Back to resultsEfficacy of Biofortified Maize to Improve Maternal and Infant Vitamin A Status
Primary Purpose
Vitamin A Deficiency
Status
Completed
Phase
Phase 3
Locations
Zambia
Study Type
Interventional
Intervention
Conventional white maize
Provitamin A carotenoid biofortified maize
Preformed vitamin A fortified maize
Sponsored by
About this trial
This is an interventional prevention trial for Vitamin A Deficiency
Eligibility Criteria
Inclusion Criteria:
- Singleton birth
- No birth defects
- Free from chronic health conditions
- Infant received 100,000 IU vitamin A at 6 months of age
- Currently breastfeeding
- Not pregnant at 9 months post partum
- Hemoglobin > 8.0 g/dL for women and > 7.0 g/dL for infants
Exclusion Criteria:
- Multiple birth
- Birth defects
- Any chronic health condition requiring regular medical visits
- Infant did not receive vitamin A capsule at 6 months of age
- No longer breastfeeding
- Pregnant
- Hemoglobin ≤ 8.0 g/dL for women or ≤ 7.0 g/dL for infants
Sites / Locations
- JHU Office
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Active Comparator
Arm Label
White maize
Biofortified maize
Fortified maize
Arm Description
Conventional maize flour
Provitamin A carotenoid biofortified maize flour
Retinyl palmitate fortified maize flour
Outcomes
Primary Outcome Measures
Infant vitamin A stores
Total body vitamin A stores of infants measured by retinol isotope dilution
Secondary Outcome Measures
Maternal breast milk retinol
Breast milk retinol concentrations of women measured by high performance liquid chromatography
Maternal plasma retinol
Plasma retinol concentrations of women measured by high performance liquid chromatography
Maternal dark adaptation
Pupillary responsiveness of women measured by portable field dark adaptometer
Full Information
NCT ID
NCT02804490
First Posted
June 15, 2016
Last Updated
August 16, 2017
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
University of California, Davis, Newcastle University, HarvestPlus
1. Study Identification
Unique Protocol Identification Number
NCT02804490
Brief Title
Efficacy of Biofortified Maize to Improve Maternal and Infant Vitamin A Status
Official Title
Efficacy of Biofortified Maize to Improve Maternal and Infant Vitamin A Status
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
June 2, 2017 (Actual)
Study Completion Date
June 2, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
University of California, Davis, Newcastle University, HarvestPlus
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this randomized control trial is to test the impact of provitamin A carotenoid biofortified maize meal consumption on maternal and infant vitamin A status.
Detailed Description
Vitamin A deficiency remains a major public health problem in low and middle income countries. Approximately 50% of Zambian children are thought to be affected. This randomized control trial will test the efficacy of provitamin A carotenoid biofortified maize meal consumption as a strategy to improve vitamin A status among lactating Zambian mothers and their infants. The investigators will enroll up to 255 mother/infant pairs to a three-month study, during which they will receive one of the following three interventions: 1) conventional white maize, 2) provitamin A carotenoid biofortified orange maize, or 3) preformed vitamin A fortified white maize.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin A Deficiency
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
255 (Actual)
8. Arms, Groups, and Interventions
Arm Title
White maize
Arm Type
Placebo Comparator
Arm Description
Conventional maize flour
Arm Title
Biofortified maize
Arm Type
Experimental
Arm Description
Provitamin A carotenoid biofortified maize flour
Arm Title
Fortified maize
Arm Type
Active Comparator
Arm Description
Retinyl palmitate fortified maize flour
Intervention Type
Dietary Supplement
Intervention Name(s)
Conventional white maize
Intervention Description
Women and their infants will receive 2 meals/day prepared with conventional white maize flour (287 g dry weight/d for women; 50 g dry weight/d for infants), 6 days/week for 15 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Provitamin A carotenoid biofortified maize
Intervention Description
