Trial | NCT02804490  Report issue

Official Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    corn ...

  • Study Participants

    255
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.
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 Started
Mar 31
2016
Primary Completion
Jun 02
2017
Study Completion
Jun 02
2017
Last Update
Aug 21
2017

Dietary Supplement Conventional 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 Supplement Provitamin 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 Supplement Preformed 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

White maize Placebo Comparator

Conventional maize flour

Biofortified maize Experimental

Provitamin A carotenoid biofortified maize flour

Fortified maize Active Comparator

Retinyl palmitate fortified maize flour

Criteria 

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
No Results Posted