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| Name | Class |
|---|---|
| National Food and Nutrition Commission, Zambia | UNKNOWN |
| Tropical Diseases Research Centre, Zambia | OTHER_GOV |
| HarvestPlus | OTHER |
| Canadian International Development Agency |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| White Maize Flour | Active Comparator | Children will receive 2 meals a day (~200 g of white maize flour), 6 days a week for 6 months. |
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| β-Carotene Biofortified Maize | Experimental | Children will receive 2 meals a day (~200 g of beta-carotene biofortified maize flour), 6 days a week for 6 months. |
|
| Non-Intervened | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| β-Carotene Biofortified Maize Flour | Dietary Supplement |
| ||
| White Maize Flour |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After 6 months of feeding |
| 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%. | After 6 months of feeding |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After 6 months of Feeding |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amanda C Palmer, PhD | Johns Hopkins Bloomberg School of Public Health | Study Director |
| Rolf Klemm, DrPH | Johns Hopkins Bloomberg School of Public Health | Study Director |
| Kerry J Schulze, PhD | Johns Hopkins Bloomberg School of Public Health | Study Director |
| Alain Labrique, PhD | Johns Hopkins Bloomberg School of Public Health | Study Director |
| Parul Christian, DrPH | Johns Hopkins Bloomberg School of Public Health | Study Director |
| Sucheta Mehra, MS | Johns Hopkins Bloomberg School of Public Health | Study Director |
| Lee Shu-Fune Wu, MS | Johns Hopkins Bloomberg School of Public Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| JHU Office | Mkushi | Zambia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16988127 | Background | 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. | |
| 17032000 | Background | 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. |
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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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| OTHER_GOV |
| Zambia Agriculture Research Institute | OTHER |
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| Dietary Supplement |
|
| 18312712 | Background | 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. |
| 18616269 | Background | 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. |
| 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. |
| 29924320 | Derived | 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. |
| 29321687 | Derived | 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. |
| 28701387 | Derived | 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. |
| 27798345 | Derived | 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. |
| 27169838 | Derived | 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. |
| D009750 |
| Nutritional and Metabolic Diseases |