Anemia in pregnancy is defined by the World Health Organization as hemoglobin levels of ≤ 11 g/dl. Globally, a prevalence rate of 38% was estimated by the World Health Organization for pregnant women.Treatment of iron deficiency anemia during pregnancy remains a main public health issue. Oral iron salts have been recommended for treatment of iron deficiency anemia e.g. ferrous fumarate. Increasing the dose of ferrous fumarate will subsequently increase the bioavailability of iron preparation, however it also increases the frequency of gastrointestinal tract side effects e.g. nausea, constipation, diarrhea, flatulence, and black stained stools. Besides, the increased bioavailable ferrous fumarate may decrease by many foods and / or chelating drugs in the gastrointestinal tract which interfere with its absorption leading to variability in the hemoglobin correction during the treatment.
Ferrous bisglycinate is an iron amino acid chelate. It is formed by reaction of ferrous iron with two molecules of the amino acid glycine by a covalent bound in a process called chelation. Ferrous bisglycinate is claimed to have better patient compliance because of fewer gastrointestinal tract side effects. It is also claimed that ferrous bisglycinate improves iron absorption, storage and increase hemoglobin level better than the conventionally used iron salts.

Start Date31 Dec 2015

Sponsor / Collaborator

Mansoura University

100 Clinical Results associated with Ferrous bisglycinate

100 Translational Medicine associated with Ferrous bisglycinate

100 Patents (Medical) associated with Ferrous bisglycinate

Literatures (Medical) associated with Ferrous bisglycinate

01 Aug 2023·The Journal of nutrition

Is a Lower Dose of More Bioavailable Iron (18-mg Ferrous Bisglycinate) Noninferior to 60-mg Ferrous Sulfate in Increasing Ferritin Concentrations While Reducing Gut Inflammation and Enteropathogen Detection in Cambodian Women? A Randomized Controlled Noninferiority Trial.

Article

Author: Goldfarb, David M ; Karakochuk, Crystal D ; Fischer, Jordie A J ; Elango, Rajavel ; Hou, Kroeun ; Pei, Lulu X

BACKGROUND:

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.

OBJECTIVES:

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.

METHODS:

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.

RESULTS:

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.

CONCLUSIONS:

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.

10 Jul 2023·Nutrition reviews

The effects of oral ferrous bisglycinate supplementation on hemoglobin and ferritin concentrations in adults and children: a systematic review and meta-analysis of randomized controlled trials

Review

Author: Karakochuk, Crystal D ; Fischer, Jordie A J ; Bone, Jeffrey N ; Cherian, Arlin M

Abstract:

Context:

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.

Objective:

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.

Data sources:

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.

Data extraction:

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.

Data analysis:

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.

Conclusion:

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.

PROSPERO registration no:

CRD42020196984.

15 Jun 2023·Microbiology spectrum

The Effect of Oral Iron Supplementation on Gut Microbial Composition: a Secondary Analysis of a Double-Blind, Randomized Controlled Trial among Cambodian Women of Reproductive Age.

Article

Author: Karakochuk, Crystal D ; Krouen, Hou ; Fischer, Jordie Aj ; Ma, Yvonne ; Nearing, Jacob ; Goldfarb, David M ; Finlayson-Trick, Emma ; Wang, Siyun

The World Health Organization recommends untargeted iron supplementation for women of reproductive age (WRA) in countries where anemia prevalence is greater than 40%, such as Cambodia. Iron supplements, however, often have poor bioavailability, so the majority remains unabsorbed in the colon. The gut houses many iron-dependent bacterial enteropathogens; thus, providing iron to individuals may be more harmful than helpful. We examined the effects of two oral iron supplements with differing bioavailability on the gut microbiomes in Cambodian WRA. This study is a secondary analysis of a double-blind, randomized controlled trial of oral iron supplementation in Cambodian WRA. For 12 weeks, participants received ferrous sulfate, ferrous bisglycinate, or placebo. Participants provided stool samples at baseline and 12 weeks. A subset of stool samples (n = 172), representing the three groups, were randomly selected for gut microbial analysis by 16S rRNA gene sequencing and targeted real-time PCR (qPCR). At baseline, 1% of women had iron-deficiency anemia. The most abundant gut phyla were Bacteroidota (45.7%) and Firmicutes (42.1%). Iron supplementation did not alter gut microbial diversity. Ferrous bisglycinate increased the relative abundance of Enterobacteriaceae, and there was a trend towards an increase in the relative abundance of Escherichia-Shigella. qPCR detected an increase in the enteropathogenic Escherichia coli (EPEC) virulence gene, bfpA, in the group that received ferrous sulfate. Thus, iron supplementation did not affect overall gut bacterial diversity in predominantly iron-replete Cambodian WRA, however, evidence does suggest an increase in relative abundance within the broad family Enterobacteriaceae associated with ferrous bisglycinate use. IMPORTANCE To the best of our knowledge, this is the first published study to characterize the effects of oral iron supplementation on the gut microbiomes of Cambodian WRA. Our study found that iron supplementation with ferrous bisglycinate increases the relative abundance of Enterobacteriaceae, which is a family of bacteria that includes many Gram-negative enteric pathogens like Salmonella, Shigella, and Escherichia coli. Using qPCR for additional analysis, we were able to detect genes associated with enteropathogenic E. coli, a type of diarrheagenic E. coli known to be present around the world, including water systems in Cambodia. The current WHO guidelines recommend blanket (untargeted) iron supplementation for Cambodian WRA despite a lack of studies in this population examining iron's effect on the gut microbiome. This study can facilitate future research that may inform evidence-based global practice and policy.

