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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 total daily zinc absorption of young Bangladeshi 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. After assignment to one of the two groups, proposed subjects will be randomized to one of four supplement groups: Micronutrient powder (MNP) with 15 mg Zn, MNP with 10 mg Zn, MNP with 5 mg Zn, and MNP with 0 mg Zn. Children will receive the supplement once with a meal on Day 8 of the study. Absorption of zinc from the supplement and from other non-supplemented meals will be determined using zinc stable isotope technology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Micronutrient Powder (MNP) + 15 mg Zn | Active Comparator | 1 sachet of Micronutrient Powder (MNP) + 15 mg Zn will be added to a single meal on study day 8 |
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| MNP + 10 mg Zn | Active Comparator | 1 sachet of MNP + 10 mg Zn will be added to a single meal on study day 8 |
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| MNP + 5 mg Zn | Active Comparator | 1 sachet of MNP + 5 mg Zn will be added to a single meal on study day 8 |
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| MNP without Zn | Placebo Comparator | 1 sachet of MNP without Zn will be added to a single meal on study day 8 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micronutrient Powder (MNP) + 15 mg Zn | Dietary Supplement | Children will have the supplement powder added to one meal on study day 1. Absorption of zinc from this meal will be measured using zinc stable isotope techniques. |
| Measure | Description | Time Frame |
|---|---|---|
| Total daily absorbed zinc (TAZ) | Measured during the meal to determine the effects of EED on zinc absorption. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Exchangeable zinc pool (EZP) | Size of exchangeable Zn pool (EZP) measured with zinc isotope methods prior to the meal. | 1 day |
| Plasma zinc | Measured prior to the meal. |
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Inclusion Criteria:
Exclusion Criteria:
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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 | Aurora | Colorado | 80045 | United States | ||
| icddr,b (International Centre for Diarrheal Disease Research, Bangladesh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30624753 | Derived | Long JM, Mondal P, Westcott JE, Miller LV, Islam MM, Ahmed M, Mahfuz M, Ahmed T, Krebs NF. Zinc Absorption from Micronutrient Powders Is Low in Bangladeshi Toddlers at Risk of Environmental Enteric Dysfunction and May Increase Dietary Zinc Requirements. J Nutr. 2019 Jan 1;149(1):98-105. doi: 10.1093/jn/nxy245. |
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| MNP + 10 mg Zn | Dietary Supplement | Same as above except MNP will contain 10 mg Zn |
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| MNP + 5 mg Zn | Dietary Supplement | Same as above except MNP will contain 5 mg Zn |
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| MNP without Zn | Dietary Supplement | Same as above except MNP will not contain Zn |
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| 1 day |
| Alkaline phosphatase | Measured prior to the meal. | 1 day |
| Serum retinol | Measured prior to the meal. | 1 day |
| Methyl malonic acid | Measured prior to the meal. | 1 day |
| Vitamin B12 | Measured prior to the meal. | 1 day |
| Serum ferritin | Measured prior to the meal. | 1 day |
| Soluble transferrin receptors | Measured prior to the meal. | 1 day |
| CRP | Measured prior to the meal. | 1 day |
| AGP | Measured prior to the meal. | 1 day |
| TNF alpha | Measured prior to the meal. | 1 day |
| Serum endocab | Measured prior to the meal. | 1 day |
| Neopterin | Measured prior to the meal. | 1 day |
| Myeloperoxidase | Measured prior to the meal. | 1 day |
| Calprotectin | Measured prior to the meal. | 1 day |
| alpha 1 antitrypsin | Measured prior to the meal. | 1 day |
| Dhaka |
| Bangladesh |