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 1 mg/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.