Efficacy and tolerability of oral bovine lactoferrin compared to ferrous sulfate in pregnant women with iron deficiency anemia: a prospective controlled randomized study

Abstract

Objective: To compare the effects of bovine lactoferrin with ferrous sulfate on iron nutritional status and to evaluate their tolerability in 100 pregnant women with iron deficiency anemia.

Design: Prospective, randomized, controlled, double blind trial.

Setting: Obstetrics clinic of a University Department of Obstetrics and Gynecology.

Population: One-hundred pregnant, healthy women to be treated either with one capsule of 100 mg bovine lactoferrin twice a day (Group A; n=49) and 520 mg ferrous sulfate once a day (Group B; n=48).

Methods: After 30 days, we evaluated hemoglobin (Hb), serum ferritin, serum iron and total iron- binding capacity (TIBC) values. All women were asked to keep a diary of five potential gastrointestinal side effects (abdominal pain, nausea, vomiting, diarrhea and constipation). For each symptom, patients had to rate its severity according to a scale ranging from 0 (absent) to 3 (severe).

Main outcome measures: Hb level before and after treatment. Secondary outcomes were serum ferritin, serum iron and TIBC levels and the difference in symptom scores between groups.

Results: In Groups A and B, Hb, serum ferritin and iron were significantly increased while TIBC was significantly reduced in comparison with basal values. No significant differences were observed between Groups A and B. The median scores of abdominal pain and constipation were significantly higher in patients treated with ferrous sulfate in comparison with those treated with bovine lactoferrin.

Conclusions: The results show that bovine lactoferrin has the same efficacy as ferrous sulfate in restoring iron deposits with significantly fewer gastrointestinal side effects.