end. The aim of this study was to determine whether administration of this association, of which each tablet contains 500 mg calcium and 400 IU vitamin D3, produces the same beneficial effects on laboratory parameters as separate administration of both active agents. A multicenter randomized study was conducted in 91 elderly institutionalized subjects (mean age 83.1 years) who had vitamin D deficiency [25-(OH)D < 6 ng/ml] without severe renal failure. Subjects were randomly assigned to one of the two treatment groups. Treatment duration was six months. One group (G1, n = 46) received one tablet of the new formulation twice daily. The other (G2, n = 45) received 8 drops of vitamin D3 (800 IU/day) and one calcium carbonate 500 mg tablet twice daily. Blood tests were carried out at inclusion and after three and six months of treatment. In group G1, plasma 25-(OH)D levels increased from 2.6 ng/ml at inclusion to 14.6 ng/ml at month 6 (p < 0.001), and iPTH fell from 63.2 pg/ml at inclusion to 33.8 pg/ml at month 6 (p < 0.001). In group G2, 25-(OH)D rose from 2.8 ng/ml at inclusion to 13.5 ng/ml at month 6 (p < 0.001), and iPTH fell from 55.4 pg/ml at inclusion to 32.5 pg/ml at month 6 (p < 0.001).(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Aged; Aged, 80 and over; Alkaline Phosphatase; Calcium; Calcium Carbonate; Cholecalciferol; Creatinine; Drug Administration Schedule; Drug Combinations; Drug Therapy, Combination; Female; Humans; Hydroxycholecalciferols; Hyperparathyroidism, Secondary; Male; Parathyroid Hormone; Vitamin D Deficiency

Serum 25-hydroxyvitamin D [25(OH)D], calcium, phosphorus, and alkaline phosphatase activities were measured from birth to 6-9 mo of age in 60 healthy neonates to assess the effectiveness and potential toxicity of three intermittent oral doses of cholecalciferol. Two weeks after a first dose of 15, 5, or 2.5 mg, 25(OH)D concentrations reached 307 +/- 160, 150 +/- 55, and 92 +/- 42 nmol/L, respectively. Prolonged vitamin D overload, up to 6 mo, was found in 50% of the children given 15 mg, but not in the other infants. Serum calcium transiently increased 2 wk after 15 mg but not after the lower doses. Oral doses of 2.5 mg given every 3 mo appear to provide the best protection against vitamin D deficiency and vitamin D overload in high-risk infant populations that are unsuitable for daily vitamin D supplementation.

Topics: 25-Hydroxyvitamin D 2; Administration, Oral; Alkaline Phosphatase; Calcifediol; Calcium; Cholecalciferol; Dose-Response Relationship, Drug; Drug Administration Schedule; Humans; Infant, Newborn; Longitudinal Studies; Phosphorus; Vitamin D Deficiency

A clinical trial carried out during the autumn/winter season in 46 institutionalized elderly subjects (35 women, 11 men) (group mean age = 83 +/- 2 years) revealed a severe deficiency in vitamin D in these subjects (25-hydroxyvitamin D level less than or equal to 3 ng/ml). After oral administration of 100,000 IU of vitamin D3, an increase in 25-hydroxyvitamin D levels above the 10 ng/ml threshold was observed and maintained for three months. A second dose, administered after 3 months, made it possible to sustain this level. No sign of toxicity was detected, notably no trace of hypercalcemia. In contrast, no change in the deficit (25-hydroxyvitamin D level less than or equal to 3 ng/ml) was seen in the placebo population. Three-monthly administration of the moderate dosage of 100,000 IU of vitamin D3 all year round would offer a simple, effective and risk-free system to counteract vitamin D deficiency in the elderly and of preventing the risk of osteomalacia, thus reducing the incidence of fractures.

Topics: Administration, Oral; Aged; Aged, 80 and over; Cholecalciferol; Drug Evaluation; Female; Fractures, Spontaneous; Humans; Hydroxycholecalciferols; Male; Osteomalacia; Vitamin D Deficiency

A poor vitamin D status is common in the elderly during the winter months. Because it is possible that hypovitaminosis D may be a cause of senile osteopenia, a simple method of prophylaxis would be useful. The single, oral, high-dose method was tested in two old-age homes, and the efficacy of vitamin D3 was compared with that of 25-hydroxyvitamin D3 (25-OHD3). The trials showed that 25-OHD3 caused a higher peak value in the serum 25-OHD levels in the second week than did vitamin D3. However, follow-up after four to five months showed that in those patients who received a single, oral dose of 25-OHD3, the serum 25-OHD levels had returned to the baseline low values, whereas in those patients who had had oral vitamin D3, the serum 25-OHD levels still remained significantly raised compared with the baseline values and were within normal limits. It is concluded that the single, oral, high-dose method using vitamin D3 is a safe and simple method of prophylaxis and could be used easily in large populations of elderly persons.

Topics: Aged; Calcifediol; Cholecalciferol; Clinical Trials as Topic; Female; Homes for the Aged; Humans; Intestinal Absorption; Male; Seasons; Time Factors; Vitamin D Deficiency

A vitamin D deficiency was observed in 22 women and 6 men aged 66 to 94 years, hospitalised in a long-stay department in the Paris region for an average of 5 years and incapable of going out. The diagnosis was confirmed by measuring serum 25 (OH) D: 1.89 +/- 0.18 ng/ml during the month of June (11.5 +/- 4.2 ng/ml at the same period in II healthy young adults). The patients were randomly divided into two groups of 11 (Group I) and 17 patients (Group II). The first group was given an improved diet in calcium and Vit. D; the second group received, in addition, an intramuscular supplement of 30 mg of Vit. D3 in monthly injections of 5 or 10 mg. The serum 25 (OH) D levels were measured each month in both groups. Patients with intramuscular supplements showed a slow rise until the total injected dose exceeded 20 mg, followed by a sudden rise to values greater than 30 ng/ml. Eight months after the last injection, mean serum 25 (OH) D was still 24.7 +/- 4.6 ng/ml compared to only 3.6 +/- 3 ng/ml in Group I. Vitamin D deficiency in geriatric patients cannot be corrected by dietary supplement alone, but parenteral Vit. D3 using an easily applicable therapeutic protocol is effective and well tolerated at the suggested dosage.

Topics: Aged; Cholecalciferol; Diet; Female; Humans; Length of Stay; Male; Time Factors; Vitamin D Deficiency

Low levels of 25-hydroxyvitamin D [25(OH)D] are frequent in chronic kidney disease and are associated with adverse outcomes. The aim of this 5-year prospective study was to evaluate the effects of cholecalciferol supplementation on mineral metabolism, inflammation and cardiac parameters in hemodialysis (HD) patients.. The study included 97 patients. Cholecalciferol was given after HD according to 25(OH)D baseline levels measured twice (end of winter and of summer). The 25(OH)D levels, circulating bone metabolism, inflammation parameters, brain natriuretic peptide (BNP), pulse pressure (PP), and left ventricular mass index (LVMI) were evaluated before and after supplementation.. There was a significant increase in 25(OH)D levels after supplementation (p < 0.001); however, serum calcium (p = 0.02), phosphorus (p = 0.018), and iPTH (p = 0.03) were decreased. Magnesium levels increased during the study (p = 0.03). A reduction in the number of patients under active vitamin D (p < 0.001) and in the dose and number of patients treated with darbepoetin (p = 0.02) was observed. Serum albumin increased (p < 0.001), and C-reactive protein decreased (p = 0.01). BNP (p < 0.001), PP (p = 0.007), and LVMI (p = 0.02) were significantly reduced after supplementation.. Long-term cholecalciferol supplementation allowed correction of 25(OH)D deficiency, improved mineral metabolism with less use of active vitamin D, attenuated inflammation, reduced the dose of the erythropoiesis-stimulating agent, and improved cardiac dysfunction.

Topics: Cholecalciferol; Dietary Supplements; Humans; Inflammation; Minerals; Prospective Studies; Renal Dialysis; Vitamin D; Vitamin D Deficiency; Vitamins

Observational studies suggest links between reduced serum 25(OH)D concentration and increased cardiometabolic disease risk. However, these studies provide limited evidence of causation, with few conclusive randomised controlled trials (RCT) having been carried out to date. This RCT investigated the effect of vitamin D. Participants were assigned to consume 125 µg day. Daily oral intake of 125 µg supplemental vitamin D. Overall, treatment significantly improved brachial pulse pressure but no other cardiometabolic disease risk markers. To follow on from this pilot RCT, future large-scale clinical trials over longer durations may offer further insights.

Topics: Adult; Cardiovascular Diseases; Cholecalciferol; Dietary Supplements; Double-Blind Method; Humans; Male; Obesity; Overweight; Pilot Projects; Randomized Controlled Trials as Topic; United Kingdom; Vitamin D; Vitamin D Deficiency

Vitamin D deficiency is common in glomerular disease. Supplementation may be ineffective due to ongoing urinary losses of vitamin D binding protein. We sought to determine if daily cholecalciferol supplementation would increase vitamin D concentrations in children with glomerular disease and persistent proteinuria, without adverse effects.. Eighteen participants at least 5 years of age with primary glomerular disease and urine protein:creatinine ratio ≥ 0.5 were enrolled from four pediatric nephrology practices to receive cholecalciferol supplementation: 4,000 IU or 2,000 IU per day for serum 25 hydroxyvitamin vitamin D (25OHD) concentrations < 20 ng/mL and 20 ng/mL to < 30 ng/mL, respectively. Measures of vitamin D and mineral metabolism were obtained at baseline and weeks 6 and 12. Multivariable generalized estimating equation (GEE) regression estimated mean percent changes in serum 25OHD concentration.. Median baseline 25OHD was 12.8 ng/mL (IQR 9.3, 18.9) and increased to 27.8 ng/mL (20.5, 36.0) at week 6 (p < 0.001) without further significant increase at week 12. A total of 31% of participants had a level ≥ 30 ng/mL at week 12. Supplementation was stopped in two participants at week 6 for mildly elevated calcium and phosphorus, respectively, with subsequent declines in 25OHD of > 20 ng/mL. In the adjusted GEE model, 25OHD was 102% (95% CI: 64, 141) and 96% (95% CI: 51, 140) higher versus baseline at weeks 6 and 12, respectively (p < 0.001).. Cholecalciferol supplementation in vitamin D deficient children with glomerular disease and persistent proteinuria safely increases 25OHD concentration. Ideal dosing to fully replete 25OHD concentrations in this population remains unknown.. NCT01835639. A higher resolution version of the Graphical abstract is available as Supplementary information.

Topics: Child; Cholecalciferol; Dietary Supplements; Humans; Kidney Diseases; Proteinuria; Vitamin D; Vitamin D Deficiency; Vitamins; Young Adult

Vitamin D is synthesized in the skin or supplied. Cholecalciferol is hydroxylated in the liver to 25(OH) vitamin D [25D]. 25D is further hydroxylated in the kidney to 1,25(OH) vitamin D [1,25D]. Catabolism occurs by further hydroxylation. Magnesium is a cofactor of all involved hydroxylases.. To investigate the association between renal function and serum magnesium levels, and the biologically active hormone 1,25D.. Anonymised serum values of 25D, 1,25D, magnesium and creatinine measured in an outpatient cohort over 2 years were analysed.. Renal function and magnesium level did not influence 25D values (r = - 0.144 and 0.030, respectively). Mean serum 1,25D values decreased from 106.5 ± 44.3 pmol/l in individuals with normal renal function to 51.7 ± 18.9 pmol/l in those with severe renal insufficiency (p < 0.01). A weak positive correlation was observed between 1,25D and eGFR (r = 0.317), and between 1,25D and serum magnesium (r = 0.217).. Impaired renal function and low magnesium serum levels are slightly associated with low 1,25D concentrations. Measuring 25D, but not 1,25D, may overestimate the patient's vitamin D status. In patients with renal insufficiency adequate magnesium supply should be ensured.

Topics: Cholecalciferol; Humans; Magnesium; Magnesium Deficiency; Renal Insufficiency; Vitamin D; Vitamin D Deficiency; Vitamins

The study assessed the relationship between vitamin D status in infants and the presence of allergic and/or respiratory disorders.. The study cohort comprised 81 hospitalized infants presenting at the Pediatric Clinic, University Clinical Center Kragujevac, Serbia, between January 2011 and June 2016.. Daily vitamin D3 supplementation with 400 IU in infants until the end of the first year of life is too low to provide optimal defense against respiratory and/or allergic conditions.

Topics: Child; Cholecalciferol; Dietary Supplements; Female; Humans; Hypersensitivity; Incidence; Infant; Infant, Newborn; Vitamin D; Vitamin D Deficiency

Multivitamins are commonly used by the general population, often without medical prescription. The purpose of this report is to inform on the daily vitamin D supply provided by multivitamins containing vitamin D that are commercialized online by Amazon in Western and Southern Europe. We surveyed multivitamins aimed at adults using the following marketplaces: amazon.es®, amazon.de®, amazon.it®, and amazon.fr®. We identified 199 vitamin D3-containing multivitamins sold by Amazon marketplaces: 77 from amazon.es®, 73 from amazon.de®, 33 from amazon.it®, and 16 from amazon.fr®. No multivitamin contained vitamin D2. The daily vitamin D3 supply ranged from 16 to 2000 IU: it was less than 400 IU daily in 108 (54%), 400−800 IU daily in 53 (27%), and more than 800 IU daily in the remaining 38 (19%) products. The vitamin D3 supply of products sold by amazon.it® was on average higher (p < 0.05) than that of products sold by amazon.de®, amazon.fr®, and amazon.es®. In conclusion, the vitamin D supply of multivitamins sold by Amazon may be insufficient, marginally sufficient, or adequate for subjects at high risk of hypovitaminosis D such as subjects 65 years or more of age, pregnant (or lactating) women, or patients on drug treatment or with an underlying disease, where a vitamin D supplementation is advocated.

Topics: Adult; Cholecalciferol; Dietary Supplements; Europe; Female; Humans; Lactation; Pregnancy; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D3 deficiency is associated with an increased risk of dementia. An association between vitamin D3 deficiency and subjective cognitive complaints in geriatric patients has been previously reported. This study aimed to evaluate the effects of two doses of vitamin D3 on spatial memory (using the Radial Maze) and cytokine levels [tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), interleukin-6 (IL-6), and interleukin-10 (IL-10)] on 2-, 6-, 13-, 22-, and 31-month-old male Wistar rats. Animals were supplemented with vitamin D3 at doses of 42 IU/kg and 420 IU/kg for 21 days. A radial maze test was performed to evaluate spatial memory. After the behavioral test, the frontal cortex and hippocampus were dissected for enzyme immunoassay analyses to measure the cytokine levels (TNFα, IL-1β, IL-6, and IL-10). Our results showed that vitamin D3 supplementation reversed spatial memory impairment at the supplemented doses (42 and 420 IU/kg) in 6-, 13-, and 22-month-old animals and at a dose of 420 IU/kg in 31-month-old animals. The lower dose (42 IU/kg) regulates both pro- and anti-inflammatory cytokines mainly in the frontal cortex. Our results suggest that vitamin D3 has a modulatory action on pro- and anti-inflammatory cytokines, since older animals showed increased cytokine levels compared to 2-month-old animals, and that vitamin D3 may exert an immunomodulatory effect on aging.

Topics: Animals; Anti-Inflammatory Agents; Cholecalciferol; Cytokines; Interleukin-10; Interleukin-6; Male; Rats; Rats, Wistar; Spatial Memory; Tumor Necrosis Factor-alpha; Vitamin D Deficiency

Peripheral neuropathy (PN) is common in multiple myeloma (MM) patients. More insight has been gained concerning the role of vitamin D in preventing PN. However, studies evaluating the effects of vitamin D. Median 25(OH)D increased from 38 (IQR 32-52) nmol/L at baseline to 77 (IQR 72-87) nmol/L after 6 months (P < 0.001). Adequate 25(OH)D levels were achieved by 66% of the subjects, and 34% were within the range of 50-75 nmol/L. Furthermore, in 37% of the participants, PN severity decreased (P = 0.007).. The use of substantially higher vitamin D

Topics: Cholecalciferol; Dietary Supplements; Humans; Multiple Myeloma; Peripheral Nervous System Diseases; Prospective Studies; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D is a steroid hormone precursor that was initially recognized for its important roles in calcium-phosphate homeostasis and bone health. However, the resent prevalence of vitamin D deficiency has highlighted its non-skeletal function, such as its important role in regulating endogenous metabolism. The aim of the present study was to examine the roles of vitamin D supplementation or deficiency on metabolic phenotypes in both male and female mice by using targeted metabolomics analysis. Six weeks old C57BL/6 mice of different sexes were fed with standard chow diet (1000 IU/kg vitamin D3 contained), vitamin D deficient diet (0 IU/kg vitamin D3 contained), or vitamin D enriched diet (10,000 IU/kg vitamin D3 contained) for a total of 14 weeks. Liver pathological analysis showed that vitamin D deficiency caused significant fat deposition in both male and female mice. While vitamin D supplementation was found to improve the accumulation of fat in the liver tissue. Metabolomics analysis indicated that metabolic perturbation related to vitamin D regulation in male mice mainly involved in tricarboxylic acid cycle, fatty acylcarnitine and fatty acid metabolism, sugar metabolism, glutathione metabolism, steroid hormone and pyrimidine metabolism. Based on the criteria of VIP> 1 in OPLS-DA analysis and P < 0.05 in hypothesis test, a total of 62 metabolites and 78 metabolites were found to be significantly changed in VD-deficiency group and VD-supplement group compared with the control group, respectively. While for female mice, the metabolites disturbance mainly involved in fatty acylcarnitine and fatty acid metabolism, TCA, sugar metabolism, folate cycle, methionine cycle, and purine metabolism. A total of 38 and 57 metabolites were found to be significantly changed (VIP>1 and P < 0.05) in VD-deficiency group and VD-supplement group compared with the control group, respectively. Energy metabolism was the most relevant metabolic pathway for vitamin D regulation in both male and female mice. Sex-specific changes of fatty acyl carnitines and dehydroepiandrosterone were observed in the vitamin D supplementation groups. However, most of the energy metabolism related compounds exhibited the same trend in vitamin D supplementation groups of different sexes. Pearson's correlation analysis indicated that vitamin D was significantly correlated (P < 0.05) with the levels of D-fructose 6-phosphate, D-glucose 1-phosphate, D-glucose 6-phosphate, DL-pyroglutamic acid, 2-oxog

Topics: Animals; Cholecalciferol; Dietary Supplements; Fatty Acids; Female; Glucose; Hormones; Male; Mice; Mice, Inbred C57BL; Phenotype; Phosphates; Sugars; Vitamin D; Vitamin D Deficiency; Vitamins

The purpose of this study is to determine the associations between Vitamin D supplementation, 25(OH) blood serum levels, suicide attempts, and intentional self-harm in a population of veterans in the Department of Veterans Affairs (VA).. A retrospective cohort study of US Veterans supplemented with Vitamin D. Veterans with any Vitamin D3 (cholecalciferol) or Vitamin D2 (ergocalciferol) fill between 2010 and 2018 were matched 1:1 to untreated control veterans having similar demographics and medical histories. Cox proportional hazards regression was used to estimate the time from the first Vitamin D3 (cholecalciferol) or Vitamin D2 (ergocalciferol) prescription fill to the first suicide attempt or intentional self-harm. Analyses were repeated in stratified samples to measure associations by race (Black or White), gender (male or female), blood levels (0-19 ng/ml, 20-39 ng/ml, and 40+ ng/ml), and average daily dosage.. Vitamin D3 and D2 supplementation were associated with a 45% and 48% lower risk of suicide attempt and self-harm ((D2 Hazard Ratio (HR) = 0.512, [95% CI, 0.457, 0.574]; D3 HR = 0.552, [95% CI, 0.511, 0.597])). Supplemented black veterans and veterans with 0-19 ng/ml vitamin D serum levels were at ~64% lower risk relative to controls (Black Veteran HR: 0.362 [95% CI: 0.298,0.440]; 0-19 ng/ml HR: 0.359 [95% CI: 0.215,0.598]). Supplementation with higher vitamin D dosages was associated with greater risk reductions than lower dosages (Log Average Dosage HR: 0.837 [95% CI: 0.779,0.900]).. Vitamin D supplementation was associated with a reduced risk of suicide attempt and self-harm in Veterans, especially in veterans with low blood serum levels and Black veterans.

Topics: Cholecalciferol; Dietary Supplements; Ergocalciferols; Female; Humans; Male; Retrospective Studies; Serum; Suicide, Attempted; Vitamin D; Vitamin D Deficiency; Vitamins

Topics: Adult; Arabs; Cardiovascular Diseases; Cholecalciferol; Cholesterol, HDL; Female; Glucose; Humans; Male; Risk Factors; Vitamin D; Vitamin D Deficiency; Vitamins

The coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARSCoV-2), was declared a global pandemic by the World Health Organization (WHO) on March 2020, causing unprecedented disease with million deaths across the globe, mostly adults. Indeed, children accounted for only a few percent of cases. Italy was the first Western country struck by the COVID-19 epidemic. Increasing age, which is one of the principal risk factors for COVID-19 mortality, is associated with declined glutathione (GSH) levels. Over the last decade, several studies demonstrated that both vitamin D (VD) and GSH have immunomodulatory properties. To verify the association between VD, GSH and the outcome of COVID-19 disease, we conducted a multicenter retrospective study in 35 children and 128 adult patients with COVID-19. Our study demonstrated a hypovitaminosis D in COVID-19 patients, suggesting a possible role of low VD status in increasing the risk of COVID-19 infection and subsequent hospitalization. In addition, we find a thiol disturbance with a GSH depletion associated to the disease severity. In children, who fortunately survived, both VD and GSH levels at admission were higher than in adults, suggesting that lower VD and thiols levels upon admission may be a modifiable risk factor for adverse outcomes and mortality in hospitalized patients with COVID-19.

Topics: Adult; Child; Cholecalciferol; COVID-19; Glutathione; Humans; Italy; Retrospective Studies; Sulfhydryl Compounds; Vitamin D; Vitamin D Deficiency; Vitamins

This study aims to investigate the serum fat-soluble vitamins A, D, and E levels of children in Zhejiang Province, and to provide a reference range of fat-soluble vitamins for children in Zhejiang Province.. Between May 2019 and December 2019, 871 children who sent peripheral blood samples to Hangzhou Biozon Medical Institute Co., Ltd. for fat-soluble vitamin A, D, and E analysis were selected, including 432 boys and 439 girls. After the peripheral blood was collected, the serum A, D, and E levels were measured, and the differences in age, gender, season, and region were compared.. With age, the level of vitamin A gradually increased (p < 0.01), and vitamin D2, D3, and total vitamin D all increased first and then decreased. Vitamin A (131.79 ± 47.05 ng/mL vs. 121.96 ± 41.01 ng/mL) and E (5.87 ± 2.23 μg/mL vs. 5.56 ± 2.13 μg/mL) levels of girls were higher than boys (p < 0.01), and vitamin D3 (15.25 ± 6.16 ng/mL vs.15.17 ± 7.26 ng/mL) and total vitamin D (18.09 ± 7.01 ng/mL vs. 17.03 ± 8.79 ng/mL) levels of boys were higher than girls (p < 0.01). From the perspective of regional distribution, the levels of vitamin A, D2, and E in Ningbo were higher than those in Hangzhou and other regions. The seasonal distribution of vitamin A and E levels were highest in summer, while vitamin D3 and D levels were highest in fall. The average vitamin concentrations were as follows: vitamin A was (126.81 ± 44.42) ng/mL; vitamin D2 was (1.84 ± 3.16) ng/mL, vitamin D3 was (15.71 ± 6.75) ng/mL, total vitamin D was (17.55 ± 7.91) ng/mL, and vitamin E was (5.72 ± 2.19) μg/mL. The reference value ranges of vitamin A, D2, D3, D, and E were (52.44 - 222.27) ng/mL, (0.01 - 11.66) ng/mL, (4.92 - 30.96) ng/mL, (4.92 - 30.96) ng/mL, and (2.66 - 10.92) μg/mL, respectively.. The childrens' fat soluble vitamin levels in Zhejiang province show significant differences in age, gender, season, and regional distribution. Corresponding reference standards should be formulated as soon as possible, and vitamin supplements should be targeted and reasonable to ensure the healthy development of children.

Topics: Child; Cholecalciferol; Ergocalciferols; Female; Humans; Male; Vitamin A; Vitamin D; Vitamin D Deficiency; Vitamins

The objective of this article is to evaluate the response to 6000 IU oral cholecalciferol (OC) treatment in children with chronic liver disease (CLD) and 25(OH)D deficiency.. This historical cohort included non-transplanted CLD patients younger than 18 years old, which were analyzed for serum 25(OH)D, liver function, bone metabolism, Child-Pugh classification, and anthropometry. Patients with 25(OH)D deficiency (defined as 25(OH)D < 20 ng/mL) who received 6000 IU/day of OC were analyzed pre- and post-intervention, and considered responders if 25(OH)D > 20 ng/mL after at least 60 days. We compared clinical and laboratory data from patients with and without 25(OH)D deficiency, responders and nonresponders.. We studied 96 patients, of which 57.2% had biliary atresia. The prevalence of 25(OH)D deficiency was 67.7% (65/96). These patients were younger ( P < 0.001), had higher Child-Pugh scores ( P < 0.001), higher levels of total bilirubin (TB) ( P < 0.001), gamma-glutamyl transferase ( P < 0.001), and alkaline phosphatase ( P = 0.002), as well as lower levels of phosphorus ( P = 0.009) compared with patients without 25(OH)D deficiency. The median treatment length was 126 days (70-307 days). At the end of treatment, we observed a higher median of 25(OH)D ( P < 0.001), and lower median of parathyroid hormone (PTH) ( P = 0.023). Nine patients (29%) restored 25(OH)D to normal range; they had lower Child-Pugh score ( P = 0.001), lower TB levels ( P = 0.001), and higher level of phosphorus ( P = 0.003) after treatment.. Despite an increase in 25(OH)D and decrease in PTH levels, 6000 IU/day of OC was not sufficient to restore 25(OH)D deficiency in most of the patients in this study.

Topics: Adolescent; Cholecalciferol; Dietary Supplements; Humans; Liver Diseases; Parathyroid Hormone; Phosphorus; Vitamin D; Vitamin D Deficiency; Vitamins

Background: hypovitaminosis D is frequent in kidney transplant recipient (KTR) patients and is associated with deleterious effects both at the bone and extraosseous levels. Treatment with cholecalciferol is effective for the normalization of 25(OH)D, demonstrating a beneficial effect on the calcium-tropic axis in other populations; however, its effect on the PTH/vitamin D/calcium and FGF23/klotho/phosphorus axis in RTR has not been reported. The aim of this study was to evaluate the effect of normalization of serum 25(OH)D concentrations on the PTH/vitamin D/calcium-FGF23/klotho/phosphorus axis in KTR treated with cholecalciferol, as well as the association between the components of this axis. Methods: a prospective study in 23 KTR with hypovitaminosis D, with evolution from 1 to 12 months post-transplantation, an estimated glomerular filtration rate > 60 mL/min/1.73 m2 and a history of primary nephropathy treated with cholecalciferol, in whom the PTH/vitamin D/calcium and FGF23/klotho/phosphorus axis was evaluated during the state of hypovitaminosis D and at normalization of 25(OH)D. Results: at the normalization of 25(OH)D, a reduction in PTH [103 (58.5-123.9) vs 45.6 (30.1-65.1) pg/mL; p = 0.002] and an increase in serum phosphorus [3.1 (2.3-3.5) vs 3.3 (3-3.6) mg/dL; p = 0.01] were evident, with no differences in calcium, klotho and FGF23 concentrations. The time to achieve normalization of 25(OH)D was 12 weeks (RIC, 4-12), with a dose of 5000 IU/day (RIC, 4000-6000). A positive association between klotho and PTH was corroborated (r = 0.54; p = 0.008; linear regression, β = 0.421; B = 0.004; 95 % CI, 0.003-0.007; p = 0.045). Conclusions: treatment with cholecalciferol is effective for the normalization of 25(OH)D, with a beneficial effect on calcium-phosphotropic metabolism characterized by a reduction in PTH concentration, without significant changes in calcemia or calciuria, as well as an increase in phosphatemia, without modifications in FGF23 or klotho concentrations.. Introducción: la hipovitaminosis D es frecuente en los receptores de trasplante renal (RTR) y se asocia con efectos deletéreos tanto a nivel óseo como extraóseo. El tratamiento con colecalciferol es eficaz para la normalización de la 25(OH)D, demostrándose un efecto benéfico sobre el eje calciotrópico; sin embargo, su efecto sobre el eje fosfotrópico no se ha reportado. El objetivo de este estudio fue evaluar el efecto de la normalización de las concentraciones séricas de 25(OH)D sobre el eje PTH/vitamina D/calcio-FGF23/klotho/fósforo en RTR tratados con colecalciferol, así como la asociación entre sus componentes. Métodos: estudio prospectivo en 23 RTR con hipovitaminosis D y antecedente de nefropatía primaria tratados con colecalciferol, en quienes se evaluó el eje PTH/vitamina D/calcio y FGF23/klotho/fósforo durante el estado de hipovitaminosis D y a la normalización de la 25(OH)D. Resultados: a la normalización de la 25(OH)D se evidenció una reducción de la PTH [103 (58,5-123,9) vs. 45,6 (30,1-65,1) pg/mL; p = 0,002] y un aumento del fósforo sérico [3,1 (2,3-3,5) vs. 3,3 (3-3,6) mg/dL; p = 0,01], sin diferencias en las concentraciones de calcio, klotho y FGF23. El tiempo para lograr la normalización de la 25(OH)D fue de 12 semanas (4-12), con una dosis de 5000 UI/día (4000-6000). Se corroboró una asociación positiva entre klotho y PTH (r = 0,54; p = 0,008; regresión lineal, β = 0,421; IC 95 %: 0,003-0,007; p = 0,045). Conclusiones: el tratamiento con colecalciferol es eficaz para la normalización de la 25(OH)D con un efecto benéfico sobre el metabolismo calcio-fosfotrópico caracterizado por una reducción de la PTH y un incremento de la fosfatemia, sin modificaciones de calcemia, calciuria, FGF23 o klotho.

Topics: Calcium; Cholecalciferol; Humans; Kidney Transplantation; Parathyroid Hormone; Phosphorus; Prospective Studies; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D deficiency has been observed in individuals with metabolic syndrome (MetS). This study evaluated the effects of vitamin D supplementation in patients with MetS and vitamin D deficiency.. The 20-week intervention resulted in an increment of 14.3 ng/mL of 25(OH)D. HbA1c showed a reduction of 0.69% (95% CI [-1.16, -0.21], p = 0.005); however, the triglycerides, HDL-cholesterol, fasting blood glucose, blood pressure, and waist circumference were not responsive to supplementation.. Vitamin D

Topics: Cholecalciferol; Dietary Supplements; Humans; Metabolic Syndrome; Pilot Projects; Vitamin D; Vitamin D Deficiency

Dry eye is a prevalent disorder of tear film resulting from either decreased tear production or increased tear evaporation. It is becoming a serious issue due to its disturbing symptoms, which become progressively troublesome affecting the work efficiency of patients and increasing financial burden due to lifelong dependency on eye drops. If not detected early, it can lead to sight-threatening complications. This study aims to explore serum vitamin D3 deficiency as a causative factor of dry eye.. The study was conducted in the outpatient department of a tertiary care hospital in India, for a period of two years from September 2018 to September 2020. About 40 patients who had dry eye and 20 controls were enrolled in this study. They were given an Ocular Surface Disease Index (OSDI) questionnaire, examined for signs of dry eye on slit lamp with Schirmer's test and tear film break-up time. All 60 participants were subjected to serum vitamin D3 level laboratory test and its deficiency prevalence was correlated with dry eye and its severity.. Serum vitamin D3 deficiency was found to be more prevalent in patients with dry eye. There was no gender predilection or change in prevalence with increasing age. Vitamin D3 level was negatively correlated with OSDI and positively with Schirmer's test 1 and 2 and tear film break-up time (TBUT) scores. Conclusion: The prevalence of vitamin D3 deficiency was not consistently found to be associated with the increasing severity of dry eye.

