Title
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
Phase
Phase 3Lead Sponsor
Johns Hopkins UniversityStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Vitamin A Deficiency Low Serum RetinolIntervention/Treatment
beta carotene corn ...Study Participants
1228The 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.
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.
Children will receive 2 meals a day (~200 g of white maize flour), 6 days a week for 6 months.
Children will receive 2 meals a day (~200 g of beta-carotene biofortified maize flour), 6 days a week for 6 months.
Children will receive no food for the duration of the study, but families in this group will receive an equivalent ration of food items at the end of the trial.
Inclusion Criteria: Children 4-8 years of age
