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Mitigating Aflatoxin Exposure to Improve Child Growth in Eastern Kenya (MAICE)

Last registered on November 23, 2016

Pre-Trial

Trial Information

General Information

Title
Mitigating Aflatoxin Exposure to Improve Child Growth in Eastern Kenya (MAICE)
RCT ID
AEARCTR-0000105
Initial registration date
November 06, 2013

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
November 06, 2013, 2:42 PM EST

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Last updated
November 23, 2016, 1:46 PM EST

Last updated is the most recent time when changes to the trial's registration were published.

Locations

Primary Investigator

Affiliation
American University

Other Primary Investigator(s)

PI Affiliation
IFPRI
PI Affiliation
IFPRI

Additional Trial Information

Status
On going
Start date
2013-02-01
End date
2017-03-31
Secondary IDs
Abstract
Whether the observed association between aflatoxin exposure and stunting in children is causal, and how exposure to this toxin can be mitigated, are open questions. This study comprises a three-arm randomized controlled trial designed to answer both questions. Within 71 randomly selected maize-growing villages of Meru and Tharaka-Nithi counties of Kenya, households that included a pregnant woman or child under 2 years of age were recruited. Villages were randomly assigned to, a post-harvest technology intervention group, an exposure reduction intervention group, or a comparison group. Within the post-harvest group, prices for an aflatoxin mitigation technology were randomly varied across households, as was the opportunity to receive a price incentive for safe stored maize. Primary outcomes in the post-harvest technology sub-study are adoption of the technology and aflatoxin levels in stored maize. Primary outcomes in the exposure reduction sub-study are blood aflatoxin levels in children and child linear growth (LAZ).
External Link(s)

Registration Citation

Citation
, , Kelly Jones and Jef Leroy. 2016. "Mitigating Aflatoxin Exposure to Improve Child Growth in Eastern Kenya (MAICE)." AEA RCT Registry. November 23. https://doi.org/10.1257/rct.105
Former Citation
, , Kelly Jones and Jef Leroy. 2016. "Mitigating Aflatoxin Exposure to Improve Child Growth in Eastern Kenya (MAICE)." AEA RCT Registry. November 23. https://www.socialscienceregistry.org/trials/105/history/22528
Sponsors & Partners

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Experimental Details

Interventions

Intervention(s)
See protocol attached
Intervention Start Date
2013-07-01
Intervention End Date
2016-10-31

Primary Outcomes

Primary Outcomes (end points)
Incidence of household maize stores with aflatoxin levels above 10 ppb; willingness to pay for the offered post-harvest technology; incidence of identification of aflatoxin albumin adduct in blood samples; child anthropometrics
Primary Outcomes (explanation)
See protocol attached

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
We propose a three arm randomized control trial in which 71 villages will be randomly allocated to an intervention group in which a package of storage technology and best practices are provided (post-harvest group); an intervention in which maize is tested and contaminated maize is swapped (aflatoxin exposure reduction group); and a control group in which information on the health effects of aflatoxin and strategies to mitigate it are provided. Within the post-harvest group, prices for an aflatoxin mitigation technology were randomly varied across households, as was the opportunity to receive a price incentive for safe stored maize.
The post-harvest sub-study is designed to investigate the effectiveness of a package of low-cost, post-harvest and storage technologies and practices for reducing aflatoxin contamination in household maize stores, and farmers' willingness to pay for such a technology, with and without a price incentive for aflatoxin-safe grain. The exposure reduction sub-study is designed to answer the following research question: does reduced aflatoxin exposure, holding all else constant, improve child growth?
Experimental Design Details
Randomization Method
Based on random numbers assigned by computer
Randomization Unit
Village
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
71 villages
Sample size: planned number of observations
1852 households
Sample size (or number of clusters) by treatment arms
Swapping treatment: 28 villages
Post-harvest practices & technology treatment: 15 villages
Control: 28 villages
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
See protocol attached
Supporting Documents and Materials

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IRB

Institutional Review Boards (IRBs)

IRB Name
International Food Policy Research Institute
IRB Approval Date
2012-12-17
IRB Approval Number
n/a
IRB Name
African Medical & Research Foundation (AMREF)
IRB Approval Date
2012-12-04
IRB Approval Number
AMREF-ESRC P49/12
Analysis Plan

Analysis Plan Documents

Data Analysis Plan - Sub-study on exposure reduction

MD5: d1a60c174a4aefc9391510d47446d195

SHA1: 02bb1d0305fd7d1aea6633d2c115b88d71cefa61

Uploaded At: November 23, 2016

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials