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

August 16, 2017 updated by: Johns Hopkins Bloomberg School of Public Health
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

255

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Zambia
    • Central Province
      • Mkushi, Central Province, Zambia
        • JHU Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: White maize
Conventional maize flour
Dietary supplement: Conventional white maize
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
Experimental: Biofortified maize
Provitamin A carotenoid biofortified maize flour
Dietary supplement: Provitamin A carotenoid biofortified maize
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
Active Comparator: Fortified maize
Retinyl palmitate fortified maize flour
Dietary supplement: Preformed vitamin A fortified maize
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant vitamin A stores
Time Frame: 90 days
Total body vitamin A stores of infants measured by retinol isotope dilution
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal breast milk retinol
Time Frame: 90 days
Breast milk retinol concentrations of women measured by high performance liquid chromatography
90 days
Maternal plasma retinol
Time Frame: 90 days
Plasma retinol concentrations of women measured by high performance liquid chromatography
90 days
Maternal dark adaptation
Time Frame: 90 days
Pupillary responsiveness of women measured by portable field dark adaptometer
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

University of California, Davis
Newcastle University
HarvestPlus

Investigators

  • Study Director: Marjorie Haskell, PhD, University of California, Davis
  • Study Director: Rose Mwanza, MD, Provincial Medical Office, Central Province, Zambia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

June 2, 2017

Study Completion (Actual)

June 2, 2017

Study Registration Dates

First Submitted

June 15, 2016

First Submitted That Met QC Criteria

June 16, 2016

First Posted (Estimate)

June 17, 2016

Study Record Updates

Last Update Posted (Actual)

August 21, 2017

Last Update Submitted That Met QC Criteria

August 16, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014H8314.JHU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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