Which form of supplemental oral iron is the most effective and best tolerated for treating nutritional iron-deficiency anemia in infants and children?

Treatment of nutritional iron-deficiency anemia (IDA) in infants and children with ferrous sulfate resulted in significantly higher hemoglobin and serum ferritin levels—as well as a higher proportion with complete resolution of anemia—than treatment with iron polysaccharide complex. Both forms of iron were similarly tolerated. (LOE = 1b)

Powers JM, Buchanan GR, Adix L, Zhang S, Gao A, McCavit TL. Effect of low-dose ferrous sulfate vs iron polysaccharide complex on hemoglobin concentration in young children with nutritional iron-deficiency anemia. A randomized clinical trial. JAMA 2017;317(22):2297-2304.  [PMID:28609534]

Randomized controlled trial (double-blinded)

Industry + govt

Concealed

Outpatient (any)

Treatment of nutritional IDA in infants and children is often incomplete because of medication nonadherence and adverse effects. These investigators identified infants and children, aged 9 months to 48 months, with a diagnosis of nutritional IDA resulting from excessive cow milk intake, breastfeeding without adequate iron supplementation, or both. IDA was defined as a hemoglobin concentration of 10 g/dL or less and a serum ferritin level of 15 ng/mL or less or total iron-binding capacity of 425 ug/dL or greater. Eligible patients (N = 80) randomly received (concealed allocation assignment) either oral ferrous sulfate drops (15 mg/mL) or oral iron polysaccharide complex drops (NovaFerrum; 15 mg/mL). Individuals masked to treatment group assignment assessed all outcomes. Complete follow-up occurred for 84% of patients at 12 weeks. Using intention-to-treat analysis after 12 weeks of therapy the mean hemoglobin concentration increased significantly more in the ferrous sulfate group than in the iron polysaccharide complex group (a difference between groups in change from baseline of 1.0 g/dL [95% CI 0.4 - 1.6], favoring ferrous sulfate). Complete resolution of IDA also occurred significantly more often in patients who received ferrous sulfate than in those who received iron polysaccharide complex (29% vs 6%, respectively; number needed to treat = 4.5; 2.4 - 38.4). In addition, the median serum ferritin level increased significantly more from baseline in the ferrous sulfate group than in the iron polysaccharide complex group (a difference between groups in change from baseline of 10.2 ng/mL [6.2 - 14.1], favoring ferrous sulfate). Although significantly more parents reported diarrhea with iron polysaccharide complex, there was no significant group difference in the overall combined gastrointestinal adverse effect profile.