Efficacy of Biofortified Maize to Improve Maternal and Infant Vitamin A Status
NCT ID: NCT02804490
Last Updated: 2017-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
255 participants
INTERVENTIONAL
2016-03-31
2017-06-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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White maize
Conventional maize flour
Conventional white maize
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
Biofortified maize
Provitamin A carotenoid biofortified maize flour
Provitamin A carotenoid biofortified maize
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
Fortified maize
Retinyl palmitate fortified maize flour
Preformed vitamin A fortified maize
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
Interventions
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Conventional white maize
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
Provitamin A carotenoid biofortified maize
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
Preformed vitamin A fortified maize
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
45 Years
FEMALE
Yes
Sponsors
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University of California, Davis
OTHER
Newcastle University
OTHER
HarvestPlus
OTHER
Johns Hopkins Bloomberg School of Public Health
OTHER
Responsible Party
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Principal Investigators
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Amanda C Palmer, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins Bloomberg School of Public Health
Marjorie Haskell, PhD
Role: STUDY_DIRECTOR
University of California, Davis
Rose Mwanza, MD
Role: STUDY_DIRECTOR
Provincial Medical Office, Central Province, Zambia
Locations
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JHU Office
Mkushi, Central Province, Zambia
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2014H8314.JHU
Identifier Type: -
Identifier Source: org_study_id
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