Efficacy of β-carotene Biofortified Maize in Reducing Vitamin A Deficiency Among Children

NCT01695148 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1228

Last updated 2014-02-07

No results posted yet for this study

Summary

The purpose of this cluster-randomized trial is to examine whether daily consumption of β-carotene biofortified maize flour can reduce the prevalence of vitamin A deficiency and improve the vitamin A status and among 4-8 year old children in rural Zambia.

Conditions

  • Vitamin A Deficiency
  • Low Serum Retinol

Interventions

DIETARY_SUPPLEMENT

β-Carotene Biofortified Maize Flour

DIETARY_SUPPLEMENT

White Maize Flour

Sponsors & Collaborators

  • National Food and Nutrition Commission, Zambia

    collaborator UNKNOWN
  • Tropical Diseases Research Centre, Zambia

    collaborator OTHER_GOV
  • HarvestPlus

    collaborator OTHER
  • Canadian International Development Agency

    collaborator OTHER_GOV
  • Zambia Agriculture Research Institute

    collaborator OTHER
  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

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

  • Rolf Klemm, DrPH · Johns Hopkins Bloomberg School of Public Health

  • Kerry J Schulze, PhD · Johns Hopkins Bloomberg School of Public Health

  • Alain Labrique, PhD · Johns Hopkins Bloomberg School of Public Health

  • Parul Christian, DrPH · Johns Hopkins Bloomberg School of Public Health

  • Sucheta Mehra, MS · Johns Hopkins Bloomberg School of Public Health

  • Lee Shu-Fune Wu, MS · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-03-31
Completion
2013-06-30

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 NCT01695148 on ClinicalTrials.gov