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.

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

Vitamin A Deficiency

Low Serum Retinol

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.

β-Carotene Biofortified Maize Flour

White Maize Flour

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

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.

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%.

Professor

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.

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.

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

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?