ferrous-bisglycinate and Anemia--Iron-Deficiency

Iron deficiency and anemia have serious consequences, especially for children and pregnant women. Iron salts are commonly provided as oral supplements to prevent and treat iron deficiency, despite poor bioavailability and frequently reported adverse side effects. Ferrous bisglycinate is a novel amino acid iron chelate that is thought to be more bioavailable and associated with fewer gastrointestinal (GI) adverse events as compared with iron salts.. A systematic review and meta-analysis of randomized controlled trials (RCTs) was conducted to evaluate the effects of ferrous bisglycinate supplementation compared with other iron supplements on hemoglobin and ferritin concentrations and GI adverse events.. A systematic search of electronic databases and grey literature was performed up to July 17, 2020, yielding 17 RCTs that reported hemoglobin or ferritin concentrations following at least 4 weeks' supplementation of ferrous bisglycinate compared with other iron supplements in any dose or frequency.. Random-effects meta-analyses were conducted among trials of pregnant women (n = 9) and children (n = 4); pooled estimates were expressed as standardized mean differences (SMDs). Incidence rate ratios (IRRs) were estimated for GI adverse events, using Poisson generalized linear mixed-effects models. The remaining trials in other populations (n = 4; men and nonpregnant women) were qualitatively evaluated.. Compared with other iron supplements, supplementation with ferrous bisglycinate for 4-20 weeks resulted in higher hemoglobin concentrations in pregnant women (SMD, 0.54 g/dL; 95% confidence interval [CI], 0.15-0.94; P < 0.01) and fewer reported GI adverse events (IRR, 0.36; 95%CI, 0.17-0.76; P < 0.01). We observed a non-significant trend for higher ferritin concentrations in pregnant women supplemented with ferrous bisglycinate. No significant differences in hemoglobin or ferritin concentrations were detected among children.. Ferrous bisglycinate shows some benefit over other iron supplements in increasing hemoglobin concentration and reducing GI adverse events among pregnant women. More trials are needed to assess the efficacy of ferrous bisglycinate against other iron supplements in other populations.. CRD42020196984.

Topics: Adult; Anemia, Iron-Deficiency; Child; Dietary Supplements; Female; Ferritins; Ferrous Compounds; Hemoglobins; Humans; Iron; Iron Deficiencies; Male; Pregnancy; Randomized Controlled Trials as Topic; Salts

Global guidelines recommend untargeted iron supplementation for women in regions of anemia prevalence ≥40%, such as Cambodia. However, the potential harms of untargeted iron on the gut have not been rigorously studied in women and likely vary depending on iron dose and form.. We investigated if a lower dose of a highly bioavailable iron amino acid chelate was as effective as the standard dose of iron salts in increasing ferritin concentrations and whether any differences were observed in gut inflammation or enteropathogen detection.. A double-blind, randomized placebo-controlled noninferiority trial was conducted in Cambodia. Nonpregnant women (n = 480, 18-45 y) were randomly assigned to 60-mg ferrous sulfate, 18-mg ferrous bisglycinate, or placebo for 12 wk. Nonfasting blood and stool specimens were collected at baseline and 12 wk. Ferritin and fecal calprotectin were measured with an ELISA. A molecular assay was used to detect 11 enteropathogens in a random subset of n = 100 women. Generalized linear mixed-effects models were used to estimate the adjusted mean difference in ferritin concentrations at 12 wk (primary outcome), as compared with our 'a priori' noninferiority margin of 20 μg/L.. Baseline anemia and iron deficiency prevalence was low (17% and 6%, respectively). The adjusted mean difference in ferritin concentrations between the iron groups was 14.6 (95% confidence interval [CI]: 7.6, 21.6) μg/L. Mean ferritin concentration at 12 wk was higher in the ferrous sulfate (99 [95% CI: 95, 103] μg/L, P < 0.001) than in ferrous bisglycinate (84 [95% CI: 80, 88] μg/L) and placebo groups (78 [95% CI: 74, 82] μg/L). No differences in fecal calprotectin concentrations or enteropathogen detection were observed across groups at 12 wk.. Ferrous bisglycinate (18-mg) was not as effective as ferrous sulfate (60-mg) in increasing ferritin concentrations and did not differentially influence biomarkers of gut health in this predominantly iron-replete population of Cambodian women. This trial was registered at clinicaltrials.gov registry as NCT04017598.

