ABSTRACT
Objectives: There have been concerns around the safety of daily iron-containing multiple micronutrient powders (MNP) in young children in malaria-endemic and malaria-free environments. We analysed the effects of different MNP delivery regimens on diarrhea-related morbidity in children in a malaria-free area of Peru. Methods: A total of 400 children 6 to 11 months of age, were randomized to one of four groups: every-other day for 6 months (A), daily for 6 months (B), every-other-day for 12 months (C), and daily for 12 months (D). All children were followed for 12 months. All MNP had the same formulation, including 12.5 mg iron, and zinc, vitamin A, vitamin C and folic acid. MNP were provided to caregivers every month and data on consumption and diarrhea morbidity were assessed twice a month. Point prevalence of diarrhea morbidity was calculated as number of days ill per total days of observation. Results: Data of 399 (99.8%) children were analyzed by intention-to-treat. Group A was the control with 2.07% diarrhea days. No differences in diarrhea morbidity were observed among groups (group B: 1.85% days with diarrhea (OR:0.89; 95%CI0.79,1.01); group C:2.06% (OR:0.96.95%CI:0.88,1.12); group D:2.14% (OR:1.03;95%CI: 0.92,1.16). There were also no differences among regimens, stratified by age at baseline (6-8 mo vs 9-11 mo) but overall young children were ill more frequently than older children. Conclusions: Daily consumption of MNPs for longer periods of time, does not lead to increased diarrhea compared to every-other-day supplementation for 6 months. The reasons for the lower OR of daily consumption for 6 months are being explored.