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

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

Sponsors

Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

Collaborator: University of California, Davis
Newcastle University
HarvestPlus

Source Johns Hopkins Bloomberg School of Public Health
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.

Overall Status Completed
Start Date March 2016
Completion Date June 2, 2017
Primary Completion Date June 2, 2017
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Infant vitamin A stores 90 days
Secondary Outcome
Measure Time Frame
Maternal breast milk retinol 90 days
Maternal plasma retinol 90 days
Maternal dark adaptation 90 days
Enrollment 255
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: Conventional white maize

Description: 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

Arm Group Label: White maize

Intervention Type: Dietary Supplement

Intervention Name: Provitamin A carotenoid biofortified maize

Description: 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

Arm Group Label: Biofortified maize

Intervention Type: Dietary Supplement

Intervention Name: Preformed vitamin A fortified maize

Description: 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

Arm Group Label: Fortified maize

Eligibility

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

Gender: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Location
Facility: JHU Office
Location Countries

Zambia

Verification Date

August 2017

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: White maize

Type: Placebo Comparator

Description: Conventional maize flour

Label: Biofortified maize

Type: Experimental

Description: Provitamin A carotenoid biofortified maize flour

Label: Fortified maize

Type: Active Comparator

Description: Retinyl palmitate fortified maize flour

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov