Background: Anaemia caused by iron deficiency is common in children younger th an age 5 years in eastern Africa. However, there is concern that universal suppl ementation of children with iron and folic acid in areas of high malaria transmi ssion might be harmful. Methods: We did a randomised, placebo-controlled trial, of children aged 1-35 months and living in Pemba, Zanzibar. We assigned childr en to daily oral supplementation with: iron (12.5 mg) and folic acid (50 μg; n= 7950), iron, folic acid, and zinc (n=8120), or placebo (n=8006); children aged 1 -11 months received half the dose. Our primary endpoints were all-cause mortal ity and admission to hospital. Analyses were by intention to treat. This study i s registered as an International Standard Randomised Controlled Trial, number IS RCTN59549825. Findings: The iron and folic acid-containing groups of the trial were stopped early on Aug 19, 2003, on the recommendation of the data and safety monitoring board. To this date, 24 076 children contributed a follow-up of 25 524 child-years. Those who received iron and folic acid with or without zinc we re 12%(95%CI 2-23, P=0.02) more likely to die or need treatment in hospital f or an adverse event and 11%(1-23%, P=0.03) more likely to be admitted to hosp ital; there were also 15%(-7 to 41, P=0.19) more deaths in these groups. Inter pretation: Routine supplementation with iron and folic acid in preschool childre n in a population with high rates of malaria can result in an increased risk of severe illness and death. In the presence of an active programme to detect and t reat malaria and other infections, iron-deficient and anaemic children can bene fit from supplementation. However, supplementation of those who are not iron def icient might be harmful. As such, current guidelines for universal supplementati on with iron and folic acid should be revised.
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Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, 615 North Wolfe Street, Baltimore, MD 21205, United States.Dr;
