Objective: To measure the effects of iron supplementation and anthelmintic treatment on iron status, anaemia, growth, morbidity, and development of children aged 6-59 months. Design: Double blind, placebo controlled randomised factorial trial of iron supplementation and anthelmintic treatment. Setting: Community in Pemba Island, Zanzibar. Participants: 614 preschool children aged 6-59 months. Main outcome measures: Development of language and motor skills assessed by parental interview before and after treatment in age appropriate subgroups. Results: Before intervention, anaemia was prevalent and severe, and geohelminth infections were prevalent and light - Plasmodium falciparum infection was nearly universal. Iron supplementation significantly improved iron status, but not haemoglobin status. Iron supplementation improved language development by 0.8 (95% confidence interval 0.2 to 1.4) points on the 20 point scale. Iron supplementation also improved motor development, but this effect was modified by baseline haemoglobin concentrations (P = 0.015 for interaction term) and was apparent only in children with baseline haemoglobin concentrations < 90 g/l. In children with a baseline haemoglobin concentration of 68 g/l (one standard deviation below the mean value), iron treatment increased scores by 1.1 (0.1 to 2.1) points on the 18 point motor scale. Mebendazole significantly reduced the number and severity of infections caused by Ascaris lumbricoides and Trichuris trichiura, but not by hookworms. Mebendazole increased development scores by 0.4 (-0.3 to 1.1) points on the motor scale and 0.3 (-0.3 to 0.9) points on the language scale. Conclusions: Iron supplementation improved motor and language development of preschool children in rural Africa. The effects of iron on motor development were limited to children with more severe anaemia (baseline haemoglobin concentration < 90 g/l). Mebendazole had a positive effect on motor and language development, but this was not statistically significant.
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