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

Johns Hopkins Bloomberg School of Public Health255 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

255

Conditions

Vitamin A Deficiency

Interventions

Conventional white maizeDIETARY_SUPPLEMENT

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

Provitamin A carotenoid biofortified maizeDIETARY_SUPPLEMENT

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

Preformed vitamin A fortified maizeDIETARY_SUPPLEMENT

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

JHU Office

Mkushi, Central Province, Zambia

Outcomes

Primary Outcomes

Infant vitamin A stores

Total body vitamin A stores of infants measured by retinol isotope dilution

Time frame: 90 days

Secondary Outcomes

Maternal breast milk retinol

Breast milk retinol concentrations of women measured by high performance liquid chromatography

Time frame: 90 days

Maternal plasma retinol

Plasma retinol concentrations of women measured by high performance liquid chromatography

Time frame: 90 days

Maternal dark adaptation

Pupillary responsiveness of women measured by portable field dark adaptometer

Time frame: 90 days

Data from ClinicalTrials.gov

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