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| Name | Class |
|---|---|
| University of California, Davis | OTHER |
| Newcastle University | OTHER |
| HarvestPlus | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| White maize | Placebo Comparator | Conventional maize flour |
|
| Biofortified maize | Experimental | Provitamin A carotenoid biofortified maize flour |
|
| Fortified maize | Active Comparator | Retinyl palmitate fortified maize flour |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional white maize | Dietary Supplement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Infant vitamin A stores | Total body vitamin A stores of infants measured by retinol isotope dilution | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal breast milk retinol | Breast milk retinol concentrations of women measured by high performance liquid chromatography | 90 days |
| Maternal plasma retinol | Plasma retinol concentrations of women measured by high performance liquid chromatography |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amanda C Palmer, PhD | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Marjorie Haskell, PhD | University of California, Davis | Study Director |
| Rose Mwanza, MD | Provincial Medical Office, Central Province, Zambia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| JHU Office | Mkushi | Central Province | Zambia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25411289 | Background | 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. | |
| 27169838 |
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| ID | Term |
|---|---|
| D014802 | Vitamin A Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| Provitamin A carotenoid biofortified maize | Dietary Supplement | 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 | Dietary Supplement | 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 |
|
| 90 days |
| Maternal dark adaptation | Pupillary responsiveness of women measured by portable field dark adaptometer | 90 days |
| Background |
| 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. |
| 24158962 | Background | 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. |
| 26156587 | Background | 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. |
| 21715509 | Background | 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. |
| 20810977 | Background | 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. |
| 33693468 | Derived | 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. |
| D009750 |
| Nutritional and Metabolic Diseases |