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

NCT02438774 | Completed DMC

• 1 other identifier: TZ-2011
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Post-harvest practices , complementary foods; aflatoxins and fumonisins exposure,; Maize, breast milk; child growth, Tanzania

Outcome Measures

Primary Outcomes (1)

• Reduction in aflatoxins and fumonisins contamination in maize and in breast milk after 6 months of intervention

  after 6 months of intervention

Secondary Outcomes (3)

• 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

• Differences in weight - for- age Z-score for intervention and control groups after the intervention

  after 6 months of intervention

• Document post-harvest practices that are effective in reducing contamination of maize with aflatoxins and fumonisins

  after 6 months of intervention

Study Arms (2)

Routine agriculture extension services

ACTIVE COMPARATOR

Routine agriculture extension services alone

Behavioral: Routine agriculture extension services

Post-harvest intervention package

EXPERIMENTAL

Post-harvest intervention package and routine agriculture extension services

Behavioral: post-harvest intervention package; Behavioral: Routine agriculture extension services

Interventions

post-harvest intervention package BEHAVIORAL

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.

Post-harvest intervention package

Routine agriculture extension services BEHAVIORAL

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

Post-harvest intervention package; Routine agriculture extension services

Eligibility Criteria

• Age: Up to 8 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Abnormalities impairing feeding or physical growth measurements

Sponsors & Collaborators

• Tanzania Food and Drugs Authority: lead
• University Ghent: collaborator
• International Foundation for Science (IFS): collaborator
• The Nelson Mandela African Institution of Science and Technology, Tanzania: collaborator
• The Open University of Tanzania: collaborator
• VLIR-UOS: collaborator

Study Sites (3)

Hanang'

Manyara, Manyara Region, Tanzania

Location

Rungwe

Mbeya, Mbeya, Tanzania

Location

Kilosa

Morogoro, Morogoro, Tanzania

Location

MeSH Terms

Conditions

Callosities

Condition Hierarchy (Ancestors)

Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Martin E Kimanya, PhD

  The Nelson Mandela African Institution of Science and Technology, Tanzania

  STUDY CHAIR

• Analice A Kamala, MSc

  Tanzania Food and Drugs Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Food Risk Assessment officer

Study Record Dates

• First Submitted: May 6, 2015
• First Posted: May 8, 2015
• Study Start: November 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: May 1, 2016
• Last Updated: September 15, 2016

Record last verified: 2016-09

Locations

TA (3)