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The purpose of this study is to investigate the therapeutic effectiveness of micronutrients (full RDA) and micronutrients + fish oil as separate interventions in restoring normal gut absorptive and immunological function as measured by the dual sugar permeability test and additional biomarkers in 1-3 year old rural Malawian children at high risk for Environmental Enteropathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fish oil and Micronutrient Supplementation | Experimental |
| |
| Micronutrient Supplementation | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fish oil and Micronutrient Supplementation | Dietary Supplement | 0.9 mL highly purified fish oil (200 mg docosahexaenoic acid, 300 mg eicosapentaenoic acid) to be given daily for 6 months 1 RDA of all known micronutrients needed for normal child growth in powder form to be given daily for 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in urine lactulose:mannitol (L:M) ratio following therapy course. | 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the expression of several fecal mRNAs | 3 months, 6 months | |
| Changes in amounts of lactulose and mannitol excreted in the urine as a percentage of the amounts ingested | 3 months, 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark J Manary, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Louis Nutrition Project | Blantyre | Malawi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25411039 | Derived | Smith HE, Ryan KN, Stephenson KB, Westcott C, Thakwalakwa C, Maleta K, Cheng JY, Brenna JT, Shulman RJ, Trehan I, Manary MJ. Multiple micronutrient supplementation transiently ameliorates environmental enteropathy in Malawian children aged 12-35 months in a randomized controlled clinical trial. J Nutr. 2014 Dec;144(12):2059-65. doi: 10.3945/jn.114.201673. Epub 2014 Oct 1. |
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|
| Micronutrient Supplement | Dietary Supplement | 1 RDA all known micronutrients needed for normal child growth to be given daily in powder form for 6 months 0.9 mL palm oil given daily for 6 months |
|
| Placebo | Drug | 10 g sugar in granule form to be given daily for 6 months 0.9 mL palm oil to be given daily for 6 months |
|
| Change in height | 3 month, 6 month |
| ID | Term |
|---|---|
| D005395 | Fish Oils |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
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