Efficacy of Biofortified Maize to Improve Maternal and Infant Vitamin A Status
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 255
- Locations
- 1
- Primary Endpoint
- Infant vitamin A stores
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
- •Hemoglobin ≤ 8.0 g/dL for women or ≤ 7.0 g/dL for infants
Arms & Interventions
White maize
Conventional maize flour
Intervention: Conventional white maize (Dietary Supplement)
Biofortified maize
Provitamin A carotenoid biofortified maize flour
Intervention: Provitamin A carotenoid biofortified maize (Dietary Supplement)
Fortified maize
Retinyl palmitate fortified maize flour
Intervention: Preformed vitamin A fortified maize (Dietary Supplement)
Outcomes
Primary Outcomes
Infant vitamin A stores
Time Frame: 90 days
Total body vitamin A stores of infants measured by retinol isotope dilution
Secondary Outcomes
- Maternal breast milk retinol(90 days)
- Maternal plasma retinol(90 days)
- Maternal dark adaptation(90 days)