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

Last registered on December 30, 2014
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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
December 30, 2014, 4:22 PM EST

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

Locations

Country
Kenya
Region
Meru & Tharaka-Nithi Counties

Primary Investigator

Name
Kelly Jones
Affiliation
American University
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Other Primary Investigator(s)

PI Name
Jef Leroy
PI Affiliation
IFPRI
Contact Investigator
PI Name
Vivian Hoffmann
PI Affiliation
IFPRI
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Additional Trial Information

Status
On going
Start date
2013-02-01
End date
2016-10-31
Keywords
Agriculture, Health
Additional Keywords
Aflatoxin, maize, child growth, nutrition, food safety
JEL code(s)
Secondary IDs
Abstract
The case for the association between aflatoxin exposure in children and stunting is still out. While the few studies that have looked at the association between stunting and aflatoxin exposure have found surprisingly large effects, the results remain inconclusive. The objectives of this study are to: (i) study the impact of reduced aflatoxin exposure on child growth and (ii) identify a package of storage technologies that will reduce aflatoxin contamination. We propose a three arm randomized control trial in which households with children under 2 years of age will be randomly allocated to an intervention group in which a package of storage technology and best practices are provided; an intervention in which maize is tested and contaminated maize is swapped; and a control group in which information on the health effects of aflatoxin and strategies to mitigate it are provided. Aflatoxin levels and stunting rates at baseline and follow up will be compared across the intervention groups to answer the following questions: Does reduced aflatoxin consumption, holding all else constant, improve child growth? What is the effectiveness of a package of low-cost, post-harvest and storage technologies and practices for reducing aflatoxin contamination in household maize stores?
External Link(s)

Registration Citation

Citation
Hoffmann, Vivian, Kelly Jones and Jef Leroy. 2014. "Mitigating Aflatoxin Exposure to Improve Child Growth in Eastern Kenya (MAICE)." AEA RCT Registry. December 30. https://doi.org/10.1257/rct.105-2.0
Former Citation
Hoffmann, Vivian, Kelly Jones and Jef Leroy. 2014. "Mitigating Aflatoxin Exposure to Improve Child Growth in Eastern Kenya (MAICE)." AEA RCT Registry. December 30. https://www.socialscienceregistry.org/trials/105/history/3358
Sponsors & Partners

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Experimental Details

Interventions

Intervention(s)
See protocol attached
Intervention Start Date
2013-07-01
Intervention End Date
2016-09-30

Primary Outcomes

Primary Outcomes (end points)
Incidence of household maize stores with aflatoxin levels above 10 ppb; 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 households with children under 2 years of age will be randomly allocated to an intervention group in which a package of storage technology and best practices are provided; an intervention in which maize is tested and contaminated maize is swapped; and a control group in which information on the health effects of aflatoxin and strategies to mitigate it are provided. Aflatoxin levels and stunting rates at baseline and follow up will be compared across the intervention groups to answer the following questions: Does reduced aflatoxin consumption, holding all else constant, improve child growth? What is the effectiveness of a package of low-cost, post-harvest and storage technologies and practices for reducing aflatoxin contamination in household maize stores?
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
1500 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
African Medical & Research Foundation (AMREF)
IRB Approval Date
2012-12-04
IRB Approval Number
AMREF-ESRC P49/12
IRB Name
International Food Policy Research Institute
IRB Approval Date
2012-12-17
IRB Approval Number
n/a
Analysis Plan

Analysis Plan Documents

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