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

Johns Hopkins Bloomberg School of Public Health

Status and phase: Completed; Phase 3

Conditions: Vitamin A Deficiency

Treatments: Dietary Supplement: Conventional white maize; Dietary Supplement: Preformed vitamin A fortified maize; Dietary Supplement: Provitamin A carotenoid biofortified maize

Study type: Interventional

Funder types: Other

Identifiers

NCT02804490

2014H8314.JHU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 255 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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255 participants in 3 patient groups, including a placebo group

White maize

Placebo Comparator group

Description:

Conventional maize flour

Treatment:

Dietary Supplement: Conventional white maize

Biofortified maize

Experimental group

Description:

Provitamin A carotenoid biofortified maize flour

Treatment:

Dietary Supplement: Provitamin A carotenoid biofortified maize

Fortified maize

Active Comparator group

Description:

Retinyl palmitate fortified maize flour

Treatment:

Dietary Supplement: Preformed vitamin A fortified maize