Skip to main content
OpenTrials
Completed

NCT Number: NCT02804490

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Vitamin A Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

JHU Office

Mkushi, Central Province, Zambia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional white maize

Dietary 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 maize

Dietary 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 maize

Dietary 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

Primary outcomes

  1. Infant vitamin A stores

    Time frame: 90 days

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

Secondary outcomes

  1. Maternal breast milk retinol

    Time frame: 90 days

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

  2. Maternal plasma retinol

    Time frame: 90 days

    Plasma retinol concentrations of women measured by high performance liquid chromatography

  3. Maternal dark adaptation

    Time frame: 90 days

    Pupillary responsiveness of women measured by portable field dark adaptometer

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • HarvestPlus
  • Newcastle University
  • University of California, Davis

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 17, 2016
Registry last updated
Aug 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.