Efficacy of Biofortified Maize to Improve Maternal and Infant Vitamin A Status

Study Overview
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Brief Summary
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The purpose of this randomized control trial is to test the impact of provitamin A carotenoid biofortified maize meal consumption on maternal and infant vitamin A status.

Detailed Description
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Vitamin A deficiency remains a major public health problem in low and middle income countries. Approximately 50% of Zambian children are thought to be affected. This randomized control trial will test the efficacy of provitamin A carotenoid biofortified maize meal consumption as a strategy to improve vitamin A status among lactating Zambian mothers and their infants. The investigators will enroll up to 255 mother/infant pairs to a three-month study, during which they will receive one of the following three interventions: 1) conventional white maize, 2) provitamin A carotenoid biofortified orange maize, or 3) preformed vitamin A fortified white maize.

Official Title
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Efficacy of Biofortified Maize to Improve Maternal and Infant Vitamin A Status

Conditions
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Vitamin A Deficiency

Intervention / Treatment
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* Dietary Supplement: Conventional white maize
* Dietary Supplement: Provitamin A carotenoid biofortified maize
* Dietary Supplement: Preformed vitamin A fortified maize


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Singleton birth No birth defects Free from chronic health conditions Infant received 100,000 IU vitamin A at 6 months of age Currently breastfeeding Not pregnant at 9 months post partum Hemoglobin > 8.0 g/dL for women and > 7.0 g/dL for infants Exclusion Criteria: Multiple birth Birth defects Any chronic health condition requiring regular medical visits Infant did not receive vitamin A capsule at 6 months of age No longer breastfeeding Pregnant Hemoglobin ≤ 8.0 g/dL for women or ≤ 7.0 g/dL for infants

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: White maize<br>Conventional maize flour | Dietary Supplement: Conventional white maize<br>* Women and their infants will receive 2 meals/day prepared with conventional white maize flour (287 g dry weight/d for women; 50 g dry weight/d for infants), 6 days/week for 15 weeks<br>|
| Experimental: Biofortified maize<br>Provitamin A carotenoid biofortified maize flour | Dietary Supplement: Provitamin A carotenoid biofortified maize<br>* Women and their infants will receive 2 meals/day prepared with provitamin A carotenoid biofortified orange maize flour (287 g dry weight/d for women; 50 g dry weight/d for infants), 6 days/week for 15 weeks<br>|
| Active Comparator: Fortified maize<br>Retinyl palmitate fortified maize flour | Dietary Supplement: Preformed vitamin A fortified maize<br>* Women and their infants will receive 2 meals/day prepared with preformed vitamin A fortified, conventional white maize flour (287 g dry weight/d for women; 50 g dry weight/d for infants), 6 days/week for 15 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant vitamin A stores | Total body vitamin A stores of infants measured by retinol isotope dilution | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal breast milk retinol | Breast milk retinol concentrations of women measured by high performance liquid chromatography | 90 days | 
| Maternal plasma retinol | Plasma retinol concentrations of women measured by high performance liquid chromatography | 90 days | 
| Maternal dark adaptation | Pupillary responsiveness of women measured by portable field dark adaptometer | 90 days |