Women and their infants will receive 2 meals/day prepared with provitamin A carotenoid biofortified orange maize flour (287 g dry weight/d for women; 50 g dry weight/d for infants), 6 days/week for 15 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Preformed vitamin A fortified maize
Intervention Description
Women and their infants will receive 2 meals/day prepared with preformed vitamin A fortified, conventional white maize flour (287 g dry weight/d for women; 50 g dry weight/d for infants), 6 days/week for 15 weeks
Primary Outcome Measure Information:
Title
Infant vitamin A stores
Description
Total body vitamin A stores of infants measured by retinol isotope dilution
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Maternal breast milk retinol
Description
Breast milk retinol concentrations of women measured by high performance liquid chromatography
Time Frame
90 days
Title
Maternal plasma retinol
Description
Plasma retinol concentrations of women measured by high performance liquid chromatography
Time Frame
90 days
Title
Maternal dark adaptation
Description
Pupillary responsiveness of women measured by portable field dark adaptometer
Time Frame
90 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Singleton birth
No birth defects
Free from chronic health conditions
Infant received 100,000 IU vitamin A at 6 months of age
Currently breastfeeding
Not pregnant at 9 months post partum
Hemoglobin > 8.0 g/dL for women and > 7.0 g/dL for infants
Exclusion Criteria:
Multiple birth
Birth defects
Any chronic health condition requiring regular medical visits
Infant did not receive vitamin A capsule at 6 months of age
No longer breastfeeding
Pregnant
Hemoglobin ≤ 8.0 g/dL for women or ≤ 7.0 g/dL for infants
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
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marjorie Haskell, PhD
Organizational Affiliation
University of California, Davis
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rose Mwanza, MD
Organizational Affiliation
Provincial Medical Office, Central Province, Zambia
Official's Role
Study Director
Facility Information:
Facility Name
JHU Office
City
Mkushi
State/Province
Central Province
Country
Zambia
12. IPD Sharing Statement
Citations:
PubMed Identifier
25411289
Citation
Gannon B, Kaliwile C, Arscott SA, Schmaelzle S, Chileshe J, Kalungwana N, Mosonda M, Pixley K, Masi C, Tanumihardjo SA. Biofortified orange maize is as efficacious as a vitamin A supplement in Zambian children even in the presence of high liver reserves of vitamin A: a community-based, randomized placebo-controlled trial. Am J Clin Nutr. 2014 Dec;100(6):1541-50. doi: 10.3945/ajcn.114.087379. Epub 2014 Oct 8.
Results Reference
background
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
background
PubMed Identifier
24158962
Citation
Oxley A, Berry P, Taylor GA, Cowell J, Hall MJ, Hesketh J, Lietz G, Boddy AV. An LC/MS/MS method for stable isotope dilution studies of beta-carotene bioavailability, bioconversion, and vitamin A status in humans. J Lipid Res. 2014 Feb;55(2):319-28. doi: 10.1194/jlr.D040204. Epub 2013 Oct 24.
Results Reference
background
PubMed Identifier
26156587
Citation
Labrique AB, Palmer AC, Healy K, Mehra S, Sauer TC, West KP Jr, Sommer A. A novel device for assessing dark adaptation in field settings. BMC Ophthalmol. 2015 Jul 9;15:74. doi: 10.1186/s12886-015-0062-7.
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
20810977
Citation
Li S, Nugroho A, Rocheford T, White WS. Vitamin A equivalence of the ss-carotene in ss-carotene-biofortified maize porridge consumed by women. Am J Clin Nutr. 2010 Nov;92(5):1105-12. doi: 10.3945/ajcn.2010.29802. Epub 2010 Sep 1.
Results Reference
background
PubMed Identifier
33693468
Citation
Palmer AC, Jobarteh ML, Chipili M, Greene MD, Oxley A, Lietz G, Mwanza R, Haskell MJ. Biofortified and fortified maize consumption reduces prevalence of low milk retinol, but does not increase vitamin A stores of breastfeeding Zambian infants with adequate reserves: a randomized controlled trial. Am J Clin Nutr. 2021 May 8;113(5):1209-1220. doi: 10.1093/ajcn/nqaa429.
Results Reference
derived
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Efficacy of Biofortified Maize to Improve Maternal and Infant Vitamin A Status
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