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Efficacy of β-carotene Biofortified Maize in Reducing Vitamin A Deficiency Among Children

Vitamin A Deficiency Clinical Trial

Official title:
Efficacy of β-carotene Biofortified Maize in Improving Vitamin A Status and Reducing the Prevalence of Vitamin A Deficiency Among Children in Rural Zambia

Clinical Trial Summary

The purpose of this cluster-randomized trial is to examine whether daily consumption of β-carotene biofortified maize flour can reduce the prevalence of vitamin A deficiency and improve the vitamin A status and among 4-8 year old children in rural Zambia.

Clinical Trial Description

Vitamin A deficiency is a major public health problem in Zambia, affecting approximately 40% of young children. We aim to conduct a cluster-randomised controlled trial in the Mkushi region of rural Zambia to test whether feeding children two daily meals containing β-carotene biofortified maize flour compared to regular white maize flour-based meals for six months can reduce the prevalence of vitamin A deficiency and improve the vitamin A status among 4-8 year old children. Five hundred children in each arm will receive 2 meals a day, 6 days a week for 6 months, after which changes in serum retinol concentrations will be compared. An additional arm of 250 children, enrolled from randomly sampled clusters, will not receive the maize flour intervention but concurrently followed in order to evaluate overall effects of the maize flour feeding scheme on measures of household food security. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01695148
Study type Interventional
Source Johns Hopkins Bloomberg School of Public Health
Contact
Status Completed
Phase Phase 3
Start date August 2012
Completion date June 2013
View Details
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