News (Medical) associated with Ferrous bisglycinate

01 Feb 2024

·www.prnewswire.com

Designs for Health Launches ElectroPure Hydration™ to Redefine Hydration

Leading supplement brand delivers another high-quality, convenient product for smarter hydration that supports everyday life and performance goals of athletes and non-athletes alike PALM COAST, Fla., Feb. 1, 2024 /PRNewswire/ -- Designs for Health, the expert-recommended and preferred brand for high-quality, professional strength, research-backed supplements, today announced the launch of ElectroPure Hydration™, a great-tasting, clementine-flavored electrolyte drink mix in a convenient stick pack that supports recommendations for optimal hydration and peak athletic performance*. ElectroPure Hydration™ delivers two times the electrolytes of the leading electrolyte powder brand and nine times the electrolytes of the leading sports drink†, allowing consumers to refuel with advanced cellular hydration*. This zero-sugar hydration formula is sweetened with stevia and monk fruit and is made with a full spectrum of balanced ingredients that replenish the electrolytes lost due to sweating.* It uniquely features sodium and potassium in a 1:1 ratio for more optimal, balanced electrolyte replacement.* It also features D-ribose, a key component in ATP synthesis to promote cellular energy production and muscle recovery*; vitamin C for antioxidant support during and post-exercise*; and magnesium bisglycinate chelate and zinc for increased cellular bioavailability*. "While physical activity and exposure to hot weather are the biggest sources of electrolyte and water loss, our bodies can also suffer water loss from everyday activity and bodily functions. This product is made for the athlete and non-athlete alike as it is imperative to maintain cellular hydration and replenish fluids or we risk a potential decrease in not only athletic performance and muscle, but also cognitive function, and even mental health*," said Dr. David M. Brady, Chief Medical Officer at Designs for Health. "Water alone is not effective in replenishing the electrolytes our bodies need. With the launch of ElectroPure Hydration™, we are providing a solution that supports functioning at our best, no matter what our daily regimen looks like. Our consumers deserve that and we're excited to deliver it." The recommended use for the gluten-free, dairy-free, soy-free, and non-GMO ElectroPure Hydration™ product is to mix 1 stick pack (8 grams) in 16 ounces of water per day or as directed by your health care provider. The product is available to purchase at: . Designs for Health began in 1989 as a small educational services company with deep roots in natural medicine and big ambitions to revolutionize the industry. More than 30 years later, the company is pioneering new approaches to nutritional science, breaking barriers in quality standards, and ultimately transforming the healthcare ecosystem. Through a robust product pipeline and a diverse portfolio of more than 300 nutritional products, Designs for Health is leading the charge in the natural and integrative medicine movement to design a well world for all. To learn more about Designs for Health and its comprehensive portfolio of products, including its line of oral health products, visit . You can also tune in to Designs for Health's podcast, Conversations for Health, to immerse yourself in the current landscape of Functional Medicine and further empower you to design a well world with us. About Designs for Health, Inc. Family-owned Designs for Health, Inc. offers high-quality dietary supplements and functional foods to health care professionals and their patients. Guided by its founding philosophy of "Science-First™," the company holds an unwavering commitment to creating research-driven formulations with meaningful quantities of functional ingredients that maximize the potential for successful health outcomes. For over 30 years, Designs for Health has been many healthcare professionals' trusted source for not only product innovation but also leadership in clinical education and practice development solutions. *These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. † 1. 2X the total electrolytes per serving vs. Liquid I.V. Hydration Multiplier Powder Packets, the leading brand per Stackline sales data as of September 2023. 2. 9X the total electrolytes per serving vs. Gatorade Classic 12 fl oz as of September 2023. Contact: 5WPR 212-999-5585 [email protected] SOURCE Designs for Health

100 Deals associated with Ferrous bisglycinate

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Diarrhea	Phase 3	EG	Mansoura University	31 Dec 2015
Flatulence	Phase 3	EG	Mansoura University	31 Dec 2015
Iron deficiency anemia of pregnancy	Phase 3	EG	Mansoura University	31 Dec 2015
Abdominal Pain	Phase 3	IN	GSK Plc	13 Oct 2010
Anemia, Iron-Deficiency	Phase 3	IN	GSK Plc	13 Oct 2010
Constipation	Phase 3	IN	GSK Plc	13 Oct 2010
Fatigue	Phase 3	IN	GSK Plc	13 Oct 2010
Headache	Phase 3	IN	GSK Plc	13 Oct 2010
Iron deficiency	Phase 3	IN	GSK Plc	13 Oct 2010
Malnutrition	Phase 3	IN	GSK Plc	13 Oct 2010

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