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

February 5, 2014 updated by: Keith P. West, Johns Hopkins Bloomberg School of Public Health

Efficacy of β-carotene Biofortified Maize in Improving Vitamin A Status and Reducing the Prevalence of Vitamin A Deficiency Among Children in Rural Zambia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Vitamin A deficiency is a major public health problem in Zambia, affecting approximately 40% of young children. We aim to conduct a cluster-randomised controlled trial in the Mkushi region of rural Zambia to test whether feeding children two daily meals containing β-carotene biofortified maize flour compared to regular white maize flour-based meals for six months can reduce the prevalence of vitamin A deficiency and improve the vitamin A status among 4-8 year old children. Five hundred children in each arm will receive 2 meals a day, 6 days a week for 6 months, after which changes in serum retinol concentrations will be compared. An additional arm of 250 children, enrolled from randomly sampled clusters, will not receive the maize flour intervention but concurrently followed in order to evaluate overall effects of the maize flour feeding scheme on measures of household food security.

Study Type

Interventional

Enrollment (Actual)

1228

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
      • Mkushi, 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

4 years to 8 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children 4-8 years of age

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: White Maize Flour
Children will receive 2 meals a day (~200 g of white maize flour), 6 days a week for 6 months.
Dietary supplement: White Maize Flour
EXPERIMENTAL: β-Carotene Biofortified Maize
Children will receive 2 meals a day (~200 g of beta-carotene biofortified maize flour), 6 days a week for 6 months.
Dietary supplement: β-Carotene Biofortified Maize Flour
NO_INTERVENTION: Non-Intervened
Children will receive no food for the duration of the study, but families in this group will receive an equivalent ration of food items at the end of the trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increased Serum Retinol Concentration
Time Frame: After 6 months of feeding
The investigators hypothesize a difference of 2.5 μg/dL or more in serum retinol among children receiving biofortified versus white maize flour-based meals. Serum retinol measures will be collected at baseline and at the end of 6 months and assessed by a High Performance Liquid Chromatography assay.
After 6 months of feeding
Decreased Prevalence of Vitamin A deficiency
Time Frame: After 6 months of feeding
The investigators hypothesize a difference of 10% or more in the prevalence of vitamin A deficiency (i.e., serum retinol < 0.7 μmol/l) among children consuming biofortified versus white maize flour-based meals, assuming a baseline prevalence of 40%.
After 6 months of feeding

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improved Dark Adaptation
Time Frame: After 6 months of Feeding
The investigators hypothesize a difference in pupillary response to a light stimulus, as detected by dark adaptometry, in children receiving biofortified versus white maize flour-based meals.
After 6 months of Feeding

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

Tropical Diseases Research Centre, Zambia
HarvestPlus
Canadian International Development Agency
National Food and Nutrition Commission, Zambia
Zambia Agriculture Research Institute

Investigators

  • Study Director: Amanda C Palmer, PhD, Johns Hopkins Bloomberg School of Public Health
  • Study Director: Alain Labrique, PhD, Johns Hopkins Bloomberg School of Public Health
  • Study Director: Parul Christian, DrPH, Johns Hopkins Bloomberg School of Public Health
  • Study Director: Lee Shu-Fune Wu, MS, Johns Hopkins Bloomberg School of Public Health

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

August 1, 2012

Primary Completion (ACTUAL)

March 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

September 25, 2012

First Submitted That Met QC Criteria

September 25, 2012

First Posted (ESTIMATE)

September 27, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 7, 2014

Last Update Submitted That Met QC Criteria

February 5, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JHU IRB 4150

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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