Effect of routine prophylactic supplementation with iron and folic acid on preschool child mortality in southern Nepal: community-based, cluster-randomised, placebo-controlled trial
Effect of routine prophylactic supplementation with iron and folic acid on preschool child mortality in southern Nepal: community-based, cluster-randomised, placebo-controlled trial
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DOI：
10.1016/s0140-6736(06)67963-4
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发表时间：
2006-01-14
期刊：
影响因子：
168.9
通讯作者：
Black, RE
中科院分区：
文献类型：
--
作者：
Tielsch, JM;Khatry, SK;Black, RE
简介缺铁在发展中国家很普遍，尤其是生活在印度次大陆的幼儿。在缺乏铁和叶酸的人群中，补充铁和叶酸可以缓解严重贫血并促进神经发育，但与补充铁和叶酸相关的死亡和发病风险知之甚少。方法我们对居住在尼泊尔南部的1-36个月大的儿童进行了一项基于社区的、整群随机、双掩蔽、安慰剂对照的2×2因素试验。我们随机分配给36个月的儿童每日口服补充剂：铁(12.5毫克)和叶酸(50微克；n=8337)，单独锌(10毫克)，铁、叶酸和锌(n=9230)，或安慰剂(n=8683)；1-11个月的儿童接受一半的剂量。我们的主要结果指标是全因死亡率，我们的次要结果指标包括特定原因的死亡率以及腹泻、痢疾和急性呼吸道疾病的发生率和严重性。通过意向治疗进行分析。这项研究在Clinicaltrials.gov上注册，编号NCT00109551。研究发现，根据数据和安全监测委员会的建议，研究中的含铁组和叶酸组于2003年11月初停止；这些组的死亡率与安慰剂没有区别，在完成登记时，检测积极或消极影响的能力很低。我们继续招募儿童加入安慰剂组和单独锌组。25490名儿童参与，分析基于29 097.3人年的跟踪调查。与安慰剂组相比，服用铁和叶酸但不含锌或含锌的组死亡率无差异(HR分别为1.03和1.00，95%CI分别为0.78-1.37和1.00，0.74-1.34)。腹泻、痢疾或呼吸道感染的发病率在不同组之间没有显著差异，尽管除了一个外，所有的相对风险都显示出适度的、不显著的保护效果。尼泊尔南部幼儿每日补充铁和叶酸并不加锌或不加锌对他们的死亡风险没有影响，但可能预防腹泻、痢疾和急性呼吸道疾病。
Introduction Iron deficiency is widespread in the developing world and is especially common in young children who live on the Indian subcontinent. Supplementation with iron and folic acid alleviates severe anaemia and enhances neurodevelopment in deficient populations, but little is known about the risks of mortality and morbidity associated with supplementation.Methods We did a community-based, cluster-randomised, double-masked, placebo-controlled, 2 X 2 factorial trial in children aged 1-36 months and residing in southern Nepal. We randomly assigned children daily oral supplementation to age 36 months with: iron (12.5 mg) and folic acid (50 mu g; n=8337), zinc alone (10 mg), iron, folic acid, and zinc (n=9230), or placebo (n=8683); children aged 1-11 months received half the dose. Our primary outcome measure was all-cause mortality, and our secondary outcome measures included cause-specific mortality and incidence and severity of diarrhoea, dysentery, and acute respiratory illness. Analyses were by intention to treat. This study is registered at clinicaltrials.gov, number NCT00109551.Findings The iron and folic acid-containing groups of the study were stopped early in November, 2003, on the recommendation of the data and safety monitoring board; mortality in these groups did not differ from placebo and there was low power to detect positive or negative effects by the time enrolment was completed. We continued to enrol children to the placebo and zinc alone groups. 25 490 children participated and analyses are based on 29 097.3 person-years of follow-up. There was no difference in mortality between the groups who took iron and folic acid without or with zinc when compared with placebo (HR 1.03, 95% CI 0.78-1.37, and 1.00, 0.74-1.34, respectively). There were no significant differences in the attack rates for diarrhoea, dysentery, or respiratory infections between groups, although all the relative risks except one indicated modest, non-significant protective effects.Interpretation Daily supplementation of young children in southern Nepal with iron and folic acid with or without zinc has no effect on their risk of death, but might protect against diarrhoea, dysentery, and acute respiratory illness.