Effects of routine prophylactic supplementation with iron and folic acid on admission to hospital and mortality in preschool children in a high malaria transmission setting: community-based, randomised, placebo-controlled trial

摘要: Summary Background Anaemia caused by iron deficiency is common in children younger than age 5 years eastern Africa. However, there concern that universal supplementation of with and folic acid areas high malaria transmission might be harmful. Methods We did a randomised, placebo-controlled trial, aged 1–35 months living Pemba, Zanzibar. assigned to daily oral with: (12·5 mg) (50 μg; n=7950), iron, acid, zinc (n=8120), or placebo (n=8006); 1–11 received half the dose. Our primary endpoints were all-cause mortality admission hospital. Analyses intention treat. This study registered as an International Standard Randomised Controlled Trial, number ISRCTN59549825. Findings The acid-containing groups trial stopped early on Aug 19, 2003, recommendation data safety monitoring board. To this date, 24 076 contributed follow-up 25 524 child-years. Those who without 12% (95% CI 2–23, p=0·02) more likely die need treatment hospital for adverse event 11% (1–23%, p=0·03) admitted hospital; also 15% (−7 41, p=0·19) deaths these groups. Interpretation Routine preschool population rates can result increased risk severe illness death. In presence active programme detect treat other infections, iron-deficient anaemic benefit from supplementation. those are not deficient As such, current guidelines should revised.