Hoffmann Vivian, Jones Kelly, Leroy Jef
International Food Policy Research Institute (IFPRI), 2033 K St. NW, Washington, DC, USA.
Trials. 2015 Dec 3;16:552. doi: 10.1186/s13063-015-1064-8.
While the few studies that have looked at the association between stunting and aflatoxin exposure have found surprisingly large effects, the results remain inconclusive due to a lack of randomized controlled studies. This protocol describes a non-blinded, cluster-randomized controlled trial with the specific objective of testing the impact of reduced aflatoxin exposure on (individual) child linear growth.
METHODS/DESIGN: Participants were recruited from among households containing women in the last 5 months of pregnancy in 28 maize-growing villages within Meru and Tharaka-Nithi Counties in Kenya. Households in villages assigned to the intervention group are offered rapid testing of their stored maize for the presence of aflatoxin each month; any maize found to contain more than 10 ppb aflatoxin is replaced with an equal amount of maize that contains less than this concentration of the toxin. They are also offered the opportunity to buy maize that has been tested and found to contain less than 10 ppb aflatoxin at local shops. Clusters (villages) were allocated to the intervention group (28 villages containing 687 participating households) or control group (28 villages containing 536 participating households) using a random number generator. The trial, which is funded by United Kingdom (UK) aid from the UK government, the Global Food Security Portal, and the Ministry for Foreign Affairs of Finland, is currently ongoing.
This study is the first randomized controlled trial (RCT) to test for a causal impact of aflatoxin exposure on child growth. Whether or not this relationship is found, its results will have implications for the prioritization of aflatoxin control efforts by governments in affected regions, as well as international donors.
American Economic Association RCT Registry # 0000105 . Initial registration date: 6 November 2013, last updated 30 December 2014.
虽然少数关于发育迟缓与黄曲霉毒素暴露之间关联的研究发现了惊人的显著影响，但由于缺乏随机对照研究，结果仍无定论。本方案描述了一项非盲法整群随机对照试验，其具体目标是测试降低黄曲霉毒素暴露对儿童个体线性生长的影响。
方法/设计：在肯尼亚梅鲁县和塔拉卡-尼蒂县的28个玉米种植村，从怀孕最后5个月的妇女家庭中招募参与者。分配到干预组的村庄的家庭每月可对储存的玉米进行黄曲霉毒素快速检测；任何被发现黄曲霉毒素含量超过10 ppb的玉米，将被等量替换为毒素浓度低于该水平的玉米。他们还将有机会在当地商店购买经检测黄曲霉毒素含量低于10 ppb的玉米。使用随机数生成器将整群（村庄）分配到干预组（28个村庄，687个参与家庭）或对照组（28个村庄，536个参与家庭）。该试验由英国政府的英国援助、全球粮食安全门户和芬兰外交部资助，目前正在进行中。
本研究是首个测试黄曲霉毒素暴露对儿童生长因果影响的随机对照试验（RCT）。无论是否发现这种关系，其结果都将对受影响地区政府以及国际捐助者确定黄曲霉毒素控制工作的优先次序产生影响。
美国经济协会RCT注册编号#0000105。初始注册日期：2013年11月6日，最后更新日期：2014年12月30日。
