Clinical Trial: Efficacy of Biofortified Maize to Improve Maternal and Infant Vitamin A Status
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Efficacy of Biofortified Maize to Improve Maternal and Infant Vitamin A Status
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 Summary: 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.
Sponsor: Johns Hopkins Bloomberg School of Public Health
Current Primary Outcome: Infant vitamin A stores [ Time Frame: 90 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Maternal breast milk retinol [ Time Frame: 90 days ]Breast milk retinol concentrations of women measured by high performance liquid chromatography
- Maternal plasma retinol [ Time Frame: 90 days ]Plasma retinol concentrations of women measured by high performance liquid chromatography
- Maternal dark adaptation [ Time Frame: 90 days ]Pupillary responsiveness of women measured by portable field dark adaptometer
Original Secondary Outcome: Same as current
Information By: Johns Hopkins Bloomberg School of Public Health
Dates:
Date Received: June 15, 2016
Date Started: March 2016
Date Completion: December 2017
Last Updated: June 16, 2016
Last Verified: June 2016
