Abstract
BackgroundWhile 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/DesignParticipants 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.DiscussionThis 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.Trial registrationAmerican Economic Association RCT Registry # 0000105. Initial registration date: 6 November 2013, last updated 30 December 2014.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-1064-8) contains supplementary material, which is available to authorized users.
Highlights
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 approach overcomes the problem of omitted variable bias: that is, the possibility that the observed relationship between aflatoxin exposure and impaired child growth is driven by confounders
In order to reduce aflatoxin exposure among those assigned to the control group, the intervention provides participants with opportunities to have their stored maize tested and replaced with aflatoxin-safe maize if contaminated, and to purchase aflatoxin-safe maize through local stockists
Summary
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. This protocol for the Mitigating Aflatoxin exposure to Improve Child growth in Eastern Kenya (MAICE) study, current as of 30 June 2015, is based on the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) reporting guidelines as detailed by Chan et al [1]. Chronic exposure to aflatoxin among livestock reduces productivity and growth rates [4]
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