Topics: Anemia; Anemia, Iron-Deficiency; Cambodia; Dietary Supplements; Female; Ferritins; Ferrous Compounds; Hemoglobins; Humans; Inflammation; Iron

Iron deficiency in pregnancy is a major public health problem that causes maternal complications. The objective of this randomized, controlled trial was to examine the bioavailability, efficacy, and safety of oral ferrous bisglycinate plus folinic acid supplementation in pregnant women with iron deficiency. Subjects (12−16 weeks of gestation, n = 120) were randomly allocated to receive oral iron as ferrous bisglycinate (equiv. iron 24 mg) in supplement form with folinic acid and multivitamins (test group, n = 60) or as ferrous fumarate (equiv. iron 66 mg iron, control group, n = 60) after breakfast daily. Iron absorption was assessed by measuring fasted serum iron levels at 1 and 2 h immediately after supplementation. Hematological biomarkers and iron status were assessed before intervention, and at 3 and 6 months. Side effects were monitored throughout the intervention. A significant increase in serum iron was seen in both groups (p < 0.001) during the bioavailability assessment; however, the test group increases were comparatively higher than the control values at each timepoint (p < 0.001). Similarly, both test and control groups demonstrated a statistically significant increases in hemoglobin (Hb) (p < 0.001), erythrocytes (p < 0.001), reticulocytes (p < 0.001), mean corpuscular volume (MCV) (p < 0.001), mean corpuscular hemoglobin (MCH) (p < 0.001), mean corpuscular hemoglobin concentration (MCHC) (p < 0.001), % transferrin saturation (p < 0.001), and ferritin (p < 0.001) at 3 and 6 months after supplementation. However, in all cases, the test group increases were numerically larger than the control group increases at each timepoint. The test intervention was also associated with significantly fewer reports of nausea, abdominal pain, bloating, constipation, or metallic taste (p < 0.001). In conclusion, ferrous bisglycinate with folinic acid as a multivitamin nutraceutical format is comparable to standard ferrous fumarate for the clinical management of iron deficiency during pregnancy, with comparatively better absorption, tolerability, and efficacy and with a lower elemental iron dosage.

Topics: Anemia, Iron-Deficiency; Biomarkers; Female; Ferrous Compounds; Glycine; Humans; Iron Deficiencies; Leucovorin; Pregnancy; Pregnancy Complications

Provision of parenteral or oral iron supplementation can restore iron stores and maintain stable hemoglobin levels in chronic kidney disease (CKD) and hemodialysis (HD) patients. The route for oral or intravenous (IV) administration of iron depends on the acuity of anemia, costs, and patient tolerance. IV iron can restore iron stores rapidly but also carries higher risks for allergy and infection. Oral iron supplementation is limited by high gastrointestinal adverse effects.. We conducted an open-label trial to study the efficiency of a film-coated iron supplementation tablet, which contains ferrous bisglycinate chelate, vitamin C, and folic acid, in CKD stage 3b to 4 and HD patients.. Twenty-seven HD patients and 20 CKD patients participated this study. After a 16-week intervention, low-dose ferrous bisglycinate chelate improved serum iron concentration (67.8 vs 87.2 mg/dL, p = 0.04) and transferrin saturation (24.7% vs 31.3%, p = 0.03) in stage 3 to 4 CKD patients, restored iron loss, and maintained stable hemoglobin levels in HD patients. No GI upset events were reported.. Ferrous bisglycinate chelate is a well-tolerated oral iron supplementation for CKD and HD patients.

Topics: Anemia, Iron-Deficiency; Dietary Supplements; Female; Ferrous Compounds; Glycine; Hemoglobins; Humans; Iron; Male; Renal Dialysis; Renal Insufficiency, Chronic

To compare the effects of oral ferrous bisglycinate 25 mg iron/day vs. ferrous sulfate 50 mg iron/day in the prevention of iron deficiency (ID) and iron deficiency anemia (IDA) in pregnant women.. Randomized, double-blind, intention-to-treat study.. Antenatal care clinic.. 80 healthy ethnic Danish pregnant women.. Women were allocated to ferrous bisglycinate 25 mg elemental iron (Aminojern®) (n=40) or ferrous sulfate 50 mg elemental iron (n=40) from 15 to 19 weeks of gestation to delivery. Hematological status (hemoglobin, red blood cell indices) and iron status (plasma iron, plasma transferrin, plasma transferrin saturation, plasma ferritin) were measured at 15-19 weeks (baseline), 27-28 weeks and 36-37 weeks of gestation.. Occurrence of ID (ferritin <15 μg/L) and IDA (ferritin <12 μg/L and hemoglobin <110 g/L).. At inclusion, there were no significant differences between the bisglycinate and sulfate group concerning hematological status and iron status. The frequencies of ID and IDA were low and not significantly different in the two iron groups. The frequency of gastrointestinal complaints was lower in the bisglycinate than in the sulfate group (P=0.001). Newborns weight was slightly higher in the bisglycinate vs. the sulfate group (3601±517 g vs. 3395±426 g, P=0.09).. In the prevention of ID and IDA, ferrous bisglycinate was not inferior to ferrous sulfate. Ferrous bisglycinate in a low dose of 25 mg iron/day appears to be adequate to prevent IDA in more than 95% of Danish women during pregnancy and postpartum.

Topics: Anemia, Iron-Deficiency; Double-Blind Method; Female; Ferritins; Ferrous Compounds; Gastrointestinal Diseases; Glycine; Hemoglobins; Humans; Infant, Newborn; Iron; Male; Obstetric Labor Complications; Patient Compliance; Placenta; Pregnancy; Pregnancy Complications, Hematologic; Reticulocyte Count

In cancer patients mild-moderate non-chemotherapy-induced iron deficiency anemia (IDA) is usually treated with oral iron salts, mostly ferrous sulfate. In this study, we compare efficacy and toxicity of oral ferrous bisglycinate chelate and ferrous sulfate in cancer patients with mild IDA. Twenty-four patients operated on for solid tumors (10 breast, 12 colorectal, 2 gastric), aged 61±10 years (range 45-75), with non-chemotherapy-induced hemoglobin (Hb) values between 10 and 12 g/dL and ferritin lower than 30 ng/mL were randomized to receive oral ferrous bisglycinate chelate, 28 mg per day for 20 days, and then 14 mg per day for 40 days (12 patients) (A group) or oral ferrous sulphate, 105 mg per day for 60 days (12 patients) (B group). Values of hemoglobin and ferritin obtained at diagnosis, 1 and 2 months from the beginning of treatment were compared. Adverse events (AEs) related to the two treatments were recorded. In the 12 patients treated with ferrous bisglycinate chelate, basal hemoglobin and ferritin values (mean±SD) were 11.6±0.8 g/dL and 16.1±8.0 ng/mL. After 2 months of treatment, they were 13.0±1.4 g/dL and 33.8±22.0 ng/mL, respectively (P=0.0003 and P=0.020). In the group treated with ferrous sulphate, hemoglobin and ferritin mean values were 11.3±0.6 g/dL and 19.0±6.4 ng/mL basally, and 12.7±0.70 g/dL and 40.8±28.1 ng/mL (P<0.0001 and P=0.017) after 2 months of treatment. AEs occurred in six cases. In all these six cases, two (17%) treated with ferrous bisglycinate chelate and four (33%) with ferrous sulphate, toxicity was grade 1. In conclusion, these data suggest that ferrous bisglycinate chelate has similar efficacy and likely lower GI toxicity than ferrous sulphate given at the conventional dose of 105 mg per day for the same time.

