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
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
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DOI：
10.1016/s0140-6736(06)67962-2
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发表时间：
2006-01-14
期刊：
影响因子：
168.9
通讯作者：
Kabole, FM
中科院分区：
文献类型：
--
作者：
Sazawal, S;Black, RE;Kabole, FM
在东非，由缺铁引起的贫血在5岁以下的儿童中很常见。然而，人们担心，普遍补充铁和叶酸的儿童在高疟疾transmission.Methods地区可能是有害的，我们做了一个随机，安慰剂对照试验，1-35个月的儿童和生活在奔巴，桑给巴尔。我们将儿童分配为每日口服补充剂：铁（12.5 mg）和叶酸（50 μ g; n=7950），铁，叶酸和锌（n=8120），或安慰剂（n=8006）; 1-11个月的儿童接受一半的剂量。我们的主要终点是全因死亡率和住院率。本研究注册为国际标准随机对照试验，编号ISRCTN 59549825。结果在数据和安全监测委员会的建议下，含铁和叶酸的试验组于2003年8月19日提前停止。到目前为止，24 076名儿童参与了25 524儿童年的随访。那些接受铁和叶酸加或不加锌的人是12%（95% CI 2-23，p=0.02）更有可能死亡或因不良事件需要住院治疗，11%（1- 23%，p=0.03）更有可能入院;也有15%（-7至41，p=0.19）在疟疾高发人群中，学龄前儿童常规补充铁和叶酸会导致严重疾病的风险增加。与死在有一个积极的方案来检测和治疗疟疾和其他感染的情况下，缺铁和贫血的儿童可以从补充剂中受益。然而，补充那些不缺铁的人可能是有害的。因此，目前普遍补充铁和叶酸的指导方针应该修订。
Background Anaemia caused by iron deficiency is common in children younger than age 5 years in eastern Africa. However, there is concern that universal supplementation of children with iron and folic acid in areas of high malaria transmission might be harmful.Methods We did a randomised, placebo-controlled trial, of children aged 1-35 months and living in Pemba, Zanzibar. We assigned children to daily oral supplementation with: iron (12.5 mg) and folic acid (50 mu g; 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 mortality and admission to hospital. Analyses were by intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN59549825.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 were 12% (95% Cl 2-23, p=0.02) more likely to die or need treatment in hospital for an adverse event and 11% (1-23%, p=0.03) more likely to be admitted to hospital; there were also 15% (- 7 to 41, p=0.19) more deaths in these groups.Interpretation Routine supplementation with iron and folic acid in preschool children 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 treat malaria and other infections, iron-deficient and anaemic children can benefit from supplementation. However, supplementation of those who are not iron deficient might be harmful. As such, current guidelines for universal supplementation with iron and folic acid should be revised.