vitamin-d-2 and Prediabetic-State

This double-blind, randomized, controlled trial evaluated whether 12 months of high-dose vitamin D2 supplementation improved insulin sensitivity and secretion and glycemic status.. African-American males (AAM) with prediabetes (glycosylated hemoglobin [A1C] 5.7-6.4%), hypovitaminosis D (25-hydroxyvitamin D [25OHD] 5-29 ng/mL), and prevalent medical problems were supplemented with vitamin D3 (400 IU/day) and then randomized to weekly placebo or vitamin D2 (50,000 IU). The primary outcome was the change in oral glucose insulin sensitivity (OGIS, from an oral glucose tolerance test [OGTT]) after 12 months of treatment. Secondary outcomes included other glycemic indices, A1C, and incident diabetes.. Baseline characteristics were similar in vitamin D-supplemented (n = 87) and placebo (n = 86) subjects completing the trial with average concentrations 14.4 ng/mL, 362 mL × min(-1) × m(-2), and 6.1% for 25OHD, OGIS and A1C, respectively. After 12 months, the vitamin D-supplemented group had a change in serum 25OHD +35 versus +6 ng/mL for placebo, P<.001; OGIS +7.8 versus -16.0 mL × min(-1) × m(-2) for placebo, P = .026; and A1C -0.01 versus +0.01% for placebo, P = .66. Ten percent of subjects in both groups progressed to diabetes. A posthoc analysis of participants with baseline impaired fasting glucose (IFG) showed that more subjects in the vitamin D subgroup (31.6%) than placebo (8.3%) returned to normal glucose tolerance, but the difference did not reach significance (P = .13).. The trial does not provide evidence that 12 months of high-dose D2 repletion improves clinically relevant glycemic outcomes in subjects with prediabetes and hypovitaminosis D (NCT01375660).

Topics: Aged; Black or African American; Blood Glucose; Dietary Supplements; Double-Blind Method; Ergocalciferols; Glycated Hemoglobin; Humans; Male; Middle Aged; Prediabetic State; Vitamin D; Vitamin D Deficiency

To investigate the effects of vitamin D supplement for three months on anthropometric and glucose homeostatic measures in Thai adults with impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT).. Forty-seven IFG and/or IGT subjects enrolled in the study. Subjects were randomized into three groups, control (n = 18), vitamin D₂ (20,000 IU weekly, n = 19) or vitamin D₃ (15,000 IU weekly, n = 10). Anthropometric variables were obtained at baseline and at 3-month. Oral glucose tolerance test was performed at baseline and at 3-month. Total serum 25(OH)D, 25(OH)D₃, and 25(OH)D2 were measured by LC-MS/MS. Insulin resistance (HOMA-IR) and insulin secretion index (HOMA%B) were calculated by the homeostasis model assessment.. The total 25(OH)D levels significantly increased from baseline in both the vitamin D₂ and the vitamin D₃ groups, while there was no change in the control group. D₃ supplementation raised 25(OH)D₃ significantly (+13.7 ± 4.9 ng/mL, p < 0.01) while D2 increased 25(OH)D2 levels (+25.9?4.2 ng/mL, p<0.001) but with a decrease in 25(OH)D3 (-13.1?3.1 ng/mL, p<0. 001). Subjects were classified into two groups, i.e., control (n = 18) and D₂ or D₃ supplementations (n = 29). After three months, waist circumference (WC) significantly decreased in subjects of vitamin D supplementation group. Body weight (BW p = 0.05), systolic blood pressure (SBP, p = 0.05), body mass index (BM, p = 0.06), and HOMA-IR (p = 0.09) also tended to decrease. Subjects with an increase of total 25(OH)D levels > 10 ng/mL (23 of 29 subjects) had significant decrease in HOMA-IR and increase in disposition index. Using robust regression analysis, we found the use of D3 was associated with a larger decrease in WC (coefficient = -3.5, p < 0.001) independent of the change in total 25(OH)D and baseline BMI. No difference between D₂ and D₃ was observed for other metabolic measures.. Weekly supplementations of vitamin D₂ (20,000 IU) or vitamin D₃ (15,000 IU) improve metabolic phenotypes in subjects with prediabetes. D₃ supplement may decrease waist circumference more than D₂ supplement.

Topics: Adult; Anthropometry; Asian People; Biological Availability; Calcifediol; Cholecalciferol; Dietary Supplements; Drug Monitoring; Ergocalciferols; Female; Glucose Tolerance Test; Humans; Insulin Resistance; Male; Middle Aged; Phenotype; Prediabetic State; Regression Analysis; Tandem Mass Spectrometry; Treatment Outcome; Vitamins

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

Randomized Clinical Trial (RCT) designs range from highly selective resulting in lack of external validity to more inclusive, requiring large sample sizes to observe significant results. Few publications, however, have compared excluded to enrolled participants. We aimed to assess our trial's design based on the effectiveness versus efficacy continuum using the Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) tool and to compare included and excluded patients.. Fifteen members of endocrinology section completed PRECIS for DIVA (D-Vitamin Intervention in VA) trial; an RCT evaluating vitamin D supplementation in improving dysglycemia in patients with prediabetes. Retrospective chart review compared subjects excluded (OUT) to those included (IN) in RCT. Student's t and Chi-square tests were used to compare continuous and categorical variables. Additionally, multiple logistic regression was completed.. PRECIS scores were nearly universally pragmatic. 178 patients enrolled in DIVA trial were compared with 178 randomly selected patients excluded from study involvement. There was no significant difference between IN and OUT for the majority of the continuous and all of the categorical variables. Multivariate logistic regression identified only the A1c, HDL and Charlson Index as significant predictors of a participant's inclusion or exclusion. There was higher HDL (51.3(13.9) versus 44.6(10.1), P = 0.001) and Charlson Index (2.85(1.6) versus 2.2(1.17), P = 0.001) for OUT versus IN groups. Subanalysis of excluded patients in A1c range 5.7 to 6.9, had lower BMI (30.7(3.4) versus 32(2.7), P = 0.002) but higher HDL (mg/l: 49.7(11.8) versus 44.6(10.1), P = 0.001) and Charlson index (2.85(1.6) versus 2.2(1.17), P = 0.001) than included participants. Additionally, there was a trend towards higher rates of cancer (22.9% versus 12.9%, P = 0.033) but less psychiatric problems (56.2% versus 72.5%, P = 0.026) and thiazide diuretic use (18.1% versus 29.8%, P = 0.034).. DIVA trial design appears to favor broad clinical applicability. The majority of objectively compared variables did not different between patients included and excluded from this RCT. Advice based on the evidence from this RCT may be applicable to a larger group of patients than those fitting inclusion/exclusion criteria alone.. ClinicalTrials.gov NCT01375660 (registered 15 June 2011).

Topics: Aged; Biomarkers; Black or African American; Blood Glucose; Chi-Square Distribution; Clinical Protocols; Comorbidity; Dietary Supplements; Ergocalciferols; Glucose Tolerance Test; Glycated Hemoglobin; Humans; Logistic Models; Male; Middle Aged; Multivariate Analysis; Patient Selection; Prediabetic State; Randomized Controlled Trials as Topic; Retrospective Studies; Treatment Outcome; Vitamin D; Vitamin D Deficiency