ABSTRACT
BACKGROUND: The standard treatment for iron deficiency anemia in preschool children has been 4.5 to 6.0 mg per kg per day of ferrous sulfate divided into 3 daily doses. Given the difficulty of giving medicine 3 times per day to young children, less frequent dosing should improve compliance.
POPULATION STUDIED: Infants aged between 6 and 18 months with a hemoglobin concentration between 7.0 and 9.9 g per dL were enrolled in the study. The study was conducted in Ghana, a malaria-endemic area, with an 83% prevalence of anemia in young children (compared with a 3%-5% prevalence in the United States).
STUDY DESIGN AND VALIDITY: The investigators of this randomized controlled trial screened 880 infants to find 557 who were eligible. These children were divided by concealed allocation to standard dose (5 mg per kg per day of elemental iron, rounded to a total of 40 mg of elemental iron given in 3 equal daily doses) or single-dose (40 mg of elemental iron as a single bolus dose) ferrous sulfate drops. Children had blood samples analyzed for hemoglobin concentration and serum ferritin at entry and after 2 months of therapy. Also, a peripheral blood smear was obtained at entry to look for malaria parasites.
OUTCOMES MEASURED: The primary outcome was percentage of children whose anemia resolved (hemoglobin concentration > 10.0 g/dL). Ferritin levels, compliance, and side effects were also measured and reported.
RESULTS: Anemia resolved in 59% of the infants after 2 months of therapy. There was no significant difference in the response rate between the once-daily group and the thrice-daily group (61% vs 56%; P=.51). Final mean hemoglobin (10.2 g/dL vs 10.0 g/dL; P=.25) and ferritin (101 μg/L vs 107 μg/L; P=0.1) values (in the once-daily and thrice-daily groups respectively) were all significantly increased from baseline but not significantly different between groups.
Once-daily iron therapy (5 mg/kg/day of elemental iron) is as effective as 3 times per day dosing in the treatment of infants with iron deficiency anemia without an increase in side effects. The Centers for Disease Control recommends a single dose of 3 mg per kg per day.1 Most parents (and probably their children as well) should prefer once-a-day dosing of medicine, which is supported by this study. Though there was no difference in compliance noted in this study, many other studies have shown that compliance increases as dosing frequency decreases. Although the overall response rate was only 59%, the response may have been blunted due to other comorbid factors that are common in this population (malaria parasitemia, Helicobacter pylori and other gastrointestinal infectious diseases, and hemoglobinopathies such as sickle cell disease or thalassemia).