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| Name | Class |
|---|---|
| International Centre for Diarrhoeal Disease Research, Bangladesh | OTHER |
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The overall objective is to determine the impact of EED on zinc absorption and homeostasis, and its impact on the absorptive capacity of vitamin A absorption of young children (18-24 months of age) in an austere setting with high rates of diarrhea, stunting, and micro-nutrient deficiencies.
Participating children are screened for EED using the lactulose:mannitol ratio test and assigned to one of two groups: +EED or -EED. All participants will be given standard, physiological dose of 3 mg zinc sulfate with a zinc stable isotope tracer on study day 8.
On study day 11, 0.5 mg of 13C10-retinyl-acetate will be administered orally to all participants.
Spot urine samples will be collected twice daily from study days 11-14. Complete fecal collections will be obtained for days 11-14. Duplicate diets of all foods consumed will be collected on days 11-14. On study day 14, a blood sample will be taken for analysis of vitamin A isotope status.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children with EED | Children are placed in this arm if they screen positive for EED using the urinary lactulose:mannitol (L:M) recovery ratio. Children will receive a one-time 3 mg standard dose of zinc sulfate with stable isotope zinc tracer and 0.5 mg standard dose of 13C10-retinyl-acetate (vitamin A isotope). |
| |
| Children without EED | Children are placed in this arm if they screen negative for EED using the urinary lactulose:mannitol (L:M) recovery ratio. Children will receive a one-time 3 mg standard dose of zinc sulfate with stable isotope zinc tracer and 0.5 mg standard dose of 13C10-retinyl-acetate (vitamin A isotope). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3 mg zinc sulfate supplement | Drug |
| ||
| 0.5 mg of 13C10-retinyl-acetate |
| Measure | Description | Time Frame |
|---|---|---|
| Absorption of zinc (AZ) from standard dose | Absorption of zinc from standard 3 mg dose will be measured using zinc isotope tracer methods | 1 day |
| Endogenous fecal zinc (EFZ) | EFZ measured from zinc isotope ratios in complete fecal collections | 4 days |
| Vitamin A absorption | Absorption efficiency of retinol will be measured by isotope ratios in blood | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma zinc | Plasma zinc concentration | 1 day |
| Alkaline phosphatase | 1 day | |
| Serum retinol |
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Inclusion Criteria:
Exclusion Criteria:
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Toddlers aged 18-24 mos living in Dhaka, Bangladesh
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| Name | Affiliation | Role |
|---|---|---|
| Nancy F Krebs, MD, MS | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver School of Medicine | Aurora | Colorado | 80045 | United States | ||
| icddr,b (International Centre for Diarrheal Disease Research, Bangladesh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31033623 | Derived | Mondal P, Long JM, Westcott JE, Islam MM, Ahmed M, Mahfuz M, Ahmed T, Miller LV, Krebs NF. Zinc Absorption and Endogenous Fecal Zinc Losses in Bangladeshi Toddlers at Risk for Environmental Enteric Dysfunction. J Pediatr Gastroenterol Nutr. 2019 Jun;68(6):874-879. doi: 10.1097/MPG.0000000000002361. |
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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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Spot urine samples x 4 days; complete fecal collections x 4 days; blood sample
| Drug |
|
|
| 1 day |
| Methyl malonic acid | serum | 1 day |
| Vitamin B12 | 1 day |
| Serum ferritin | 1 day |
| Soluble transferrin receptors | 1 day |
| C-reactive Protein (CRP) | 1 day |
| Alpha-Glycoprotein (AGP) | 1 day |
| Tumor necrosis factor (TNF) alpha | 1 day |
| Serum endocab | 1 day |
| Fecal neopterin | 1 day |
| Myeloperoxidase | 1 day |
| Alpha 1 antitrypsin | 1 day |
| Calprotectin | 1 day |
| Dhaka |
| Bangladesh |
| D009750 |
| Nutritional and Metabolic Diseases |