Iron formula - Efficacy and Safety of Ferrous Bisglycinate and Folinic Acid in the Control of Iron Deficiency in Pregnant Women: A Randomized, Controlled Trial

A clinical trial published in the journal, Nutrients, in 2022, describes how supplementation with an Iron bisglycinate multi performed comparably to standard management for women with iron deficiency.

The iron supplement is a multi-nutrient soft-gel formula comprising of iron in the form of iron bisglycinate (equivalent to 24mg of elemental iron), folinic acid, and vitamins B1, B2, B6, B9 and B12.

In this randomized, double-blind, placebo-controlled clinical trial, researchers at the Antenatal Care Clinical of the Health Promotion Hospital in Ratchaburi, Thailand, evaluated the efficacy of the product in post-menopausal women.

A total of 120 women at 12-16 weeks of pregnancy were recruited for the trial, and randomly allocated to the test group (Iron Up®, 24mg iron, with folinic acid) or the control group (66mg iron) with identical levels of the other ingredients in either group.

Blood samples were taken at baseline, 3- and 6-months, for the measurement of iron absorption, hemoglobin, immature and mature red blood cell counts, ferrtin and high sensitivity C-reactive protein (hsCRP, a marker of inflammation). Additionally, the recruited subjects were surveyed about their quality of life, adverse effects and newborn weight.

Results showed that both test and control groups experienced an increase in serum iron, however the Iron Up® group showed a more marked increase per timepoint. Similarly, both groups showed increases in serum hemoglobin, red cell counts and ferritin, but the test group again showed a more pronounced improvement. Furthermore, instantaneous iron absorption was higher for the test group compared to the control group.

Subjects who took the test nutraceutical reported fewer instances of metallic taste, bloating, abdominal pain, nausea or constipation, and reported an improvement in their quality of life at 3 and 6 months, despite quality of life showing a decrease in all groups as pregnancy progressed. In terms of birth outcome, children born to women in the test group had a small but statistically significant birthweight compared to control babies.

In summary, the results of this study suggest that supplementation with the test formula improves short-term iron absorption and progressive iron levels across pregnancy, along with improved hematological outcomes, quality of life and newborn weight, with fewer side effects, in women with iron deficiency. This is despite the test formula having 66% lower iron than the control and highlights the importance of considering the type of iron used, rather than simply the dosage given.


Reference: Bumrungpert et al. Nutrients. 2022 Jan 20;14(3):452

Financial sponsor of study: Max Biocare Pty Ltd.

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