A randomized controlled trial examining the addition of folic acid to iron supplementation in the treatment of postpartum anemia

OBJECTIVE: To evaluate the efficacy of adding folic acid to oral iron supplementation in postpartum women with anemia. METHODS: A randomized controlled trial was conducted in the Netherlands between April 8, 2008, and August 31, 2010. A total of 112 postpartum women with anemia (hemoglobin <10.5 g/dL) were randomly allocated to receive 600 mg/day ferrous fumarate plus 1mg/day folic acid (FFFA group) or 600/day ferrous fumarate alone (FF group) for 4 weeks. Primary outcome measures were hemoglobin and health status. Secondary outcome measures were fatigue, compliance, and adverse reactions. RESULTS: No between-group differences were observed in hemoglobin and health status after treatment, and no differences were found in fatigue scores. Approximately 75% of all women reported having at least one symptom resulting from ferrous fumarate use. Constipation caused by ferrous fumarate was significantly associated with non-compliance (P=0.014). CONCLUSION: The addition of folic acid to iron supplementation is not beneficial in women with postpartum anemia, as it has no effect on hematologic or health status parameters. CLINICAL TRIAL REGISTRATION: CCMO website NL21797.028.08 and Netherlands Trial Register NTR2232.