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

NCT02804490 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2017-08-21

No results posted yet for this study

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.

Conditions

  • Vitamin A Deficiency

Interventions

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

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

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

Sponsors & Collaborators

  • University of California, Davis

    collaborator OTHER
  • Newcastle University

    collaborator OTHER
  • HarvestPlus

    collaborator OTHER
  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • Amanda C Palmer, PhD · Johns Hopkins Bloomberg School of Public Health

  • Marjorie Haskell, PhD · University of California, Davis

  • Rose Mwanza, MD · Provincial Medical Office, Central Province, Zambia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-06-02
Completion
2017-06-02

Countries

  • Zambia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02804490 on ClinicalTrials.gov