Topics: Cholecalciferol; Dry Eye Syndromes; Humans; Ophthalmic Solutions; Tears; Vitamin D Deficiency

Low 25-hydroxyvitamin D (25[OH]D) concentrations (<30 ng/mL [<50 nmol/L]) have been associated with muscle weakness and impaired physical performance in observational studies. However, the effect of vitamin D supplementation on changes in muscle strength and physical performance in randomized controlled trials has been mixed.. To determine the effect of daily vitamin D supplementation on leg power, strength, and physical performance in low-functioning older adults with 25(OH)D concentrations of 18 to <30 ng/mL.. In this double-blind, randomized controlled trial, 136 low-functioning [Short Physical Performance Battery (SPPB) scores ≤10] adults aged 65-89 y with 25(OH)D concentrations of 18 to <30 ng/mL were randomly assigned to 2000 IU/d vitamin D. Participants' mean ± SD age and SPPB scores at baseline were 73.4 ± 6.3 y and 7.8 ± 1.8, respectively. Mean ± SD 25(OH)D concentrations at baseline and 12 mo were 19.4 ± 4.2 ng/mL and 28.6 ± 6.7 ng/mL in the vitamin D group and 19.9 ± 4.9 ng/mL and 20.2 ± 5.0 ng/mL in the placebo group for a mean ± SE difference of 9.1 ± 1.1 ng/mL (P < 0.0001). However, there were no differences in change in leg power, leg or grip strength, SPPB score, TUG, postural sway, or gait velocity and spatiotemporal parameters by intervention group over 12 mo or muscle fiber composition and contractile properties over 4 mo.. In low-functioning older adults with 25(OH)D concentrations of 18 to <30 ng/mL, randomization to 2000 IU/d vitamin D

Topics: Aged; Cholecalciferol; Dietary Supplements; Double-Blind Method; Humans; Muscle Strength; Muscles; Physical Functional Performance; Randomized Controlled Trials as Topic; Vitamin D; Vitamin D Deficiency; Vitamins

Although clinical research is still going on to determine any relationship between vitamin D and sleep regulation, only few studies have identified the role of vitamin D metabolism in sleep disorders. The current study aims to examine the incidence of vitamin D deficiency/insufficiency in the sample group and its effects on sleep quality and melatonin level.. A cross-sectional study was designed. A total of 79 women aged 18-49 years who applied to the research and training hospital between 1 October and 30 November 2021 participated in the study. Data were collected using a socio-demographic questionnaire prepared by the authors and the Pittsburgh Sleep Quality Index (PSQI). Blood samples were taken from the participants, also, 25-OH-vitamin D3 and melatonin levels in serum samples were measured by ELISA.. The participants (n = 79) were aged 29.61 ± 11.14 years. The mean total PSQI scores of the participants were calculated as 5.77 ± 2.70. We determined that 64.6% of the participants had vitamin D deficiency, 21.5% had vitamin D insufficiency, and 13.9% of the participants were vitamin D sufficient. The mean melatonin level was found to be 24.77 ± 27.77 ng/L. We determined that an increase in the melatonin levels decreases the risk of vitamin D deficiency. Besides, our findings showed a good positive correlation between serum melatonin and 25 OH vitamin D3 levels (r = 0.544, p < 0.001).. Our results indicate that the correction of vitamin D insufficiency can positively affect melatonin levels, therefore, it may positively contribute to the treatment of sleep disorders related to melatonin deficiency.

Topics: Cholecalciferol; Cross-Sectional Studies; Female; Humans; Melatonin; Sleep; Sleep Wake Disorders; Vitamin D; Vitamin D Deficiency

Topics: Benign Paroxysmal Positional Vertigo; Calcifediol; Cholecalciferol; Female; Humans; Male; Osteoporosis; Vitamin D; Vitamin D Deficiency

This study aimed to evaluate the association between maternal gestational Vitamin D3 supplementation and early respiratory health in offspring. This was a population-based record-linkage study which used data from the French National Health Database System. Maternal Vitamin D3 supplementation consisted of a single high oral dose of cholecalciferol, (100,000 IU) from the seventh month of pregnancy, according to national guidelines. In total, 125,756 term-born singleton children were included, of which 37% had respiratory illness defined as hospital admission due to respiratory causes or inhalation treatment up to 24 months of age. Infants prenatally exposed to maternal Vitamin D3 supplementation (n = 54,596) were more likely to have a longer gestational age (GA) at birth (GA 36-38 weeks, 22% vs. 20%,

Topics: Birth Weight; Child; Child, Preschool; Cholecalciferol; Dietary Supplements; Female; Humans; Infant; Infant, Newborn; Pregnancy; Vitamin D; Vitamin D Deficiency; Vitamins

Topics: Alzheimer Disease; Cholecalciferol; Dietary Supplements; Humans; Vitamin D; Vitamin D Deficiency

Topics: Atrial Fibrillation; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Finland; Humans; Male; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D plays a crucial role in calcium and phosphate metabolism, relating to bone health and preventing metabolic bone disorders such as rickets and osteomalacia. Vitamin D deficiency (serum 25-OH-D values <20 ng/mL or 50 nmol/L) is common also in Italian people; it is recommended to maintain levels above 30 ng/mL (75 nmol/L) in categories at risk. Supplementation and/or fortification with either ergocalciferol (vitamin D2) or cholecalciferol (vitamin D3) aimed to modify this condition have commonly been proposed. Studies about vitamin D intake are numerous in the literature but not adequately designed and are very often incomplete in Mediterranean Countries such as in the Italian population. On these bases, we performed a survey to validate a frequency food questionnaire (FFQ) specifically created to rapidly assess dietary vitamin D intake in Italian people. For this aim, the data of questionnaires were compared with results derived in the same population from a designed 14-day frequency food diary (FFD). Overall, a good correlation between FFQ and FFD was observed (r = 0.89,

Topics: Cholecalciferol; Diet; Humans; Italy; Surveys and Questionnaires; Vitamin D; Vitamin D Deficiency; Vitamins

Secondary hyperparathyroidism (SHPT) after bariatric surgery has significant adverse implications for bone metabolism, increasing the risk for osteoporosis and fracture. Our aim was to characterize prevalence and identify risk factors for SHPT in bariatric surgery patients.. We performed a single-institution, retrospective chart review of patients who underwent bariatric surgery from June 2017 through December 2021. Demographic and clinical data were collected, including serum parathyroid hormone, calcium, and vitamin D3 at enrollment and 3, 6, and 12-months postoperatively. Chi-square or Fisher's exact tests were used to analyze categorical data and Mann-Whitney U test for continuous data. Multivariable analysis using binomial logistic regression assessed risk factors for SHPT. P-values ≤ 0.05 were considered significant.. 350 patients were analyzed. SHPT prevalence at any time point was 72.9%. 65.8% had SHPT at enrollment; 45.9% resolved with intensive vitamin supplementation; and 19.7% had recurrent SHPT. New-onset SHPT occurred in 8.6%. Persistent SHPT was present in 42.4% at 1-year. Baseline SHPT correlated with black race and T2DM. SHPT at any time point correlated with T2DM and higher baseline BMI. 1-year SHPT correlated with RYGB, depression, and longer time in program. SHPT was not correlated with %TBWL at any time point. In patients with SHPT, vitamin D3 deficiency prevalence was significantly higher at baseline (77.0%) compared to all post-bariatric time points (16.7%, 17.3%, and 23.1%; P < 0.0001).. SHPT is highly prevalent in patients with obesity seeking weight loss surgery. 42% had persistent SHPT at 1-year despite appropriate vitamin supplementation. Current vitamin D3 and calcium supplementation protocols may not effectively prevent SHPT in many post-bariatric patients. Low prevalence of concomitant vitamin D3 deficiency with SHPT after bariatric surgery suggests that there may be alternative mechanisms in this population. Further studies are needed to develop effective treatment strategies to mitigate the adverse effects of bariatric surgery on bone metabolism.

Topics: Bariatric Surgery; Calcium; Cholecalciferol; Diabetes Mellitus, Type 2; Humans; Hyperparathyroidism, Secondary; Parathyroid Hormone; Prevalence; Retrospective Studies; Risk Factors; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D deficiency is a global concern, linked to suboptimal musculoskeletal health and immune function, with status inadequacies owing to variations in UV dependent cutaneous synthesis and limited natural dietary sources. Endogenous biofortification, alongside traditional fortification and supplement usage is urgently needed to address this deficit. Evidence reviewed in the current article clearly demonstrates that feed modification and UV radiation, either independently or used in combination, effectively increases vitamin D content of primary produce or ingredients, albeit in the limited range of food vehicles tested to date (beef/pork/chicken/eggs/fish/bread/mushrooms). Fewer human trials have confirmed that consumption of these biofortified foods can increase circulating 25-hydroxyvitamin D [25(OH)D] concentrations (

Topics: Animals; Biofortification; Calcifediol; Cattle; Cholecalciferol; Food, Fortified; Humans; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D (25OHD) deficiency is associated with poor outcomes in intensive care populations. The primary objective of this 7-center study was to determine if 25OHD deficiency is associated with infectious outcomes in adult burn patients. Generalized linear mixed modeling was used to control for center effect, percent total body surface area burn (% TBSA), age, and presence of inhalation injury. A total of 1147 patients were initially included (admitted January 2016 through August 2019). After exclusions, 234 (56.8%) in the deficient (25OHD<20 ng/mL) and 178 in the non-deficient group (25OHD ≥ 20 ng/mL) remained, surpassing a priori power requirements. The non-deficient group had their concentration drawn earlier (p < 0.001), were more likely to be male (p = 0.006), Caucasian (p < 0.001), have lower body mass index (p = 0.009), lower % TBSA (p = 0.002), and taking a 25OHD supplement prior to admission (p < 0.001). Deficient patients were more likely to have an infectious outcome (52.1% vs 36.0%, p = 0.002), acute kidney injury with renal replacement therapy (p = 0.009), less ventilator free days in the first 28 days (p < 0.001), and vasopressors (p = 0.01). After controlling for center, % TBSA, age, and inhalation injury the best model also included presence of deficiency (OR 2.425 [CI 1.206-4.876]), days until 25OHD supplement initiation (OR 1.139 [CI 1.035-1.252]), and choice of cholecalciferol over ergocalciferol (OR 2.112 [CI 1.151-3.877]). To the authors' knowledge, this is the first multicenter study to evaluate the relationship between 25OHD and infectious complications in burn patients.

Topics: Adult; Burns; Cholecalciferol; Female; Humans; Male; Vitamin D; Vitamin D Deficiency; Vitamins

Since the beginning of the COVID-19 pandemic, many Iranian people have been taking 50 000 IU of vitamin D3 on weekly or biweekly bases in order to enhance their immune system function. This cross-sectional study was conducted on the patients of endocrinology clinic to compare 25(OH)D levels of weekly or biweekly consumption with the monthly users of vitamin D3 50 000 IU. The level >100 ng/mL of 25(OH)D was defined as hypervitaminosis D. In total, 211 patients (108 and 103 patients in monthly and weekly/biweekly groups, respectively) were studied. In the subgroups of weekly and biweekly users, the rates of hypervitaminosis were 18.9% and 4.5%, respectively. In contrast, only 0.9% of monthly users had hypervitaminosis D. The highest vitamin D value of 185 ng/mL was detected in a patient who had consumed 50 000 IU vitamin D3 weekly for 6 years. No hypercalcaemia was detected in patients with hypervitaminosis D.

Topics: Cholecalciferol; COVID-19; Cross-Sectional Studies; Dietary Supplements; Humans; Iran; Pandemics; Vitamin D; Vitamin D Deficiency; Vitamins

The emerging literature on prevalence of vitamin D deficiency in India, prevention and treatment strategies of rickets, and extra-skeletal benefits of vitamin D suggest the need for revising the existing guidelines for prevention and treatment of vitamin D deficiency in India.. To review the emerging literature on vitamin D prevalence and need for universal vitamin D supplementation. To suggest optimum vitamin D therapy for treatment of asymptomatic and symptomatic vitamin D deficiency, and rickets. To evaluate the extra-skeletal health benefits of vitamin D in children.. A National consultative committee was formed that comprised of clinicians, epidemiologists, endocrinologists, and nutritionists. The Committee conducted deliberations on different aspects of vitamin D deficiency and rickets through ten online meetings between March and September, 2021. A draft guideline was formulated, which was reviewed and approved by all Committee members.. The group reiterates the serum 25-hydroxy vitamin D cutoffs proposed for vitamin D deficiency, insufficiency, and sufficiency as <12 ng/mL, 12-20 ng/mL and >20 ng/mL, respectively. Vitamin D toxicity is defined as serum 25OHD >100 ng/mL with hypercalcemia and/or hypercalciuria. Vitamin D supplementation in doses of 400 IU/day is recommended during infancy; however, the estimated average requirement in older children and adolescents (400-600 IU/day, respectively) should be met from diet and natural sources like sunlight. Rickets and vitamin D deficiency should be treated with oral cholecalciferol, preferably in a daily dosing schedule (2000 IU below 1 year of age and 3000 IU in older children) for 12 weeks. If compliance to daily dosing cannot be ensured, intermittent regimens may be prescribed for children above 6 months of age. Universal vitamin D supplementation is not recommended in childhood pneumonia, diarrhea, tuberculosis, HIV and non-infectious conditions like asthma, atopic dermatitis, and developmental disorders. Serum 25-hydroxy vitamin D level of >20 ng/mL should be maintained in children with conditions at high-risk for vitamin deficiency, like nephrotic syndrome, chronic liver disease, chronic renal failure, and intake of anticonvulsants or glucocorticoids.

Topics: Adolescent; Child; Cholecalciferol; Dietary Supplements; Humans; Pediatrics; Rickets; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D deficiency is prevalent in patients with inflammatory bowel disease (IBD). The goal of this study was to assess the efficacy and safety of high-dose, interval cholecalciferol administration in patients with IBD receiving infliximab.. This prospective, longitudinal, open-label study enrolled pediatric and young adult patients with IBD and vitamin D deficiency. Subjects received 50,000 IU every 4 to 5 weeks (n = 11) or 100,000 IU every 6 to 8 weeks (n = 32) of oral cholecalciferol for 1 year. Dosing was directly observed and administered in conjunction with infliximab infusions. The primary endpoint was vitamin D sufficiency, defined as a 25-hydroxy-vitamin D (25-OHD) level ≥30 ng/mL.. Forty-three participants constituted the primary analysis population. 25-OHD levels reached steady-state after the third dose, and mean increases in 25-OHD levels were 8 vs. 4.5 ng/mL in the 100,000 IU vs. 50,000 IU treatment groups, respectively. Only 43.8% of patients receiving 100,000 IU and 18.2% of patients receiving 50,000 IU achieved sufficiency. There was no difference in the 25-OHD level responsiveness in patients with Crohn disease versus those with ulcerative colitis (P = 0.72). There was no correlation between 25-OHD levels and clinical disease activity in patients with Crohn disease (P = 0.85) or ulcerative colitis (P = 0.24).. Supplementation with cholecalciferol was well-tolerated and direct observation is a promising paradigm for ensuring compliance with therapy. Patients with IBD, however, appear to require high doses of cholecalciferol, with less than half of patients (37% overall) achieving vitamin D sufficiency. Additional studies are necessary to determine the optimal treatment regimens.

Topics: Child; Cholecalciferol; Chronic Disease; Colitis, Ulcerative; Crohn Disease; Dietary Supplements; Humans; Inflammatory Bowel Diseases; Infliximab; Prospective Studies; Vitamin D; Vitamin D Deficiency; Vitamins; Young Adult

The default supply of vitamin D

Topics: Cholecalciferol; Humans; Skin Pigmentation; Vitamin D; Vitamin D Deficiency

In this study, we investigated the effect of calcium and vitamin D (Ca/Vit D) supplementation on the clinical, hormonal, and metabolic profile of patients with low vitamin D levels. In addition, we investigated the effect of Ca/Vit D supplementation on asymmetric dimethylarginine (ADMA) level in patients with polycystic ovary syndrome (PCOS).. In total, 75 patients aged 19-35 years, with a normal body mass index and a diagnosis of PCOS and Vit D deficiency/insufficiency, were included in the study. Patients received 50,000 IU of vitamin D3 once a week for 8 weeks. Afterward, 2500 mg calcium carbonate equivalent to 1000 mg calcium ion and 9.68 mg cholecalciferol equivalent to 880 IU vitamin D3 were administered orally as a maintenance treatment once a day.. The mean age of the patients was 21.7 ± 3.5. After Ca/Vit D supplementation, Vit D levels significantly increased compared to baseline (8.6 ng/ml) levels. An increase in SHBG levels (p < 0.001), a decrease in total testosterone, FAI (p = 0.042), and ADMA levels (p < 0.001) were observed in the first and third months compared to the onset. Significant improvement compared to baseline was observed in menstrual irregularity and median mFG score.. Ca/Vit D supplementation can improve PCOS symptoms such as menstrual dysfunction, hirsutism, and hyperandrogenism. It may be effective in reducing the risk of cardiovascular disease in patients with PCOS later in life by decreasing ADMA levels, which is an indicator of endothelial dysfunction.

Topics: Calcium; Cholecalciferol; Dietary Supplements; Female; Humans; Metabolome; Polycystic Ovary Syndrome; Vitamin D; Vitamin D Deficiency

Topics: Breast Neoplasms; Cholecalciferol; Dietary Supplements; Female; Genetic Predisposition to Disease; Humans; Vitamin D; Vitamin D Deficiency

Hyperuricemia is common among patients with chronic kidney disease (CKD). In the general population, hyperuricemia is associated with secondary hyperparathyroidism (SHPT), in a mechanism that involves vitamin D metabolism. Data for patients with CKD, however, are scarce. We aimed to evaluate the relationship between hyperuricemia and mineral and bone metabolism, particularly hyperparathyroidism.. This is a retrospective study that included 922 adult patients with stages 3, 4, or 5 CKD, not on dialysis. Clinical, demographic, and biochemical data were collected from charts and included uric acid, parathyroid hormone (PTH), 25(OH)-vitamin D, calcium, phosphate, renal function (estimated glomerular filtration rate-eGFR), and medications such as allopurinol, furosemide, and cholecalciferol. SHPT was defined as PTH > 65 pg/ml.. Our patients were mostly Caucasian women, with a mean age of 64 ± 16 years. SHPT and hyperuricemia were observed in 70% and 62.4% of patients, respectively. Patients with SHPT presented higher levels of uric acid (7.2 ± 1.8 vs. 6.6 ± 1.7 mg/dL, p = 0.0001) and a higher frequency of hyperuricemia (66% vs. 33%, p = 0.0001). Patients with hyperuricemia were mostly female, with lower eGFR, higher phosphate, and higher PTH. The risk of hypovitaminosis D was higher among patients with SHPT (69.7% vs. 53.1%, p = 0.0001). Hyperuricemia remained independently associated with hyperparathyroidism, (p = 0.033) even after adjustments for eGFR, calcium, phosphate, hypovitaminosis D, and use of allopurinol, calcitriol, furosemide, and cholecalciferol.. Hyperuricemia seems to be a contributing factor for SHPT in patients with CKD. The mechanisms behind this finding have yet to be elucidated.

Topics: Adult; Aged; Aged, 80 and over; Allopurinol; Calcium; Cholecalciferol; Female; Furosemide; Humans; Hyperparathyroidism, Secondary; Hyperuricemia; Male; Middle Aged; Parathyroid Hormone; Phosphates; Renal Insufficiency, Chronic; Retrospective Studies; Uric Acid; Vitamin D; Vitamin D Deficiency

Topics: Adult; Aged; Bone Density Conservation Agents; Cholecalciferol; Dietary Supplements; Female; Humans; Male; Middle Aged; Pilot Projects; Vitamin D Deficiency; Vitamins; Young Adult

Paediatric patients with recessive dystrophic epidermolysis bullosa (RDEB) are at risk of vitamin D deficiency, owing to lack of sunlight from reduced mobility and having large areas of skin being covered with dressings, and to impaired nutritional intake and status.. To establish an appropriate level of vitamin D supplementation in paediatric patients with RDEB.. Patients with RDEB attending the EB tertiary multidisciplinary team clinic were enrolled. Serum levels of total 25(OH)D were retrospectively recorded for the study period 2012-2018. Data from clinical records on supplements, bone mineral density (BMD) Z scores, compliance, and use of enteral feeds and/or formula were also recorded.. In total, 24 patients met the inclusion criteria: 20 with severe RDEB, 3 with RDEB inversa and 1 with intermediate RDEB. Of the 24 patients, 21 (88%) were advised to take a vitamin D3 supplement in line with Department of Health Guidelines (UK), with the remaining 3 patients receiving sufficient intake from formula or enteral feeds. Thirteen of the 24 (54%) had vitamin D deficiency or insufficiency despite advice to supplement; 9 of these 13 (69%) subsequently started or increased the dosage of vitamin D supplements and levels became sufficient (> 50 nmol/L), while the remaining 4 patients (31%) continued to have persistent insufficient levels due to noncompliance with supplements. Reasons for noncompliance were palatability, cost and forgetting to take the tablets. The dose required to maintain sufficient serum levels increased with age, up to 300% of the reference nutrient intake (RNI).. All patients with RDEB require a supplement or a formula or enteral/sip feed containing vitamin D to maintain sufficient serum vitamin D. The dose required increases with age and can be up to three times higher than the RNI for the normal population. Compliance may improve using a once-weekly loading dose of vitamin D3. Vitamin D deficiency was not solely causative of a low BMD Z score.

Topics: Child; Cholecalciferol; Dietary Supplements; Epidermolysis Bullosa; Epidermolysis Bullosa Dystrophica; Humans; Retrospective Studies; Vitamin D; Vitamin D Deficiency

Background: The primary objective of the study was to assess serum 25-hydroxyvitamin D [25(OH)D] values in patients with Cushing’s disease (CD), compared to controls. The secondary objective was to assess the response to a load of 150,000 U of cholecalciferol. Methods: In 50 patients with active CD and 48 controls, we evaluated the anthropometric and biochemical parameters, including insulin sensitivity estimation by the homeostatic model of insulin resistance, Matsuda Index and oral disposition index at baseline and in patients with CD also after 6 weeks of cholecalciferol supplementation. Results: At baseline, patients with CD showed a higher frequency of hypovitaminosis deficiency (p = 0.001) and lower serum 25(OH)D (p < 0.001) than the controls. Six weeks after cholecalciferol treatment, patients with CD had increased serum calcium (p = 0.017), 25(OH)D (p < 0.001), ISI-Matsuda (p = 0.035), oral disposition index (p = 0.045) and decreased serum PTH (p = 0.004) and total cholesterol (p = 0.017) values than at baseline. Multivariate analysis showed that mean urinary free cortisol (mUFC) was independently negatively correlated with serum 25(OH)D in CD. Conclusions: Serum 25(OH)D levels are lower in patients with CD compared to the controls. Vitamin D deficiency is correlated with mUFC and values of mUFC > 240 nmol/24 h are associated with hypovitaminosis D. Cholecalciferol supplementation had a positive impact on insulin sensitivity and lipids.

Topics: Cholecalciferol; Dietary Supplements; Humans; Pituitary ACTH Hypersecretion; Rickets; Vitamin D Deficiency

Nutritional vitamin D supplements are often used in general pediatrics. Here, the aim is to address vitamin D supplementation and calcium nutritional intakes in newborns, infants, children, and adolescents to prevent vitamin D deficiency and rickets in general populations.. We formulated clinical questions relating to the following categories: the Patient (or Population) to whom the recommendation will apply; the Intervention being considered; the Comparison (which may be "no action," placebo, or an alternative intervention); and the Outcomes affected by the intervention (PICO). These PICO elements were arranged into the questions to be addressed in the literature searches. Each PICO question then formed the basis for a statement. The population covered consisted of children aged between 0 and 18 years and premature babies hospitalized in neonatology. Two groups were assembled: a core working group and a voting panel from different scientific pediatric committees from the French Society of Pediatrics and national scientific societies.. We present here 35 clinical practice points (CPPs) for the use of native vitamin D therapy (ergocalciferol, vitamin D. This consensus document was developed to provide guidance to health care professionals on the use of nutritional vitamin D and dietary modalities to achieve the recommended calcium intakes in general pediatric populations. These CPPs will be revised periodically. Research recommendations to study key vitamin D outcome measures in children are also suggested.

Topics: Adolescent; Calcium; Calcium, Dietary; Child; Child, Preschool; Cholecalciferol; Consensus; Dietary Supplements; Humans; Infant; Infant, Newborn; Neonatology; Vitamin D; Vitamin D Deficiency; Vitamins

Acute kidney injury (AKI) is a common complication in patients with potentially life-threatening diseases, and it is also usually associated with unacceptable morbidity and mortality rates. Therefore, new and efficient therapies are urgently required to relieve AKI. It is well known that, reactive oxygen species (ROS), the NF-κB signaling pathways and pyroptosis are involved in AKI induced by ischemia/reperfusion (I/R). The present study seeks to further confirm the internal relationship between vitamin D deficiency and I/R-induced AKI in patients, and to explore the underlying mechanisms of ROS, NF-κB signaling pathways and pyroptosis in the renal ischemia-reperfusion injury, as well as investigating the protective role of cholecalciferol. Patients with vitamin D deficiency show worse renal function reflected by postoperative glomerular filtration rate (GFR) and more release of proinflammatory cytokine IL-1β and IL-18. Renal cell injury and renal dysfunction induced by I/R surgery were attenuated in the ICR mice administered with cholecalciferol. Cholecalciferol reduced ROS production, suppressed activated NF-κB signaling, and inhibited gasdermin D (GSDMD, a pyroptosis execution protein)-mediated pyroptosis. Cholecalciferol therefore has potential, as a clinical drug, to protect renal function in I/R-induced AKI through reducing ROS production, NF-κB activation and GSDMD-mediated pyroptosis.

Topics: Acute Kidney Injury; Animals; Cholecalciferol; Humans; Ischemia; Kidney; Mice; Mice, Inbred ICR; NF-kappa B; Pyroptosis; Reactive Oxygen Species; Reperfusion; Reperfusion Injury; Vitamin D Deficiency

Topics: Cholecalciferol; COVID-19; Dietary Supplements; Humans; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D deficiency is a global health issue with consequences for bone health. Complexation of vitamin D

Topics: Animals; Biomarkers; Cholecalciferol; Dietary Supplements; Male; Rats; Rats, Sprague-Dawley; Vitamin D; Vitamin D Deficiency; Vitamins; Whey Proteins

Topics: Calcifediol; Cholecalciferol; Dietary Supplements; Female; Humans; Osteoporosis, Postmenopausal; Postmenopause; Vitamin D; Vitamin D Deficiency

The intent of this study was an evaluation of our effort to reduce the incidence of hypercalcemia in critically ill vitamin D-deficient patients with multiple traumatic injuries given cholecalciferol. Vitamin D deficiency was defined as a serum 25-hydroxy vitamin D concentration (25-OH vit D) of <20 ng/mL. Adult patients (>17 years of age) were given 10,000 IU of cholecalciferol daily with an intended target 25-OH vit D of >19.9 ng/mL. These patients were compared to a historical control group that underwent therapy with a higher target of >29.9 ng/mL. Patients received cholecalciferol via the feeding tube along with enteral nutrition (EN) until the target 25-OH vit D was achieved, EN discontinued, the nutrition support service signed off the patient, or the patient was discharged from the TICU. Patients were included if two consecutive weekly 25-OH vit D were measured. One hundred and three critically ill trauma patients were retrospectively studied. Fifty were given cholecalciferol therapy with the new lower target 25-OH vit D, and 53 were from a historical cohort aiming for the higher target. Hypercalcemia (serum ionized calcium concentration > 1.32 mmol/L) was reduced from 40% (21 out of 53 patients) to 4% (2 out of 50 patients; p < 0.001). None of the hypercalcemic patients were symptomatic. Readjustment of target 25-OH vit D concentration resulted in a ten-fold decrease in the rate of hypercalcemia and improved the safety of cholecalciferol therapy for critically ill patients with traumatic injuries.

Topics: Adult; Calcifediol; Cholecalciferol; Critical Illness; Humans; Hypercalcemia; Retrospective Studies; Vitamin D; Vitamin D Deficiency; Vitamins

Obesity increases the risk of vitamin D insufficiency, which exacerbates secondary hyperparathyroidism in chronic kidney disease. Recent studies suggest that serum total 25-hydroxyvitamin D (25OHD) levels of ≥50 ng/mL are necessary to produce significant reductions in elevated parathyroid hormone levels in nondialysis patients. Data from real-world and randomized controlled trials (RCTs) involving these patients were examined for (1) relationships between vitamin D treatments and the achieved levels of serum 25OHD and between serum 25OHD and body weight (BW)/body mass index (BMI); and (2) the impact of BW/BMI on achieving serum 25OHD levels ≥50 ng/mL with extended-release calcifediol (ERC) treatment or vitamin D supplementation (cholecalciferol or ergocalciferol).. Data obtained from nondialysis patients participating in two real-world studies, one conducted in Europe (Study 1) and the other (Study 2) in the USA, and in two US RCTs (Studies 3 and 4) were analyzed for serum 25OHD outcomes after treatment with ERC, vitamin D supplements, or placebo.. More than 50% of subjects treated with vitamin D supplements in both real-world studies (Studies 1 and 2) failed to achieve serum 25OHD levels ≥30 ng/mL, a level widely viewed by nephrologists as the threshold of adequacy; only 7.3-7.5% of subjects achieved levels ≥50 ng/mL. Data from the European study (Study 1) showed that serum 25OHD levels had significant and nearly identical inverse relationships with BW and BMI, indicating that high BW or BMI thwarts the ability of vitamin D supplements to raise serum 25OHD. One RCT (Study 3) showed that 8 weeks of ERC treatment (60 μg/day) raised serum 25OHD levels to ≥30 and 50 ng/mL in all subjects, regardless of BW, while cholecalciferol (300,000 IU/month) raised serum 25OHD to these thresholds in 56% and 0% of subjects, respectively. The other RCT (Study 4) showed that ERC treatment (30 or 60 μg/day) successfully raised mean serum 25OHD levels to at least 50 ng/mL for subjects in all BW categories, whereas no increases were observed with placebo treatment.. Real-world studies conducted in Europe and USA in nondialysis patients (Studies 1 and 2) showed that vitamin D supplements (cholecalciferol or ergocalciferol) were unreliable in raising serum total 25OHD to targets of 30 or 50 ng/mL. In contrast, ERC was demonstrated to be effective in one real-world study (Study 2) and two RCTs (Studies 3 and 4) conducted in US nondialysis patients in raising serum 25OHD to these targeted levels irrespective of BW.

Topics: Calcifediol; Cholecalciferol; Ergocalciferols; Humans; Hyperparathyroidism, Secondary; Overweight; Parathyroid Hormone; Randomized Controlled Trials as Topic; Renal Insufficiency, Chronic; Vitamin D; Vitamin D Deficiency; Vitamins

Topics: Cholecalciferol; Dietary Supplements; Humans; Vitamin D; Vitamin D Deficiency; Vitamins

Topics: Adult; Calcifediol; Case-Control Studies; Cholecalciferol; Humans; Periodontitis; Vitamin D Deficiency

Vitamin D plays a role in innate immune system activation, and deficiency increases susceptibility to respiratory infections and disease severity including COVID-19. We determined whether vitamin D levels and medications were associated with contracting COVID-19, and disease severity defined by hospitalisation and dialysis patient mortality.. We reviewed serum vitamin D levels, and prescription of cholecalciferol and alfacalcidol along with corresponding medical records of adult dialysis patients from a United Kingdom tertiary centre between March 2020 and May 2021. COVID-19 infection was determined by polymerase chain reaction (PCR) results.. 362 (35%) of 1035 dialysis patients tested PCR positive for COVID-19. COVID-19 positive patients had lower native median vitamin D (65 (39-95) versus 74 (40.5-101) nmol/L (p = .009) despite greater prescription of cholecalciferol (median 20 000 (20000-20 000) versus 20 000 (0-20 000) IU/week), p < .001, but lower prescription of alfacalcidol 0 (0-3.0) versus 2.0 (0.-5.0) ug/week, p < .001. On multivariate logistic regression COVID-19 infection was associated with haemodialysis versus peritoneal dialysis (p < .001), cholecalciferol dose (p < .001) and negatively with alfacalcidol (p < .001). However, serum vitamin D levels and alfacalcidol dosages were not significantly different for those requiring hospitalisation compared to those managed at home, although those who died were prescribed lower alfacalcidol dosages.. Dialysis patients who contracted COVID-19 had lower levels of native vitamin D prior to COVID-19 and were prescribed lower dosages of alfacalcidol. However, there was no association between vitamin D status and disease severity. This retrospective observational analysis supports a potential role for vitamin D and susceptibility to COVID-19 infection in dialysis patients.

