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

Study Overview
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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.

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.

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

Conditions
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Vitamin A Deficiency, Low Serum Retinol

Intervention / Treatment
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* Dietary Supplement: β-Carotene Biofortified Maize Flour
* Dietary Supplement: White Maize Flour


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children 4-8 years of age

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: White Maize Flour<br>Children will receive 2 meals a day ( 200 g of white maize flour), 6 days a week for 6 months. | Dietary Supplement: White Maize Flour<br> <br> |
| Experimental: β-Carotene Biofortified Maize<br>Children will receive 2 meals a day ( 200 g of beta-carotene biofortified maize flour), 6 days a week for 6 months. | Dietary Supplement: β-Carotene Biofortified Maize Flour<br> <br> |
| No Intervention: Non-Intervened<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increased Serum Retinol Concentration | 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. | After 6 months of feeding | 
| Decreased Prevalence of Vitamin A deficiency | 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%. | After 6 months of feeding | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved Dark Adaptation | 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. | After 6 months of Feeding | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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beta-carotene biofortified maize, micronutrients, vitamin A, serum retinol, dark adaptation