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Mycotoxin Mitigation Trial

NCT03940547 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2842

Last updated 2022-02-07

No results posted yet for this study

Summary

Multiple observational studies show an association between fetal and post-natal aflatoxin exposure and reduced linear growth. However, the effects of confounding factors such as socio-economic status, food insecurity and nutrient deficiencies due to monotonous diets have not been ruled out. This trial will quantify the causal role of infant aflatoxin ingestion on post-natal growth by performing a cluster randomized trial in children 6-18 months of age in the Dodoma Region of Tanzania.

All health facilities in one district in Dodoma will be randomized to the control or intervention arm. Infants will be recruited into the study over one year to account for seasonal variation in AF exposure. Both arms will receive infant and young child feeding education, a thermos flask and plastic measuring scoops. The intervention arm will receive a low-aflatoxin pre-blended porridge flour containing maize and groundnut (ratio 4:1 respectively) and low-aflatoxin groundnut flour, whereas in the control arm the same porridge mix will be promoted through education, but acquired by the household. The primary outcome is length-for-age Z-score at 18 months.

Conditions

  • Aflatoxin Ingestion

Interventions

OTHER

Provision of flour

Infant and young child feeding education and provision of low AF porridge and groundnut flours from 6-18 months

OTHER

Promotion of flour

Infant and young child feeding education and promotion of porridge and groundnut flours from 6-18 months

Sponsors & Collaborators

  • University of Maryland

    collaborator OTHER

  • The Nelson Mandela African Institution of Science and Technology

    collaborator UNKNOWN

  • Cornell University

    lead OTHER

Principal Investigators

  • Rebecca J Stoltzfus, PhD · Cornell University

  • Rebecca J Nelson, PhD · Cornell University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-24
Primary Completion
2021-08-20
Completion
2021-08-20

Countries

  • Tanzania

Study Locations

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Entities

Companies

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 NCT03940547 on ClinicalTrials.gov