Effect of neonatal vitamin A supplementation on mortality in infants in Tanzania (Neovita): a randomised, double-blind, placebo-controlled trial
Effect of neonatal vitamin A supplementation on mortality in infants in Tanzania (Neovita): a randomised, double-blind, placebo-controlled trial
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DOI：
10.1016/s0140-6736(14)61731-1
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发表时间：
2015-04-04
期刊：
影响因子：
168.9
通讯作者：
Fawzi, Wafaie W.
中科院分区：
文献类型：
--
作者：
Masanja, Honorati;Smith, Emily R.;Fawzi, Wafaie W.
6-59个月儿童补充维生素A可提高儿童存活率，并作为全球政策实施。对新生儿期婴儿补充的功效的研究结果不一致。我们的目的是评估口服补充维生素A的婴儿在生命的前3天，以减少补充和180天（6个月）之间的死亡率的有效性。方法我们做了一个单独的随机，双盲，安慰剂对照试验的婴儿出生在Morogoro和达累斯萨拉姆地区的坦桑尼亚。妇女是在产前门诊或达累斯萨拉姆公共卫生设施的产房中被发现的。在基隆贝罗、乌兰加和基洛萨区，妇女在家中被视为健康和人口监测系统的一部分。如果新生儿能够经口喂养，并且家庭打算在研究区域停留至少6个月，则新生儿有资格进行随机化。我们随机分配婴儿在出生后的前3天接受一剂50 000 IU的维生素A或安慰剂。婴儿被随机分配到20个区组中，研究者、参与者的家庭和数据分析小组对治疗分配不知情。我们在给药后第1天和第3天以及出生后1、3、6和12个月对婴儿进行了评估。主要终点是6个月时的死亡率，通过现场访谈进行评估。结果2010年8月26日至2013年3月3日期间，31999名新生儿被随机分配接受维生素A（n= 15995）或安慰剂（n= 16004; 6个月死亡率分析分别包括15428和15464）。我们没有发现任何证据表明维生素A补充剂对6个月婴儿的死亡率有有益影响（维生素A组每1000例活产死亡26例，安慰剂组每1000例活产死亡24例;风险比1.10，95% CI 0.95-1.26; p=0.193）。没有证据表明维生素A补充剂对不同性别的死亡率有不同的影响;男孩6个月时死亡率的风险比为1.08（0.90-1.29），女孩为1.12（0.91-1.39）。也没有证据表明，在3天内补充dose.Interpretation新生儿维生素A补充剂的副作用没有导致任何直接的不良事件，但在坦桑尼亚的婴儿的生存没有有益的影响。这些结果加强了反对新生儿维生素A补充全球政策建议的证据。版权所有（C）2014世界卫生组织。由爱思唯尔有限公司出版。保留所有权利。
Background Supplementation of vitamin A in children aged 6-59 months improves child survival and is implemented as global policy. Studies of the efficacy of supplementation of infants in the neonatal period have inconsistent results. We aimed to assess the efficacy of oral supplementation with vitamin A given to infants in the first 3 days of life to reduce mortality between supplementation and 180 days (6 months).Methods We did an individually randomised, double-blind, placebo-controlled trial of infants born in the Morogoro and Dares Salaam regions of Tanzania. Women were identified during antenatal clinic visits or in the labour wards of public health facilities in Dares Salaam. In Kilombero, Ulanga, and Kilosa districts, women were seen at home as part of the health and demographic surveillance system. Newborn infants were eligible for randomisation if they were able to feed orally and if the family intended to stay in the study area for at least 6 months. We randomly assigned infants to receive one dose of 50 000 IU of vitamin A or placebo in the first 3 days after birth. Infants were randomly assigned in blocks of 20, and investigators, participants' families, and data analysis teams were masked to treatment assignment. We assessed infants on day 1 and day 3 after dosing, as well as at 1, 3, 6, and 12 months after birth. The primary endpoint was mortality at 6 months, assessed by field interviews. The primary analysis included only children who were not lost to follow-up.Findings Between Aug 26, 2010, and March 3, 2013, 31 999 newborn babies were randomly assigned to receive vitamin A (n=15 995) or placebo (n=16 004; 15 428 and 15 464 included in analysis of mortality at 6 months, respectively). We did not find any evidence for a beneficial effect of vitamin A supplementation on mortality in infants at 6 months (26 deaths per 1000 livebirths in vitamin A vs 24 deaths per 1000 livebirths in placebo group; risk ratio 1.10, 95% CI 0.95-1.26; p=0.193). There was no evidence of a differential effect for vitamin A supplementation on mortality by sex; risk ratio for mortality at 6 months for boys was 1.08 (0.90-1.29) and for girls was 1.12 (0.91-1.39). There was also no evidence of adverse effects of supplementation within 3 days of dosing.Interpretation Neonatal vitamin A supplementation did not result in any immediate adverse events, but had no beneficial effect on survival in infants in Tanzania. These results strengthen the evidence against a global policy recommendation for neonatal vitamin A supplementation. Copyright (C) 2014 World Health Organization. Published by Elsevier Ltd. All rights reserved.