Effect of Daily Consumption of β-carotene Biofortified Maize on Milk Retinol Concentration in Lactating Zambian Women
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 149
- Locations
- 1
- Primary Endpoint
- Breast milk retinol concentration
Study Overview
Brief Summary
The purpose of the study is to determine whether daily consumption of beta-carotene biofortified maize will increase breast milk retinol concentration in lactating Zambian women.
Detailed Description
Lactating women were randomly assigned to one of three intervention groups to receive 6d/wk for 3 wk either 1) provitamin A biofortified orange maize and a corn oil capsule, 2) white maize and a vitamin A capsule, or 3) white maize and a corn oil capsule. The 'orange maize' and 'vitamin A' groups received ~600 ug RAE/d as provitamin A biofortified maize or retinyl palmitate, respectively. The 'white maize' group was a negative control group that did not receive any supplemental vitamin A.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Apparently healthy lactating women 18-35 years of age
- •who are breastfeeding a single infant, 4-12 mo of age.
Exclusion Criteria
- •Pregnancy,
- •Chronic disease,
- •Hb concentration <90 g/L,
- •Signs or symptoms of vitamin A deficiency
Arms & Interventions
white maize
white maize and a corn oil capsule
Intervention: white maize and a corn oil capsule (Other)
orange maize
orange maize and a corn oil capsule
Intervention: orange maize and a corn oil capsule (Other)
vitamin A
white maize and a vitamin A capsule
Intervention: white maize and a vitamin A capsule (Other)
Outcomes
Primary Outcomes
Breast milk retinol concentration
Time Frame: After 3 weeks of intervention
Breast milk retinol concentration will be measured before and after 3 wk of consumption of orange maize (6 d/wk)
Secondary Outcomes
- Breastmilk beta-carotene concentration(After 3 wk of intervention)