Randomized, controlled trial of single versus 3-times-daily ferrous sulfate drops for treatment of anemia

Objective. Adherence to treatment of iron-deficiency anemia often is poor in both developed and developing countries. The current standard therapy is ferrous sulfate drops (or syrup) administered 3 times daily. It is possible that adherence would improve with a single-dose daily treatment regimen. We compared the use of single versus 3-times-daily ferrous sulfate drops, at the same total iron dose, on treatment of anemia in infants. Methods. To obtain a large enough cohort of anemic subjects, we performed the study in rural Ghana. Using a prospective, randomized, controlled design, we studied 557 anemic children (age range: 6-24 months; hemoglobin values: 70-99 g/L). One group (n = 280) received ferrous sulfate drops once daily (40 mg elemental iron), and the control group (n = 277) received ferrous sulfate drops 3 times per day (total dose, 40 mg elemental iron). Treatment lasted for 2 months. Hemoglobin and serum ferritin values were measured at baseline and at the end of the study. Results. Successful treatment of anemia (hemoglobin >100 g/L) occurred in 61% of the single-dose and in 56% of the 3-times-daily group. Geometric mean ferritin levels increased significantly in each group from baseline to the final visit. Side effects were minimal and similar between the 2 groups. Conclusion. A single versus a 3-times-daily dose of ferrous sulfate drops over 2 months resulted in a similar rate of successful treatment of anemia, without side effects. To our knowledge, this is the first demonstration of the use of a single-dose daily regimen to treat anemia. Although not examined in the current study, use of a single-dose daily regimen may improve adherence to treatment of anemia in infants.