Growth Retardation Clinical Trial
Official title:
Effectiveness of Post-harvest Intervention Package in Minimizing Aflatoxins and Fumonisins Exposure to Infants and Young Children Through Maize Based Complementary Foods and Breastfeeding in Rural Tanzania
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
Status | Completed |
Enrollment | 300 |
Est. completion date | May 2016 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A to 8 Months |
Eligibility |
Inclusion Criteria: - Infants aged 0-8 months at the time of recruitment into the study - Infants currently being breastfed - Parents anticipated local residence, maize grower and capacity of storing maize for the period not less than six months after harvest Exclusion Criteria: - Abnormalities impairing feeding or physical growth measurements |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Tanzania | Hanang' | Manyara | |
Tanzania | Rungwe | Mbeya | |
Tanzania | Kilosa | Morogoro |
Lead Sponsor | Collaborator |
---|---|
Tanzania Food and Drugs Authority | International Foundation for Science, The Nelson Mandela African Institution of Science and Technology, Tanzania, The Open University of Tanzania, University Ghent, VLIR-UOS |
Tanzania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in aflatoxins and fumonisins contamination in maize and in breast milk after 6 months of intervention | after 6 months of intervention | No | |
Secondary | The proportion of children exceeding the health based guidance value of aflatoxins and fumonisins Tolerable Daily Intake (TDI) or provisional Maximum Tolerable Daily Intake (PTWI) | after 6 months of intervention | No | |
Secondary | Differences in weight - for- age Z-score for intervention and control groups after the intervention | after 6 months of intervention | No | |
Secondary | Document post-harvest practices that are effective in reducing contamination of maize with aflatoxins and fumonisins | after 6 months of intervention | No |
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