Efficacy of ferrous bis -glycinate versus ferrous glycine sulfate in the treatment of iron deficiency anemia with pregnancy: a randomized double-blind clinical trial

Objective: The aim of this study is to compare the efficacy and tolerability of oral ferrous bis-glycinate versus ferrous glycine sulfate in the treatment of iron deficiency anemia (IDA) with pregnancy.Methods: A randomized double-blind clinical trial (NCT02590224) conducted at a tertiary University Hospital in the period between 1 January 2016 and 31 July 2017 included pregnant women at 14-18 weeks of gestation with mild to moderate IDA. Patients were randomized into two groups: (Group I) received oral ferrous bis-glycinate tablets once daily for eight consecutive weeks and (Group II) received oral ferrous glycine sulfate capsules in the same dose and duration. The primary outcome of the study was the rate of increase of hemoglobin (HB) level after 8 weeks of iron treatment.Results: The study included 187 women in the final analysis. The mean increase in HB level after 8 weeks of treatment in ferrous bis-glycinate group was 2.48 ± 0.12 g/dL versus 1.32 ± 0.18 g/dL in ferrous glycine sulfate group (p ≤ .0001). The percentage of women with HB level more than 11 g/dL after 8 weeks of treatment was 89.2% in ferrous bis-glycinate group versus 71.3% in ferrous glycine sulfate group (p < .0001). The rate of adverse effects was significantly higher in ferrous glycine sulfate group (p = .001).Conclusions: Pregnant women with second trimester IDA could be supplied with ferrous bis-glycinate which is more efficient in increasing HB level. Moreover, it has tolerable adverse effects and high compliance than ferrous glycine sulfate.