Vitamin A Deficiency
Conditions
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.
Interventions
DIETARY_SUPPLEMENTConventional white maize
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
DIETARY_SUPPLEMENTProvitamin A carotenoid biofortified maize
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
DIETARY_SUPPLEMENTPreformed vitamin A fortified maize
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
Sponsors
University of California, Davis
Newcastle University
HarvestPlus
Johns Hopkins Bloomberg School of Public Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
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 * Pregnant * Hemoglobin ≤ 8.0 g/dL for women or ≤ 7.0 g/dL for infants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infant vitamin A stores | 90 days | Total body vitamin A stores of infants measured by retinol isotope dilution |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal breast milk retinol | 90 days | Breast milk retinol concentrations of women measured by high performance liquid chromatography |
| Maternal plasma retinol | 90 days | Plasma retinol concentrations of women measured by high performance liquid chromatography |
| Maternal dark adaptation | 90 days | Pupillary responsiveness of women measured by portable field dark adaptometer |
Countries
Zambia
Outcome results
None listed