Efficacy of β-carotene Biofortified Maize in Reducing Vitamin A Deficiency Among Children
This study is currently recruiting participants.
Verified September 2012 by Johns Hopkins Bloomberg School of Public Health
Sponsor:
Johns Hopkins Bloomberg School of Public Health
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: September 26, 2012
Last verified: September 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Estimated Enrollment: | 1250 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | June 2013 |
| Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01695148
Contacts
| Contact: Keith P West Jr., DrPH | 410-955-2061 | kwest@jhsph.edu |
Locations
| Zambia | |
| JHU Office | Recruiting |
| Mkushi, Zambia | |
| Contact: Amanda C Palmer, PhD acpalmer@jhsph.edu | |
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: | September 26, 2012 |
| 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:
|
Vitamin A Deficiency Night Blindness Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Vision Disorders Eye Diseases Carotenoids Retinol palmitate Vitamin A Vitamins |
Beta Carotene Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Micronutrients Growth Substances Anticarcinogenic Agents Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013