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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-06-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Vitamin A Deficiency Low Serum Retinol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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White Maize Flour

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

Group Type ACTIVE_COMPARATOR

White Maize Flour

Intervention Type DIETARY_SUPPLEMENT

β-Carotene Biofortified Maize

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

Group Type EXPERIMENTAL

β-Carotene Biofortified Maize Flour

Intervention Type DIETARY_SUPPLEMENT

Non-Intervened

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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β-Carotene Biofortified Maize Flour

Intervention Type DIETARY_SUPPLEMENT

White Maize Flour

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Children 4-8 years of age

Minimum Eligible Age

4 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Keith P. West

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR