NCT01695148

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,228 (actual)
• Sponsor: Johns Hopkins Bloomberg School of Public Health · Academic / Other
• Sex: All
• Age: 4 Years – 8 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Vitamin A Deficiency
• Low Serum Retinol

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	β-Carotene Biofortified Maize Flour
DIETARY_SUPPLEMENT	White Maize Flour

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-03-01
• Completion: 2013-06-01
• First posted: 2012-09-27
• Last updated: 2014-02-07

Locations

1 site across 1 country: Zambia