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Trial record 2 of 28 for:    "Keratomalacia"

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

This study has been completed.
Sponsor:
Collaborators:
National Food and Nutrition Commission, Zambia
Tropical Diseases Research Centre, Zambia
HarvestPlus
Canadian International Development Agency
Zambia Agricultural Research Institute
Information provided by (Responsible Party):
Keith P. West, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT01695148
First received: September 25, 2012
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Vitamin A Deficiency
Low Serum Retinol
Dietary Supplement: β-Carotene Biofortified Maize Flour
Dietary Supplement: White Maize Flour
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Increased Serum Retinol Concentration [ Time Frame: After 6 months of feeding ] [ Designated as safety issue: No ]
    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.

  • Decreased Prevalence of Vitamin A deficiency [ Time Frame: After 6 months of feeding ] [ Designated as safety issue: No ]
    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:
  • Improved Dark Adaptation [ Time Frame: After 6 months of Feeding ] [ Designated as safety issue: No ]
    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.


Enrollment: 1228
Study Start Date: August 2012
Study Completion Date: June 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   4 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children 4-8 years of age
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Agricultural Research Institute
Investigators
Study Director: Amanda C Palmer, PhD Johns Hopkins School of Public Health
Study Director: Rolf Klemm, DrPH Johns Hopkins School of Public Health
Study Director: Kerry J Schulze, PhD Johns Hopkins School of Public Health
Study Director: Alain Labrique, PhD Johns Hopkins School of Public Health
Study Director: Parul Christian, DrPH Johns Hopkins School of Public Health
Study Director: Sucheta Mehra, MS Johns Hopkins School of Public Health
Study Director: Lee Shu-Fune Wu, MS Johns Hopkins School of Public Health
  More Information

Publications:
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
Study First Received: September 25, 2012
Last Updated: February 5, 2014
Health Authority: United States: Institutional Review Board
Zambia: Tropical Diseases Research Centre, Ethics Review Committee

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

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

ClinicalTrials.gov processed this record on November 24, 2014