[Comparative evaluation of efficacy and tolerance of iron polymaltose complex and ferrous sulphate for treatment of iron deficiency anemia in infants]. / Evaluacion comparativa de eficacia y tolerancia de hierro sulfato y hierro polimaltosato para el tratamiento de anemia ferropenica en lactantes.

INTRODUCTION: Iron deficiency anemia is the most common nutritional deficiency in children under 2 years, affecting to 34.1% in Argentina. Iron supplementation is the standard treatment. The aim of our study was to evaluate the efficacy and tolerability of two iron containing drugs. METHODS: Randomized, double-blind, controlled trial, including children aged 6 to 18 months with iron deficiency anemia (hemoglobin < 11 g/dl, transferrine saturation < 20%). Patients were randomly assigned to one of two treatments: iron polymaltose complex (IPC) or ferrous sulphate (FS). Efficacy, tolerance and adverse events occurrence were evaluated. RESULTS: 60 children with iron deficiency anemia were included; 29 in the FS group and 31 in the IPC group. There were no significant differences between groups regarding hemoglobin at baseline (10,09 ± 0,92 vs. 10,26 ± 0,41; p= 0,17) and after 90 days treatment (11,26 ± 0,49 vs. 11,14 ± 0,60; p= 0,21). Also, there were no differences regarding adverse events frequency (FS: 4/29 y IPC: 9/31; p=0,2). CONCLUSIONS: In our study, there were no differences in efficacy and safety between FS and IPC in the treatment of children with iron deficiency anemia.