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

Phase 3

Completed

• Conditions: Vitamin A Deficiency
• Interventions: Dietary Supplement: Conventional white maize; Dietary Supplement: Provitamin A carotenoid biofortified maize; Dietary Supplement: Preformed vitamin A fortified maize

• Registration Number: NCT02804490
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-06-15
• Study First Submitted QC: 2016-06-16
• Study First Posted: 2016-06-17
• Primary Completion: 2017-06-02
• Study Completion: 2017-06-02
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-16
• Last Update Posted: 2017-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 255

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
White maize	Conventional white maize	Conventional maize flour
Biofortified maize	Provitamin A carotenoid biofortified maize	Provitamin A carotenoid biofortified maize flour
Fortified maize	Preformed vitamin A fortified maize	Retinyl palmitate fortified maize flour

Primary Outcome Measures

Name	Time	Method
Infant vitamin A stores	90 days	Total body vitamin A stores of infants measured by retinol isotope dilution

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

JHU Office; 🇿🇲 Mkushi, Central Province, Zambia