Topics: Adult; Cholecalciferol; COVID-19; Humans; Kidney; Renal Dialysis; Retrospective Studies; Vitamin D; Vitamin D Deficiency; Vitamins

The 25-hydroxyvitamin D3 (25OHD3) deficiency in chronic kidney disease (CKD) is associated with immune system dysfunction (pro-inflammatory cytokines storm) through macrophages renal infiltration, oxidative stress (OxS) damage and athero-thromboembolic risk. Conversely, cholecalciferol supplementation (25OHD-S) prevents kidney fibrosis by inhibition of vascular calcification and nephrotic apoptosis (nephrons reduction). The objective of this study was to investigate the pleiotropic effects of 25OHD-S on immunomodulation, antioxidant status and in protecting against thromboembolic events in deficiency CKD Black and White individuals living in the Southern Sahara (SS). The oral 25OHD-S was evaluated in 60,000 IU/month/36 weeks versus in 2000 IU/day/24 weeks in Black (n = 156) and White (n = 150). Total serum vitamin D was determined by liquid chromatography-tandem mass spectrometry. All biomarkers of pro-inflammatory cytokines (PIC) were assessed by ELISA tests. OxS markers were assessed by Randox kits. Homocysteine and lipoproteine (a) were evaluated by biochemical methods as biomarkers of atherothromboembolic risk. All statistical analyses were performed with Student’s t-test and one-way ANOVA. The Pearson test was used to calculate the correlation coefficient. The means will be significantly different at a level of p value < 0.05. Multiple logistic regressions were performed using Epi-info and Statview software. Vitamin D deficiency alters the PIC profile, OxS damage and atherothrombogenic biomarkers in both SS groups in the same manner; however, these disorders are more acute in Black compared to White SS individuals. The results showed that the serum 25OHD3 concentrations became normal (>75 nmol/L or >30 ng/mL) in the two groups. We have shown that the dose and duration of 25OHD-S treatment are not similar in Black SS residents compared to White SS subjects, whilst the same inhabit the south Sahara environment. It appears that a high dose intermittent over a long period (D60: 36 weeks) was more efficient in Black people; while a lower dose for a short time is sufficient (D2: 24 weeks) in their White counterparts. The oral 25OHD-S attenuates PIC overproduction and OxS damage, but does not reduce athero-thromboembolic risk, particularly in Black SS residents.

Topics: Cholecalciferol; Cytokine Release Syndrome; Cytokines; Dietary Supplements; Humans; Oxidative Stress; Renal Insufficiency, Chronic; Vitamin D; Vitamin D Deficiency

To see the efficacy of oral cholecalciferol administered to chronic kidney disease patients with vitamin D deficiency.. The prospective interventional study was conducted at the Indus Hospital, Karachi, from January 11, 2017, to January 10, 2018, and comprised diagnosed pre-dialysis chronic kidney disease patients of either gender aged >14 years having vitamin D deficiency. Oral vitamin D 50,000IU was given weekly to those who had severe deficiency <10ng/ml, and every other week to those with less severe 10-25ng/ml deficiency for 3 months. Improvement in vitamin D level was checked along with other chronic kidney disease markers every month over the 3-month period. Data was analysed using SPSS 24.. Of the 186 patients enrolled, 129(%) completed the study; 76(58.5%) males and 53(40.8%) females. Overall, 105(81.4%) patients achieved normal vitamin D levels after 3 months of treatment. Significant negative but weak correlation of phosphate, creatinine and intact parathyroid hormone levels was found with vitamin D (p<0.05). Significant positive but weak correlation was found between albumin and vitamin D levels (p<0.05).. Significant efficacy of oral vitamin D in chronic kidney disease patients was seen.

Topics: Cholecalciferol; Female; Humans; Male; Parathyroid Hormone; Prospective Studies; Renal Insufficiency, Chronic; Vitamin D; Vitamin D Deficiency; Vitamins

Data on the effect of vitamin D supplementation on fibroblast growth factor 23 (FGF23), in chronic kidney disease (CKD) are scarce. In a prospective interventional study, the effect of vitamin D supplementation on cFGF23 (C-terminal FGF23) levels in children with CKD stages 2-4 was examined. Forty-one children with CKD and vitamin D insufficiency were administered 600,000 units of cholecalciferol over 3 d; 88% of patients achieved sufficiency at 8 wk. Significant increase in serum cFGF23 and phosphate levels was observed in CKD stage 2 after supplementation, but not in CKD stages 3 and 4. There was no correlation of the change in cFGF23 level with baseline or change in bone health parameters (calcium, phosphate, parathormone or alkaline phosphatase) or with change in flow-mediated dilatation (FMD) of the brachial artery. It is concluded that cholecalciferol supplementation increases serum calcium and reduces PTH, but does not adversely affect FGF23 levels in CKD.

Topics: Alkaline Phosphatase; Calcium; Child; Cholecalciferol; Dietary Supplements; Fibroblast Growth Factors; Humans; Parathyroid Hormone; Phosphates; Prospective Studies; Renal Insufficiency, Chronic; Vitamin D; Vitamin D Deficiency; Vitamins

Epidemiological studies show that a significant fraction of the global population presents low levels of vitamin D

Topics: Cellulose; Cholecalciferol; Delayed-Action Preparations; Humans; Spectroscopy, Fourier Transform Infrared; Vitamin D Deficiency; Vitamins

Vitamin D deficiency is a global public health problem, a pandemic that commonly affects the elderly and those with comorbidities such as obesity, diabetes, hypertension, respiratory disorders, recurrent infections, immune deficiency, and malignancies, as well as ethnic minorities living in temperate countries. The same groups were worst affected by COVID-19. Since vitamin D deficiency weakens the immune system, it increases the risk of infections, complications, and deaths, such as from sepsis and COVID-19. Deficiency can be remedied cost-effectively through targeted food fortification, supplementation, and/or daily safe sun exposure. Its endocrine functions are limited to mineral metabolism, musculoskeletal systems, specific cell membrane interactions, and parathyroid gland functions. Except for the rapid, endocrine, and cell membrane-based non-genomic functions, all other biological and physiological activities of vitamin D depend on the adequate intracellular synthesis of 1,25(OH)2D (calcitriol) in peripheral target cells via the genome. Calcitriol mediates autocrine (intracrine) and paracrine signalling in immune cells, which provides broader, protective immune functions crucial to overcoming infections. The synthesis of 1,25(OH)2D (calcitriol) in peripheral target cells is dependent on diffusion and endocytosis of D3 and 25(OH)D from the circulation into them, which requires maintenance of serum 25(OH)D concentration above 50 ng/mL. Therefore, in acute infections such as sepsis and respiratory infections like COVID-19, it is necessary to rapidly provide its precursors, D3 and 25(OH)D, through the circulation to generate adequate intracellular calcitriol. Immune defence is one of the crucial non-hormonal functions of vitamin D. A single oral (bolus) dose or divided upfront loading doses between 100,000 and 500,000 IU, using 50,000 IU vitamin D3 increase the serum 25(OH)D concentrations to a therapeutic level of above 50 ng/mL that lasts between two to three months. This takes three to five days to raise serum 25(OH)D. In contrast, a single oral dose of calcifediol (0.014 mg/kg body weight) can generate the needed 25(OH)D concentration within four hours. Considering both D3 and 25(OH)D enter immune cells for generating calcitriol, using the combination of D3 (medium-term) and calcifediol (immediate) is cost-effective and leads to the best clinical outcome. To maximise protection against infections, particularly to reduce COVID-19-associated complicati

Topics: Aged; Calcifediol; Calcitriol; Cholecalciferol; COVID-19; Dietary Supplements; Humans; Immune System; Sepsis; Vitamin D; Vitamin D Deficiency; Vitamins

A French ministerial decree planning to include cholecalciferol, i.e. vitamin D3 (VD3), in the endocrine disruptors (ED) list has generated a lot of concerns in French physicians and scientists. The aim of the present article was to discuss the scientific rationale that may support or not this decision, which seems to be due to the use of VD3 overdose as a rodenticide in some European countries. First, it is noticeable that cholecalciferol is not an “exogenous substance”, a term used in all the definitions of ED, as it is largely synthesized in the skin after UVB rays exposure. Second, we did not find any published article that may support the inclusion of VD3 in the ED list. The request “vitamin D AND endocrine disruptor” reported 33 references in the PubMed database on March, 10, 2022, most of them discussing disturbances of vitamin D metabolism by EDs. Third, a large amount of studies conclude that VD3 has or may have beneficial effects on many functions that are known to be altered by EDs. In addition, we warn that learning that VD3 could be legally considered as a PE may cause the general public to mistrust vitamin D supplementation, which is not desirable in terms of public health as it may increase the already too high prevalence of vitamin D deficient individuals. We consider the aberrant decision of including cholecalciferol in the ED list should be rapidly invalidated before being effective in France and possibly disseminated in the European Union.. Un projet d'arrêté ministériel inscrivant le cholécalciférol, c'est-à-dire la vitamine D3 (VD3), dans la liste des perturbateurs endocriniens (PE) est à l'origine de débats en France. L'objectif de notre article était de préciser les arguments scientifiques pour et contre l'inscription de la VD3 dans la liste des PE, qui semble être initialement due à son utilisation à très forte dose comme raticide/rodenticide dans certains pays. Premièrement, le cholécalciférol ne peut être défini comme une substance exogène, terme utilisé dans les différentes définitions des PE, car il est largement synthétisé dans la peau suite à l'exposition aux UVB. Deuxièmement, il n'existe aucune publication dans la base de données PubMed en faveur d'une inscription de la VD3 dans la liste des PE. La requête « vitamin D AND endocrine disruptor » retrouvait 33 références au 10 mars 2022, la plupart évoquant des perturbations du métabolisme de la vitamine D par les PE. Troisièmement, un grand nombre d'études concluent, au contraire, que la VD3 a des effets bénéfiques sur de nombreuses fonctions altérées par les PE. Plus largement, nous alertons sur le fait qu'apprendre que la VD3 pourrait être règlementairement considérée comme un PE pourrait occasionner, auprès du grand public, une défiance vis-à-vis de la supplémentation en vitamine D, ce qui n'est pas souhaitable en termes de santé publique car de nature à aggraver la prévalence déjà trop élevée des individus carencés en vitamine D. Il est encore temps d'éviter cette décision aberrante et non fondée.

Topics: Cholecalciferol; Endocrine Disruptors; Humans; Vitamin D; Vitamin D Deficiency; Vitamins

Several studies have shown that cholecalciferol supplementation (25OHD-S) in chronic kidney disease (CKD) improves kidney injury by reducing fibrosis-related vascular calcification and declining apoptosis-linked nephron damage.. Vitamin D deficiency alters in the same manner CMet, CRenal, and others biomarkers in both groups SS; however, these disorders are more acute in blacks compared to whites SS. Oral 25OHD-S a highlighted improvement of eGFR drop, SHPT decrease, decline proteinuria, and cardiac failure risk (NT-proBNP and cTnT) attenuation. Concomitantly, 25OHD-S normalizes

Topics: Biomarkers; Cardio-Renal Syndrome; Cholecalciferol; Dietary Supplements; Humans; Hyperparathyroidism, Secondary; Renal Insufficiency, Chronic; Troponin T; Vitamin D Deficiency

HIV infection is still a serious public health issue globally. Suboptimal vitamin D status is highly prevalent in HIV-infected children and adolescents throughout the world.. To evaluate the outcome of vitamin D supplementation on CD4 count in HIV-infected children and adolescents with suboptimal vitamin D status.. Vitamin D level of HIV-infected children and adolescents were measured at enrolment. Suboptimal vitamin D level was defined as 25(OH)D < 30 ng/ml. Vitamin D insufficiency and deficiency were defined as 21-29 and <20 ng/ml, respectively. Children with suboptimal vitamin D levels were supplemented with vitamin D.. This was a single-centre, non-randomized comparative study enrolling 50 eligible participants. There were 20 patients who were vitamin D sufficient, 7 were vitamin D insufficient and 23 were found to be vitamin D deficient at enrolment. However, after supplementation, the status of sufficient remained same and 7 insufficient become sufficient, whereas in 23 deficient, 18 (78.3%) become sufficient and 5 (21.7%) become insufficient and this change was found statistically significant among the groups (χ2 = 6.52, p = 0.038). There was a significant improvement of CD4 count from baseline to 4 months in deficient group on vitamin D supplementation (p value < 0.001; 1.2-fold rise). No significant change was seen in vitamin D insufficient (p value = 0.791) and sufficient groups (p value = 0.168).. Vitamin D should be supplemented in HIV-infected children on ART with low CD4 counts.

Topics: Adolescent; CD4 Lymphocyte Count; Child; Cholecalciferol; Dietary Supplements; HIV Infections; Humans; India; Vitamin D; Vitamin D Deficiency; Vitamins

One of the many factors involved in the development of uterine fibroids is vitamin D deficiency. One aspect of this deficiency is decreased serum concentration of calcidiol-25(OH)D, a metabolite of D3 vitamin. The active form of vitamin D3, which arises after numerous enzymatic reactions, is calcitriol-1,25(OH)2D3; this compound is transported to various body tissues. Vitamin D possesses extra-genomic effects due to its influence on various signaling pathways, i.e., through activating tyrosine kinases and by genomic effects via binding to a specific nuclear receptor, vitamin D receptor (VDR). The vitamin D/VDR complex regulates the expression of genes and is involved in the pathogenesis of fibroids. Numerous studies have shown that vitamin D supplementation reduces fibroid size. It has also been shown that the expression of VDR in myoma tissue is significantly lower than in the uterine muscle tissue at the tumor periphery. However, the expression of VDR in non-myoma uterine muscle has not previously been investigated. Our VDR expression studies were performed immunohistochemically with tissue microarrays (TMA) in three tissue groups: 98 uterine myoma tissues, 98 uterine tissues (tumor margin), and 12 tissues of normal uterine muscle (i.e., without fibroids). A statistical analysis showed significantly lower VDR expression in uterine muscle at the periphery of the fibroid than in healthy uterine muscle. Lower expression of VDR at the periphery of the myoma compared to that in normal uterine muscle may indicate potential for new myomas. This observation and the described reduction in the size of fibroids after vitamin D supplementation supports the hypothesis of causal development of uterine fibroids and may be useful for the prevention of re-development in the event of their excision from the uterus.

Topics: Cholecalciferol; Female; Humans; Immunohistochemistry; Leiomyoma; Receptors, Calcitriol; Vitamin D; Vitamin D Deficiency

Reparative giant cell granulomas are benign masses of multi-etiological nature, which account for 1%-7% of all benign lesions of the jaws. The objective of this case report is to present the relationship between isolated vitamin D deficiency and the development of reparative giant cell granuloma.Herein, we present the case of a 70-year-old female patient with a painless mass of increased mobility in the mandibular region, and pain in the involved teeth. After histological confirmation and laboratory screening, а reparative giant cell granuloma caused by serious deficiency of vitamin D3 - (25-OH)D was diagnosed. The treatment protocol included surgical removal of the lesion and vitamin D replacement therapy.In rare cases, this type of lesion can be a primary manifestation of vitamin D deficiency; therefore, it is extremely important to be aware of this pathology.

Topics: Aged; Cholecalciferol; Female; Giant Cell Tumors; Granuloma, Giant Cell; Humans; Vitamin D; Vitamin D Deficiency

Despite multiple studies suggesting that low 25(OH)D-vitamin levels are associated with worse outcomes in critically ill individuals, attempts to mitigate the outcomes by fixed dose enteral supplementation unguided by baseline or target blood levels have been unsuccessful. Since a single measurement of 25(OH)D may not optimally reflect an individual's vitamin D status, we studied the plasma concentration of different vitamin D metabolites and their recovery during and following resolution of acute critical illness.. Most individuals were vitamin D deficient when assessed during critical illness, with 25(OH)D-vitamin levels under 30 ng/ml for 37/40 individuals at timepoint S1 and 34/38 at S2. After recovery, 18/30 patients were deficient at S3. Levels of all vitamin D metabolites measured were low during critical illness but rose substantially following resolution of acute illness. No strong correlation was found between markers of acute illness severity or duration and resolution of vitamin D metabolites in the interval between acute illness and recovery.. In critically ill patients, levels of multiple vitamin D metabolites are low but substantial recovery occurs following resolution of acute illness. It is unclear whether a single metabolite is sufficient to assess vitamin D status of critically ill patients and guide potential supplementation.

Topics: Acute Disease; Cholecalciferol; Chromatography, Liquid; Critical Illness; Humans; Tandem Mass Spectrometry; Vitamin D; Vitamin D Deficiency; Vitamin D-Binding Protein; Vitamins

Topics: Aged; Boston; Calcifediol; Calcium; Calcium, Dietary; Cholecalciferol; Dietary Supplements; Double-Blind Method; Female; Humans; Male; Muscles; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D deficiency has increased in the general population and is a public health issue. Vitamin D plays an important role in regulating the immune system, e.g., by modulating the production of inflammatory cytokines. In most countries, the recommended maximal daily dose of vitamin D

Topics: Biomarkers; Calcium; Cholecalciferol; Dietary Supplements; Humans; Interleukin-6; Interleukin-8; Male; Parathyroid Hormone; Phosphates; Saudi Arabia; Triglycerides; Tumor Necrosis Factors; Vitamin D; Vitamin D Deficiency; Vitamins

Background: Early childhood rickets increased in Alaska Native children after decreases in vitamin D-rich subsistence diet in childbearing-aged women. We evaluated the impact of routine prenatal vitamin D supplementation initiated in Alaska’s Yukon Kuskokwim Delta in Fall 2016. Methods: We queried electronic health records of prenatal women with 25(OH) vitamin D testing during the period 2015−2019. We evaluated 25(OH)D concentrations, vitamin D3 supplement refills, and decayed, missing, and filled teeth (dmft) scores and rickets in offspring. Results: Mean 25(OH)D concentrations increased 36.5% from pre- to post-supplementation; the percentage with deficient 25(OH)D decreased by 66.4%. Women with ≥ 60 vitamin D3 refill days had higher late pregnancy 25(OH)D concentrations than those with no refill days (p < 0.0001). Women with late pregnancy insufficient 25(OH)D concentrations had offspring with higher dmft scores than those with sufficient 25(OH)D (RR 1.3, p < 0.0001). Three children were diagnosed with nutritional rickets during the period 2001−2021, and none after 2017. Conclusions: These findings suggest that prenatal vitamin D supplementation can improve childhood outcomes in high-risk populations with high rates of rickets.

Topics: Aged; Alaskan Natives; Child; Child, Preschool; Cholecalciferol; Dental Caries; Dental Caries Susceptibility; Dietary Supplements; Female; Humans; Pregnancy; Rickets; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D deficiency is a global health problem that not only leads to metabolic bone disease but also to many other illnesses, most of which are associated with chronic inflammation. Thus, our aim was to investigate the safety and effectiveness of a single high dose of vitamin D

Topics: Calcium; Calcium, Dietary; Cholecalciferol; Cytokines; Dietary Supplements; Female; Humans; Interleukin-6; Interleukin-8; Parathyroid Hormone; Phosphates; Tumor Necrosis Factors; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D3 has a preventive, anti-inflammatory effect. However, there are still few studies linking the effects of athlete training to vitamin D3 supplementation and the immune response. The study evaluated the impact of vitamin D3 supplementation on interleukin 6 (IL-6) release during physical exercise in relation to C-reactive protein (CRP) levels in healthy male athletes. Twenty-five soccer players were divided into two groups-with (GS) and without (GN) vitamin D3 supplementation in a dose of 20,000 IU twice a week for 8 wk (about 6,000 IU/d). At the baseline (T1) and at the end (T2) of the training cycle serum concentrations of 25-hydroxyvitamin D [25(OH)D], IL-6 and CRP were measured. In the GS group, we observed a significant increase in 25(OH)D concentration (p=0.004), and non-significantly increased levels (p>0.05) of IL-6 and CRP. At the baseline, CRP in the supplemented athletes who had suboptimal vitamin D3 concentration in T1 (GSO) was significantly higher than in those with an optimal baseline vitamin D3 level (GO) (p=0.028). However, in GO in T2, a non-significant trend of negative correlation (p=0.055) between 25(OH)D concentration and IL-6 level was found. In the total study group (TG), a statistically significant (p=0.021) negative correlation in T1 was observed between 25(OH)D and CRP. However, our results do not support the immune-modulatory effect of vitamin D3 supplementation in a dose of 6,000 IU/d in athletes, in relation to IL-6 production and its subsequent stimulatory effect on CRP releasing.

Topics: Athletes; C-Reactive Protein; Cholecalciferol; Dietary Supplements; Double-Blind Method; Humans; Interleukin-6; Male; Vitamin D; Vitamin D Deficiency

Vitamin D deficiency is common in patients with chronic liver disease and is associated with increased risk of infection and mortality. This study evaluated the effects of preoperative vitamin D levels on clinical outcomes after liver transplant.. This single-center retrospective study included liver transplant recipients from June to November 2017 who had preoperative 25-OH-vitamin D3 (25-OH-D3) data. Severe vitamin D deficiency, insufficiency, and normal levels were defined as serum 25-OH-D3 concentrations of < 10 ng/mL, 10 to 20 ng/mL, and ≥ 20 ng/mL, respectively. The primary outcome was length of hospital stay; secondary outcomes included the duration of normalization of inflammatory markers after liver transplant, new infection rates, rejection rates, length of intensive care unit stay, and mortality according to preoperative 25-OH-D3 levels.. Among 219 liver transplant recipients, 67.6% were vitamin D-deficient. The mean (standard deviation) 25-OH-D3 concentration was 17.8 (13.2) ng/mL, and 65 (29.7%) patients had levels < 10 ng/mL. Patients with lower mean 25-OH-D3 levels had significantly longer intensive care unit (13.8 [21.9] days vs 5.9 [12.3] days vs 2.7 [4.6] days, P < .001) and hospital (59.0 [66.0] days vs 42.0 [67.4] days vs 27.2 [17.1] days, P = .001) stays. The incidence of new infections was higher in the vitamin D deficiency group. (46.2% vs 28.9% vs 14.1%, P < .001). A higher Nutritional Risk Screening 2002 score (adjusted odds ratio, 1.77; 95% confidence interval [CI], 1.24-2.56; P = .002) and severe vitamin D deficiency (adjusted odds ratio, 3.43; 95% CI, 1.57-7.57; P = .002) were significant risk factors for poor outcome among patients who had been in the hospital for more than 43 days.. Vitamin D deficiency before liver transplant was associated with increased intensive care unit and hospital lengths of stay. Although several factors may influence the clinical outcomes of patients with liver transplant, low vitamin D3 was an independent risk factor.

Topics: Cholecalciferol; Humans; Liver Transplantation; Retrospective Studies; Vitamin D; Vitamin D Deficiency; Vitamins

Topics: Cholecalciferol; COVID-19; Dietary Supplements; Humans; Pandemics; Vitamin D; Vitamin D Deficiency; Vitamins

The goal of this study was to assess the anthropometric and biochemical parameters of children and adolescents with phenylketonuria (PKU).. The participants in this cross-sectional study ranged in age from four to 18 years old. Biochemical markers such as vitamin B12, folic acid, iron, ferritin, calcium, 25-hydroxy vitamin D3, zinc, plasma phenylalanine (Phe) and tyrosine (Tyr) levels in blood were evaluated, as well as demographics and anthropometric measurements. A three-day dietary recall questionnaire was completed by all individuals.. 80% (64) of the 80 patients (42 females, 52.5%) had typical PKU. Consanguineous marriages were found in 57.5% (46) of the patients' parents. According to the height for age index, 17.5% of the study group (n = 14) were short or very short. According to age-related weight and body mass index (BMI), 37.5% (n = 30) and 43.8% (n = 35) of people are obese or overweight, respectively. Biochemical tests revealed increased vitamin B12 levels and 25-hydroxy vitamin D3 deficiency in 35% (n = 28) of the patients, insufficient folic acid in 12.5% (n = 10), and elevated phenylalanine levels in 70.3% (n = 45) of children under 12 years old, and adolescents 62.5% (n = 10). A high Phe intake (OR = 4.44, CI %95 = 1.27-15.57) is a risk factor for obesity and overweight.. Patients with PKU had a high rate of overweight and obesity. PKU patients who are overweight or obese do not differ from normal-weight patients in terms of dietary intake or laboratory findings (except for serum iron levels). One-third of patients with phenylketonuria were vitamin D deficient and had a BMI/A index of overweight/obese. It is recommended to use special medical food to help solve energy and nutrient deficiencies.

Topics: Adolescent; Child; Child, Preschool; Cholecalciferol; Cross-Sectional Studies; Female; Folic Acid; Humans; Iron; Nutritional Status; Obesity; Overweight; Phenylalanine; Phenylketonurias; Vitamin B 12; Vitamin D Deficiency

The effects of different cholecalciferol supplementation regimens on serum inflammatory cytokines in healthy subjects with vitamin D deficiency are still lacking. This is a single-center, open-label, randomized, parallel group study involving healthy subjects deficient in vitamin D (baseline 25OHD < 20 ng/mL) receiving oral cholecalciferol with three different dosing regimens: Group A: 10,000 IU/day for 8 weeks followed by 1000 IU/day for 4 weeks; Group B: 50,000 IU/week for 12 weeks and Group C: 100,000 IU every other week for 12 weeks. IL-17A, IL-6, IL-8, IL-10, IL-23 and TNFα were measured at baseline and at week 4, 8, 12, and 16. 75 healthy subjects were enrolled (58.7% female), with an average age of 34.1 ± 10.2 years. No statistical differences were observed among groups at baseline for either IL-6, IL-17A, IL-23, IL-8 or IL-10 at any time point; TNFα was indetectable. Concerning the whole sample, the time trend analysis showed a statistically significant linear trend for decreasing values over the treatment period for IL-6 (p = 0.016) and IL-17A (p = 0.006), while no significant time trends were observed for the other teste cytokines. No significant differences were found in the serum concentrations of the tested cytokines between week 12 and week 16. In young healthy individuals deficient in vitamin D, cholecalciferol administration showed a decrease in the serum IL-6 and IL-17A concentrations, without marked differences using the three regimens.

Topics: Adult; Cholecalciferol; Cytokines; Dietary Supplements; Female; Healthy Volunteers; Humans; Interleukin-10; Interleukin-17; Interleukin-23; Interleukin-6; Interleukin-8; Male; Tumor Necrosis Factor-alpha; Vitamin D; Vitamin D Deficiency; Vitamins; Young Adult

Vitamin D deficiency is common in the United States and leads to altered immune function, including T cell and macrophage activity that may impact responses to SARS-CoV-2 infection. This study investigated 131 adults with a history of a positive SARS-CoV-2 nasopharyngeal PCR and 18 adults with no COVID-19 diagnosis that were recruited from the community or hospital into the Northern Colorado Coronavirus Biorepository (NoCo-COBIO). Participants consented to enrollment for a period of 6 months and provided biospecimens at multiple visits for longitudinal analysis. Plasma 25-hydroxyvitamin D levels were quantified by LC-MS/MS at the initial visit (n = 149) and after 4 months (n = 89). Adults were classified as deficient (<30 nM or <12 ng/mL), insufficient (<30−50 nM or 12−20 ng/mL), or optimal (50−75 nM or >20 ng/mL) for 25-hydroxyvitamin D status. Fisher’s exact test demonstrated an association between disease severity, gender, and body mass index (BMI) at baseline. Mixed model analyses with Tukey-Kramer were used for longitudinal analysis according to BMI. Sixty-nine percent (n = 103) of the entire cohort had optimal levels of total 25(OH)D, 22% (n = 32) had insufficient levels, and 9% (n = 14) had deficent levels. Participants with severe disease (n = 37) had significantly lower 25-hydroxyvitamin D (total 25(OH)D) when compared to adults with mild disease (p = 0.006) or no COVID-19 diagnosis (p = 0.007). There was 44% of the cohort with post-acute sequalae of COVID-19 (PASC) as defined by experiencing at least one of the following symptoms after 60 days’ post-infection: fatigue, dyspnea, joint pain, chest pain, forgetfulness or absent-mindedness, confusion, or difficulty breathing. While significant differences were detected in 25-hydroxyvitamin D status by sex and BMI, there were no correlations between 25-hydroxyvitamin D for those without and without PASC. This longitudinal study of COVID-19 survivors demonstrates an important association between sex, BMI, and disease severity for 25-hydroxyvitamin D deficiency during acute stages of infection, yet it is not clear whether supplementation efforts would influence long term outcomes such as developing PASC.

Topics: Adult; Calcifediol; Cholecalciferol; Chromatography, Liquid; Colorado; COVID-19; Dietary Supplements; Humans; Longitudinal Studies; Patient Acuity; SARS-CoV-2; Tandem Mass Spectrometry; Vitamin D; Vitamin D Deficiency

Vitamin D deficiency is now recognized as an independent risk factor and is involved in the pathogenesis of carpal tunnel syndrome (CTS). The purpose of this study was to evaluate the effects of vitamin D. A total of 42 patients were analyzed. At 3 months posttreatment, there was a significant reduction in the severity of pain (VAS score) from baseline (. Vitamin D

Topics: Carpal Tunnel Syndrome; Cholecalciferol; Humans; Pain; Prospective Studies; Vitamin D Deficiency

The aims of this study were to examine the efficacy among various vitamin D supplementation regimens on serum 25-hydroxyvitamin D (25(OH)D) concentrations and determine the minimal dose rate required to achieve sufficient serum concentrations (≥75 nmol/l) among older adults in long-term care (LTC).. A 1-year medical history was abstracted from medical records, and a one-time blood draw to measure serum 25(OH)D concentrations was obtained. Individuals were stratified into vitamin D-supplemented and non-supplemented groups. The supplemented group was further categorised into four treatment forms: single-ingredient vitamin D2or3, multivitamin, Ca with vitamin D or combination of the three, and by daily prescribed doses: 0-9·9, 10-19·9, 20-49·9, 50-99·9 and >100 μg/d.. Five LTC communities in Austin, Texas.. One hundred seventy-three older (≥65 years) adults.. Of the participants, 62% received a vitamin D supplement and 55% had insufficient (≤75 nmol/l) 25(OH)D serum concentrations. Individuals receiving single-ingredient vitamin D2or3 supplementation received the highest daily vitamin D mean dose (72·5 μg/d), while combination of forms was the most frequent treatment (44%) with the highest mean serum concentration (108 nmol/l). All supplementation doses were successful at reaching sufficient serum concentrations, except those<20 μg/d. Using a prediction model, it was observed that 0·025 μg/d of vitamin D supplementation resulted in a 0·008 nmol/l increase in serum 25(OH)D concentrations.. Based on the predictive equation, results suggest that supplementation of 37·5 μg/d of vitamin D2or3 or combination of vitamin D is most likely to achieve sufficient serum 25(OH)D concentrations in older adults in LTC.

Topics: Aged; Cholecalciferol; Dietary Supplements; Humans; Long-Term Care; Vitamin D; Vitamin D Deficiency; Vitamins

To analyze the associations between cholecalciferol or calcifediol supplementation, serum 25-hydroxyvitamin D (25OHD) levels and COVID-19 outcomes in a large population.. All individuals ≥ 18 years old living in Barcelona-Central Catalonia (n = 4.6 million) supplemented with cholecalciferol or calcifediol from April 2019 to February 2020 were compared with propensity score-matched untreated controls. Outcome variables were SARS-CoV2 infection, severe COVID-19 and COVID-19 mortality occuring during the first wave of the pandemic. Demographical data, comorbidities, serum 25OHD levels and concomitant pharmacological treatments were collected as covariates. Associations between cholecalciferol or calcifediol use and outcome variables were analyzed using multivariate Cox proportional regression.. Cholecalciferol supplementation (n = 108,343) was associated with slight protection from SARS-CoV2 infection (n = 4352 [4.0%] vs 9142/216,686 [4.2%] in controls; HR 0.95 [CI 95% 0.91-0.98], p = 0.004). Patients on cholecalciferol treatment achieving 25OHD levels ≥ 30 ng/ml had lower risk of SARS-CoV2 infection, lower risk of severe COVID-19 and lower COVID-19 mortality than unsupplemented 25OHD-deficient patients (56/9474 [0.6%] vs 96/7616 [1.3%]; HR 0.66 [CI 95% 0.46-0.93], p = 0.018). Calcifediol use (n = 134,703) was not associated with reduced risk of SARS-CoV2 infection or mortality in the whole cohort. However, patients on calcifediol treatment achieving serum 25OHD levels ≥ 30 ng/ml also had lower risk of SARS-CoV2 infection, lower risk of severe COVID-19, and lower COVID-19 mortality compared to 25OHD-deficient patients not receiving vitamin D supplements (88/16276 [0.5%] vs 96/7616 [1.3%]; HR 0.56 [CI 95% 0.42-0.76], p < 0.001).. In this large, population-based study, we observed that patients supplemented with cholecalciferol or calcifediol achieving serum 25OHD levels ≥ 30 ng/ml were associated with better COVID-19 outcomes.

