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

Phase 3

Completed

• Conditions: Vitamin A Deficiency; Low Serum Retinol
• Interventions: Dietary Supplement: White Maize Flour; Dietary Supplement: β-Carotene Biofortified Maize Flour

• Registration Number: NCT01695148
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

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 Description

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 Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-09-25
• Study First Submitted QC: 2012-09-25
• Study First Posted: 2012-09-27
• Primary Completion: 2013-03
• Study Completion: 2013-06
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-05
• Last Update Posted: 2014-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1228

Inclusion Criteria

• Children 4-8 years of age

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
White Maize Flour	White Maize Flour	Children will receive 2 meals a day (\~200 g of white maize flour), 6 days a week for 6 months.
β-Carotene Biofortified Maize	β-Carotene Biofortified Maize Flour	Children will receive 2 meals a day (\~200 g of beta-carotene biofortified maize flour), 6 days a week for 6 months.

Primary Outcome Measures

Name	Time	Method
Decreased Prevalence of Vitamin A deficiency	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%.
Increased Serum Retinol Concentration	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.

Secondary Outcome Measures

Name	Time	Method
Improved Dark Adaptation	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.

Trial Locations

Locations (1)

JHU Office; 🇿🇲 Mkushi, Zambia