Intervention in Minimizing Aflatoxins and Fumonisins Exposure to Children Through Food and Breastfeeding in Tanzania

NCT02438774 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2016-09-15

No results posted yet for this study

Summary

It has been shown that exposure to mycotoxins through complementary foods and breast milk had profound effects on growth of children from 6 months to 1 year of age. In Tanzania maize is the main ingredient for complementary food, however, the crop is vulnerable to mycotoxins contamination. it has been reported that the most effective way to reduce mycotoxin exposure is to lower the mycotoxins contamination of maize. This study has developed a post-harvest intervention package for use in rural Tanzania to reduce contamination of maize and breast milk with two forms of mycotoxins; aflatoxins and fumonisins. It is composed of 5 components; 1) hand sorting, 2) drying surface, 3) proper drying 4) application of insecticide, 5) dehulling and was introduced in three main maize producing agro-ecological zones. The intervention used randomised controlled trial design where infants less than 8 six months of age were recruited and followed up 6 months after recruitment. The intervention expects to demonstrate the effectiveness of the post harvest intervention package in reducing aflatoxins and fumonisins contamination of maize and subsequent exposure of these toxins to infants and young children through maize based complementary food and breast milk. The findings will be used in developing guidelines for farmers and extension officers to reduce aflatoxins and fumonisins contamination of maize and improve the health of the infants and the whole population.

The study hypothiseses that introducing post-harvest intervention package can reduce aflatoxins and fumonisins contamination of maize and subsquent exposure of these toxins to infants and young children through maize based complementary foods and breast milk than routine agriculture extension services offered to the farmers in rural Tanzania. The specific objectives include;

* To evaluate the effectiveness of post-harvest intervention package on reduction of aflatoxins and fumonisins contamination of maize and in breast milk
* To perform exposure assessment of aflatoxins and fumonisins to infants and young children through maize based complementary food and breast milk
* To perform risk characterization of aflatoxins and fumonisins exposure to infants and young children through maize based complementary foods and breast milk
* To assess the association between exposure to aflatoxins and fumonisins and child growth

Conditions

  • Growth Retardation

Interventions

BEHAVIORAL

post-harvest intervention package

The intervention group received post-harvest intervention package. The package is composed of 5 components, namely 1) hand sorting, 2) drying surface, 3) proper drying, 4) application of insecticide, 5) dehulling . The intervention will last for 7 months.

BEHAVIORAL

Routine agriculture extension services

This group continued to receive routine agriculture education on good practices for handling crops; an agricultural extension service offered to farmers regularly by village agriculture extension officer at village level. The extension services provided includes the provision of farmers with knowledge, information, experiences and technologies needed to increase and sustain productivity and avoiding crop spoilage during storage for improved wellbeing and livelihoods

Sponsors & Collaborators

  • University Ghent

    collaborator OTHER
  • International Foundation for Science (IFS)

    collaborator OTHER
  • The Nelson Mandela African Institution of Science and Technology, Tanzania

    collaborator UNKNOWN
  • The Open University of Tanzania

    collaborator UNKNOWN
  • VLIR-UOS

    collaborator UNKNOWN
  • Tanzania Food and Drugs Authority

    lead OTHER_GOV

Principal Investigators

  • Martin E Kimanya, PhD · The Nelson Mandela African Institution of Science and Technology, Tanzania

  • Analice A Kamala, MSc · Tanzania Food and Drugs Authority

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
8 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-10-31
Completion
2016-05-31

Countries

  • Tanzania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02438774 on ClinicalTrials.gov