Ferrous bisglycinate 25 mg iron is as effective as ferrous sulfate 50 mg iron in the prophylaxis of iron deficiency and anemia during pregnancy in a randomized trial.
Milman N, Jønsson L, Dyre P, Pedersen PL, Larsen LG.
OBJECTIVE: 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.
DESIGN: Randomized, double-blind, intention-to-treat study.
SETTING: Antenatal care clinic.
SAMPLE: 80 healthy ethnic Danish pregnant women.
METHODS: 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.
MAIN OUTCOME MEASURES: Occurrence of ID (ferritin
RESULTS: 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).
CONCLUSIONS: 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.
Iron deficiency is the most common nutritional deficiency and the leading cause of anemia in most parts of the world. Untreated, iron deficiency (ID) can compromise the development of cognitive functions in infants and ID during pregnancy increases the risk for preterm delivery. Small and preterm babies are more likely to have health problems in the first years than infants who are born full term.
Various studies indicate that one particular iron FORMULA, FERROUS BISGLYCINATE, WHICH IS AN IRON-amino acid chelate (Ferrochel®, Albion Laboratories, USA) provides a superior bio-availability when compared with the conventional iron salts including ferrous sulphate. This RCT, carried out according to Good Clinical Practices at a Danish hospital demonstrates that the bioavailability of ferrous bisglycinate is indeed twice as good as the comparator product, iron sulphate. In addition, the women, who received ferrous bisglycinate reported fewer incidents of gastro intestinal (GI) side effects, such as constipation, than the women who received ferrous sulphate. It is important to minimize GI side effects in order to obtain a high compliance. Ferrous bisglycinate combines an optimal absorption profile with fewer side effects and thus might improve the standards of care concerning iron prophylaxis and oral iron treatment in pregnant women.
Dr. Nils MILMAN, a leading scientist in iron metabolism during pregnancy and the leading author of this trial.