Topics: Aged; Aged, 80 and over; Calcifediol; Cholecalciferol; Cohort Studies; Comorbidity; COVID-19; COVID-19 Drug Treatment; Dietary Supplements; Female; Humans; Male; Middle Aged; Renal Insufficiency, Chronic; Retrospective Studies; SARS-CoV-2; Severity of Illness Index; Spain; Vitamin D; Vitamin D Deficiency

No publications have reported on osteomalacia in patients receiving intermittent cyclical therapy with etidronate (a bisphosphonate) and undergoing long-term hemodialysis (HD).. We report on a 46-year-old Japanese man admitted to our hospital for further examination of left forearm pain. Maintenance HD was started at age 24 years, and the man had been on HD since then. At age 38 years, surgical parathyroidectomy was performed for secondary hyperparathyroidism; iliac crest bone biopsy performed at the same time showed osteitis fibrosa. The active vitamin D. We believe that intermittent cyclical etidronate therapy without administration of active vitamin D

Topics: Bone and Bones; Bone Density Conservation Agents; Calcitriol; Cholecalciferol; Etidronic Acid; Humans; Ilium; Male; Middle Aged; Osteitis Fibrosa Cystica; Osteomalacia; Renal Dialysis; Vitamin D Deficiency

We examined the vasoactive effect of estradiol in a rat model of early PCOS and the influence of vitamin D deficiency (VDD). We created a model of chronic hyperandrogenism and VDD in adolescent female Wistar rats (N = 46) with four experimental groups: vitamin D supplemented (T-D+), VDD (T-D-), hyperandrogenic and vitamin D supplemented (T+D+), and hyperandrogenic and VDD (T+D-). T+ groups received an 8-week-long transdermal Androgel treatment, D-animals were on vitamin D-reduced diet and D+ rats were supplemented orally with vitamin D3. Estrogen-induced vasorelaxation of thoracic aorta segments were measured with a wire myograph system with or without the inhibition of endothelial nitric oxide synthase (eNOS) or cyclooxygenase-2 (COX-2). The distribution of estrogen receptor (ER), eNOS and COX-2 in the aortic wall was assessed by immunohistochemistry. VDD aortas showed significantly lower estradiol-induced relaxation independently of androgenic status that was further decreased by COX-2 inhibition. COX-2 inhibition failed to alter vessel function in D+ rats. Inhibition of eNOS abolished the estradiol-induced relaxation in all groups. Changes in vascular function in VDD were accompanied by significantly decreased ER and eNOS staining. Short-term chronic hyperandrogenism failed to, but VDD induced vascular dysfunction, compromised estrogen-dependent vasodilatation and changes in ER and eNOS immunostaining.

Topics: Animals; Aorta; Cholecalciferol; Disease Models, Animal; Estradiol; Estrogens; Female; Nitric Oxide Synthase Type III; Polycystic Ovary Syndrome; Rats; Rats, Wistar; Vasodilation; Vitamin D Deficiency; Vitamins

Severe prolonged vitamin D deficiency can cause rickets or osteomalacia. Both can be prevented by sunshine exposure or vitamin D supplementation. Although New Zealand guidance does not recommend vitamin D supplementation for the general population, it can be considered for individuals at risk of vitamin D deficiency. Routine measurement of 25-hydroxyvitamin D (25OHD) is also considered unnecessary.. We investigated the rates of vitamin D supplementation, rickets and osteomalacia in New Zealand, and of 25OHD results in Auckland, over the last two decades.. Vitamin D prescriptions increased 14-fold, from 86,295/year to 1,215,507/year, between 2003 and 2019, with medication costs alone in 2019 being >$1 million. Despite these changes, the annual prevalence of hospital admissions for rickets, osteomalacia and unspecified vitamin D deficiency remained low and stable (10-20/year). 25OHD concentrations increased between 2002 and 2003 and between 2009 and 2019, and in the later time-period, 25OHD tests mainly identified individuals without vitamin D deficiency (40-50% >75nmol/L, 65-70% >50nmol/L and only 7-12.5% <25nmol/L).. Osteomalacia and rickets persist at low rates despite widespread, increasingly costly vitamin D supplementation and testing, which largely identifies individuals without vitamin D deficiency. These results suggest that vitamin D guidance and practice in New Zealand should change.

Topics: Blood Chemical Analysis; Cholecalciferol; Dietary Supplements; Humans; New Zealand; Osteomalacia; Practice Guidelines as Topic; Practice Patterns, Physicians'; Prevalence; Rickets; Risk Assessment; Vitamin D; Vitamin D Deficiency; Vitamins

To assess the efficacy of an oral high-dose cholecalciferol regimen in correcting vitamin D deficiency (VDD) in adolescents and to explore potential predictive factors on the response to treatment.. This is a retrospective chart review conducted in the Adolescent Outpatient Clinic, Geneva University Hospitals, Switzerland. One hundred-three otherwise healthy vitamin D deficient [serum 25-hydroxyvitamin D, 25(OH)D, level <50 nmol/L] adolescents (mean age 16.6) attending the clinic between 1 January 2016 and 31 December 2018 received 150,000 IU of oral cholecalciferol every month for 3 months (cumulative dose of 450,000 IU). We measured the change in serum 25(OH)D levels pre- and post-treatment and the achievement of serum 25(OH)D level post-treatment ≥75 nmol/L.. The mean serum 25(OH)D level increased by 320%, from 26 nmol/L at baseline to 83 nmol/L at the end of the study (P < .001). The rise was significantly higher for patients initially tested in the winter/spring (mean 65 nmol/L) compared with those initially tested in the summer/autumn (mean 48 nmol/L) (P < .003). No clear relationship was found between the response to treatment and the vitamin D status at baseline. The effect of age, gender, origin and body mass index was not statistically significant.. The present intermittent high-dose regimen is effective in treating VDD in healthy adolescents without significant variations in response between different subgroups.

Topics: Adolescent; Cholecalciferol; Dietary Supplements; Humans; Infant; Retrospective Studies; Seasons; Vitamin D; Vitamin D Deficiency; Vitamins

Topics: Bread; Cholecalciferol; Food, Fortified; Humans; Ultraviolet Rays; Vitamin D; Vitamin D Deficiency

Sunlight exposure and oral supplementation are the key strategies to increase serum 25-hydroxyvitamin D [25(OH)D] concentration. We aimed to determine elevation in serum 25(OH)D levels by comparing sunlight exposure and oral vitamin D supplementation in vitamin D-deficient participants who chose the treatment strategy by shared decision-making. We enrolled 197 participants aged ≥19 y who had vitamin D deficiency (serum 25(OH)D<20 ng/mL). Participants selected their treatment method through shared decision-making by preference: sunlight exposure or 1,000 IU oral vitamin D3 supplementation daily. Changes in serum 25(OH)D concentration and duration of sunlight exposure were evaluated after 3 mo. Among 197 participants, 26 (13%) selected sunlight exposure and 171 (87%) selected oral vitamin D supplementation. Seasonal distribution of participants and follow-up rate after 3 mo were not significantly different. There was no significant increase in mean serum 25(OH)D levels in the sunlight exposure group. Conversely, the mean serum 25(OH)D level increased by 11 ng/mL after 3 mo in the oral vitamin D supplementation group. The duration of mean sunlight exposure per day during the study period was not significantly different between the groups. Oral supplementation with 1,000 IU vitamin D3 daily significantly increased serum 25(OH)D levels in vitamin D-deficient participants after 3 mo, while sunlight exposure did not. This study suggests that oral supplementation is more effective than sun exposure in increasing vitamin D levels in the Korean population. Therefore, new recommendations on maintaining adequate vitamin D levels are needed in the Korean population.

Topics: Cholecalciferol; Dietary Supplements; Humans; Sunlight; Vitamin D; Vitamin D Deficiency; Vitamins

The aim of the study was to evaluate the effect of vitamin D on the cognitive functions and quality of life in elderly and senile patients with cerebrovascular disease. 100 elderly and senile patients with cerebrovascular disease were examined: 60 people - level 25 (OH)D in blood serum <20 ng/ml (deficiency, pronounced deficiency), in 40 people this indicator was ≥30 ng/ml (within the normal range). Cognitive functions were evaluated according to neuropsychological scales (MMSE, MoCA, FAB, «clock drawing test», Schulte tables). To study the quality of life, all patients filled out a general questionnaire SF-36. The body's vitamin D supply was judged by the content of 25 (OH)D in the blood serum. Patients with low vitamin D levels (25 (OH)D <20 ng / ml) were divided into two subgroups: 30 people were prescribed cholecalciferol at a dosage of 8 000 IU/day for three months and 30 people who were not treated with cholecalciferol. The study showed that patients with low levels of vitamin D [25 (OH)D <20 ng/ml] had significantly worse indicators when assessing both cognitive functions and quality of life. The work proved that cognitive functions affect the quality of life. In patients with extremely low levels of vitamin D [25 (OH)D <20 ng/ml], after taking cholecalciferol at a dosage of 8000 IU/day for three months, there was a normalization of the level of 25 (OH)D (the average level of which was 34,10±7,42 ng/ml) in the blood serum and there was a significantly significant positive dynamics in assessing cognitive functions and quality of life.. Целью исследования была оценка влияния витамина D на когнитивные функции и качество жизни пациентов пожилого и старческого возраста с цереброваскулярной болезнью. Обследованы 100 пациентов пожилого и старческого возраста с цереброваскулярной болезнью: у 60 человек уровень 25(OH)D в сыворотке крови <20 нг/мл (дефицит, выраженный дефицит), у 40 человек данный показатель был ≥30 нг/мл (в пределах нормы). Когнитивные функции оценивали по нейропсихологическим шкалам MMSE, MoCA, FAB, тест «рисование часов», таблицы Шульте. Для исследования качества жизни все пациенты заполняли общий опросник SF-36. Об обеспеченности организма витамином D судили по содержанию 25(OH)D в сыворотке крови. Пациенты с низким уровнем витамина D [25(ОН)D <20 нг/мл] были разделены на две подгруппы: 1-я — 30 человек, которым холекальциферол назначили в дозировке 8 000 МЕ/сут в течение 3 мес; 2-я — 30 человек, которым терапию холекальциферолом не проводили. Исследование показало, что пациенты с низким уровнем витамина D [25(OH)D <20 нг/мл] имели достоверно значимо ниже показатели как когнитивных функций, так и качества жизни. В работе было доказано, что когнитивные функции влияют на качество жизни. У пациентов с исходно низким уровнем витамина D [25(ОН)D <20 нг/мл] после приема холекальциферола в дозировке 8 000 МЕ/сут в течение 3 мес наблюдали нормализацию уровня 25(ОН)D (средний уровень составил 34,10±7,42 нг/мл) в сыворотке крови и отмечали достоверно значимую положительную динамику при оценке когнитивных функций и качества жизни.

Topics: Aged; Cholecalciferol; Cognition; Dietary Supplements; Humans; Quality of Life; Vitamin D; Vitamin D Deficiency

Children with cerebral palsy (CP) are at risk of poor nutrition due to a number of factors. Feeding, eating, drinking, and swallowing (FEDS) problems are common in these children and may result in protein-calorie malnutrition usually accompanied by micronutrient deficiencies. Vitamin D is among the elements whose uptake is obstructed. Insufficient exposure to solar radiation in children and adolescents with CP adds to further decreasing serum vitamin D levels thus potentially affecting growth, bone density, and muscle function. Since maintaining long-term adherence to daily oral administration of vitamin D in this population is often difficult, bolus therapy by using vitamin D-fortified products could be an alternative way of effective and safe vitamin D intake.. Assessing the efficacy of administration of bolus vitamin D in fortified juice for increasing 25(OH)D levels in a group of 15 children with CP.. The juice was well tolerated, and a significant increase in 25(OH)D levels was observed from 54.1 to 110.3 nmol/L (p < 0.0001) 4 weeks after the administration without any case of hypercalcemia.. Bolus therapy with vitamin D

Topics: Adolescent; Cerebral Palsy; Child; Cholecalciferol; Food, Fortified; Humans; Vitamin D; Vitamin D Deficiency; Vitamins

Outbreaks of a respiratory ailment in Wuhan, China, known as the Corona virus Disease-2019 (COVID-19), began in late December 2019. Since then, several pieces of advice have been made to boost the immune system to fight more efficiently with this infection. Previously published studies showed that vitamin D3 (Vit D3) level was low in COVID-19 patients. One of the most important factors in COVID-19 severity would be the inflammatory response. It is well documented that the inflammatory cytokine storm increases the severity of COVID-19. Cytokine storm results from dysregulation of the innate immune system with an outpouring of proinflammatory cytokines and chemokines, leading to abnormal activation of the adaptive immune pathway. It has been approved that Vit D3 has immunomodulatory functions and plays an anti-inflammatory role, particularly in viral infections. Therefore, the current study was designed to investigate the possible role of Vit D3 deficiency in the COVID-19 patients' innate immunity. This study included 180 participants who were divided into group (A) consisted of 60 COVID-19 positive patients with normal level of Vit D3, group (B) consisted of 60 COVID-19 positive patients with Vit D3 deficiency, and group (C) consisted of 60 COVID-19 positive patients that had received Vit D3 therapy. The results showed that the rate of hospitalization in the group (B) (41.3%) was significantly increased, compared to group (A) (12.5%). In this regard, Vit D3 therapy led to a significant increase in the level of Vit D3, and the patients who received Vit D3 were recovered from hospital 5 days on average sooner than those in the group (B). Therefore, the consumption of Vit D3 as a daily supplement would be a reasonable suggestion for these days of the COVID-19 pandemic to increase the power of immunity of the body.

Topics: Cholecalciferol; COVID-19; Dietary Supplements; Humans; Immunity, Innate; Pandemics; Vitamin D Deficiency

Vitamin D (VD) deficiency has been related to several endocrine metabolic and cardiovascular diseases. The effect of VD supplementation on blood pressure (BP) in patients with diabetes is controversial.. The aim of this study was to evaluate high-dose vitamin D supplementation effects on blood pressure of normotensive patients with diabetes mellitus 1 (DM1) patients by 24-hour ambulatory blood pressure monitoring (ABPM).. We performed a clinical trial including 35 DM1 normotensive patients, who received doses of 4,000 or 10,000 IU/day of cholecalciferol for 12 weeks according to previous VD levels. They underwent 24-hour ABPM, along with glycated hemoglobin, creatine, lipids profile and PCRus dosage before and after VD supplementation.. We found an expressive reduction of systolic and diastolic morning blood pressures (117±14 vs 112±14, p<0,05; 74±9 vs 70±10 mmHg, p<0,05, respectively) with no changes in other pressoric markers. Besides, we noticed a relationship between levels of VD after supplementation and diastolic morning blood pressure (r= -0,4; p<0.05).. Our study suggests an association between supplementation of high doses of vitamin D and the reduction of morning blood pressure in normotensive DM1 patients.

Topics: Blood Pressure; Blood Pressure Monitoring, Ambulatory; Cholecalciferol; Dietary Supplements; Humans; Vitamin D Deficiency

Topics: Cholecalciferol; COVID-19; Female; Humans; Metabolic Syndrome; Non-alcoholic Fatty Liver Disease; Pandemics; SARS-CoV-2; Vitamin D; Vitamin D Deficiency; Volunteers

Renal fibrosis is common especially in the elderly population. Recently, we found that vitamin D deficiency caused prostatic hyperplasia. This study aimed to investigate whether vitamin D deficiency promotes renal fibrosis and functional impairment. All mice except controls were fed with vitamin D-deficient (VDD) diets, beginning from their early life. The absolute and relative kidney weights on postnatal week 20 were decreased in VDD diet-fed male pups but not in female pups. A mild pathological damage was observed in VDD diet-fed male pups but not in females. Further analysis showed that VDD-induced pathological damage was aggravated, accompanied by renal dysfunction in 40-week-old male pups. An obvious collagen deposition was observed in VDD diet-fed 40-week-old male pups. Moreover, renal α-smooth muscle actin (α-SMA), a marker of epithelial-mesenchymal transition (EMT), and Tgf-β mRNA were up-regulated. The in vitro experiment showed that 1,25-dihydroxyvitamin D3 alleviated transforming growth factor-β1 (TGF-β1)-mediated down-regulation of E-cadherin and inhibited TGF-β1-evoked up-regulation of N-cadherin, vimentin and α-SMA in renal epithelial HK-2 cells. Moreover, 1,25-dihydroxyvitamin D3 suppressed TGF-β1-evoked Smad2/3 phosphorylation in HK-2 cells. These results provide experimental evidence that long-term vitamin D deficiency promotes renal fibrosis and functional impairment, at least partially, through aggravating TGF-β/Smad2/3-mediated EMT in middle-aged male mice.

Topics: Actins; Animals; Antigens, CD; Cadherins; Calcitriol; Cell Line; Cholecalciferol; Epithelial-Mesenchymal Transition; Female; Fibrosis; Humans; Kidney; Kidney Diseases; Kidney Tubules, Proximal; Male; Mice; Mice, Inbred ICR; Organ Size; Transforming Growth Factor beta; Vimentin; Vitamin D; Vitamin D Deficiency

Micturition dysfunction is a problem in the general population that progresses with aging in both males and females. In the past few decades, the relationship between voiding symptoms and body biochemical status has been a subject of research in several disciplines. Micronutrition is considered to affect different aspects of urinary flow, including neuroregulation, detrusor muscle function, and the structures around the bladder outlet such as the pelvic floor and prostate. Therefore, the objective of our study was to determine the correlation between urine flow rate (UFR) and 25-hydroxyvitamin D (25(OH)D) in the general healthy population.. Our study involved 3981 adult participants over age 20 from the U.S. National Health and Nutrition Examination Survey datasets (2011-2012). The associations between UFR and serum 25(OH)D concentration were analyzed through multivariate regression models.. There was a significant positive association of serum 25(OH)D concentration with UFR (25(OH)D. UFR was associated with increased level of total vitamin D and bioactive form vitamin D

Topics: Adult; Cholecalciferol; Female; Humans; Male; Middle Aged; Nutrition Surveys; Urinary Bladder; Urination; Vitamin D; Vitamin D Deficiency

Topics: Cholecalciferol; Dietary Supplements; Gastric Antral Vascular Ectasia; Humans; Male; Middle Aged; Vitamin D Deficiency

Vitamin D deficiency represents a pandemic health problem with a broad spectrum of clinical implications. Several studies have involved lower levels of vitamin D with inflammatory disorders including cardiovascular, autoimmune and infectious disease. Indeed, the pathophysiological mechanisms are still poorly ascertained. We aimed at evaluating the impact of cholecalciferol (25(OH)D) levels on the biomarkers of acute-phase response and inflammation in a large cohort of patients with cardiovascular disease.. Consecutive patients undergoing coronary angiography were included. Main clinical features and chemistry parameters were assessed at admission. 25(OH)D levels were measured by chemiluminescence immunoassay kit LIAISON® Vitamin D assay (Diasorin Inc, Stillwater, US). Hypovitaminosis D was defined for 25(OH)D < 10 ng/ml.. A total of 3974 patients were included, of whom 29.4% had hypovitaminosis D. 25(OH)D deficiency was associated to age, female gender, diabetes mellitus, renal failure, previous percutaneous coronary intervention and smoke, acute presentation, severe coronary disease, higher glycemia and cholesterol and lower hemoglobin and ejection fraction (p < 0.001), higher platelet count (p = 0.004) and BMI (p = 0.05). 25(OH)D significantly directly related with white blood cells count and the different components of leukocytes formula, Neutrophils-to-Lymphocytes Ratio, Monocytes-to-Lymphocytes Ratio and C-reactive protein, but not with lymphocytes levels. In fact, hypovitaminosis D predicted levels above the median for both Neutrophils-to-Lymphocytes Ratio (≥2.56; 57.3% vs. 47.6%; p < 0.001; adjusted OR[95%CI] = 1.28[1.07-1.52; p = 0.007) and Monocytes -to-Lymphocytes Ratio (≥0.33; 59.1% vs. 49.8%; p < 0.001; adjusted OR[95%CI] = 1.3[1.1-1.54; p = 0.002), results were confirmed in major subgroups of patients.. The present study demonstrates that, among patients with cardiovascular disease, 25(OH)D deficiency is associated with a higher metabolic and clinical risk profile and with an elevation of cellular and humoral inflammatory parameters. Future dedicated studies should be, therefore, advocated in order to define whether 25(OH)D supplementation can modulate the mediators of the acute phase response and therefore potentially offer clinical and prognostic advantages on a broad spectrum of inflammatory disease.

Topics: Acute-Phase Reaction; Aged; Cardiovascular Diseases; Cholecalciferol; Cohort Studies; Female; Humans; Leukocyte Count; Lymphocyte Count; Male; Monocytes; Neutrophils; Vitamin D; Vitamin D Deficiency

Vitamin D deficiency is associated with acute myocardial infarction (AMI); thus we aimed to explore improvement effects of 1,25-dihydroxyvitamin D3 (VD3) on the AMI and its potential mechanism. AMI models were constructed using male C57/BL6J mice and randomly treated with normal saline or VD3, using sham rats as control. Heart functions, myocardial damage, apoptosis, and inflammation were evaluated. Cardiomyocytes isolated from 3-day-old suckling mice were used for in vitro verification. After VD3 treatment, AMI-induced cardiac dysfunction was reversed with better cardiac function parameters. VD3 treatment reduced inflammatory cell infiltration and myocardial infarction area accompanied by the reduction of inflammatory factors and myocardial infarction markers compared with the AMI group. VD3 treatment obviously alleviated AMI-induced myocardial apoptosis, along with Bcl-2 upregulation and downregulation of caspase-3, caspase-9, and Bax. Both in vivo and in vitro experiments revealed that VD3 enhanced the expression of LC3II and Beclin-1 and decreased soluble p62. Furthermore, VD3 enhanced the AMI-caused inhibition of PI3K, p-AKT, and p-mTOR expression, which was conversely reversed by the addition of 3-methyladenine in vitro. The study highlights the improvement effects of VD3 on cardiac functions. We proposed a potential mechanism that VD3 protects against myocardial damage, inflammation, and apoptosis by promoting autophagy through PI3K/AKT/mTOR pathway.

Topics: Animals; Autophagy; Cells, Cultured; Cholecalciferol; Male; Mice; Mice, Inbred C57BL; Myocardial Infarction; Myocytes, Cardiac; Phosphatidylinositol 3-Kinases; Proto-Oncogene Proteins c-akt; Rats; TOR Serine-Threonine Kinases; Vitamin D Deficiency

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Topics: Black People; Cholecalciferol; COVID-19; Hispanic or Latino; Humans; Inflammation; Risk Factors; SARS-CoV-2; United States; Vitamin D Deficiency; Vitamins

Low vitamin D in patients with hip fracture is common. In the present study, 407 of 872 (47%) patients had serum calcidiol less than 50 nmol/L. Patients with low vitamin D had more delirium, more new hip fractures, and more medical readmissions, but not more orthopedic complications after 1 year.. We wanted to study the relation between vitamin D level and postoperative orthopedic and medical complications in patients with hip fracture. In addition, we investigated the effect of giving a single-dose cholecalciferol 100.000 IU.. Data were taken from the local hip fracture register. Logistic regression analyses including vitamin D level and potentially confounding variables were performed for complications and readmissions.. A total of 407 (47%) of 872 included hip fractures had low vitamin D at baseline. A total of 155 (18%) developed delirium, and the risk was higher in vitamin D-deficient patients (odds ratio (OR) 1.48, 95% confidence interval (CI) 1.04 to 2.12; p = 0.03). A total of 261 (30%) were readmitted for non-hip-related conditions. Low vitamin D was associated with a higher risk of medical readmissions within 30 days (OR 1.64 (1.03 to 2.61); p = 0.036) and 12 weeks (OR 1.47 (95% CI 1.02 to 2.12); p = 0.039). There was a higher risk of a new hip fracture (OR 2.84 (95% CI 1.15 to 7.03) p = 0.024) in vitamin D-deficient patients. A total of 105 (12%) developed at least one orthopedic complication, with no correlation to baseline vitamin D. Among vitamin D-deficient patients, those receiving a single-dose of 100.000 IU cholecalciferol had fewer orthopedic complications (OR 0.32 (95% CI 0.11 to 0.97) p = 0.044) the first 30 days after surgery.. Low vitamin D at admission for hip fracture increased the risk of delirium, a new hip fracture, and medical readmissions, but not orthopedic complications. The role of vitamin D supplementation to prevent orthopedic complications requires further study.

Topics: Cholecalciferol; Hip Fractures; Humans; Patient Readmission; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D intoxication (VDI) is a well-known cause of hypercalcemia in children and leads to serious kidney, heart, and neurological problems. In the treatment of VDI, the goal is to correct hypercalcemia. Our aim was to evaluate the clinical features of patients with VDI, identify the causes of VDI in our region, and help guide precautions and treatment of VDI.. The medical records of patients with VDI presenting between January 2015 and December 2019 were retrospectively analyzed.. Stoss therapy should not be administered for children of families with problems of adherence to treatment. It should be noted that VDI may develop as a result of improperly produced nutritional supplements. General practitioners and pediatricians must be aware of VDI risks and explain them to parents. Pamidronate is effective for treating VDI in children.

Topics: Child, Preschool; Cholecalciferol; Dietary Supplements; Emergency Medical Services; Female; Fish Oils; Humans; Hypercalcemia; Inappropriate Prescribing; Infant; Male; Parents; Patient Compliance; Professional-Family Relations; Retrospective Studies; Vitamin D Deficiency; Vitamins

A 54-year-old Chinese man presented with ascites for 2 weeks. He had a preceding 2-year history of intermittent dysphagia, lethargy and general malaise. Blood investigations revealed leucocytosis with eosinophilia of 26.5%, whereas paracentesis showed turbid fluid with high protein content (45 g/L) and a high white blood cell count of 5580/µL, predominantly eosinophils (90%). An incidental assay of vitamin D showed a very low level of 13.5 ng/mL. No other cause of ascites was found. Gastroscopy was normal except for duodenitis. However, biopsies from lower oesophagus confirmed the presence of eosinophilic infiltration. Following vitamin D replacement, the patient experienced marked improvement in symptoms of dysphagia within 2 weeks and no recurrence of ascites after 3 months. The reason for the patient's vitamin D deficiency remains unclear. The marked improvement in the patient's health indicates a causative role of vitamin D deficiency in causing eosinophilic esophagogastroenteritis and associated eosinophilic ascites.

Topics: Ascites; Asian People; Calcium-Regulating Hormones and Agents; Cholecalciferol; Enteritis; Eosinophilia; Eosinophils; Gastritis; Humans; Leukocyte Count; Male; Middle Aged; Paracentesis; Tomography, X-Ray Computed; Vitamin D Deficiency

Breast milk is considered the optimal source of nutrition during infancy. Although the vitamin D concentration in human breast milk is generally considered poor for infants, vitamin D in breast milk is an important source for exclusively breastfed infants. Increases in vitamin D insufficiency and deficiency in lactating mothers may reduce vitamin D concentrations in breast milk. This study aimed to compare vitamin D and 25-hydroxyvitamin D (25OHD) concentrations in breast milk collected in 1989 and 2016-2017 and simultaneously analyze them with liquid chromatography-tandem mass spectrometry (LC-MS/MS); the association between the lifestyle of recent lactating mothers (2016-2017) and vitamin D status in human breast milk was also evaluated.. Both vitamin D and 25OHD concentrations in breast milk were higher in the summer regardless of the survey year. Significantly lower vitamin D and 25OHD concentrations were observed in 2016-2017 compared with 1989 in summer, but no survey year difference was observed in winter. The stepwise multiple regression analyses identified season, daily outdoor activity, and suntan in the last 12 months as independent factors associated with vitamin D. The results suggest that low vitamin D status in recent lactating mothers may have decreased vitamin D and 25OHD concentrations in breast milk compared with the 1980s. These results are helpful for developing public health strategies to improve vitamin D status in lactating mothers and infants.

Topics: Adult; Cholecalciferol; Female; Humans; Infant; Japan; Lactation; Life Style; Milk, Human; Nutritional Status; Seasons; Sunlight; Time Factors; Vitamin D; Vitamin D Deficiency

Metabolism differs in women and men at homeostasis. Critically ill patients have profound dysregulation of homeostasis and metabolism. It is not clear if the metabolic response to critical illness differs in women compared to men. Such sex-specific differences in illness response would have consequences for personalized medicine. Our aim was to determine the sex-specific metabolomic response to early critical illness. We performed a post-hoc metabolomics study of the VITdAL-ICU trial where subjects received high dose vitamin D

Topics: Aged; Aged, 80 and over; Basal Metabolism; Cholecalciferol; Critical Illness; Female; Humans; Male; Metabolome; Metabolomics; Middle Aged; Sex Characteristics; Sex Factors; Vitamin D Deficiency

Vitamin D deficiency (VDD) owing to its immunomodulatory effects is believed to influence outcomes in COVID-19. We conducted a prospective, observational study of patients, hospitalized with COVID-19. Serum 25-OHD level < 20 ng/mL was considered VDD. Patients were classified as having mild and severe disease on basis of the WHO ordinal scale for clinical improvement (OSCI). Of the 410 patients recruited, patients with VDD (197,48.2%) were significantly younger and had lesser comorbidities. The levels of PTH were significantly higher in the VDD group (63.5 ± 54.4 vs. 47.5 ± 42.9 pg/mL). The proportion of severe cases (13.2% vs.14.6%), mortality (2% vs. 5.2%), oxygen requirement (34.5% vs.43.4%), ICU admission (14.7% vs.19.8%) was not significantly different between patients with or without VDD. There was no significant correlation between serum 25-OHD levels and inflammatory markers studied. Serum parathormone levels correlated with D-dimer (r 0.117, p- 0.019), ferritin (r 0.132, p-0.010), and LDH (r 0.124, p-0.018). Amongst VDD patients, 128(64.9%) were treated with oral cholecalciferol (median dose of 60,000 IU). The proportion of severe cases, oxygen, or ICU admission was not significantly different in the treated vs. untreated group. In conclusion, serum 25-OHD levels at admission did not correlate with inflammatory markers, clinical outcomes, or mortality in hospitalized COVID-19 patients. Treatment of VDD with cholecalciferol did not make any difference to the outcomes.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Child; Cholecalciferol; COVID-19; Cross-Sectional Studies; Female; Humans; India; Male; Middle Aged; Parathyroid Hormone; Prevalence; Prospective Studies; Severity of Illness Index; Vitamin D; Vitamin D Deficiency; Young Adult

Topics: Aged; Aged, 80 and over; Aging; Betacoronavirus; Cholecalciferol; COVID-19; Dietary Supplements; Humans; Oxygen Inhalation Therapy; Pandemics; SARS-CoV-2; Vitamin D; Vitamin D Deficiency; Vitamins

To assess the potential effect of cholecalciferol supplementation to reduce symptom burden for women with metastatic breast cancer (MBC).. 11 clinically stable women with estrogen receptor-positive MBC were recruited from a single cancer center for this phase 1, nonrandomized study (NCT02186015).. Women with insufficient serum 25-hydroxyvitamin D (25[OH]D) levels qualified to receive high-dose repletion therapy. Clinical and questionnaire data on common symptoms and quality of life were obtained prior to and following supplementation.. Serum 25(OH)D increased significantly pre- versus postintervention. Trends for improvements in endocrine symptoms, bone pain, and fatigue were observed following the intervention.. Women achieved normal serum 25(OH)D levels after eight weeks of supplementation and reported reduced symptom burden. Vitamin D may be a low-cost supportive care therapy; however, future studies should be considered.

