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 3
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Study Participants

    1228
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.
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 Started
Aug 31
2012
Primary Completion
Mar 31
2013
Study Completion
Jun 30
2013
Last Update
Feb 07
2014
Estimate

Dietary Supplement β-Carotene Biofortified Maize Flour

Dietary Supplement White Maize Flour

White Maize Flour Active Comparator

Children will receive 2 meals a day (~200 g of white maize flour), 6 days a week for 6 months.

β-Carotene Biofortified Maize Experimental

Children will receive 2 meals a day (~200 g of beta-carotene biofortified maize flour), 6 days a week for 6 months.

Non-Intervened No Intervention

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.

Criteria

Inclusion Criteria:

Children 4-8 years of age
No Results Posted