Topics: Aged; Anemia, Iron-Deficiency; Breast Neoplasms; Colorectal Neoplasms; Dietary Supplements; Female; Ferritins; Ferrous Compounds; Follow-Up Studies; Glycine; Hematinics; Hemoglobins; Humans; Iron Chelating Agents; Male; Middle Aged; Stomach Neoplasms

Celiac disease (CD) is an immunologically-mediated enteropathy resulting in small-bowel mucosal villous atrophy with crypt hyperplasia. Iron malabsorption is usually observed in CD. Only few studies investigated oral iron absorption in subjects with gastrointestinal diseases and Iron Deficiency Anemia (IDA), using the oral iron absorption test (OIAT). We considered useful to investigate the OIAT, using ferrous bisglycinate chelate (FBC), in patients with CD at diagnosis or on gluten free diet (GFD) from at least 1 year.. A total of 25 patients with CD (3-18 years old) and iron depletion, at diagnosis of CD (N.=12) or on GFD from at least 12 months (N.=13), were considered. Serum iron was evaluated at baseline (T0) and after 3 hours (T1) from the oral iron ingestion. Statistical analyses were conducted using SPSS 21.0 software for Mac.. OIAT was well tolerated by all patients. An important increase of the serum iron at T1, of at least twice the baseline values, occurred in all patients except in one (P value <0.0005).. These results demonstrated good efficacy of the FBC, not only in patients with CD on GFD but also in children with newly diagnosed CD with the characteristic intestinal lesions.

Topics: Administration, Oral; Adolescent; Anemia, Iron-Deficiency; Celiac Disease; Child; Child, Preschool; Diet, Gluten-Free; Female; Ferrous Compounds; Glycine; Humans; Male

Food fortification is one approach for addressing anemia, but information on program effectiveness is limited.. We evaluated the impact of Costa Rica's fortification program on anemia in women aged 15-45 y and children aged 1-7 y.. Reduced iron, an ineffective fortificant, was replaced by ferrous fumarate in wheat flour in 2002, and ferrous bisglycinate was added to maize flour in 1999 and to liquid and powdered milk in 2001. We used a one-group pretest-posttest design and national survey data from 1996 (baseline; 910 women, 965 children) and 2008-2009 (endline; 863 women, 403 children) to assess changes in iron deficiency (children only) and anemia. Data were also available for sentinel sites (1 urban, 1 rural) for 1999-2000 (405 women, 404 children) and 2008-2009 (474 women, 195 children), including 24-h recall data in children. Monitoring of fortification levels was routine.. Foods were fortified as mandated. Fortification provided about one-half the estimated average requirement for iron in children, mostly and equally through wheat flour and milk. Anemia was reduced in children and women in national and sentinel site comparisons. At the national level, anemia declined in children from 19.3% (95% CI: 16.8%, 21.8%) to 4.0% (95% CI: 2.1%, 5.9%) and in women from 18.4% (95% CI: 15.8%, 20.9%) to 10.2% (95% CI: 8.2%, 12.2%). In children, iron deficiency declined from 26.9% (95% CI: 21.1%, 32.7%) to 6.8% (95% CI: 4.2%, 9.3%), and iron deficiency anemia, which was 6.2% (95% CI: 3.0%, 9.3%) at baseline, could no longer be detected at the endline.. A plausible impact pathway suggests that fortification improved iron status and reduced anemia. Although unlikely in the Costa Rican context, other explanations cannot be excluded in a pre/post comparison.

Topics: Adolescent; Adult; Anemia, Iron-Deficiency; Animals; Child; Child, Preschool; Costa Rica; Female; Ferrous Compounds; Food, Fortified; Glycine; Hemoglobins; Humans; Infant; Iron, Dietary; Male; Mandatory Programs; Middle Aged; Nutrition Policy; Nutrition Surveys; Prevalence; Program Evaluation; Sentinel Surveillance; Young Adult