Topics: Breast Neoplasms; Cholecalciferol; Dietary Supplements; Female; Humans; Pilot Projects; Quality of Life; Self Report; Vitamin D Deficiency

Topics: Cholecalciferol; COVID-19; Hospitals; Humans; Length of Stay; SARS-CoV-2; Vitamin D; Vitamin D Deficiency

The epilepsy-related risk factors for vitamin D deficiency, particularly the use of enzyme-inducing antiepileptic drugs (EIAEDs), and how to treat vitamin D deficiency in patients with epilepsy remain unclear. Our aims were to explore risk factors and the influence of EAIEDs in vitamin D status and to determine the efficacy of a daily dose of oral cholecalciferol (vitamin D3) in epileptic patients with vitamin D deficiency. Clinical data were collected and 25-hydroxyvitamin D (25(OH)D) serum levels were measured. All patients with vitamin D deficiency (25(OH)D ≤20 ng/mL) or insufficiency (25(OH)D from 21-29 ng/mL) were treated with 6,670 IU/day cholecalciferol for eight weeks and 25(OH)D was then remeasured. Descriptive and inferential statistics were employed. A total of 92 patients (44.6% males), with mean age of 41.0±14.8 years, were included. Measurements of 25(OH)D revealed that 79.3% patients had abnormal levels: 56.5% were vitamin D deficient and 22.8% were vitamin D insufficient. The statistically significant risk factors for vitamin D deficiency identified were: number of AEDs, treatment with EIAEDs, low sun exposure, high body mass index (BMI) and a high frequency of epileptic seizures. After treatment, 25(OH)D mean level increased by 98.99% (regardless of EIAED use or being overweight). In our sample, more than half of the adults with epilepsy showed 25(OH)D deficiency. Patients on EIAEDs had lower 25(OH)D levels. A daily dose of 6,670 IU cholecalciferol successfully led to the correction of 25(OH)D levels. A higher dose in obese patients or in patients taking EIAEDs may not be warranted and this should be considered in future guidelines for routine vitamin D deficiency treatment.

Topics: Adult; Cholecalciferol; Epilepsy; Female; Humans; Male; Middle Aged; Portugal; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D (VitD) is a pleiotropic hormone with effects on a multitude of systems and metabolic pathways. Consequently, the relevance of a sufficiently high VitD serum level becomes self-evident.. A rapid immunofluorescence assay designed for the point-of-care measurement of serum VitD. An overall linear correlation of r = 0.89 (Pearson, 95% CI 0.88-0.92, p < 0.01) between the point of care and the conventional reference assay was registered. Accuracy and precision were of special interest at cut-points (10 ng/ml [mean deviation 1.7 ng/ml, SD 1.98 ng/ml, SE 0.16 ng/ml], 12 ng/ml [MD 0.41, SD 1.89, SE 0.19] and 30 ng/ml [MD - 1.11, SD 3.89, SE 0.35]). Only a slight deviation was detected between the two assays when using fresh (r = 0.91, 95% CI 0.86-0.94, p < 0.01) and frozen serum samples (r = 0.86, 0.82-0.89, p < 0.01). Results remained steady when samples were frozen several times. Inter- and intra-assay validation according to the CLSI protocol as well as multiuser testing showed stable results.. This novel, innovative, and controlled study indicates that the evaluated rapid point of care VitD assay is reliable, accurate, and suited for clinical practice.

Topics: Cholecalciferol; Dimensional Measurement Accuracy; Fluorescent Antibody Technique; Humans; Luminescent Measurements; Point-of-Care Systems; Rapid On-site Evaluation; Reproducibility of Results; Vitamin D Deficiency

Equivocal association the contribution of 25-hydroxyvitamin D (25(OH)D) and the well-accepted role of vitamin D-binding protein (VDBP) on bioavailability of 25(OH)D or its independent roles, has led to possible association of the VDBP in glucose metabolism. This study was conducted to evaluate the relationships among 25(OH)D, VDBP, glucose/insulin metabolism and homeostatic model assessment (HOMA-IR). Blood samples were collected from 236 obese and overweight women. VDBP and 25(OH)D levels, and biochemical parameters were measured using an enzyme-linked immunosorbent assay (ELISA). An impedance fat analyzer was utilized to acquire the body composition.. Using the multivariate linear regression, a reverse relationship was observed between VDBP and (HOMA-IR), such that women with higher VDBP displayed lower insulin resistance. The relationship was independent of age, body mass index, standardized energy intake and physical activity (p = 0.00). No significant relationship between 25(OH)D levels, FBS, body composition or insulin resistance were observed (p > 0.2). Current study observed that higher level of VDBP may be associated with lower levels of insulin and HOMA-IR, thus the evaluation of VDBP in diverse population groups seems to have significant clinical value in evaluating the prevalence of DM or early stage of glucose intolerance.

Topics: Body Mass Index; Cholecalciferol; Female; Humans; Insulin; Insulin Resistance; Obesity; Overweight; Vitamin D; Vitamin D Deficiency; Vitamin D-Binding Protein

In the present study, we aimed to investigate the relationship between serum vitamin D3 concentration and anaemia in patients with chronic kidney disease (CKD) in China, to assist understanding of the effects of vitamin D treatment in such patients.. A total of 225 patients with CKD were enrolled and a range of laboratory parameters were measured. The participants were allocated to three groups, according to their serum 25-hydroxyvitamin D3 concentration: a severe deficiency group, a deficiency group, and a sufficiency group. The prevalences of anaemia in the three groups were assessed, and the factors associated with anaemia in patients with CKD were analysed using logistic regression.. The prevalences of anaemia were 79.5% in the severe deficiency group, 63.5% in the deficiency group, and 48.0% in the sufficiency group. The prevalence of anaemia gradually increased with the severity of vitamin D3 deficiency. The prevalences of anaemia in participants with stages 1 to 5 CKD were 21.1%, 30.4%, 39.5%, 78.7%, and 94.6%, respectively.. Vitamin D3 deficiency may increase the risk of anaemia in patients with CKD.

Topics: Anemia; China; Cholecalciferol; Cross-Sectional Studies; Humans; Renal Insufficiency, Chronic; Vitamin D; Vitamin D Deficiency

In addition to its canonical functions, vitamin D has been proposed to be an important mediator of the immune system. Despite ample sunshine, vitamin D deficiency is prevalent (>80%) in the Middle East, resulting in a high rate of supplementation. However, the underlying molecular mechanisms of the specific regimen prescribed and the potential factors affecting an individual's response to vitamin D supplementation are not well characterized. Our objective is to describe the changes in the blood transcriptome and explore the potential mechanisms associated with vitamin D3 supplementation in one hundred vitamin D-deficient women who were given a weekly oral dose (50,000 IU) of vitamin D3 for three months. A high-throughput targeted PCR, composed of 264 genes representing the important blood transcriptomic fingerprints of health and disease states, was performed on pre and post-supplementation blood samples to profile the molecular response to vitamin D3. We identified 54 differentially expressed genes that were strongly modulated by vitamin D3 supplementation. Network analyses showed significant changes in the immune-related pathways such as TLR4/CD14 and IFN receptors, and catabolic processes related to NF-kB, which were subsequently confirmed by gene ontology enrichment analyses. We proposed a model for vitamin D3 response based on the expression changes of molecules involved in the receptor-mediated intra-cellular signaling pathways and the ensuing predicted effects on cytokine production. Overall, vitamin D3 has a strong effect on the immune system, G-coupled protein receptor signaling, and the ubiquitin system. We highlighted the major molecular changes and biological processes induced by vitamin D3, which will help to further investigate the effectiveness of vitamin D3 supplementation among individuals in the Middle East as well as other regions.

Topics: Adolescent; Adult; Cholecalciferol; Dietary Supplements; Female; Gene Expression; Humans; Immunomodulation; Lipopolysaccharide Receptors; Nutrition Therapy; Toll-Like Receptor 4; Vitamin D; Vitamin D Deficiency; Young Adult

COVID-19 is a major health problem because of saturation of intensive care units (ICU) and mortality. Vitamin D has emerged as a potential treatment able to reduce the disease severity.. This work aims to elucidate the effect of 25(OH)D3 (calcifediol) treatment on COVID-19-related outcomes.. This observational cohort study was conducted from March to May 2020, among patients admitted to COVID-19 wards of Hospital del Mar, Barcelona, Spain. A total of 930 patients with COVID-19 were included; 92 were excluded because of previous calcifediol intake. Of the remaining 838, a total of 447 received calcifediol (532 μg on day 1 plus 266 μg on days 3, 7, 15, and 30), whereas 391 were not treated at the time of hospital admission (intention-to-treat). Of the latter, 53 patients were treated later during ICU admission and were allocated in the treated group in a second analysis. In healthy individuals, calcifediol is about 3.2-fold more potent on a weight basis than cholecalciferol. Main outcome measures were ICU admission and mortality.. ICU assistance was required by 102 (12.2%) participants. Out of 447 patients treated with calcifediol at admission, 20 (4.5%) required the ICU, compared to 82 (21%) out of 391 nontreated (P < .001). Logistic regression of calcifediol treatment on ICU admission, adjusted by age, sex, linearized 25-hydroxyvitamin D levels at baseline, and comorbidities showed that treated patients had a reduced risk of requiring the ICU (odds ratio [OR] 0.13; 95% CI 0.07-0.23). Overall mortality was 10%. In the intention-to-treat analysis, 21 (4.7%) out of 447 patients treated with calcifediol at admission died compared to 62 patients (15.9%) out of 391 nontreated (P = .001). Adjusted results showed a reduced mortality risk with an OR of 0.21 (95% CI, 0.10-0.43). In the second analysis, the obtained OR was 0.52 (95% CI, 0.27-0.99).. In patients hospitalized with COVID-19, calcifediol treatment significantly reduced ICU admission and mortality.

Topics: Adult; Aged; Calcifediol; Cholecalciferol; Cohort Studies; Comorbidity; COVID-19; COVID-19 Drug Treatment; Female; Hospital Mortality; Hospitalization; Humans; Intensive Care Units; Male; Middle Aged; SARS-CoV-2; Spain; Treatment Outcome; Vitamin D; Vitamin D Deficiency

The abnormal growth of the craniofacial bone leads to skeletal and dental defects, which result in the presence of malocclusions. Not all causes of malocclusion have been explained. In the development of skeletal abnormalities, attention is paid to general deficiencies, including of vitamin D3 (VD3), which causes rickets. Its chronic deficiency may contribute to skeletal malocclusion. The aim of the study was to assess the impact of VD3 deficiency on the development of malocclusions. The examination consisted of a medical interview, oral examination, an alginate impression and radiological imaging, orthodontic assessment, and taking a venous blood sample for VD3 level testing. In about 42.1% of patients, the presence of a skeletal defect was found, and in 46.5% of patients, dentoalveolar malocclusion. The most common defect was transverse constriction of the maxilla with a narrow upper arch (30.7%). The concentration of vitamin 25 (OH) D in the study group was on average 23.6 ± 10.5 (ng/mL). VD3 deficiency was found in 86 subjects (75.4%). Our research showed that VD3 deficiency could be one of an important factor influencing maxillary development. Patients had a greater risk of a narrowed upper arch (OR = 4.94), crowding (OR = 4.94) and crossbite (OR = 6.16). Thus, there was a link between the deficiency of this hormone and the underdevelopment of the maxilla.

Topics: Adolescent; Adult; Cholecalciferol; Female; Humans; Hydroxycholecalciferols; Male; Malocclusion; Maxilla; Middle Aged; Risk Factors; Sunlight; Vitamin D Deficiency; Young Adult

In many studies, vitamin D has been found to be low in COVID-19 patients. In this study, we aimed to investigate the relationship between clinical course and inhospital mortality with parenteral administration of high-dose vitamin D. In this study, which was performed for the first time in the literature, it was observed that high-dose parenteral vitamin D

Topics: Cholecalciferol; Cohort Studies; COVID-19; Hospital Mortality; Humans; Intensive Care Units; SARS-CoV-2; Vitamin D; Vitamin D Deficiency

Vitamin D deficiency (VDD) affects the health and wellbeing of millions worldwide. In high latitude countries such as the United Kingdom (UK), severe complications disproportionally affect ethnic minority groups.. To develop a decision-analytic model to estimate the cost effectiveness of population strategies to prevent VDD.. An individual-level simulation model was used to compare: (I) wheat flour fortification; (II) supplementation of at-risk groups; and (III) combined flour fortification and supplementation; with (IV) a 'no additional intervention' scenario, reflecting the current Vitamin D policy in the UK. We simulated the whole population over 90 years. Data from national nutrition surveys were used to estimate the risk of deficiency under the alternative scenarios. Costs incurred by the health care sector, the government, local authorities, and the general public were considered. Results were expressed as total cost and effect of each strategy, and as the cost per 'prevented case of VDD' and the 'cost per Quality Adjusted Life Year (QALY)'.. Wheat flour fortification was cost saving as its costs were more than offset by the cost savings from preventing VDD. The combination of supplementation and fortification was cost effective (£9.5 per QALY gained). The model estimated that wheat flour fortification alone would result in 25% fewer cases of VDD, while the combined strategy would reduce the number of cases by a further 8%.. There is a strong economic case for fortifying wheat flour with Vitamin D, alone or in combination with targeted vitamin D3 supplementation.

Topics: Adolescent; Adult; Aged; Child; Cholecalciferol; Cost-Benefit Analysis; England; Ethnicity; Female; Flour; Food, Fortified; Humans; Male; Middle Aged; Minority Groups; Triticum; Vitamin D; Vitamin D Deficiency; Wales; Young Adult

Vitamin D deficiency during critical illness has been associated with worsened outcomes. Because most critically ill patients with severe traumatic injuries are vitamin D deficient, we investigated the efficacy and safety of cholecalciferol therapy for these patients.. Fifty-three patients (>17 years of age) admitted to the trauma intensive care unit who had a serum 25-hydroxy vitamin D (25-OH vit D) concentration <20 ng/mL were given 10,000 IU of cholecalciferol daily. Efficacy was defined as achievement of a 25-OH vit D of 30-79.9 ng/mL. Safety was evaluated by the presence of hypercalcemia (serum ionized calcium [iCa] >1.32 mmol/L) or hypervitaminosis D (25-OH vit D >79.9 nmol/L). Patients were monitored for 2 weeks during cholecalciferol therapy.. Twenty-four patients (45%) achieved target 25-OH vit D. No patients experienced hypervitaminosis D. Hypercalcemia occurred in 40% (n = 21) of patients; 2 patients experienced an iCa >1.49 nmol/L. 25-OH vit D was significantly greater for those who developed hypercalcemia (37.2 + 11.2 vs 28.4 + 5.6 ng/mL, respectively, P < 0.001) by the second week of cholecalciferol. Of 24 patients who achieved target 25-OH vit D, 14 (58%) experienced hypercalcemia in contrast to 24% of patients (7 out of 29) who did not achieve target 25-OH vit D (P = 0.024).. Cholecalciferol normalized serum 25-OH vit D concentrations in less than half of patients yet was associated with a substantial proportion of patients with hypercalcemia without hypervitaminosis D.

Topics: Adult; Calcium; Cholecalciferol; Critical Illness; Dose-Response Relationship, Drug; Enteral Nutrition; Female; Humans; Hypercalcemia; Incidence; Intensive Care Units; Male; Middle Aged; Risk Factors; Vitamin D; Vitamin D Deficiency; Vitamins; Wounds and Injuries; Young Adult

Topics: Calcifediol; Cholecalciferol; Dietary Supplements; Humans; Vitamin D; Vitamin D Deficiency

Vitamin D

Topics: Animals; Brain; Cholecalciferol; Cholesterol; Disease Models, Animal; gamma-Aminobutyric Acid; Glutamic Acid; Inflammation; Male; Membrane Fusion; Mice, Inbred C57BL; Nervous System Diseases; Neural Pathways; Phospholipids; Rats; Rats, Wistar; Reactive Oxygen Species; Receptors, Metabotropic Glutamate; Synapses; Vitamin D Deficiency; Vitamins

Alzheimer's disease (AD) starts with memory impairments that can be observed before the appearance of significant neuropathology; thus, identifying mechanisms to stop AD progression is an urgent priority. Epidemiological and clinical data show that the consequences of vitamin D deficiency are relevant to disease risk and can be observed in the progression of many diseases, especially AD, whereas higher serum levels of vitamin D are associated with better cognitive test performance. However, the potential therapeutic strategy and underlying mechanisms of vitamin D supplementation against AD still need to be further investigated. In the present study, we found that 3xTg-AD mice with vitamin D supplementation exhibited an increase in serum vitamin D concentrations and improved cognition. We measured serum vitamin D binding protein (VDBP) concentrations and found that serum VDBP levels were increased in 3xTg-AD mice compared to B6129S control mice, but there was no significant difference between control- and vitamin D-treated 3xTg-AD groups. The vitamin D-mediated memory improvement may be accompanied by the suppression of increased hippocampal collapsin response mediator protein-2 (CRMP2) phosphorylation, and the restoration of CRMP2 phosphorylation by okadaic acid (OA) could abolish the beneficial effects of vitamin D. In addition, we found that CRMP2 was associated with NR2B and PSD-95 in 3xTg-AD mice with vitamin D supplementation. This CRMP2-NR2B interaction could be disrupted by a TAT-CBD3 peptide or OA, leading to attenuated memory protection in vitamin D-treated 3xTg-AD mice. Therefore, CRMP2 may be involved in vitamin D-mediated memory improvement in AD.

Topics: Alzheimer Disease; Animals; Cholecalciferol; Cognitive Dysfunction; Dietary Supplements; Hippocampus; Intercellular Signaling Peptides and Proteins; Male; Maze Learning; Memory; Mice; Mice, Neurologic Mutants; Mice, Transgenic; Nerve Tissue Proteins; Phosphorylation; Receptors, N-Methyl-D-Aspartate; Vitamin D; Vitamin D Deficiency

Body stores of vitamin D are measured as "total" serum 25-hydroxy vitamin D (25(OH)D). Its largest component is protein bound and lost in urine in nephrotic syndrome (NS). Our study investigates whether "free" 25(OH)D levels are a better guide to bone health and need for vitamin D supplementation in patients with steroid-sensitive NS (SSNS).. A cross-sectional study was performed in children with SSNS and healthy controls. Blood was tested for albumin, creatinine, calcium, phosphate, ALP, total and free (by direct ELISA) 25(OH)D, iPTH, and urine for protein-creatinine ratio.. These results confirm that total 25(OH)D levels are low in NS and related to degree of proteinuria. However levels of free 25(OH)D, ALP, and iPTH did not change in relapse or remission in comparison with healthy controls. Our results suggest that in proteinuric renal diseases, free 25(OH)D rather than total 25(OH)D levels should be used to diagnose vitamin D deficiency and guide therapy.

Topics: Case-Control Studies; Child; Child, Preschool; Cholecalciferol; Cross-Sectional Studies; Dietary Supplements; Ergocalciferols; Female; Glucocorticoids; Humans; Male; Nephrotic Syndrome; Proteinuria; Risk Factors; Serum Albumin, Human; Severity of Illness Index; Vitamin D Deficiency

In burn patients, vitamin D has been studied primarily in the pediatric population and focused mainly on the correlation with bone marker measurements and incidence of fractures. There is an association between vitamin D deficiency and the development of sepsis in non-burn critically-ill patients. However, there is limited data on vitamin D concentrations and clinical outcomes in burn patients, such as sepsis. The objective of this study is to evaluate the impact of vitamin D concentrations on the incidence of sepsis in adult burn patients.. This was a retrospective cohort of patients 18 years of age and older admitted between February 1, 2016 and February 28, 2018 to an American Burn Association (ABA) verified burn center with diagnosis of burn injury. The primary endpoint was incidence of sepsis using the ABA 2007 Sepsis Consensus Criteria between patients with adequate vitamin D concentrations (25[OH]D > 20 ng/mL) and insufficient vitamin D (25[OH]D < 20 ng/mL) concentrations measured on admission. Descriptive statistics were used for baseline demographics. Univariate analysis was conducted using Chi-square, Fisher's exact test or Mann-Whitney U test, as appropriate.. A total of 115 patients were screened and 107 patients were included in this study. Sixty three patients (58.9%) had insufficient vitamin D concentrations. Patient demographics were overall similar between groups. The median total body surface area burned was 14.6% in the insufficient vitamin D group, and 12.1% in the adequate vitamin D group (p = 0.2). There was a trend towards greater incidence of sepsis in the insufficient vitamin D group in the univariate analysis (15.9% vs. 4.5%, p = 0.07). The multivariable logistic regression analysis found that adequate vitamin D concentrations was associated with a reduction in the incidence of sepsis (OR 0.10, 95% CI 0.01-0.88). The insufficient vitamin D group had a longer median hospital LOS (19 [IQR 11-37] vs 11.5 [IQR 7-20] days, p < 0.05), longer intensive care unit LOS (17 [IQR 10-37] vs 5 [IQR 2-19.5] days, p < 0.05) and fewer ventilator free days (26 [IQR 18-28] vs 28 [IQR 27-28] days, p < 0.05). There was no difference in mortality between groups (p = 0.69).. Patients with adequate vitamin D concentrations on admission had a reduction in the incidence of sepsis as compared to patients with insufficient vitamin D concentrations. Insufficient vitamin D concentrations may contribute to other worsened clinical outcomes in burn patients. Our findings set the stage for future, multicenter studies to determine the role of vitamin D supplementation in burn patients.

Topics: Adult; Body Surface Area; Burns; Case-Control Studies; Cholecalciferol; Cohort Studies; Ergocalciferols; Female; Hospital Mortality; Humans; Incidence; Intensive Care Units; Length of Stay; Male; Middle Aged; Respiration, Artificial; Retrospective Studies; Risk Factors; Sepsis; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D deficiency is frequent in pediatric nephrology. The 2017 European guidelines recommend keeping 25OH vitamin D (25-D) levels within the 75-120 nmol/L range, ideally with daily supplementation. Intermittent supplementation with D3 has also been proposed. We aimed to assess the influence of our local protocol of intermittent vitamin D supplementation on the evolution of 25-D levels between baseline and 2 months. VITATOL is a prospective single-center study performed in our tertiary unit in children and teenagers followed for chronic kidney disease (CKD), kidney transplantation, or stable chronic nephrotic syndrome with 25-D levels below 75 nmol/L. Intermittent oral cholecalciferol (100,000 IU) was administered depending on baseline vitamin D levels and body weight. The primary outcome was the change in 25-D levels between baseline and 2 months. Secondary outcomes were the evolution of the main mineral biomarkers. Thirty-seven patients were included. Two months after beginning supplementation, corresponding to a median(min-max) of 46 (14-79) days after the last dose of vitamin D, 25-D levels increased from 50 to 76 nmol/L (p < 0.001), 18 patients having 25-D levels within the target range and 2 above. All patients displayed 25-D levels above 50 nmol/L. There were no significant changes in phosphate, PTH, alkaline phosphatase, and FGF23 levels before and after supplementation. Calcium levels increased from 2.39 to 2.44 mmol/L (p = 0.017), but no differences in calciuria and urinary calcium/creatinine ratio were observed.Conclusion: This vitamin D supplementation protocol using intermittent moderate doses of cholecalciferol seems efficient in 54% of cases, with neither significant overdose nor hypercalciuria. What is Known: • Vitamin D deficiency is frequent in pediatric nephrology. • The 2017 European guidelines recommend keeping 25OH vitamin D levels within the 75-120 nmol/L range ideally with daily supplementation, but intermittent supplementation with D3 has also been proposed. What is New: • We assessed the influence of a local protocol of intermittent vitamin D supplementation on the evolution of 25-D levels between baseline and 2 months in children and teenagers followed in pediatric nephrology. • The intermittent cholecalciferol supplementation protocol seems efficient in 54% of cases, with neither significant overdose nor hypercalciuria.

Topics: Administration, Oral; Adolescent; Calcium-Regulating Hormones and Agents; Child; Cholecalciferol; Female; Fibroblast Growth Factor-23; Humans; Male; Renal Insufficiency, Chronic; Vitamin D; Vitamin D Deficiency

Vitamin D (25(OH)D) deficiency has become an emerging public health problem due to its influence on skeletal and extraskeletal diseases. Bone health in patients with sickle cell disease (SCD) is especially compromised and they are more likely to have 25(OH)D deficiency than the general population. Despite this, there is little information on the efficacy of vitamin D3 (vitD3) prophylaxis and its role in improving bone mineral density (BMD) in this population.. A prospective, longitudinal, single-center study was conducted with 136 children with SCD monitored at a tertiary referral hospital for SCD. Demographic, clinical and management data, 25(OH)D levels and bone densitometries (DXA) were collected.. Eighty patients were included. There are significant differences between the means of each of 25(OH)D levels as a function of whether the patient started prophylactic treatment as an infant or not (35.71 vs. 27.89 ng/ml, respectively [p = .014]). In multivariate analysis, 800 IU daily dose was shown as a protective factor (p = .044) to reach optimal blood levels (≥30 ng/ml). According to Kaplan-Meier curves, patients younger than 10 years reached optimal levels earlier than older (p = .002), as well as those who were not being treated with hydroxyurea (p = .039).. VitD3 prophylaxis is a safe practice in SCD. It is important to start this prophylactic treatment when the child is an infant. The daily regimen with 800 IU could be more effective for reaching levels ≥30 ng/ml, and, especially in preadolescent and adolescent patients, we should raise awareness about the importance of good bone health.

Topics: Adolescent; Anemia, Sickle Cell; Bone Density; Child; Cholecalciferol; Humans; Infant; Prospective Studies; Vitamin D; Vitamin D Deficiency

The association of antiseizure medication (ASM) and bone density abnormalities has long been recognized; however, there remains a lack of consensus on efficacy and optimal vitamin D dosing in patients receiving enzyme inducing and non-inducing ASMs. The objective was to explore the relationship between ASMs and vitamin D supplementation requirements in a population of adult patients with epilepsy.. Patients with a diagnosis of epilepsy receiving supplemental vitamin D were included in this retrospective chart review. All instances of 25-hydroxyvitamin D. There were 542 vitamin D levels evaluated from 172 unique patients. There was an 11.5 % higher absolute percent increase in patients who achieved a 25-OHD level over 30 ng/mL in the NIASM (p = 0.012). Patients on EIASMs were supplemented with an additional 508 units of vitamin D daily (95 %CI 136-878, p = 0.007). When adjusted for CKD, OTC vitamin D use, OTC multivitamin use, age, gender, and ethnicity, patients on EIASMs were supplemented with an additional 445 units of vitamin D (95 %CI -69 to 960, p = 0.089) compared to NIASM use.. Patients taking EIASMs had an increase in vitamin D deficiency and vitamin D supplementation suggesting that EIASMs impact vitamin D metabolism. Closer monitoring of vitamin D status in patients with epilepsy, especially those on EIASMs, is warranted. This evaluation suggests that for patients taking ASM, use of a lower dose OTC requires closer monitoring of vitamin D status in patients with epilepsy, especially those on EIASMs, is warranted. vitamin D agent may not be adequate.

Topics: Adult; Cholecalciferol; Dietary Supplements; Epilepsy; Female; Humans; Male; Middle Aged; Veterans; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D is a micronutrient that plays a key role in phosphocalcic metabolism. The postmenopausal population presents a risk of deficiency in this vitamin due to hormonal alterations which, in the case of obesity, would be exacerbated. The objective was to assess the status of vitamin D in a postmenopausal population and determine the relationship of 25-hydroxivitamin D [25(OH)D] and its metabolites with anthropometric parameters. The study included 78 healthy postmenopausal women aged from 44 to 76. The nutrient intake assessment was carried out using the 24 h reminder (R24h). 25(OH)D was analyzed using ultra-high-performance liquid chromatography (UHPLC). A total of 80% and 68% of the women studied did not reach sufficient values of 25(OH)D and 25-hydroxivitamin D

Topics: Adipose Tissue; Adiposity; Adult; Aged; Body Mass Index; Cholecalciferol; Cross-Sectional Studies; Feeding Behavior; Female; Humans; Middle Aged; Nutrition Assessment; Postmenopause; Quality of Life; Vitamin D Deficiency

Vitamin D insufficiency and deficiency can be associated with adverse effects on pregnancy outcomes, which may include recurrent pregnancy loss through the mechanisms that are yet unknown. The aim of this study was to evaluate the effect of 1,25VitD3 on regulatory T cells (Tregs) and T helper17 (Th17) cell populations In vitro in unexplained recurrent pregnancy loss (URPL) patients and healthy women.. Samples from 20 non-pregnant women with a history of URPL were compared to 20 normal non-pregnant women. Peripheral blood mononuclear cells (PBMC) were divided into 3 wells for each subject: in the presence of 1, 25 VitD3 (50 nM, for 16 hours), PHA (positive control) (10μM), and without any treatment (as a baseline or negative control). The percentage of regulatory T cells and Th17 cells was measured by flow cytometry at baseline and then after cell culture experiments.. Our study indicated that the percentage of Tregs in patients with URPL was significantly lower than the control group (2.42 ± 0.27 vs. 3.41 ± 0.29, P= 0.01). The percentage of Th17 cells was significantly greater in URPL patients compared to the control group (2.91 ± 0.33 vs. 1.18± 0.15, P=0.001). 1, 25VitD3 treatment significantly increased the percentage of Tregs from the baseline in the URPL group compared to that in the control group (1.23 ± 0.03 vs. 1.00 ± 0.03, P= 0.01).. Vitamin D deficiency may be a contributor to recurrent pregnancy loss and suggests supplementation of women with Vit D pre-pregnancy may be protective against URPL.

Topics: Abortion, Habitual; Adult; Case-Control Studies; Cell Differentiation; Cholecalciferol; Female; Gonadal Steroid Hormones; Humans; Pregnancy; Receptors, Calcitriol; Recurrence; T-Lymphocytes, Regulatory; Th17 Cells; Vitamin D Deficiency

Vitamin D deficiency was associated with obesity. However, the causal relationship remains controversial. We hypothesized that there would be family-based associations in both vitamin D deficient families and obese families for the SNPs associated with vitamin D deficiency, if vitamin D deficiency was a causal factor of obesity. We aimed to investigate the family-based association of SNPs in CYP27B1 with both vitamin D deficiency and obesity.. Four hundred and nineteen pedigrees containing 1505 rural individuals aged from 18 to 79 years in Henan Province of China were included in this study. Family-based associations of rs10877012 and rs4646536 in CYP27B1 with vitamin D deficiency and obesity were investigated. Serum 25(OH)D3 concentration <20 μg/L was defined as vitamin D deficiency. BMI ≥ 28 kg/m. Vitamin D deficiency may be a causal factor of obesity. Maintaining sufficient vitamin D is beneficial to obesity prevention.

Topics: 25-Hydroxyvitamin D3 1-alpha-Hydroxylase; Adolescent; Adult; Aged; Alleles; China; Cholecalciferol; Family Health; Female; Genetic Predisposition to Disease; Humans; Male; Middle Aged; Obesity; Pedigree; Vitamin D Deficiency; Young Adult

The impact of vitamin D supplementation on thyroid function is not clear and the relationship between hypovitaminosis D and autoimmune thyroiditis (ATD) incidence and evolution is still a matter of debate. The aim of this study was to retrospectively evaluate the impact of vitamin D supplementation on thyroid function in subjects with and without ATD.. One hundred and ninety-eight euthyroid subjects, with diagnosis of "hypovitaminosis D" (<30 ng/mL) who had been taking supplementation therapy with cholecalciferol for different time periods, were included. They were divided in two groups according to the previous diagnosis of ATD: "ATD-neg" group including subjects without ATD [n = 103 (52%)]; "ATD-pos" group including subjects with a confirmed diagnosis of ATD [n = 95 (48%)]. For both groups, we considered TSH and 25 hydroxyvitamin D (25OHD) levels before (T0) and after (T1) cholecalciferol supplementation. We also considered the treatment duration and the monthly dose of cholecalciferol expressed as IU/month.. In hypovitaminosis D subjects with ATD, TSH levels significantly decreased after therapy with cholecalciferol 100.000 IU/month [mean ± SD, TSH at T0: 2.67 ± 1.21 vs. TSH at T1: 2.28 ± 0.86, p = 0.028]. No significant TSH variation was observed in ATD-neg group, irrespective of treatment dose and duration. As expected, 25OHD levels significantly improved with all monthly doses and especially in the group receiving 100.000 IU/month.. Cholecalciferol supplementation improved thyroid function in euthyroid ATD-pos subjects affected with severe hypovitaminosis D. In particular, a significant reduction in TSH levels was observed in subjects with very low baseline 25OHD levels, after taking high monthly doses of cholecalciferol.

