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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: Johns Hopkins Bloomberg School of Public Health

Current Primary Outcome:

  • Increased Serum Retinol Concentration [ Time Frame: After 6 months of feeding ]
    The investigators hypothesize a difference of 2.5 μg/dL or more in serum retinol among children receiving biofortified versus white maize flour-based meals. Serum retinol measures will be collected at baseline and at the end of 6 months and assessed by a High Performance Liquid Chromatography assay.
  • Decreased Prevalence of Vitamin A deficiency [ Time Frame: After 6 months of feeding ]
    The investigators hypothesize a difference of 10% or more in the prevalence of vitamin A deficiency (i.e., serum retinol < 0.7 μmol/l) among children consuming biofortified versus white maize flour-based meals, assuming a baseline prevalence of 40%.


Original Primary Outcome:

  • Increased Serum Retinol Concentration [ Time Frame: After 6 months of feeding ]
    We hypothesize an increase of 2.5 μg/dL or more in serum retinol among children receiving biofortified versus white maize flour-based meals.
  • Decreased Prevalence of Vitamin A deficiency [ Time Frame: After 6 months of feeding ]
    We hypothesize a reduction of 10% or more in the prevalence of vitamin A deficiency (i.e., serum retinol < 0.7 μmol/l) among children consuming biofortified versus white maize flour-based meals, assuming a baseline prevalence of 40%.


Current Secondary Outcome: Improved Dark Adaptation [ Time Frame: After 6 months of Feeding ]

The investigators hypothesize a difference in pupillary response to a light stimulus, as detected by dark adaptometry, in children receiving biofortified versus white maize flour-based meals.


Original Secondary Outcome: Improved Dark Adaptation [ Time Frame: After 6 months of Feeding ]

We hypothsize an improvement in pupillary response to a light stimulus, as detected by dark adaptometry, in children receiving biofortified versus white maize flour-based meals.


Information By: Johns Hopkins Bloomberg School of Public Health

Dates:
Date Received: September 25, 2012
Date Started: August 2012
Date Completion:
Last Updated: February 5, 2014
Last Verified: February 2014