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Completed

NCT Number: NCT01695148

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

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.

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Key information

Conditions

Vitamin A Deficiency Avitaminosis Deficiency Diseases Low Serum Retinol Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

JHU Office

Mkushi, Zambia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children 4-8 years of age

Treatment and study plan

β-Carotene Biofortified Maize Flour

Dietary Supplement

White Maize Flour

Dietary Supplement

Primary outcomes

  1. 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.

  2. 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%.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • Canadian International Development Agency
  • HarvestPlus
  • National Food and Nutrition Commission, Zambia
  • Tropical Diseases Research Centre, Zambia
  • Zambia Agriculture Research Institute

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 27, 2012
Registry last updated
Feb 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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