Topics: Cholecalciferol; Dietary Supplements; Humans; Retrospective Studies; Thyroiditis, Autoimmune; Thyrotropin; Vitamin D; Vitamin D Deficiency

Topics: Cholecalciferol; Critical Illness; Humans; Vitamin D; Vitamin D Deficiency

Topics: Cholecalciferol; Critical Illness; Humans; Vitamin D; Vitamin D Deficiency

Topics: Cholecalciferol; Critical Illness; Humans; Vitamin D; Vitamin D Deficiency

Topics: Cholecalciferol; Critical Illness; Humans; Vitamin D; Vitamin D Deficiency

Background Although vitamin D deficiency is associated with several inflammatory conditions, there have been few studies on the effects of vitamin D supplementation on markers of oxidative stress (OS) and inflammation. The aim of the current study was to evaluate the effects of high-dose vitamin D supplementation on heat shock protein 27 antibody (anti-Hsp27) titers in adolescent girls. Methods Five hundred and fifty adolescent girls received vitamin D3 at a dose of 50,000 IU/week for 9 weeks. Demographic, clinical and biochemical markers including serum fasting blood glucose (FBG), lipid profile and anti-Hsp27 titers as well as hematological parameters including white blood cell (WBC) count and red blood cell (RBC) distribution width (RDW) were determined in all the subjects at baseline and at the end of the study. Results Serum vitamin D significantly increased from 6.4 (4.2-9.6) ng/mL to 35.6 (25.8-47.5) ng/mL (p < 0.001) following the intervention. Furthermore, serum anti-Hsp27 titers were significantly lower after the 9-week vitamin D administration period (0.22 [0.12-0.33] optical density [OD] vs. 0.19 [0.11-0.31] OD; p = 0.002). A significant correlation was found between serum anti-Hsp27 and RDW (r = 0.13, p = 0.037). The reduction in RDW values after intervention was particularly evident in subjects with the greatest increase in serum vitamin D levels. Conclusions High-dose vitamin D supplementation was found to reduce antibody titers to Hsp27. Further randomized placebo-controlled trials are warranted to determine the long-term effect of vitamin D administration on the inflammatory process especially that associated with chronic disease.

Topics: Adolescent; Autoantibodies; Biomarkers; Blood Glucose; Cholecalciferol; Erythrocyte Indices; Female; HSP27 Heat-Shock Proteins; Humans; Leukocyte Count; Lipids; Oxidative Stress; Vitamin D Deficiency

All subjects were taking vitamin D. In this Qatari cohort, vitamin D

Topics: Adult; Aged; Blood Glucose; Cholecalciferol; Cohort Studies; Cross-Sectional Studies; Diabetes Mellitus, Type 2; Dietary Supplements; Ergocalciferols; Female; Humans; Male; Middle Aged; Qatar; Vitamin D Deficiency

Topics: Calcimimetic Agents; Calcitriol; Chelating Agents; Cholecalciferol; Ergocalciferols; Humans; Hyperparathyroidism, Secondary; Male; Middle Aged; Parathyroid Hormone; Parathyroidectomy; Phosphates; Phosphorus, Dietary; Polycystic Kidney, Autosomal Dominant; Renal Insufficiency, Chronic; Vitamin D; Vitamin D Deficiency

Topics: Cholecalciferol; Dietary Supplements; Environmental Pollutants; Humans; Skin Neoplasms; Sunscreening Agents; Vitamin D; Vitamin D Deficiency

Older adults are frequently cited as an at-risk population for vitamin D deficiency that may in part be due to decreased cutaneous synthesis, a potentially important source of cholecalciferol (vitamin D. 30 healthy individuals with skin type II/III were recruited; a younger cohort, aged 20-37 (. D. Serum D

Topics: Adult; Age Factors; Aged; Cholecalciferol; Female; Humans; Male; Middle Aged; Regression Analysis; Skin; Sunlight; Time Factors; Vitamin D; Vitamin D Deficiency; Young Adult

The world is desperately seeking for a sustainable solution to combat the coronavirus strain SARS-CoV-2 (COVID-19). Recent research indicated that optimizing Vitamin D blood levels could offer a solution approach that promises a heavily reduced fatality rate as well as solving the public health problem of counteracting the general vitamin D deficiency. This paper dived into the immunoregulatory effects of supplementing Vitamin D

Topics: Betacoronavirus; Cholecalciferol; Coronavirus Infections; COVID-19; Dietary Supplements; Humans; Immunologic Factors; Metabolic Networks and Pathways; Pandemics; Pneumonia, Viral; SARS-CoV-2; Vitamin D Deficiency; Vitamin K 2

The aim of work was to evaluate the efficacy of combination therapy with vitamin D metabolites on mineral bone density and markers of bone remodeling in postmenopausal women with arterial hypertension, obesity and vitamin D deficiency working in adverse environmental conditions. We examined 95 women aged from 48 to 60 years, 79 people (main group) had arterial hypertension, obesity and deficiency vitamin D and worked in adverse conditions of production, 16 were healthy women. The main group depending on the conducted treatment were divided into 3 groups: А group - received standard antihypertensive therapy, Cholecalciferol and Alfacalcidol; group B - standard antihypertensive therapy and Cholecalciferol; group C - standard antihypertensive therapy. The examination included anthropometric measurements (body weight, height, calculation of body mass index, waist circumference, hip circumference, calculation of index waist circumference / hip circumference), measurement of blood pressure, laboratory tests - determination of the 25-hydroxyvitamin D, parathyroid hormone, C-terminal telopeptide, osteocalcin, osteoprotegerin, instrumental study of mineral density of bone tissue (the definition of T-criterion). The dynamics of the level of 25-hydroxyvitamin D, parathyroid hormone, C-terminal telopeptide, osteocalcin, osteoprotegerin and mineral density of bone tissue after 6 and 12 months. The results showed a positive effect of Cholecalciferol and Alfacalcidol on the level of 25-hydroxyvitamin D, markers of bone formation in serum and parameters of mineral bone density in women. However, combination therapy with vitamin D metabolites showed a more pronounced effect on the processes of bone formation and mineral density of bone tissue (p<0.05). Found that the lack of correction of deficiency and insufficiency of vitamin D contributes to the progressive decrease in mineral density of bone tissue and disruption of the processes of bone formation. Combination therapy with vitamin D metabolites is effective (p<0.05) and pathogenetically justified in the treatment of vitamin D deficiency and structural and functional changes of bone tissue in postmenopausal women with arterial hypertension and obesity, working in adverse environmental conditions.

Topics: Bone and Bones; Bone Density; Cholecalciferol; Female; Humans; Hypertension; Middle Aged; Obesity; Parathyroid Hormone; Vitamin D; Vitamin D Deficiency

There is increased evidence that the massive release of pro-inflammatory cytokines leading to the cytokine storm syndrome shapes the evolution of COVID-19 and is responsible of the severity of COVID-19 in some patients. A recent review argued that vitamin D deficiency could have increased the COVID-19 outbreak and suggested vitamin D supplementation as a preventive action. In fact, many factors seem to be correlated both to low vitamin D levels and the importance of COVID-19 spreading and severity. It is also important to highlight that the lockdown, implemented in many countries, prevents people to go out and then increases the risk of vitamin D deficiency. COPD patients are particularly at risk to have low levels of vitamin D due to multiple risk factors. COPD may generate a systemic inflammatory process responsible of secondary extra-pulmonary impairments. Vitamin D deficiency could sustain and aggravate the systemic inflammation associated to COPD. Reports have also shown that vitamin D deficiency was associated to exacerbations and hospital admissions, as well as lung function. Recent research showed that vitamin D supplementation significantly reduced COPD exacerbations. Although vitamin D deficiency was not proved to be neither a risk factor of COVID-19, nor a determinant of its severity, vitamin D supplementation represents a preventive perspective that needs to be further studied.

Topics: Cholecalciferol; Coronavirus Infections; COVID-19; Dietary Supplements; Female; Humans; Male; Pandemics; Pneumonia, Viral; Primary Prevention; Pulmonary Disease, Chronic Obstructive; Risk Factors; Vitamin D Deficiency

Vitamin D deficiency has been associated with human abdominal aortic aneurysm (AAA); however, its role in AAA pathogenesis is unclear. The aim of the present study was to investigate the effect of vitamin D deficiency on AAA development and examine if administering cholecalciferol (CCF) could limit growth of established AAA within the angiotensin-II (AngII) infused apolipoprotein E-deficient mouse model. Mice were rendered vitamin D deficiency through dietary restriction and during AngII infusion developed larger AAAs as assessed by ultrasound and ex vivo morphometry that ruptured more commonly (48% vs. 19%; P=0.028) than controls. Vitamin D deficiency was associated with increased aortic expression of osteopontin and matrix metalloproteinase-2 and -9 than controls. CCF administration to mice with established aortic aneurysms limited AAA growth as assessed by ultrasound (P<0.001) and ex vivo morphometry (P=0.036) and reduced rupture rate (8% vs. 46%; P=0.031). This effect was associated with up-regulation of circulating and aortic sclerostin. Incubation of human aortic smooth muscle cells with 1,25-dihyroxyvitamin D3 (the active metabolite of vitamin D) for 48 h induced up-regulation of sclerostin (P<0.001) and changed the expression of a range of other genes important in extracellular matrix remodeling. The present study suggests that vitamin D deficiency promotes development of large rupture-prone aortic aneurysms in an experimental model. CCF administration limited both growth and rupture of established aneurysms. These effects of vitamin D appeared to be mediated via changes in genes involved in extracellular matrix remodeling, particularly sclerostin.

Topics: Adaptor Proteins, Signal Transducing; Angiotensin II; Animals; Aorta, Abdominal; Aortic Aneurysm, Abdominal; Aortic Rupture; Apolipoproteins E; Blood Pressure; Caloric Restriction; Cholecalciferol; Dietary Supplements; Disease Models, Animal; Disease Progression; Gene Expression Regulation; Humans; Mice, Inbred C57BL; Mice, Knockout; Muscle, Smooth, Vascular; Myocytes, Smooth Muscle; Up-Regulation; Vitamin D Deficiency

Vitamin D3 (vit. D3) deficiency is considered as one of the main factors involved in the development of type 2 diabetes (T2D). We assessed insulin resistance (IR), β-cell functional activity and metabolic profile according to 25(OH) vit. D3 status in patients with T2D.. The study included 109 patients with T2D, divided in 3 groups: group 1 (N.=11) with normal levels of vit. D3 (>30 ng/mL); group 2 (N.=38) with vit. D3 insufficiency (21-29 ng/mL); and group 3 (N.=60) with vit. D3 deficiency (<20 ng/mL). IR and β-cell functional activity were assessed as change in C-peptide concentration and homeostasis model assessment-estimated (HOMA) β-cell function which was calculated using HOMA2 calculator.. Patients with vit. D3 deficiency presented significantly higher C-peptide concentration compared to other groups. HOMA2 (3.29±1.89 vs. 2.12±0.71; P=0.049) and hemoglobin (H8b)A1c (9.11±1.63 vs. 7.75±1.06; P=0.016) levels changed significantly only in patients with vit. D3 deficiency compared to diabetics with normal vit. D3 levels. Furthermore, in univariate Pearson's correlation analysis, we observed significant association between vit. D3 levels and C-peptide, insulin sensitivity, HOMA2, triglyceride-glucose index, HbA1c and Body Mass Index, only in the vit. D3 deficiency group. In multivariate logistic regression analysis, poor glycemic control, as defined by HbA1c levels, was independent from metformin use while high density lipoprotein-cholesterol levels were associated with vit. D3 deficiency.. Our study demonstrated that vit. D3 deficiency in patients with T2D was associated with more severe IR, poor glycemic control and obesity compared to normal status or vit. D3 insufficiency.

Topics: Adolescent; Adult; Aged; Body Mass Index; C-Peptide; Cholecalciferol; Cross-Sectional Studies; Diabetes Mellitus, Type 2; Ergocalciferols; Female; Glycemic Control; Humans; Hypoglycemic Agents; Insulin Resistance; Male; Metformin; Middle Aged; Obesity; Vitamin D Deficiency; Young Adult

The purpose was to determine if increasing serum 25(OH)D and calcium in postmenopausal women increased skeletal muscle size, strength, balance, and functional task performance while decreasing muscle fatigue. PCSA of the vastus lateralis increased and ascent of stairs time decreased after 6 months of increased serum 25(OH)D.. The Institute of Medicine recommends ≥ 20 ng/ml of serum 25-hydroxyvitamin D [25(OH)D] for bone and overall health. Serum 25(OH)D levels have been associated with physical performance, postural sway, and falls. The purpose of this study was to determine if increasing postmenopausal women's serum 25(OH)D levels from 20-30 ng/ml to 40-50 ng/ml improved skeletal muscle size, strength, balance, and functional performance while decreasing skeletal muscle fatigue.. Twenty-six post-menopausal women (60-85 years old) with baseline serum 25(OH)D levels between 20 and 30 ng/ml were recruited. Oral over-the-counter (OTC) vitamin D3 and calcium citrate were prescribed to increase subjects' serum 25(OH)D to levels between 40 and 50 ng/ml, serum calcium levels above 9.2 mg/dl, and PTH levels below 60 pg/ml, which were confirmed at 6 and 12 weeks. Outcome measures assessed at baseline and 6 months included muscle physiological cross-sectional area (PCSA), muscle strength, postural balance, time to perform functional tasks, and muscle fatigue. Repeated measures comparisons between baseline and follow-up were performed.. Nineteen subjects completed the study. One individual could not afford the time commitment for the repeated measures. Three individuals did not take their vitamin D as recommended. Two subjects were lost to follow-up (lack of interest), and one did not achieve targeted serum 25(OH)D. Vastus lateralis PCSA increased (p = 0.007) and ascent of stair time decreased (p = 0.042) after 6 months of increasing serum 25(OH)D levels from 20-30 ng/ml to 40-50 ng/ml. Isometric strength was unchanged. Anterior-posterior center of pressure (COP) excursion and COP path length decreased (p < 0.1) albeit non-significantly, suggesting balance may improve from increased serum 25(OH)D and calcium citrate levels.. Several measures of muscle structure and function were sensitive to elevated serum 25(OH)D and calcium levels indicating that further investigation of this phenomenon in post-menopausal women is warranted.

Topics: Absorptiometry, Photon; Aged; Aged, 80 and over; Bone Density Conservation Agents; Calcium; Calcium Citrate; Cholecalciferol; Dose-Response Relationship, Drug; Female; Humans; Middle Aged; Motor Activity; Muscle Fatigue; Muscle Strength; Pilot Projects; Postmenopause; Task Performance and Analysis; Treatment Outcome; Vitamin D; Vitamin D Deficiency; Vitamins

The current evidence regarding the association between vitamin D deficiency and cardiovascular diseases/metabolic disorders is contradictory and inconclusive. In this large-scale observational study, we investigated the relationship between the serum 25-hydroxy vitamin D3 [25(OH)D] concentration and subclinical atherosclerosis in an elderly Asian population. In the I-Lan longitudinal study (ILAS), 1798 elderly, aged 50 and older, were enrolled. For each subject, serum 25-hydroxy vitamin D3 [25(OH)D] concentration and demographic data were recorded. The participants were divided into two groups according to their serum 25(OH)D level (sufficient, > 20 ng/mL and deficient, ≤ 20 ng/mL). Carotid intima-media thickness (cIMT) was measured at bilateral common carotid arteries. Subclinical atherosclerosis was defined as a mean cIMT > 0.81 mm. The mean subject age was 64 ± 9 years old, and 604 (33.6%) were identified as having serum 25(OH)D level ≤ 20 ng/mL. Subjects with serum 25(OH)D level ≤ 20 ng/mL were younger, more likely to be female and smoker, and had a higher incidence of hypertension, dyslipidemia, and metabolic syndrome, compared to those with serum 25(OH)D level > 20 ng/mL. Additionally, patients with serum 25(OH)D level ≤ 20 ng/mL were associated with a lower risk of subclinical atherosclerosis (crude OR: 0.63, 95% CI 0.50-0.81, p < 0.001), according to univariate analysis. However, after adjusting for gender and age, serum 25(OH)D level ≤ 20 ng/mL was not a significant risk factor for subclinical atherosclerosis. Serum 25(OH)D level ≤ 20 ng/mL was not an independent risk factor for subclinical atherosclerosis in this large elderly Asian population. Association observed in the univariate analysis may be confounded by gender or comorbidities.

Topics: Aged; Aging; Anthropometry; Asian People; Atherosclerosis; Carotid Intima-Media Thickness; Cholecalciferol; Cross-Sectional Studies; Female; Humans; Longitudinal Studies; Male; Middle Aged; Nutritional Sciences; Regression Analysis; Risk Factors; Sex Factors; Vitamin D Deficiency

Topics: Cholecalciferol; Depression; Dietary Supplements; Humans; Vitamin D Deficiency

Vitamin D plays a crucial and very well-known role in regulation of calcium homeostasis and bone metabolism and mineralization. However, a huge and more recent body of evidence supports the positive influence of vitamin D on the regulation of immune response, ranging from protection against respiratory tract infections to prevention and management of asthma. Nevertheless, vitamin D deficiency is a very common condition and there is an increasing need for suitable products for proper supplementation, allowing good compliance also in specific populations. Orally disintegrating tablets (ODT) were first developed to overcome the difficulty experienced by pediatric and geriatric patients of swallowing traditional oral dosage forms and, recently, orodispersible films (ODF) are gaining popularity as novel dosage form for assuming active pharmaceutical ingredients, vitamins, and ingredients for food supplements. This study describes a 2000 IU Vitamin D3 ODF for daily intake, consisting of hydrophilic polymers and suitable excipients, manufactured by film-casting process. Elongation-at-break (E%), Young's modulus (Y), and tensile strength (TS) were investigated using a dynamometer. Chemical stability was evaluated assaying the vitamin D3 in the films stored at different environmental conditions. In addition, in vitro disintegration and dissolution studies were performed. Correlation existed between the mechanical properties of the film and the residual water, acting as plasticizer. The stability study showed that vitamin D3 assay was ≥90% also after 3 months at 40 °C. The film disintegrated in less than 1 min and the vitamin D3 released was ≥75% after 15 min. An ODF with suitable properties can be manufactured and used as innovative dosage form for vitamin D3 food supplements.

Topics: Administration, Oral; Asthma; Chemistry, Pharmaceutical; Cholecalciferol; Dietary Supplements; Drug Compounding; Drug Design; Drug Liberation; Edible Films; Elastic Modulus; Escherichia coli; Excipients; Humans; Hypromellose Derivatives; Plasticizers; Polymers; Solubility; Stress, Mechanical; Tablets; Temperature; Tensile Strength; Vitamin D Deficiency; Water

The purpose of the study is to increase the effectiveness of treatment of metabolic syndrome (MS) in young patients with vitamin D deficiency.. The study involved 54 patients with MS and vitamin D deficiency (50% of women, 50% of men), aged 2044years. To assess the concentration of melatonin at a young age, a control group of 42 practically healthy volunteers with comparable demographic characteristics with no signs of MS was formed.. In patients with MS and vitamin D deficiency, there was a significant decrease in the average daily level of 6-sulfatoxymelatonin in the urine by 3.7 times, compared with the group of individuals without MS. Patients with MS and vitamin D deficiency (n=54) were randomly assigned to two groups with comparable clinical and demographic characteristics. Patients of the 1st group (n=27) observed dietary recommendations and took the drug Metformin at a dose of 1700 mg/day for 12 months. In the 2nd group (n=27), in addition to the one indicated in the 1st treatment group, correction of vitamin D deficiency was performed (a micelled preparation of cholecalciferol at a dose of 4000 IU/day, for 6 months, then 2000 IU/day for another 6 months) and the level of melatonin (melatonin preparation at a dose of 3 mg/day for 6 months). After treatment in young patients with MS, there was a significant change in the median of the studied parameters in all therapeutic groups, but more pronounced dynamics was observed in group 2 in terms of: WC in women, BMI, insulin resistance index, LDL cholesterol, TG, hs-CRP, hs-TNF-, IL-6, leptin.. To increase the effectiveness of MS treatment in young patients with vitamin D deficiency, it is necessary to determine the level of melatonin (urinary 6-sulfatoxymelatonin) and, if it decreases, carry out correction of melatonin and 25 (OH) vitamin D in addition to the standard therapy of this syndrome.. Цель.Повысить эффективность лечения метаболического синдромом (МС) у молодых пациентов с дефицитом витамина D. Материалы и методы.В исследовании участвовали 54 пациента с МС и дефицитом витамина D (50% женщин, 50% мужчин), в возрасте 2044 лет. Для оценки концентрации мелатонина в молодом возрасте сформирована контрольная группа из 42 практически здоровых добровольцев с сопоставимыми демографическими характеристиками без признаков МС. Результаты.У пациентов с МС и дефицитом витамина D наблюдали достоверное снижение среднесуточного уровня 6-сульфатоксимелатонина в моче в 3,7 раза по сравнению с группой лиц без МС. Пациенты с МС и дефицитом витамина D (n=54) рандомизированы на две сопоставимые по клинико-демографическим характеристикам группы. Пациенты 1-й группы (n=27) соблюдали диетические рекомендации и принимали препарат метформин в дозе 1700 мг/сут в течение 12 мес. Во 2-й группе (n=27) дополнительно к указанному в 1-й группе лечения проводили коррекцию дефицита витамина D (мицеллированным препаратом колекальциферола в дозировке 4000 МЕ/сут в течение 6 мес, затем 2000 МЕ/сут еще в течение 6 мес) и уровня мелатонина (препаратом мелатонина в дозе 3 мг/сут в течение 6 мес). После проведенной терапии у молодых пациентов с МС отметили значимое изменение медианы изучаемых показателей во всех терапевтических группах, но более выраженную динамику наблюдали во 2-й группе по показателям: окружность талии у женщин, индекс массы тела, индекс инсулинорезистентности, холестерин липопротеидов низкой плотности, триглицериды, высокочувствительный С-реактивный белок, высокочувствительный фактор некроза опухоли, интерлейкин-6, лептин. Заключение.Для повышения эффективности лечения МС у молодых пациентов с дефицитом витамина D необходимо определять уровень мелатонина (6-сульфатоксимелатонина мочи) и при его снижении проводить коррекцию мелатонина и 25 (ОН) витамина D дополнительно к стандартной терапии данного синдрома.

Topics: Cholecalciferol; Dietary Supplements; Female; Humans; Male; Metabolic Syndrome; Vitamin D Deficiency; Vitamins

With intermittent vitamin D supplementation, serum 25-hydroxyvitamin D (25OHD) levels may remain stable only if the dosing interval is shorter than 3 months, the ideal perhaps being about 1 month. Recent data support moderate daily vitamin D doses instead of high intermittent doses, notably in elderly patients prone to falls. The level of evidence is low, however, with no head-to-head comparisons of clinical outcomes such as fractures and falls in groups given identical dosages daily versus intermittently. A challenge to daily vitamin D supplementation in France is the absence of a suitable pharmaceutical formulation. In addition, daily dosing carries a high risk of poor adherence. Until suitable vitamin D3 formulations such as tablets or soft capsules each containing 1000 or 1500 IU become available, we suggest intermittent supplementation according to 2011 GRIO guidelines. Among the available dosages, the lowest should be preferred, with the shortest possible interval, e.g., 50,000 IU monthly rather than 100,000 every two months.

Topics: Aged; Cholecalciferol; Dietary Supplements; France; Humans; Osteoporosis; Vitamin D; Vitamin D Deficiency

Vitamin D is a lipophilic vitamin possessing a myriad of physiologic functions, including hormonal, in human body. It participates in calcium homeostasis and influences cells differentiation via genome. In the context of the broad research aimed at mapping its physiological effects in the human body it is obvious that it significantly interferes with the whole range of physiological and pathological conditions. This text briefly discusses its contribution to gynecology.

Topics: Cholecalciferol; Female; Gynecology; Humans; Vitamin D; Vitamin D Deficiency; Vitamins

To study the relationship between vitamin D and thyroid antibodies with thyroid benign-malign neoplasms.. The vitamin D vitamin and thyroid antibodies of 179 patients who underwent thyroidectomy for thyroid nodule were retrospectively reviewed.. The mean age of the patients was 44.97 ± 14.139. Vitamin D levels were 14.473 ± 4.9999 ng/ml in women and 19.584 ± 6.1981 ng/ml in men and the mean was 15.016 ± 5.3579 ng/ml. There was a significant relationship between sex and vitamin D level (P < 0, 05). Antithyroglobulin antibody (anti-TGB) had been detected in 95 patients and Antithyroid peroxidase antibody (anti TPO) in 58 patients. There was no significant relationship between vitamin D levels (P: 0, 65), anti-TPO positivity (P: 0, 86), and anti-TGB (P: 0, 12) with benign-malignant neoplasm of thyroid. There was no relationship between vitamin D and metastatic disease (P: 0, 30) as well. In addition, no association was found between malignancy and metastasis (P = 0.068, P = 0.14, P: 0, P = 0, respectively) with thyroid antibody positivity (anti TPO and/or anti TGB) in severe deficiency (<10 ng/ml) and deficiency (<20 ng/ml) of vitamin D.. Vitamin D deficiency or thyroid autoantibodies did not have any significant effect on thyroid malignancies or metastatic disease separately or together.

Topics: Adenoma, Oxyphilic; Adult; Age Distribution; Autoantibodies; Cholecalciferol; Female; Humans; Male; Middle Aged; Retrospective Studies; Sex Distribution; Thyroid Neoplasms; Thyroidectomy; Vitamin D; Vitamin D Deficiency

Vitamin D (25(OH)D) insufficiency and deficiency are highly prevalent in adult soccer players and can exceed 80% even in regions with high insolation; however, the treatment of this condition is often complicated. The aim of the present study was to examine the prevalence of vitamin D insufficiency and deficiency in youth Russian soccer players and the efficacy of its treatment. Participants were 131 young male football players (age 15.6 ± 2.4 years). Low vitamin D levels (below 30 ng/mL) were observed in 42.8% of the analyzed participants. These athletes were split in two groups composed of persons with vitamin D deficiency (serum vitamin D below 21 ng/mL) and insufficiency (serum vitamin D in range of 21-29 ng/mL). A dietary supplement of 5000 IU cholecalciferol per day was administered for two months. After the treatment, an average 92% increase in vitamin D concentration was observed (before treatment-19.7 ± 5.4 ng/mL, after treatment-34.7 ± 8.6 ng/mL, p<0.001) and 74% of the post-treatment values were within the reference range (30-60 ng/mL). Serum concentration of vitamin D increased by 200% ± 98% (p<0.001) during the first month of treatment with vitamin D deficiency and insufficiency being successfully treated in 83% of the football players. In summary, the prevalence of vitamin D insufficiency and deficiency was high in young Russian soccer players. Furthermore, it was indicated that the daily usage of cholecalciferol in a dose 5000 IU was an effective and well-tolerated treatment for vitamin D insufficiency. No linear dependency between the duration of treatment and increase in vitamin 25(OH)D concentration was observed.

Topics: Adolescent; Athletes; Body Composition; Body Mass Index; Cholecalciferol; Dietary Supplements; Humans; Male; Prevalence; Russia; Soccer; Vitamin D; Vitamin D Deficiency

The aim of this study is to evaluate the association between urinary megalin, renal function, blood pressure, lipid profile, vitamin D and glycemic control in patients with type 2 diabetes mellitus (T2DM).. . This was a cross-sectional study which recruited 209 patients with T2DM. Urinary megalin was positively associated with systolic blood pressure (SBP) (r=0.218, p=0.04) but negatively with glomerular filtration rate (GFR) (r=-0.16, p=0.023). The levels of urinary albumin, triglycerides (TGs) and glycosylated hemoglobin (HbA1c) were higher in the "high-megalin" group, compared to those in "low-megalin" group. Moreover, there was a significant inverse association between vitamin D3 levels and megalin levels in urine (OR=0.281, p=0.047).. Our study showed for the first time that megalin is associated with progression factors of diabetic nephropathy as well as vitamin D deficiency (Tab. 3, Fig. 1, Ref. 15).

Topics: Albuminuria; Cholecalciferol; Cross-Sectional Studies; Diabetes Mellitus, Type 2; Diabetic Nephropathies; Disease Progression; Glomerular Filtration Rate; Glycated Hemoglobin; Humans; Low Density Lipoprotein Receptor-Related Protein-2; Triglycerides; Vitamin D Deficiency

Topics: Calcifediol; Cholecalciferol; Dietary Supplements; Humans; Vitamin D; Vitamin D Deficiency; Vitamins

Topics: Aged, 80 and over; Calcium; Cholecalciferol; Cinacalcet; Dietary Supplements; Dose-Response Relationship, Drug; Ergocalciferols; Female; Humans; Hyperparathyroidism; Nutrition Disorders; Parathyroid Hormone; Vitamin D; Vitamin D Deficiency

Vitamin D3 cholecalciferol is produced from its cholesterol precursors in the skin under the influence of ultraviolet calc. Its subsequent hydroxylation in the liver and kidneys leads to the formation of its most active metabolite calcitriol, which plays one of the key roles in the management of calcium phosphate metabolism. However, it also has the ability to regulate the function of a number of cells and tissues that express the vitamin D receptor. The most widespread method to evaluate the status of vitamin D in the body is to measure serum levels of its meta-bolite 25 hydroxyvitamin D - 25 (OH) D. Optimal values range between 75-125 nmoll / l. Its deficit is widespread in the human population worldwide and has a significant impact on the prevalence of metabolic bone diseases. Its deficiency may support the dysfunction of many other body systems. Ensuring optimal levels of vitamin D in the popula-tion is a challenge not only for health care and especially for government administration.

Topics: Cholecalciferol; Humans; Vitamin D Deficiency

Topics: Adolescent; Adult; Athletes; Athletic Performance; Canada; Cholecalciferol; Dietary Supplements; Female; Hand Strength; Humans; Male; Middle Aged; Spinal Cord Injuries; Sports for Persons with Disabilities; United States; Vitamin D; Vitamin D Deficiency; Wheelchairs; Young Adult

Topics: Cholecalciferol; Humans; Vitamin D Deficiency; Vitamins

This study aims to determine Vitamin-D level in patients with primary dysmenorrhea and investigate the effect of Vitamin-D replacement on symptoms. About 100 patients in the 18-30 age group followed-up with primary dysmenorrhea diagnosis were included in this observational study. The pain severity was assessed using the visual analog scale (VAS). 25-hydroxy vitamin D(25(OH)D) levels of the patients were measured and the replacement therapy was applied according to measurement results. The patients were followed for three months in total. At the end of the three-month period, the 25(OH)D level was measured and the VAS score was assessed once more after the therapy. 25(OH)D level was insufficient in 23.0%, deficient in 45.0%, and severely deficient in 32.0% of the patients. It was found that the VAS score increased as the 25(OH)D level decreased (r = -0.320; p = .002). A significant reduction was observed in VAS scores after Vitamin-D treatment in all three groups; the amount of reduction in VAS score was determined to be higher in the patients with severely deficient levels of 25(OH)D, compared to the patients with deficient or insufficient levels (p < .001). A significant and negative correlation was found between Vitamin-D and symptoms associated with dysmenorrhea in our study. The Vitamin-D replacement therapy led to a significant decrease in symptoms.

Topics: Adolescent; Cholecalciferol; Dysmenorrhea; Female; Humans; Pain Measurement; Treatment Outcome; Vitamin D; Vitamin D Deficiency; Young Adult

High prevalence of vitamin D deficiency is well known around the world in risk populations. Although less is known about the athletic population, some studies report vitamin D deficiency amongst athletic population and adequate vitamin D levels are crucial for athletic population as they can prevent injuries such as stress fractures and might even have ergogenic effects for example on muscle function. The main objectives were to evaluate the basal serum levels of 25(OH)D and calcium in professional soccer athletes on the latitude 40°N, to evaluate the effects in 25(OH)D and calcium serum levels following supplementation of 1667 IU/day of cholecalciferol during a period of 8 weeks and evaluate eventual toxicity arising from it.. Twenty-eight professional athletes were evaluated according to the skin type. Basal serum levels of 25(OH)D and calcium were evaluated during winter months. Athletes were then supplemented with cholecalciferol 25.000 IU every two weeks. Serum levels of 25(OH)D and calcium were evaluated after supplementation.. 25(OH)D initially ranged between 9.9 ng/mL and 32.9 ng/mL with a median of 19.2 IQR 7.24 ng/mL. A statistically significant inverse correlation exists between vitamin D deficiency and the Fitzpatrick Scale (ρ=-0.555 P=0.003). After 8 weeks, 25(OH)D ranged between 10.6 ng/mL and 43.4 ng/mL with a median of 33.2 ng/mL IQR 6.1 ng/mL. We verified a statistically significant increase of serum 25(OH) D levels (11.74±5.988; CI 95% [9,02; 14,47]; P<0.001. In addition, there was a statistically significant reduction of calcium: -0.36±0.457; CI 95% [- 0.57; -0.15]; P=0.002.. Professional athletes have a high prevalence of vitamin D deficiency. Supplementation with cholecalciferol in winter months during 8 weeks is safe and effective in raising 25(OH)D serum levels. However, it may not be sufficient for athletes to reach adequate vitamin D levels.

