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The purpose of this study is to investigate the therapeutic effectiveness of high-dose zinc therapy and de-worming albendazole 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 |
|---|---|---|---|
| Zinc therapy | Experimental | High-dose zinc, equivalent 20 mg elemental zinc, to be given once per day for 14 days |
|
| Albendazole | Experimental | Albendazole to be given once on the day of enrollment. Placebo will then be given for 13 days following. |
|
| Placebo | Placebo Comparator | Placebo will be given for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albendazole | Drug | Pill form, to be given once, 200 mg dosage for children 1-2 years of age, 400 mg dosage for children 2-3 years of age |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in urine lactulose:mannitol (L:M) ratio following therapy course. | 4 weeks, 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood endoCAb | 7 weeks | |
| Change in fecal calprotectin mRNA | 4 weeks, 7 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark J Manary, MD | 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 |
|---|---|---|---|
| 24462483 | Derived | Ryan KN, Stephenson KB, Trehan I, Shulman RJ, Thakwalakwa C, Murray E, Maleta K, Manary MJ. Zinc or albendazole attenuates the progression of environmental enteropathy: a randomized controlled trial. Clin Gastroenterol Hepatol. 2014 Sep;12(9):1507-13.e1. doi: 10.1016/j.cgh.2014.01.024. Epub 2014 Jan 22. |
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| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D015766 | Albendazole |
| D015032 | Zinc |
| ID | Term |
|---|---|
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Pill form, 400 mg dose to be given once per day for 14 days in Placebo arm and 13 days in Albendazole arm following one dose of Albendazole. |
|
| High-dose Zinc | Dietary Supplement | Pill form, equivalent to 20 mg elemental zinc, to be given once per day for 14 days |
|
| D001562 |
| Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |