微量营养素粉家庭强化计划对中国农村幼儿贫血及认知结果的影响：一项整群随机试验
The effect of a micronutrient powder home fortification program on anemia and cognitive outcomes among young children in rural China: a cluster randomized trial.
作者信息
Luo Renfu, Yue Ai, Zhou Huan, Shi Yaojiang, Zhang Linxiu, Martorell Reynaldo, Medina Alexis, Rozelle Scott, Sylvia Sean
机构信息
China Center for Agricultural Policy, School of Advanced Agricultural Sciences, Peking University, Beijing, China.
Center for Experimental Economics in Education, Shaanxi Normal University, 620 Chang'an Road West, Xi'an, 710119, China.
出版信息
BMC Public Health. 2017 Sep 25;17(1):738. doi: 10.1186/s12889-017-4755-0.
BACKGROUND
Anemia early in life has been associated with delayed cognitive and motor development. The WHO recommends home fortification using multiple micronutrient powders (MNPs) containing iron as a strategy to address anemia in children under two. We evaluated the effects of a program freely distributing MNP sachets to caregivers of infants in rural China.
METHODS
We conducted a cluster-randomized controlled trial in Shaanxi province, enrolling all children aged 6-11 months in target villages. Following a baseline survey, investigators randomly assigned each village/cluster to a control or treatment group. In the treatment group, caregivers were instructed to give MNPs daily. Follow-up was after 6, 12, and 18 months of intervention. Primary outcomes were hemoglobin concentrations and scores on the Bayley Scales of Infant Development.
RESULTS
One thousand, eight hundred and-two eligible children and their caregivers were enrolled. At baseline 48% (870) of children were anemic and 29% (529) were developmentally delayed. Six hundred and-ten children (117 villages) were assigned to the control group and 1192 children (234 villages) were assigned to the treatment group. Assignment to the treatment group was associated with an improvement in hemoglobin levels (marginal effect 1.77 g/L, 95% CI 0.017-3.520, p-value = 0.048) and cognitive development (marginal effect 2.23 points, 95% CI 0.061-4.399, p-value = 0.044) after 6 months but not thereafter. There were no significant effects on motor development. Zero effects after the first 6 months were not due to low compliance, low statistical power, or changes in feeding behavior. Hemoglobin concentrations improved in both the treatment and control groups over the course of the study; however, 22% (325) of children remained anemic at endline, and 48% (721) were cognitively delayed.
CONCLUSIONS
Providing caregivers with MNP sachets modestly hastened improvement in hemoglobin levels that was occurring absent intervention; however, this improvement did not translate into improved developmental outcomes at endline.
TRIAL REGISTRATION
ISRCTN44149146 ; prospectively registered on 15th April 2013.
背景
生命早期的贫血与认知和运动发育迟缓有关。世界卫生组织建议采用含强化铁的多种微量营养素粉（MNPs）进行家庭强化补充，作为解决两岁以下儿童贫血问题的一项策略。我们评估了在中国农村地区向婴儿看护者免费发放MNPs小包装产品项目的效果。
方法
我们在陕西省开展了一项整群随机对照试验，纳入目标村庄所有6至11个月大的儿童。在进行基线调查后，研究人员将每个村庄/群组随机分配到对照组或治疗组。在治疗组中，指导看护者每日给孩子服用MNPs。干预6、12和18个月后进行随访。主要结局指标为血红蛋白浓度和贝利婴儿发育量表得分。
结果
共纳入1802名符合条件的儿童及其看护者。基线时，48%（870名）儿童贫血，29%（529名）发育迟缓。610名儿童（117个村庄）被分配到对照组，1192名儿童（234个村庄）被分配到治疗组。分配到治疗组与6个月后血红蛋白水平改善（边际效应1.77g/L，95%CI 0.017 - 3.520，p值 = 0.048）和认知发育改善（边际效应2.23分，95%CI 0.061 - 4.399，p值 = 0.044）相关，但之后无此关联。对运动发育无显著影响。最初6个月后无效果并非由于依从性低、统计效能低或喂养行为改变。在研究过程中，治疗组和对照组的血红蛋白浓度均有所改善；然而，在研究结束时，仍有22%（325名）儿童贫血，48%（721名）儿童存在认知发育迟缓。
结论
向看护者提供MNPs小包装产品适度加快了在无干预情况下血红蛋白水平的改善；然而，这种改善并未转化为研究结束时发育结局的改善。
试验注册
ISRCTN44149146；于2013年4月15日进行前瞻性注册。
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