Topics: Adolescent; Adult; Athletes; Calcium; Cholecalciferol; Dietary Supplements; Female; Humans; Male; Prevalence; Seasons; Soccer; Sports; Vitamin D Deficiency; Vitamins; Young Adult

Uterine fibroids (UFs) are the most common benign neoplastic threat to women's health and associated with DNA damage and genomic instability. Hypovitaminosis D is a known risk factor for UFs, especially among African Americans. Vitamin D3 has been shown to effectively inhibit UF phenotype, but its mechanisms remain unclear. We hypothesize that Vitamin D3 ameliorates UFs by recovering the damaged DNA repair system, thus inhibits tumor progression. We compared the DNA damage status and Vitamin D receptor (VDR) expression between normal myometrial and UF primary cells. Unrepaired DNA double-strand breaks (DSBs) accumulated but VDR expression decreased in UFs. The RNA and protein levels of key DNA repair members belonging to DNA DSB sensors (MRE11, NBS1, RAD50), mediators and effectors (CHECK2, BRCA1, RAD51) were downregulated in UFs compared with myometrial cells. VDR KD induced DSB accumulation and DNA damage response (DDR) defects in myometrial cells. Using the DNA damage PCR array, the expression of many additional DNA repair genes was downregulated in VDR KD cells. Treatment of UF cells with Vitamin D3 (100 nM) significantly decreased DNA damage and restored DDR concomitant with VDR induction. Notably, the PCR array demonstrated that among 75 downregulated genes after VDR KD, 67 (89.3%) were upregulated after vitamin D3 treatment. These studies demonstrate a novel link between DNA damage and the vitamin D3/VDR axis in UFs. Vitamin D3 suppresses the UF phenotype through orchestrated targeting at multiple molecules in DNA repair pathways, thus offering novel mechanistic insights into the clinical effectiveness of vitamin D3 on UFs.

Topics: Cell Line; Cholecalciferol; DNA; DNA Breaks, Double-Stranded; DNA Repair; Female; Humans; Leiomyoma; Up-Regulation; Uterus; Vitamin D Deficiency

Vitamin D (VitD) hypovitaminosis and androgen excess (AE) are both risk factors for cardiovascular diseases in fertile women. However, the possible early interaction between AE and VitD status is not clear. Our goal was to describe how VitD status influences early changes in the biomechanical reactivity of small coronary arterioles in adult female rats after transdermal testosterone treatment. Forty-six adolescent, 90-110-gram-weighed female Wistar rats were randomly grouped into 4 groups. Twenty-four animals received an optimal VitD-supplemented diet, from which 12 animals underwent transdermal testosterone treatment. Twenty-two animals received a VitD-deficient diet, from which 11 were treated with testosterone. At 8 weeks of treatment, invasive arterial blood pressure was registered after in vivo cannulation of carotid artery. Arteriolar end and side branches (200 μm diameter) of the left anterior descendent coronary artery (LAD) were obtained and examined with pressure arteriography in vitro. Similar segments were removed for histological examination. The inner and outer radii of the arterioles were measured using video-microscopy. Normal myogenic tone, maximal passive vasorelaxation and vasoconstriction of the arterioles were measured and statistically analyzed. The vessels' maximal smooth muscle relaxant potential, thromboxane-induced contraction capacity and normal myogenic tone were significantly influenced by actual VitD status. A lower relaxation capacity and increased wall thickness were observed in VitD-deficient groups, which could cause rigidity of the coronary arterioles and elevate cardiovascular risk. Supplementation of VitD could improve myogenic tone and relaxation and hold cardiovascular benefits.

Topics: Animals; Arterioles; Biomechanical Phenomena; Cholecalciferol; Coronary Vessels; Disease Models, Animal; Elastic Modulus; Elastic Tissue; Female; Hyperandrogenism; Rats, Wistar; Vascular Remodeling; Vascular Stiffness; Vasoconstriction; Vasoconstrictor Agents; Vasodilation; Vasodilator Agents; Vitamin D Deficiency

In recent years, vitamin D deficiency has become a major worldwide problem that can exert harmful effects. The aim of the present study was to evaluate the sex- and age-related prevalence of vitamin D deficiency in people from Mashhad, northeastern Iran.. In this cross-sectional study conducted over a period of 1 year (2015-2016), 7504 subjects who referred to Mashhad medical centers were randomly enrolled in the study. The study population was divided into four groups based on sex and age, as following: group 1, 6 to 18 years; group 2, 19 to 35 years; group 3, 36 to 50 years; and group 4, 51 to 65 years. Since vitamin D levels <10, 10 to 20, and 20 to 30 ng/mL are considered as severe, moderate, and mild deficiency, respectively, we used these criteria for categorizing our population.. Of the total population in our study, 65.26% (4902; 57.81% of men and 72.07% of women) showed some degree of vitamin D deficiency. In addition, we found that vitamin D deficiency was common in all age groups (6-18, 19-35, 36-50, and 51-65 years), and more common in women (58.5%, 80.12%, 63.83%, and 88.44%, respectively) than men (41.66%, 59.86%, 44.97%, and 84.75%, respectively).. Vitamin D deficiency is a major health problem in all age groups and is more common in women. This information would help to provide a progressive prevention program to maintain health and manage some of the vitamin-related disorders and diseases that especially affect women.

Topics: Adolescent; Adult; Aged; Child; Cholecalciferol; Cross-Sectional Studies; Female; Humans; Iran; Male; Middle Aged; Prevalence; Vitamin D Deficiency; Vitamins; Young Adult

The purpose of this study is to assess the effect of vitamin D replacement on cognitive function in older adults. A total of 560 patients who underwent comprehensive geriatric assessment including Global cognitive assessment, Basic Activities of Daily Living (BADL), and Instrumental Activities of Daily Living (IADL) twice in 6-month period were retrospectively reviewed. Oral cholecalciferol was replaced to patients with vitamin D deficiency routinely. In baseline cognitive scores, BADL-IADL scores were lower in the severe deficiency group than in the deficiency and adequate groups (

Topics: Activities of Daily Living; Aged; Cholecalciferol; Cognition; Female; Follow-Up Studies; Geriatric Assessment; Humans; Male; Neuropsychological Tests; Retrospective Studies; Vitamin D Deficiency

Vitamin D3 is a secosteroid hormone produced in the skin in amounts estimated up to 25,000 international units (IUs) a day by the action of UVB radiation on 7-dehydrocholesterol. Vitamin D deficiency is common due to both lack of adequate sun exposure to the skin, and because vitamin D is present in very few food sources. Deficiency is strongly linked to increased risk for a multitude of diseases, several of which have historically been shown to improve dramatically with either adequate UVB exposure to the skin, or to oral or topical supplementation with vitamin D. These diseases include asthma, psoriasis, rheumatoid arthritis, rickets and tuberculosis. All patients in our hospital have been routinely screened on admission for vitamin D deficiency since July 2011, and offered supplementation to either correct or prevent deficiency. During this time, we have admitted over 4700 patients, the vast majority of whom agreed to supplementation with either 5000 or 10,000 IUs/day. Due to disease concerns, a few agreed to larger amounts, ranging from 20,000 to 50,000 IUs/day. There have been no cases of vitamin D3 induced hypercalcemia or any adverse events attributable to vitamin D3 supplementation in any patient. Three patients with psoriasis showed marked clinical improvement in their skin using 20,000 to 50,000 IUs/day. Analysis of 777 recently tested patients (new and long-term) not on D3 revealed 28.7% with 25-hydroxyvitaminD3 (25OHD3) blood levels < 20 ng/ml, 64.1% < 30 ng/ml, a mean 25OHD3 level of 27.1 ng/ml, with a range from 4.9 to 74.8 ng/ml. Analysis of 418 inpatients on D3 long enough to develop 25OHD3 blood levels > 74.4 ng/ml showed a mean 25OHD3 level of 118.9 ng/ml, with a range from 74.4 to 384.8 ng/ml. The average serum calcium level in these 2 groups was 9.5 (no D3) vs 9.6 (D3), with ranges of 8.4 to 10.7 (no D3) vs 8.6 to 10.7 mg/dl (D3), after excluding patients with other causes of hypercalcemia. The average intact parathyroid hormone levels were 24.2 pg/ml (D3) vs. 30.2 pg/ml (no D3). In summary, long-term supplementation with vitamin D3 in doses ranging from 5000 to 50,000 IUs/day appears to be safe.

Topics: Adult; Aged; Cholecalciferol; Female; Hospitalization; Humans; Hypercalcemia; Male; Middle Aged; Vitamin D Deficiency; Vitamins; Young Adult

Vitamin D (vitD) insufficiency affects 1 billion people worldwide. Androgen excess (AE) occurs in 8% of fertile females. There are few data about the combined effect of vitD deficiency and AE on the early biomechanical changes of cerebral arterioles in fertile-aged female. Forty-six adolescent female Wistar rats (21-28 day-old, weighing 90-110 g) were grouped randomly in four groups: vitD supplemented groups with and without transdermal testosterone (T) treatment, as well as vitD deficient groups also with and without transdermal T (n = 11 or 12, in all cases). After 8 weeks of treatment, anterior cerebral arterioles (in vivo diameter of 90-130 µm) were obtained and cylindrical segments were examined by pressure arteriography. Myogenic tone, tangential stress and incremental elastic moduli were computed and statistically analyzed. Elastic density was studied on resorcin-fuchsin-stained histological section. VitD deficiency with T treatment resulted in significantly lower inner radii and higher wall thickness values with reduced tangential stress and increased elastic fiber density. VitD deficiency reduced myogenic tone at higher intraluminar pressures (>110 mmHg). Our conclusion is that plasma vitD level is an important factor in the control of myogenic tone in cerebral resistance arteries. AE and vitD deficiency acting parallel induce remodeling of their wall.

Topics: Androgens; Angiography; Animals; Arterioles; Cholecalciferol; Female; Rats; Rats, Wistar; Testosterone; Vascular Remodeling; Vitamin D Deficiency

The growing number of overweight and obese individuals is an alarming global problem; these conditions are risk factors for the development of health problems such as metabolic syndrome (MetS), type-2 diabetes, atherosclerosis, and cardiovascular disease. Numerous studies have suggested that vitamin D₃ deficiency plays a role in the pathogenesis of MetS. The aim of this study was to analyze the relationship between MetS and vitamin D₃ levels in women. Laboratory analysis demonstrated that only 26.89% of the participants had vitamin D₃ levels close to normal, and waist-to-hip ratio (WHR) measurements revealed android obesity in 75.63% of the women. The menstruating women more often suffered from vitamin D₃ deficiency, and less often had elevated vitamin D₃ levels. The conclusions are as follows: (1) There were no statistically significant relationships between vitamin D₃ levels and MetS parameters, namely the level of triglycerides, the levels of low- and high-density lipoproteins (LDL and HDL), the level of total cholesterol, and systolic and diastolic blood pressure (SBP and DBP). Vitamin D deficiency was only observed in the women with abdominal obesity. (2) Low vitamin D₃ levels were typical of perimenopausal women. Age was a variable correlating with vitamin D. (3) The presence of menstrual cycles was an important contributor to vitamin D levels. Vitamin D deficiency was significantly more common in the menstruating women.

Topics: Adult; Cholecalciferol; Female; Humans; Menstrual Cycle; Metabolic Syndrome; Middle Aged; Obesity; Poland; Risk Factors; Vitamin D Deficiency; Waist-Hip Ratio

The appropriate dose of vitamin D supplementation in children is still debated. We calculated that the recommended dose of 600-1000 IU vitamin D3/day is not sufficient to reach a serum 25-hydroxyvitamin D (25-OH-D) level of at least 30 ng/ml (75 nmol/l) in north Italian children > 12 months. The aim of this study was to analyse the effect of seasonal supplementation with 1500 IU (=37.5 μg) vitamin D3/day.. DINOS (D-vitamIN Oral Supplementation) study was a pilot, monocentric, non-random case-control register study. It was conducted in a paediatric primary care setting near Padova (North Italy, 45°N latitude). The data of 203 children (girls:boys 1:1,33) aged 2-15 years, collected between November 2010 and January 2015, were analysed. Active group A (n = 82) were given 1500 IU vitamin D3/day from November to April; control Group B (n = 121) received no supplementation. The serum 25-OH-D test was part of a laboratory tests panel and performed using a chemiluminescence immunoassay method.. Serum 25-OH-D mean level + standard deviation throughout the period was 32 + 13 ng/ml (80 + 32 nmol/l) in group A vs 22 + 10 ng/ml (55 + 25 nmol/l) in group B. In group A 12% had vitamin D deficiency 25-OH-D < 20 ng/ml (50 nmol/l) and 1.2% severe vitamin D deficiency 25-OH-D < 10 ng/ml (25 nmol/l). In group B 46% had vitamin D deficiency and 9% severe deficiency (P <  0.001). In group A mean levels were normal or near-normal all the year except in May. Group B reached mean 25-OH-D levels close to 30 ng/ml (75 nmol/l) only in late summer. The active group mean 25-OH-D level was normal in preschoolers and schoolers but not in adolescents. Non-white children had a three-times vitamin D deficiency probability despite supplementation.. Vitamin D supplementation with at least 1500 IU vitamin D3/day from November to April was found appropriate for children in North Italy. A prolongation until May could be useful. Higher doses and/or prolonged periods could be more appropriate especially in adolescents and in non-white children.. DINOS gained the approval of Padova Ethics Committee (n. 3960/U16/2016).

Topics: Adolescent; Case-Control Studies; Child; Child, Preschool; Cholecalciferol; Dietary Supplements; Female; Humans; Italy; Male; Seasons; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D insufficiency is highly prevalent among renal transplant recipients and in observational studies is associated with adverse outcomes. Hypercalcemia, usually due to persistent hyperparathyroidism, also commonly occurs in this population and often coexists with vitamin D insufficiency. However, concern that vitamin D supplementation might exacerbate the pre-existing hypercalcemia often leads clinicians to avoid vitamin D supplementation in such patients. This feasibility study aimed to quantify the effect on serum calcium of short-term low-dose cholecalciferol supplementation in a group of renal transplant recipients with a recent history of serum calcium levels >10 mg/dL.. A 2-week, single arm, open-label trial.. Renal transplant follow-up clinic in an Irish University Hospital.. Two weeks of treatment with 1,000 IU cholecalciferol/day.. Change in ionized calcium and urine calcium:creatinine ratio at follow-up compared with baseline.. Mean (standard deviation [SD]) baseline 25 (OH) vitamin D (25 (OH) D) concentration was 15.9 (5.97) ng/mL and mean (SD) baseline serum calcium was 10.50 (0.6) mg/dL. Following the 2-week intervention, median (interquartile range [IQR]) change in serum calcium from baseline was -0.08 (-3.6 to 0.08) mg/dL, P = .3. Mean (SD) ionized calcium decreased from 5.24 (0.32) mg/dL at baseline to 5.16 (0.28) mg/dL, P = .05. Median (IQR) change in the urinary calcium:creatinine ratio was 0.001 (-0.026 to 0.299) mg/mg, P = .88. Median (IQR) change in 25 (OH) D was 3.6 (2.9-6.2) ng/mL, P < .05.. In vitamin D-insufficient renal transplant recipients at risk of hypercalcemia, low-dose short-term oral cholecalciferol supplementation improves 25 (OH) D concentrations without exacerbating hypercalcemia or increasing the urinary calcium:creatinine ratio.

Topics: Adult; Calcium; Cholecalciferol; Creatinine; Dietary Supplements; Feasibility Studies; Female; Humans; Hypercalcemia; Kidney Transplantation; Male; Middle Aged; Prospective Studies; Risk Factors; Transplant Recipients; Vitamin D; Vitamin D Deficiency

Inflammatory bowel diseases (IBD) such as ulcerative colitis and Crohn's disease have been linked to vitamin D-deficiency. Using a dextran sodium sulphate (DSS)-induced model of IBD we have shown previously that mice raised on vitamin D-deficient diets from weaning have lower serum 25-hydroxyvitamin D (25OHD) levels and develop more severe colitis compared to vitamin D-sufficient counterparts. We have also shown in vitro that immune responses to 25OHD may depend on 'free' rather than total serum concentrations of 25OHD. To investigate the possible effects of free versus total 25OHD on anti-inflammatory immune responses in vivo we have studied DSS-induced colitis in wild type C57BL/6 mice raised from weaning on diets containing vitamin D2 (D2) or vitamin D3 (D3) only (both 1000 IU/kg feed). 25OHD2 has lower binding affinity for the vitamin D binding protein than 25OHD3 which results in higher levels of free 25OHD2 relative to free 25OHD3 in mice raised on a D2-only diet. Total serum 25OHD concentrations, measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS), showed that D2 mice had significantly lower levels of 25OHD than D3 mice (6.85 ± 2.61 nmol/L vs. 49.16 ± 13.8 nmol/L for D2 and D3 respectively). Despite this, direct ELISA measurement showed no difference in free serum 25OHD levels between D2 and D3 mice (13.62 ± 2.26 pmol/L vs. 14.11 ± 2.24 pmol/L for D2 and D3 respectively). Analysis of DSS-induced colitis also showed no difference in weight loss or disease progression between D2 and D3 mice. These data indicate that despite D2-fed mice being vitamin D-deficient based on serum total 25OHD concentrations, these mice showed no evidence of increased inflammatory colitis disease relative to vitamin D-sufficient D3 mice. We therefore propose that free, rather than total serum 25OHD, may be a better marker of immune responses to vitamin D in vivo.

Topics: 25-Hydroxyvitamin D 2; Animals; Calcifediol; Cholecalciferol; Colitis; Ergocalciferols; Male; Mice, Inbred C57BL; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D plays a key role in gut immunity and maintenance of the mucosal barrier. Vitamin D deficiency (VDD) worsens ulcerative colitis (UC) and its supplementation ameliorates the disease in mouse models. The prevalence and predictors of VDD in UC are not known.. The patients and controls were similar in age and gender (40 ± 11.4 years, 51% male vs. 40 ± 12 years, 51% male; p = 1.000). Median vitamin D levels among patients were lower than the controls (18.1 ng/mL [IQR 14] vs. 32.5 ng/mL [IQR 36]; p < 0.001). Patients were more often VDD (56% vs. 40%) or insufficient (34% vs. 9%) and less often sufficient (9% vs. 40%) or optimal (1% vs. 11%), in contrast to controls (p < 0.001). Median vitamin D levels were lower in those with UCDAI > 6 (15 vs. 21 ng/mL; p = 0.01), having pancolitis (13 vs. 21 ng/mL, p = 0.01), and longer duration of illness > 2 years (13.8 vs. 20.8; p = 0.025). Vitamin D levels showed a negative correlation with frequency of stools (rho = - 0.244, p = 0.05), disease duration (rho = - 0.244, p = 0.007) and UCDAI score (r = - 0.348, p = 0.002).. VDD is highly prevalent among patients with UC. Patients with longer disease duration, more severe symptoms, and pancolitis are likely to have lower vitamin D levels.

Topics: Adult; Animals; Cholecalciferol; Colitis, Ulcerative; Comorbidity; Female; Humans; Male; Mice; Middle Aged; Prevalence; Severity of Illness Index; Time Factors; Vitamin D Deficiency

Vitamin D deficiency is a major health problem which affects about one billion people in the world. Although, vitamin D supplementation is recommended as standard treatment of vitamin D deficiency, there are controversies on dose response relationship. In this regard, the present study aimed to determine the impact of vitamin D3 supplement on raising of serum 25 hydroxyvitamin D[25(OH)D] in healthy subjects with varying degrees of vitamin D deficiency.. In this clinical trial 114 subjects with varying degrees of vitamin D deficiency were entered and divided into three groups: serum levels of 25(OH) D less than 10 ng/ml, 10-20 ng/ml, and 20-30 ng/ml. All of the participants were given 50,000 units vitamin D3 per week for 8 weeks, thereafter, changes in serum levels of vitamin D and PTH were evaluated at week twelve. The results were analyzed using SPSS version 16 and P < 0.05 was considered to be significant.. Of the 114 vitamin D deficient subjects, serum level of vitamin D was below 10 ng/ml in 22 persons (19.3%), 10-20 ng/ml in 52 persons (45.6%) and 20-30 ng/ml in 40 persons (35.1%). Following vitamin D prescription all people with varying degrees of vitamin D deficiency obtained a favorable serum level. The increase in vitamin D levels were 26.4, 18.5, and 8.3 ng/ml, in individuals with baseline vitamin D levels below 10 ng/ml, 10-20 ng/ml and 20-30 ng/ml, respectively. The changes in 25(OH) vitamin D in all three groups were significant (P < 0.05), nonetheless no significant alterations in serum levels of PTH were observed (P > 0.05).. Our results indicated an inverse relationship between baseline serum levels of 25(OH) D and its increment following treatment with vitamin D3. Therefore, the magnitude of increments in serum 25(OH) D is greater in subjects with lower baseline levels of 25(OH) D.

Topics: Adult; Cholecalciferol; Dose-Response Relationship, Drug; Female; Healthy Volunteers; Humans; Male; Treatment Outcome; Vitamin D; Vitamin D Deficiency; Young Adult

Palaeontological deductions from the fossil remnants of extinct dinosaurs tell us much about their classification into species as well as about their physiological and behavioural characteristics. Geological evidence indicates that dinosaurs became extinct at the boundary between the Cretaceous and Paleogene eras, about 66 million years ago, at a time when there was worldwide environmental change resulting from the impact of a large celestial object with the Earth and/or from vast volcanic eruptions. However, apart from the presumption that climate change and interference with food supply contributed to their extinction, no biological mechanism has been suggested to explain why such a diverse range of terrestrial vertebrates ceased to exist. One of perhaps several contributing mechanisms comes by extrapolating from the physiology of the avian descendants of dinosaurs. This raises the possibility that cholecalciferol (vitamin D

Topics: Animals; Birds; Cholecalciferol; Climate Change; Dinosaurs; Earth, Planet; Eggs; Extinction, Biological; Food Supply; Paleontology; Reproduction; Sunlight; Vitamin D Deficiency; Volcanic Eruptions

Vitamin D. To test effects of VitD supplementation on the response to cisplatin we analyzed patient serum VitD levels and correlated that with survival. In vivo, VitD deficient mice were treated with cisplatin, with or without pretreatment with the active VitD metabolite, 1,25 dihydroxyvitamin D. In this study, we determined that low serum 25 hydroxyvitamin D. Our data suggest that VitD deficiency could be a biomarker for poor response to cisplatin, and pretreating with VitD can increase the apoptotic response to cisplatin through VDR and TAp73 signaling crosstalk.

Topics: Animals; Apoptosis; Cell Line, Tumor; Cholecalciferol; Cisplatin; Disease Models, Animal; Drug Synergism; Female; Gene Expression; Humans; Immunohistochemistry; Mice; Models, Biological; Prognosis; Receptors, Calcitriol; Signal Transduction; Tumor Protein p73; Urinary Bladder Neoplasms; Vitamin D Deficiency; Xenograft Model Antitumor Assays

Studies suggest association between low serum 25-OH-Vitamin D. Twenty-seven Tamil periodontitis patients living in Norway were compared to 21 Tamil controls as well as to 21 Norwegian periodontitis patients and 23 Norwegian controls. Marginal bone level was diagnosed on radiographs. VitD levels were diagnosed in blood samples by high-performance liquid chromatography-mass spectrometry.. VitD levels were lower in Norwegian periodontitis patients than in controls, while no significant differences were observed between Tamil periodontitis patients and controls despite the significant difference between RBL between the periodontitis patients and controls in both groups. When calculating the odds ratio for having periodontal disease in both populations together, it appeared that one unit increased serum VitD (i.e. 1 nmol/L) decreased the odds of having radiographic bone loss by 4%.. According to logistic regression, and after correcting for confounding factors, VitD levels showed significant association with the presence of periodontitis, as expressed by radiographic bone loss, in all patients combined.

Topics: Animals; Bone and Bones; Cholecalciferol; Humans; India; Norway; Periodontitis; Vitamin D; Vitamin D Deficiency

Accumulating studies have suggested that gut microbiota (GM) dysbiosis and vitamin D3 deficiency each play an important role during the progression of hypertension (HTN). However, few studies have characterized the underlying interaction between GM shift and vitamin D3 deficiency in HTN patients.. This study aimed to evaluate the possible crosstalk between GM dysbiosis and vitamin D deficiency in the pathogenesis of HTN.. In a cohort of 34 HTN patients and 15 healthy controls, we analyzed the fecal microbiota products, GM composition, and the interaction between GM and vitamin D3.. Vitamin D3 was significantly decreased in feces of HTN patients (P = .006, vs controls) and was correlated with altered GM, including decreased Shannon index (R. Our findings suggest that the GM dysbiosis contributing to the development of HTN might be partially mediated by vitamin D3 deficiency. Future studies involving the underlying mechanism and intervention strategies targeting microbiome composition and vitamin D3 to counteract the progression of HTN are warranted.

Topics: Blood Pressure; Cholecalciferol; Chromatography, Liquid; Disease Progression; Dysbiosis; Feces; Female; Gastrointestinal Microbiome; Humans; Hypertension; Male; Middle Aged; Vitamin D Deficiency

Topics: Child; Child, Preschool; Cholecalciferol; Dietary Supplements; Female; Humans; Vitamin D; Vitamin D Deficiency

Topics: Child; Child, Preschool; Cholecalciferol; Dietary Supplements; Female; Humans; Vitamin D; Vitamin D Deficiency

Vitamin D plays an important role in insulin secretion. As the enzyme that initiates degradation of the active metabolite of vitamin D (1,25-(OH)

Topics: Adult; Aged; China; Cholecalciferol; DNA Copy Number Variations; Female; Humans; Insulin; Insulin Secretion; Male; Middle Aged; Risk Factors; Vitamin D Deficiency; Vitamin D3 24-Hydroxylase

Pre-clinical toxicology studies of human Gc-protein (vitamin D binding protein) are of special interest as to the transport of vitamin D and its biological activities. We have demonstrated that the oral application of a special dimeric vitamin D complex reduces oxidative stress and increases the quality of life in autistic children. Therefore, safety and toxic effects of two dimeric cholecalciferol-N-acetyl-galactosamine-albumin complexes were evaluated in increasing intravenous (iv.) vitamin D levels administered in a pre-clinical trial in mice over a 5-week period.. Over a period of 5 weeks, two times a week, mice received iv. administration of one of the following: (a) 1.2 IE of vitamin D-N-acetyl-galactosamine-albumin (Vitamin D3 NAGA, ImmunoD® group), (b) 1.2 IE of vitamin-D-poly-N-acetyl-galactosamine-albumin (Poly-Nac group), or (c) isotonic saline solution (sham group). Before and after the trial, red and white blood cell panels (RBS, WBC and platelets) were determined. Furthermore, vitamin D levels, electrolytes, and C-reactive protein levels were measured directly before sacrificing.. No toxic effects were observed during iv. injection with dimeric vitamin D complexes, neither in the sham group, nor in the two treatment groups. Vitamin D levels increased significantly within 5 weeks in the Poly-Nac group (26.6 ± 8.8 ng/mL; p = 0.001) compared to the sham group (3.1 ± 0.9 ng/mL), and the Poly-Nac group to the ImmunoD group (7.0 ± 3.6 ng/mL; p = 0.003). A significant increase of vitamin D was also obtained in favor of the ImmunoD group compared to the sham (p = 0.03). Electrolytes (K, Na, Cl, Mg, Ca) and C-reactive protein showed no significant differences after administration in all three mice groups. Also, no significant differences were observed between these three groups in the WBC and RBC blood panels.. The two dimeric vitamin D complexes used in this pre-clinical study showed no side or toxic effects after iv. administration in mice, but a sole increase in vitamin D levels without any change in electrolytes or blood cells. Therefore, we assume this newly developed composition to be safe in oral or iv.-administration and further pre-clinical studies can be conducted to evaluate the value in treatment of various diseases related to vitamin D deficiencies.

Topics: Albumins; Animals; Cholecalciferol; Dimerization; Drug Administration Schedule; Erythrocyte Count; Galactosamine; Injections, Intravenous; Leukocyte Count; Mice; Treatment Outcome; Vitamin D Deficiency

Vitamin D

Topics: Animals; Bacterial Load; Cells, Cultured; Cholecalciferol; Cytokines; Dietary Supplements; Disease Models, Animal; Ethanol; Female; Host-Pathogen Interactions; Macrophages; Mice, Inbred C57BL; Mycobacterium bovis; Tuberculosis; Vitamin D Deficiency

Adequate vitamin D status is essential for skeletal health. Paget's disease of bone (PDB) is a common metabolic skeletal disorder, but data regarding the vitamin D status in PDB patients are lacking. We performed a case-control study to estimate vitamin D status in 708 PDB patients and in 1803 healthy controls from Italy and an observational prospective study to evaluate the efficacy-safety profile of oral cholecalciferol treatment [400.000 International Units (UI) of cholecalciferol administered in cycles of 8 weeks until 25OHD levels reaches 70 nmol/L as primary therapy and 50.000 UI of cholecalciferol administered every 2 weeks for 52 weeks for the maintenance therapy] in 82 PDB patients with hypovitaminosis D, i.e., 25OHD < 50 nmol/L. The main outcome measures for the prospective study were 25OHD levels, metabolic risk factors (RF) for nephrolithiasis, bone pain score (BPS), and pain medication score (PMS). Over half of PDB patients had hypovitaminosis D. Among PDB patients treated with cholecalciferol, 76 patients reached 25OHD levels ≥ 70 nmol/L after the first cycle of primary therapy and the remaining six patients after a second cycle. The maintenance therapy guaranteed 25OHD levels ≥ 70 nmol/L during the entire follow-up. The increase in 25OHD levels reduced PTH, BPS, and PMS levels, without changes in RF for nephrolithiasis. We can conclude that (i) hypovitaminosis D is frequent in PDB patients, (ii) cholecalciferol significantly increased 25OHD levels in PDB patients, and (iii) the correction of hypovitaminosis D improves the quality of life of PDB patients without inducing significant changes in RF for nephrolithiasis.

Topics: Adult; Bone and Bones; Calcium; Case-Control Studies; Cholecalciferol; Female; Humans; Male; Middle Aged; Osteitis Deformans; Parathyroid Hormone; Prospective Studies; Quality of Life; Vitamin D; Vitamin D Deficiency; Vitamins

Poor vitamin D status is associated with a higher relapse rate and earlier disability in multiple sclerosis. Based on these associations, patients with multiple sclerosis are frequently supplemented with the vitamin D precursor cholecalciferol, although it is unclear whether this regimen is of therapeutic benefit. To model consequences of this common practice, mice were fed for more than 3 months with a low, medium or high dose of cholecalciferol, representative of vitamin D deficiency, modest and disproportionally high supplementation, respectively, in patients with multiple sclerosis. Compared to vitamin D-deprived mice, its moderate supplementation reduced the severity of subsequent experimental autoimmune encephalomyelitis, which was associated with an expansion of regulatory T cells. Direct exposure of murine or human T cells to vitamin D metabolites inhibited their activation. In contrast, mice with 25-(OH) vitamin D levels above 200 nmol/l developed fulminant experimental autoimmune encephalomyelitis with massive CNS infiltration of activated myeloid cells, Th1 and Th17 cells. When dissecting this unexpected outcome, we observed that high, but not medium dose vitamin D had caused mild hypercalcaemia, which rendered T cells more prone to pro-inflammatory activation. Exposing murine or human T cells to equivalent calcium concentrations in vitro enhanced its influx, triggering activation, upregulation of pro-inflammatory gene products and enhanced transmigration across a blood-brain barrier model. These findings suggest that vitamin D at moderate levels may exert a direct regulatory effect, while continuous high dose vitamin D treatment could trigger multiple sclerosis disease activity by raising mean levels of T-cell excitatory calcium.

