Lactoferrin versus ferrous sulphate for the treatment of iron deficiency anemia during pregnancy: a randomized clinical trial.

OBJECTIVE: This study was conducted to evaluate the efficacy and safety of lactoferrin in comparison to ferrous sulphate for the treatment of iron deficiency anemia (IDA) during pregnancy.

MATERIALS AND METHODS: This prospective, randomized, parallel-group, single-center study was conducted in the Department of Obstetrics and Gynecology at Menoufia University Hospital, Egypt and included a total of 200 pregnant women in the second trimester with IDA who were enrolled and randomly assigned either to receive 150 mg of dried ferrous sulphate capsules or lactoferrin 250 mg capsules once daily for eight consecutive weeks. The primary efficacy parameter was the amount of increase in hemoglobin concentration by 4 and 8 weeks, the adverse effects related to iron therapy and the patient compliance to the treatment.

RESULTS: Total increase in Hb after 2 months with lactoferrin was higher (2.26 ± 0.51 g/dL) compared to ferrous sulfate (1.11 ± 0.22 g/dL) (p < 0.001). Gastrointestinal adverse events occurred more frequently with ferrous sulphate than the lactoferrin group (p < 0.001). The number of women requesting change the drug was higher in the ferrous sulphate group (p < 0.001).

CONCLUSION: Lactoferrin was more effective than ferrous sulfate over a two-month period in pregnant women with IDA, with fewer gastrointestinal adverse events and better treatment acceptability.