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

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ClinicalTrials.gov Identifier: NCT01695148
Recruitment Status : Completed
First Posted : September 27, 2012
Last Update Posted : February 7, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Vitamin A Deficiency Low Serum Retinol Dietary Supplement: β-Carotene Biofortified Maize Flour Dietary Supplement: White Maize Flour Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficacy of β-carotene Biofortified Maize in Improving Vitamin A Status and Reducing the Prevalence of Vitamin A Deficiency Among Children in Rural Zambia
Study Start Date : August 2012
Primary Completion Date : March 2013
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin A
U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. 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%.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria

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Ages Eligible for Study:   4 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children 4-8 years of age
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01695148


Locations
Zambia
JHU Office
Mkushi, Zambia
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
National Food and Nutrition Commission, Zambia
Tropical Diseases Research Centre, Zambia
HarvestPlus
Canadian International Development Agency
Zambia Agriculture Research Institute
Investigators
Study Director: Amanda C Palmer, PhD Johns Hopkins Bloomberg School of Public Health
Study Director: Rolf Klemm, DrPH Johns Hopkins Bloomberg School of Public Health
Study Director: Kerry J Schulze, 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: Sucheta Mehra, MS Johns Hopkins Bloomberg School of Public Health
Study Director: Lee Shu-Fune Wu, MS Johns Hopkins Bloomberg School of Public Health
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Keith P. West, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01695148     History of Changes
Other Study ID Numbers: JHU IRB 4150
First Posted: September 27, 2012    Key Record Dates
Last Update Posted: February 7, 2014
Last Verified: February 2014

Keywords provided by Keith P. West, Johns Hopkins Bloomberg School of Public Health:
beta-carotene biofortified maize
micronutrients
vitamin A
serum retinol
dark adaptation

Additional relevant MeSH terms:
Vitamin A Deficiency
Night Blindness
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vision Disorders
Eye Diseases
Vitamins
Vitamin A
Beta Carotene
Retinol palmitate
Carotenoids
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Provitamins