Topics: Animals; Autoimmunity; Blood-Brain Barrier; Calcifediol; Calcium; Calcium Signaling; Chlorides; Cholecalciferol; Dose-Response Relationship, Drug; Encephalomyelitis, Autoimmune, Experimental; Female; Humans; Hypercalcemia; Lymphocyte Activation; Mice; Mice, Inbred C57BL; Mice, Transgenic; Multiple Sclerosis; Phosphates; Sodium; T-Lymphocyte Subsets; Th1 Cells; Th17 Cells; Vitamin D; Vitamin D Deficiency

While vitamin D deficiency is common in patients with end stage renal disease on dialysis and treatment with Vitamin D. The subjects given Vitamin D. We conclude that the enzymatic activity of CYP24A1 is abnormal in end stage renal patients on dialysis. These trials were registered on clinicaltrials.govNCT00511225 on 8/1/2007; NCT01325610 on 1/17/2011; and NCT01675557 on 8/28/2012.

Topics: 24,25-Dihydroxyvitamin D 3; Aged; Cholecalciferol; Dietary Supplements; Ergocalciferols; Female; Humans; Male; Middle Aged; Renal Dialysis; Renal Insufficiency, Chronic; Vitamin D Deficiency; Vitamins

The aim of this study was to identify the effects of vitamin D supplementation on insulin sensitivity and androgen levels in vitamin-D-deficient polycystic ovary syndrome (PCOS) patients.. Sixty-seven vitamin-D-deficient (25-hydroxyvitamin D [25(OH)D] levels below 20 ng/mL) PCOS patients and 54 vitamin-D-deficient non-PCOS volunteer subjects matched for age and body mass index were enrolled to this prospective study. All participants were given 50 000 IU/week cholecalciferol orally for 8 weeks and 1500 IU/day for 4 weeks. Insulin sensitivity was calculated with the Matsuda insulin sensitivity index (ISI) based on an oral glucose tolerance test. Matsuda ISI, gonadal hormones (estrogen, testosterone, androstenedione), and 25(OH)D levels were studied before and at the end of the 12th week of vitamin D load.. After vitamin D supplementation, serum androstenedione levels had decreased significantly (P = 0.007) and Matsuda ISI values had increased significantly (P = 0.001) in the PCOS group but no significant changes were seen in those parameters in controls. We observed positive correlations between 25(OH)D levels and Matsuda ISI (r = 0.307; P < 0.01), and negative correlations between 25(OH)D levels and total testosterone (r = -0.306; P < 0.01) and androstenedione (r = -0.275; P < 0.01) levels in the PCOS group.. Vitamin D supplementation increased insulin sensitivity and decreased androgen levels in vitamin-D-deficient women with PCOS but did not have any effect in vitamin-D-deficient non-PCOS women. These results may indicate the possible role of vitamin D in the complex pathogenesis of PCOS.

Topics: Adolescent; Adult; Androstenedione; Blood Glucose; Body Mass Index; Cholecalciferol; Dietary Supplements; Female; Humans; Insulin Resistance; Polycystic Ovary Syndrome; Prospective Studies; Testosterone; Vitamin D; Vitamin D Deficiency; Young Adult

There is growing evidence that vitamin D deficiency plays a role in the development and the course of inflammatory bowel disease (IBD). However, the correlation between vitamin D deficiency and clinical parameters in IBD is still not completely understood.. A retrospective study of IBD patients was performed. Vitamin D values were analyzed, regardless of vitamin D substitution administration, and correlated with clinical parameters such as medical therapy, anatomical situation, location of the disease and disease activity. Level of 25-hydroxyvitamin D [25(OH)D] <50 nmoL/L was regarded as vitamin D deficiency and <75 nmoL/L as insufficiency.. In total, 208 IBD patients were analyzed, including 123 with Crohn's disease (CD) and 85 with ulcerative colitis (UC). Therapy with azathioprine did not affect the vitamin D values of either disease entity. But CD patients benefited from therapy with tumor necrosis factor-α inhibitor and exhibited significantly higher vitamin D levels than those without. Furthermore, significantly lower vitamin D levels were found if CD was located in the small bowel or if the small bowel had been resected. Moreover, significantly lower levels of vitamin D were detectable for high disease activity (reflected by high simple clinical colitis activity index values) in patients with UC.. Vitamin D deficiency is common in patients with IBD. However, certain clinical situations lead to significantly lower vitamin D levels and may therefore require close monitoring for vitamin D deficiency.

Topics: Azathioprine; Cholecalciferol; Colitis, Ulcerative; Crohn Disease; Gastrointestinal Agents; Germany; Humans; Inflammatory Bowel Diseases; Postoperative Period; Retrospective Studies; Seasons; Tumor Necrosis Factor-alpha; Vitamin D; Vitamin D Deficiency

This observational retrospective cross-sectional and case-controlled study measures levels of 25-hydroxy-vitamin D (25-OH-VD) in pediatric cancer survivors at different intervals and assesses the effect of 2 supplementation regimens over a period of 12 months. Sixty-eight patients were included in this quasi-experimental study, of which 32 were boys and 36 were girls. A control group of 30 healthy children were included. It was found that initial 25-OH-VD levels were insufficient (<30 ng/mL) in 61 patients (89.7%). Yet, no significant difference between the levels of 25-OH-VD in these patients as compared with the healthy control group was evidenced. However, 25-OH-VD levels were significantly higher at 18 months in patients who were supplemented with oral 50,000 IU/month vitamin D during the 12 months in comparison with patients supplemented with 1000 IU/day. Our findings indicate that pediatric cancer survivors who require frequent monitoring of their 25-OH-VD levels yielded better results when supplemented with higher doses of vitamin D over longer periods of time. A course of oral vitamin D supplementation regimen of 50,000 IU/month gave effective results with excellent compliance and no reports of any adverse or harmful effects.

Topics: Adolescent; Cancer Survivors; Child; Child, Preschool; Cholecalciferol; Cross-Sectional Studies; Dietary Supplements; Female; Humans; Male; Retrospective Studies; Vitamin D; Vitamin D Deficiency

This study assessed bioavailability and utilisation of vitamin D3 in two feeding trials using young, growing Sprague-Dawley male rats. Trial one fed animals standard AIN-93G diet (casein protein) containing no vitamin D3 and goat or cow skimmed milk supplemented with vitamin D3. Trial two fed animals modified dairy-free AIN-93G diet (egg albumin) containing no vitamin D3 and goat or cow skimmed or full-fat milk supplemented with vitamin D3. Control groups received AIN-93G diets with or without vitamin D, and water. At 8 weeks of age, blood samples were collected for vitamin and mineral analysis, and femurs and spines were collected for assessment of bone mineralisation and strength. In both trials, analyses showed differences in bioavailability of vitamin D3, with ratios of serum 25-hydroxyvitamin D3 to vitamin D3 intake more than 2-fold higher in groups drinking supplemented milk compared with groups fed supplemented solid food. Bone mineralisation was higher in groups drinking supplemented milk compared with groups fed supplemented solid food, for both trials (P<0·05). There was no difference in the parameters tested between skimmed milk and full-fat milk or between cow milk and goat milk. Comparison of the two trials suggested that dietary protein source promoted bone mineralisation in a growing rat model: modified AIN-93G with egg albumin produced lower bone mineralisation compared with standard AIN-93G with casein. Overall, this study showed that effects of vitamin D3 deficiency in solid diets were reversed by offering milk supplemented with vitamin D3, and suggests that using milk as a vehicle to deliver vitamin D is advantageous.

Topics: Animals; Biological Availability; Bone Density; Calcifediol; Calcification, Physiologic; Calcium; Cattle; Cholecalciferol; Diet; Dietary Proteins; Dietary Supplements; Fats; Goats; Male; Milk; Ovalbumin; Rats; Rats, Sprague-Dawley; Recoverin; Vitamin D Deficiency

Vitamin D deficiency has been reported to be a negative prognostic factor in elderly patients with aggressive B-cell lymphomas. In vitro data suggest that vitamin D supplementation may enhance rituximab-mediated cytotoxicity. We prospectively assessed 25-hydroxyvitamin D [25(OH)D] levels at diagnosis in a cohort of 155 patients with aggressive B-cell lymphomas of whom 128 had diffuse large B-cell lymphoma (DLBCL) not otherwise specified. 25(OH)D levels were deficient (<20 ng/mL) in 105 (67%), insufficient (20-29 ng/mL) in 32 (21%), and normal (≥30 ng/mL) in 18 (12%) patients with a seasonal variation. Patient characteristics associated with lower 25(OH)D levels were poor performance status, overweight, B-symptoms, elevated LDH, lower albumin and hemoglobin levels. As a result of a change in practice pattern, 116 patients received vitamin D3 (cholecalciferol) supplementation that included a loading phase with daily replacement and subsequent maintenance phase with a weekly dose of 25,000 IU until end of treatment. This resulted in a significant increase in 25(OH)D levels, with normalization in 56% of patients. We analyzed the impact of 25(OH)D levels on event-free survival in patients treated with Rituximab-CHOP. 25(OH)D levels below 20 ng/mL at diagnosis and IPI were independently associated with inferior EFS. Moreover, patients with normalized 25(OH)D levels following supplementation showed better EFS than patients with persistently deficient/insufficient 25(OH)D levels. Our study provides the first evidence that achievement of normal 25(OH)D levels after vitamin D3 supplementation is associated with improved outcome in patients with DLBCL and deficient/insufficient 25(OH)D levels when receiving rituximab-based treatment.

Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Cholecalciferol; Cyclophosphamide; Dietary Supplements; Disease-Free Survival; Doxorubicin; Female; Humans; Immunotherapy; Lymphoma, Large B-Cell, Diffuse; Male; Middle Aged; Prednisone; Rituximab; Treatment Outcome; Vincristine; Vitamin D; Vitamin D Deficiency

Topics: Bone Density Conservation Agents; Calcium Citrate; Cholecalciferol; Female; Fractures, Bone; Humans; Hypocalcemia; Ibandronic Acid; Middle Aged; Osteoporosis; Pubic Bone; Sacrum; Vitamin D Deficiency

Cholecalciferol (vitamin D3) is widely supplemented in breast cancer survivors because of the role of vitamin D in multiple health outcomes.. We conducted an observational study in 332 women in Eastern Switzerland with early, i.e., nonmetastatic breast cancer. Tumour-, patient-related and sociodemographic variables were recorded. Cholecalciferol intake and serum 25-hydroxyvitamin D (25(OH)D) and 1,25-dihydroxyvitamin D (1,25(OH)2D) levels were measured at the first visit (baseline) and during a follow-up visit in a median of 210 days (range 87-857) after the first visit. Patients presenting 25(OH)D deficiency were advised to take cholecalciferol supplementation.. At baseline, 60 (18%) patients had 25(OH)D deficiency (≤50 nmol/l, ≤20 ng/l), and 70 (21%) had insufficiency (50-74 nmol/l, 20-29 ng/l). Out of 121 patients with ongoing cholecalciferol supplementation at baseline, 25(OH)D deficiency and insufficiency was observed in 9 (7%) and 16 (13%) patients, respectively, whereas out of 52 patients with no supplementation, 15 (29%) had deficiency and 19 (37%) had insufficiency. Only 85 (26%) patients had optimal 25(OH)D levels (75-100 nmol/l, 30-40 ng/l) at baseline. Seasonal variation was significant for 25(OH)D (p = 0.042) and 1,25(OH)2D (p = 0.001) levels. Living in a rural area was associated with a higher median 25(OH)D concentration as compared with living in an urban area (87 nmol/l, range 16-216 vs 72 nmol/l, range 17-162; p = 0.001). Regular sporting activity was positively associated with 25(OH)D (p = 0.045). Body mass index was inversely related to both 25(OH)D and 1,25(OH)2D (Spearman's rho = -0.24, p <0.001; rho = -0.23, p <0.001, respectively). The levels of 25(OH)D and 1,25(OH)2D were correlated (rho = 0.21, p <0.001). Age and bone mineral density had no significant correlation with the levels of 25(OH)D. Follow-up 25(OH)D was available for 230 patients, 44 (19%) of whom had 25(OH)D deficiency and 47 (21%) had insufficiency; 25 (41.6%) initially 25(OH)D-deficient patients attained sufficient 25(OH)D levels, whereas 33 (16.5%) patients with sufficient baseline 25(OH)D levels became deficient. Only 67 (30%) patients presented optimal 25(OH)D at the follow-up.. A remarkable fraction of the patients had serum 25(OH)D below (40%) or above (30%) optimal levels, and only around 30% of patients had optimal levels. Levels of 25(OH)D and 1,25(OH)2D increased on cholecalciferol supplementation, but the usual supplementation regimens were not adequate to bring 25(OH)D to the optimal range for a large proportion of patients.. EKSG 08/082/2B.

Topics: Breast Neoplasms; Cancer Survivors; Cholecalciferol; Dietary Supplements; Female; Humans; Middle Aged; Surveys and Questionnaires; Switzerland; Vitamin D; Vitamin D Deficiency

Vitamin D is produced in the skin upon sun-exposure or obtained through the diet. Vitamin D is hydroxylated to 25-hydroxyvitamin D (25(OH)D) in the liver and to the active form 1,25-dihydroxyvitamin D (1,25(OH)

Topics: Cholecalciferol; Humans; Hydroxylation; Models, Theoretical; Observational Studies as Topic; Receptors, Calcitriol; Risk Factors; Skin; Sunlight; Vitamin D; Vitamin D Deficiency

The effect of a high dose oral cholecalciferol repletion strategy in Vitamin D insufficient adults with CF is still unknown. Therefore, we assessed the effectiveness of our current approach, giving oral vitamin D3 supplementation at a dose of 10,000 IU from Monday to Friday for a total of 50,000 IU D3 weekly in vitamin D insufficient adult with CF.. We performed a retrospective chart review of all 59 adult CF patients between the ages of 17 and 64 years routinely followed at the CF Adult Program of Winnipeg Health Sciences Centre. Through consultation with the endocrinologist, our clinic vitamin D repletion protocol for treating CF adult patients who have serum 25-hydroxyvitamin D (25-OHD) < 30 ng/ml (<75 nmol/L) was to prescribe vitamin D3 10,000 IU orally from Monday to Friday (or the weekly equivalent of 50,000 IU) for 12 weeks in addition to their regular CF vitamin that supplied from 800 to 2000 IU vitamin D3 daily. Cholecalciferol was conveniently administered orally as either one capsule (oil-based) 10,000 IU or one tablet (powder-based) 10,000 IU. All patients were instructed to obtain follow-up serum 25-OHD levels post completion of treatment.. Of the 59 adult patients at our CF Clinic, 35 patients (59%) had below optimal serum 25-OHD levels. Of the 35 patients identified, 10 patients with insufficient serum 25-OHD levels between 10 and 30 ng/ml (25-75 nmol/L) fulfilled the inclusion criteria. A significant increase in serum 25-OHD levels was observed (P < 0.01) from mean value of 21.6 ± 5.9 ng/ml (54.1 ± 14.8 nmol/L) at baseline to 31.7 ± 9.1 ng/ml (79.3 ± 22.8 nmol/L) ≥ 2 months post intervention. The current treatment approach was successful in treating Vitamin D insufficiency in 70% of the patients with low 25-OHD levels.. The results of this study demonstrate that a large number of adults attending Winnipeg Health Sciences Centre CF Clinic have serum 25-OHD levels below 30 ng/ml (75 nmol/L). This supports the need for dedicated and individualized approach to manage this condition. High dose therapy of vitamin D3, although a more aggressive treatment approach, may result in achieving optimal levels of serum 25-OHD in adults with CF.

Topics: Adolescent; Adult; Body Mass Index; Cholecalciferol; Cystic Fibrosis; Diet; Dietary Supplements; Dose-Response Relationship, Drug; Female; Humans; Male; Middle Aged; Retrospective Studies; Seasons; Vitamin D Deficiency; Young Adult

There is ample evidence associating vitamin D deficiency in primary hyperparathyroidism (PHP) patients with more severe disease manifestations and increased risk of postoperative hypocalcemia. Yet, there is limited data regarding the safety of vitamin D repletion in these patients.. To assess the safety of vitamin D repletion in PHP patients in a real-world setting.. We included patients with asymptomatic PHP and few symptomatic patients who declined surgery, followed in our clinic, and treated on a routine basis with 2000 IU/day of vitamin D3.. Serum calcium (sCa), PTH, 25-hydroxyvitamin D, and 24 h urinary calcium (uCa) and creatinine collections were compared between the lowest and the highest vitamin D time points.. There were 40 patients of a mean age was 63 ± 10 years. 25(OH)D at lowest and highest vitamin D time points was 15.5 ± 6.2 ng/ml and 33.2 ± 8, respectively (P < 0.001). Serum calcium was not affected by the changes in vitamin D levels. In none of the patients did sCa exceed 11.5 mg/dL. uCa was 220 ± 110 mg/24 h at the lowest vitamin D time point and 260 ± 140 at the highest vitamin D time point (P = 0.14). uCa exceeded 400 mg/24 h in two vs. five patients (P = 0.23) at the lowest and highest vitamin D time points, respectively. PTH was not significantly different between the different vitamin D time points.. Vitamin D repletion in PHP seems safe. Considering the documented adverse influence of vitamin D deficiency in PHP, particularly on skeletal manifestations and on the postoperative course, vitamin D repletion is warranted.

Topics: Adult; Aged; Aged, 80 and over; Calcium; Cholecalciferol; Creatinine; Female; Humans; Hyperparathyroidism, Primary; Male; Middle Aged; Parathyroid Hormone; Retrospective Studies; Vitamin D; Vitamin D Deficiency

Hypovitaminosis D is common in chronic kidney disease (CKD) and is associated with endothelial dysfunction and cardiovascular events. This study aimed to investigate the effects of vitamin D supplementation on endothelial dysfunction in non-dialysis CKD patients.. Seventy-one non-dialysis CKD patients with low vitamin D (serum 25(OH)D < 30 ng/mL) were recruited. Patients received oral cholecalciferol 50,000 units once a week for 12 weeks. Changes in endothelial function by brachial artery flow-mediated dilation (FMD), soluble vascular cell adhesion molecule-1 (sVCAM-1), and sE-selectin were studied.. There was a significant increase in serum levels of 25(OH)D after cholecalciferol supplementation (33.7 ± 12.1 vs. 13.2 ± 5.4 ng/mL, P < 0.001). Multivariable regression analysis showed that higher proteinuria (β = - 0.548, P < 0.001) and lower levels of 25(OH)D (β = 0.360, P < 0.001) at baseline were related to lower 25(OH)D level after supplementation. FMD increased significantly from 4.4 ± 1.3 to 5.1 ± 1.5% (P < 0.001), and soluble endothelial biomarkers decreased: sVCAM-1 from 926.9 ± 158.0 to 867.0 ± 129.0 ng/mL (P < 0.001), and sE-selectin 69.7 ± 15.8 to 63.3 ± 14.7 ng/mL (P < 0.001).. Vitamin D supplementation can improve endothelial dysfunction in pre-dialysis CKD patients.

Topics: Adult; Aged; Brachial Artery; Cholecalciferol; Dietary Supplements; E-Selectin; Endothelium; Female; Humans; Male; Middle Aged; Renal Insufficiency, Chronic; Vascular Cell Adhesion Molecule-1; Vasodilation; Vitamin D; Vitamin D Deficiency; Vitamins

To determine the incidence of hypovitaminosis D and to evaluate a supplementation intervention. We hypothesized that patients would exhibit high adherence with a free sample, and levels would become sufficient.. Prospective observational study.. Level 1 trauma center.. One hundred forty-four consecutive, skeletally mature patients treated for acute fractures.. All were provided 600 mg calcium and 800 IU vitamin D3 capsules twice daily.. Serum 25(OH) D levels were obtained on presentation and after supplementation. Patient surveys determined adherence, vitamin D intake, and sun exposure.. Ninety-one men and 53 women, mean age 45 years, mean body mass index 28.1, were studied. Mean baseline 25(OH) D level was 20.2 ng/mL, including 9 patients taking vitamin D supplements before injury. All others (mean baseline 16.9 ng/mL) were prescribed calcium and vitamin D and were offered free supplements when discharged. Seventy-seven patients completed surveys, and mean 25(OH) D level was 36.7 ng/mL after a mean of 7.0 weeks of supplementation (P < 0.0001). Seventy-nine percent reported adherence to supplement recommendations. All adherent patients achieved normal levels. Sixteen patients were nonadherent, with 10 who forgot to take the supplement, 4 choosing not to use it, 1 choosing to sell the sample, and 1 losing the sample.. Hypovitaminosis D was present in 97% of orthopaedic trauma patients who were not already taking supplements. The intervention was effective in reducing hypovitaminosis D within several weeks, with all supplemented patients achieving normal levels. Seventy-nine percent of patients adhered to recommendations. Further study to determine the long-term cost-effectiveness of this strategy seems warranted.. Therapeutic, Level II. See Instructions for Authors for a complete description of levels of evidence.

Topics: Adult; Bone Density Conservation Agents; Calcium, Dietary; Cholecalciferol; Dietary Supplements; Female; Fractures, Bone; Humans; Incidence; Male; Medication Adherence; Middle Aged; Prospective Studies; Vitamin D Deficiency

The aims of this study were to investigate the interplay between autophagy and apoptosis and to investigate the association between both of autophagy and apoptosis and vitamin D and its receptor in hepatitis C virus (HCV) viral infection and its implication in the progression into hepatocellular carcinoma (HCC).A cross-sectional study where serum levels of microtubule-associated protein 1A/1B-light chain 3 (LC3); marker of autophagy, caspase-3; marker of apoptosis, vitamin D3 and vitamin D receptor (VDR) were measured in healthy subjects as well as HCV and HCV-HCC patients using enzyme-linked immunosorbent assay technique.Collectively, the liver profile revealed hepatic dysfunctions in HCV patients with or without HCC. A significant reduction in the serum concentration levels LC3 and caspase-3 were observed referring to the down regulation of autophagy and host-mediated apoptosis in HCV patients with or without HCC. Deficiency of vitamin D and decreased levels of its receptor were observed in HCV and HCV-HCC patients.The perturbation in vitamin D/VDR axis, which modulates both of autophagy and apoptosis in HCV infection, may point out to its involvement and implication in the pathogenesis of HCV infection and the development of HCV-related HCC. Therefore, supplementation with vitamin D may not be the only solution to restore the vital biological functions of vitamin D but VDR-targeted therapy may be of great importance in this respect.

Topics: Apoptosis; Autophagy; Biomarkers; Carcinoma, Hepatocellular; Caspase 3; Cholecalciferol; Cross-Sectional Studies; Hepacivirus; Hepatitis C; Humans; Liver; Liver Neoplasms; Microtubule-Associated Proteins; Receptors, Calcitriol; Serum Albumin; Vitamin D Deficiency

Topics: Calcifediol; Cholecalciferol; Humans; Male; Vitamin D; Vitamin D Deficiency; Vitamins

Patients with sickle cell disease (SCD) are at risk for bone fragility from multiple factors including vitamin D deficiency. To date, no studies have evaluated the efficacy and safety of long-term vitamin D therapy for bone disease in children with SCD. We report a cohort of 4 children with SCD found to have severe vitamin D deficiency, secondary hyperparathyroidism, and abnormal bone mineral density treated with monthly high-dose oral cholecalciferol over 2 years. All patients exhibited a positive response to therapy without hypervitaminosis D or hypercalcemia. Further studies are needed to standardize guidelines for optimal vitamin D dosing and prevention of toxicity.

Topics: Adolescent; Anemia, Sickle Cell; Bone Density; Bone Diseases; Child; Cholecalciferol; Female; Humans; Male; Time Factors; Vitamin D Deficiency

Vitamin D may be immunomodulatory and alter faecal microbiota, but results from clinical studies in humans to date have been inconclusive. This study aimed to assess the effect of vitamin D replacement in vitamin D-deficient patients with and without ulcerative colitis [UC] on inflammation and faecal microbiota.. Vitamin D was replaced over 8 weeks in patients with active UC [defined by faecal calprotectin ≥ 100 µg/g], inactive UC [faecal calprotectin < 100 µg/g] and non-inflammatory bowel disease [IBD] controls with baseline serum 25[OH] vitamin D <50 nmol/l, and markers of inflammation and faecal microbiota were analysed.. Eight patients with active UC, nine with inactive UC and eight non-IBD controls received 40000 units cholecalciferol weekly for 8 weeks. Mean baseline 25[OH] vitamin D increased from 34 [range 12-49] to 111 [71-158] nmol/l [p < 0.001], with no difference across the groups [p = 0.32]. In patients with active UC, faecal calprotectin levels decreased from a median 275 to 111 µg/g [p = 0.02], platelet count decreased [mean 375 to 313 × 109/l, p = 0.03] and albumin increased [mean 43 to 45 g/l, p = 0.04]. These parameters did not change in patients with inactive UC or non-IBD controls. No changes in overall faecal bacterial diversity were noted although a significant increase in Enterobacteriaceae abundance was observed in patients with UC [p = 0.03].. Vitamin D supplementation was associated with reduced intestinal inflammation in patients with active UC, with a concomitant increase in Enterobacteriaceae but no change in overall faecal microbial diversity.

Topics: Adult; Aged; Case-Control Studies; Cholecalciferol; Colitis, Ulcerative; Enterobacteriaceae; Feces; Female; Gastrointestinal Microbiome; Humans; Leukocyte L1 Antigen Complex; Male; Middle Aged; Pilot Projects; Platelet Count; Prospective Studies; Serum Albumin; Vitamin D; Vitamin D Deficiency; Vitamins

Vitamin D deficiency is common in the Kingdom of Saudi Arabia (KSA). Therefore, it is significant to recognize which biochemical markers modulate serum 25 hydroxyvitamin D (25(OH)D) in response to vitamin D supplementation in such a population. Our aim was to study the correlation of insulin-like growth factor (IGF) and insulin growth factor binding protein (IGFBP) with serum 25(OH)D in response to vitamin D supplementation in a Saudi population. A total of 199 (89 males/110 females) vitamin D deficient subjects (25(OH)D level <50 nmol/L), aged 40.4 ± 11.4 years, were given vitamin D supplements (50,000 IU/mL every week) for the first 2 months, then twice a month for 2 months, followed by daily 1000 IU in the last 2 months. Fasting blood samples were taken at baseline and 6 months after the final dose of vitamin D. Serum 25(OH)D, IGF-1 and IGF-2, and IGFBPs 2-5 were measured. Vitamin D response was computed for all subjects as the difference in levels of serum 25(OH)D concentration at the end of 6 months compared to baseline. After intervention, serum 25(OH)D concentration significantly increased from 35.6 nmol/L (26.6-43.5) to 61.8 nmol/L (54.8-73.3) in responder subjects (P < .01) and from 35.1 nmol/L (21.2-58.2) to 38.3 nmol/L (25.5-48.3) in nonresponders (P = .13). Subjects with lower baseline serum IGF-II, IGFBP-2, and IGF-1/IGFBP-3 ratio are more sensitive to acute vitamin D status changes. IGF1 and IGF-1/IGFBP-3 ratio significantly increased in all subjects after 6 months (P = .01). Changes in 25(OH)D was significantly associated with changes in IGFBP-2 and IGF-1/IGFBP-3 ratio in responders only. This study proposes that changes in circulating IGF-I and IGFBP-3 are modulated by vitamin D supplementation and can be taken into consideration in investigations involving vitamin D correction. Moreover, increase in serum 25(OH)D and IGF-I/IGFBP-3 molar ratio are more sensitive markers for the response to vitamin D supplementation in Saudi population.

Topics: Adult; Biomarkers; Cholecalciferol; Dietary Supplements; Female; Humans; Insulin-Like Growth Factor Binding Proteins; Insulin-Like Growth Factor I; Male; Overweight; Prospective Studies; Saudi Arabia; Vitamin D; Vitamin D Deficiency

To evaluate the effect of 25 (OH) vitamin D supplementation on blood pressure (BP) variability in hypertensive women in the pre-menopausal and post-menopausal periods.. 881 hypertensive women prospectively followed for an interventional study between January 2016 and September 2017, in specialized consultation at the department of internal medicine at the Blida University Hospital (Algeria). Four hundred and thiry nine premenopausal women (group I) and 442 menopausal women (group II). The initial serum 25 (OH) D level for each group was determined by the enzyme immunoassay. In groups I and II, we identified 2 subgroups, A: insufficiency (vit D between 29 and 20ng/ml) and B: deficiency (vit D less than 20ng/L). Antihypertensive therapy was supplemented with an additional 200000IU/month cholecalciferol for the two B subgroups. The variability in BP was calculated as the ratio of mean systolic and diastolic BP during daytime and nighttime, with performing ambulatory BP measurement at baseline, 3, 6, and 12 months of follow-up.. At inclusion, the level of 25 (OH) D was lower (P<0.05) in subgroups IB (19.3±8.5ng/ml) and IIB (18.2±9, 5ng/ml) compared to subgroups IA (28.1±10.7ng/ml) and IIA (25.2±10.1ng/ml). After supplementation, the level of 25 (OH) D increased in subgroup IB (38.3±11.9ng/ml) and in subgroup IIB (37.3±10, 5ng/ml) and became higher (P<0.001) than in subgroups IA and IIA. Between subgroups IA and IB, at inclusion, there is no difference (P>0.05) in the SBP and DBP variability during the day and at night. After treatment, the variability of the SBP at night became lower (P<0.02) in group IB compared to group IA. In subgroup IIB, daytime variability indices were higher (P=0.04) at inclusion than in group IIA. After treatment, the variability of SBP during the day decreased but remained the highest (P<0.05) in subgroup IIB (14.8±10.8mmHg) compared to subgroup IB (12.0±8.1mmHg), as well as to subgroups IIA (10.9±9.8mmHg) and IA (10±8.1mmHg). We found a significant correlation of cholecalciferol with the variability of SBP during the day.. Vitamin D deficiency appears to be a factor of BP variability. Although the variability of the postmenopausal group remains higher than that of the other groups, the correction of the level of 25 (OH) D by the supply of cholecalciferol 200000 IU per month leads to a reduction in the variability of BP in the studied hypertensive women could help to prevent morbimortal complications.

Topics: Algeria; Blood Pressure; Cholecalciferol; Female; Humans; Hypertension; Menopause; Middle Aged; Premenopause; Prospective Studies; Vitamin D Deficiency

Vitamin D (vit-D) deficiency is highly prevalent in patients with gastro-entero-pancreatic neuroendocrine tumors (GEP-NET) and has been linked to reduced overall survival. We here assessed the vit-D status in 183 patients with GEP-NET at the time of their first presentation in the ARDEN NET Centre. We further examined the effect of simple advice to increase vit-D intake using over-the-counter vit-D preparations [colecalciferol (Vit-D3), 1,000-2,000 units/day], over a prospective observation period of 24 mo. At baseline, only 33.3% of patients showed vit-D sufficiency (25-OH-vit-D; >50 nmol/L), the remainder was insufficient (31.3%; 25-OH-vit-D; 25-50 nmol/L) or deficient (35.5%; 25-OH-vit-D; <25 nmol/L). Repeated advice to increase vit-D intake at routine 6-monthly follow-up appointments was associated with increased 25-OH-vit-D from 37.8 ± 3.5 nmol/L at baseline to 60.4 ± 5.6 nmol/L (P < 0.0001) and 56.8 ± 7.0 nmol/L (P = 0.039) after 12 and 24 mo. Percentage of vit-D insufficiency decreased from 66.6% at baseline to 44.9% and 46.2% after 12 and 24 months, respectively. Previous abdominal surgery, but not treatment with somatostatin analogues predicted 25-OH-vit-D levels in bootstrapped linear regression analyses (P = 0.037). In summary, simple advice to increase vit-D intake using over-the-counter preparations was associated with significant improvement of vit-D deficiency/insufficiency, although, 15% of GEP-NET patients remained deficient and may benefit from additional measures of vit-D replacement.

Topics: Cholecalciferol; Chromogranin A; Female; Gastrointestinal Neoplasms; Humans; Male; Middle Aged; Neuroendocrine Tumors; Nonprescription Drugs; Prospective Studies; Regression Analysis; Vitamin D; Vitamin D Deficiency