Efficacy of β-carotene Biofortified Maize in Reducing Vitamin A Deficiency Among Children
Primary Purpose
Vitamin A Deficiency, Low Serum Retinol
Status
Completed
Phase
Phase 3
Locations
Zambia
Study Type
Interventional
Intervention
β-Carotene Biofortified Maize Flour
White Maize Flour
Sponsored by
About this trial
This is an interventional prevention trial for Vitamin A Deficiency focused on measuring beta-carotene biofortified maize, micronutrients, vitamin A, serum retinol, dark adaptation
Eligibility Criteria
Inclusion Criteria:
- Children 4-8 years of age
Sites / Locations
- JHU Office
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
No Intervention
Arm Label
White Maize Flour
β-Carotene Biofortified Maize
Non-Intervened
Arm Description
Children will receive 2 meals a day (~200 g of white maize flour), 6 days a week for 6 months.
Children will receive 2 meals a day (~200 g of beta-carotene biofortified maize flour), 6 days a week for 6 months.
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.
Outcomes
Primary Outcome Measures
Increased Serum Retinol Concentration
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
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
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.
Full Information
NCT ID
NCT01695148
First Posted
September 25, 2012
Last Updated
February 5, 2014
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 Agriculture Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01695148
Brief Title
Efficacy of β-carotene Biofortified Maize in Reducing Vitamin A Deficiency Among Children
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 Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the 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 Agriculture Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin A Deficiency, Low Serum Retinol
Keywords
beta-carotene biofortified maize, micronutrients, vitamin A, serum retinol, dark adaptation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1228 (Actual)
8. Arms, Groups, and Interventions
Arm Title
White Maize Flour
Arm Type
Active Comparator
Arm Description
Children will receive 2 meals a day (~200 g of white maize flour), 6 days a week for 6 months.
Arm Title
β-Carotene Biofortified Maize
Arm Type
Experimental
Arm Description
Children will receive 2 meals a day (~200 g of beta-carotene biofortified maize flour), 6 days a week for 6 months.
Arm Title
Non-Intervened
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
β-Carotene Biofortified Maize Flour
Intervention Type
Dietary Supplement
Intervention Name(s)
White Maize Flour
Primary Outcome Measure Information:
Title
Increased Serum Retinol Concentration
Description
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.
Time Frame
After 6 months of feeding
Title
Decreased Prevalence of Vitamin A deficiency
Description
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%.
Time Frame
After 6 months of feeding
Secondary Outcome Measure Information:
Title
Improved Dark Adaptation
Description
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.
Time Frame
After 6 months of Feeding
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Children 4-8 years of age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda C Palmer, PhD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rolf Klemm, DrPH
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kerry J Schulze, PhD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alain Labrique, PhD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Parul Christian, DrPH
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sucheta Mehra, MS
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lee Shu-Fune Wu, MS
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Study Director
Facility Information:
Facility Name
JHU Office
City
Mkushi
Country
Zambia
12. IPD Sharing Statement
Citations:
PubMed Identifier
16988127
Citation
Howe JA, Tanumihardjo SA. Carotenoid-biofortified maize maintains adequate vitamin a status in Mongolian gerbils. J Nutr. 2006 Oct;136(10):2562-7. doi: 10.1093/jn/136.10.2562.
Results Reference
background
PubMed Identifier
17032000
Citation
Howe JA, Tanumihardjo SA. Evaluation of analytical methods for carotenoid extraction from biofortified maize (Zea mays sp.). J Agric Food Chem. 2006 Oct 18;54(21):7992-7. doi: 10.1021/jf062256f.
Results Reference
background
PubMed Identifier
18312712
Citation
Davis C, Jing H, Howe JA, Rocheford T, Tanumihardjo SA. beta-Cryptoxanthin from supplements or carotenoid-enhanced maize maintains liver vitamin A in Mongolian gerbils ( Meriones unguiculatus) better than or equal to beta-carotene supplements. Br J Nutr. 2008 Oct;100(4):786-93. doi: 10.1017/S0007114508944123. Epub 2008 Mar 3.
Results Reference
background
PubMed Identifier
18616269
Citation
Davis CR, Howe JA, Rocheford TR, Tanumihardjo SA. The xanthophyll composition of biofortified maize (Zea mays Sp.) does not influence the bioefficacy of provitamin a carotenoids in Mongolian gerbils (Meriones unguiculatus). J Agric Food Chem. 2008 Aug 13;56(15):6745-50. doi: 10.1021/jf800816q. Epub 2008 Jul 11.
Results Reference
background
PubMed Identifier
21715509
Citation
Muzhingi T, Gadaga TH, Siwela AH, Grusak MA, Russell RM, Tang G. Yellow maize with high beta-carotene is an effective source of vitamin A in healthy Zimbabwean men. Am J Clin Nutr. 2011 Aug;94(2):510-9. doi: 10.3945/ajcn.110.006486. Epub 2011 Jun 29.
Results Reference
background
PubMed Identifier
29924320
Citation
Healy K, Palmer AC, Barffour MA, Schulze KJ, Siamusantu W, Chileshe J, West KP Jr, Labrique AB. Nutritional Status Measures Are Correlated with Pupillary Responsiveness in Zambian Children. J Nutr. 2018 Jul 1;148(7):1160-1166. doi: 10.1093/jn/nxy069. Erratum In: J Nutr. 2019 Mar 1;149(3):542.
Results Reference
derived
PubMed Identifier
29321687
Citation
Palmer AC, Craft NE, Schulze KJ, Barffour M, Chileshe J, Siamusantu W, West KP Jr. Impact of biofortified maize consumption on serum carotenoid concentrations in Zambian children. Eur J Clin Nutr. 2018 Feb;72(2):301-303. doi: 10.1038/s41430-017-0054-1. Epub 2018 Jan 10.
Results Reference
derived
PubMed Identifier
28701387
Citation
Barffour MA, Schulze KJ, Coles CL, Chileshe J, Kalungwana N, Arguello M, Siamusantu W, Moss WJ, West KP Jr, Palmer AC. High Iron Stores in the Low Malaria Season Increase Malaria Risk in the High Transmission Season in a Prospective Cohort of Rural Zambian Children. J Nutr. 2017 Aug;147(8):1531-1536. doi: 10.3945/jn.117.250381. Epub 2017 Jul 12.
Results Reference
derived
PubMed Identifier
27798345
Citation
Palmer AC, Healy K, Barffour MA, Siamusantu W, Chileshe J, Schulze KJ, West KP Jr, Labrique AB. Provitamin A Carotenoid-Biofortified Maize Consumption Increases Pupillary Responsiveness among Zambian Children in a Randomized Controlled Trial. J Nutr. 2016 Dec;146(12):2551-2558. doi: 10.3945/jn.116.239202. Epub 2016 Oct 19.
Results Reference
derived
PubMed Identifier
27169838
Citation
Palmer AC, Siamusantu W, Chileshe J, Schulze KJ, Barffour M, Craft NE, Molobeka N, Kalungwana N, Arguello MA, Mitra M, Caswell B, Klemm RD, West KP Jr. Provitamin A-biofortified maize increases serum beta-carotene, but not retinol, in marginally nourished children: a cluster-randomized trial in rural Zambia. Am J Clin Nutr. 2016 Jul;104(1):181-90. doi: 10.3945/ajcn.116.132571. Epub 2016 May 11.
Results Reference
derived
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Efficacy of β-carotene Biofortified Maize in Reducing Vitamin A Deficiency Among Children
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