An interventional study of Micronutrient Powder (MNP) + 15 mg Zn and MNP + 10 mg Zn in Environmental Enteric Dysfunction and Zinc Deficiency, sponsored by University of Colorado, Denver. Completed at 2 sites in 2 countries. Open to participants aged 18 Months to 24 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-05.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Basic science
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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Exclusion Criteria:
1 sachet of Micronutrient Powder (MNP) + 15 mg Zn will be added to a single meal on study day 8
Dietary Supplement: Micronutrient Powder (MNP) + 15 mg Zn
1 sachet of MNP + 10 mg Zn will be added to a single meal on study day 8
Dietary Supplement: MNP + 10 mg Zn
1 sachet of MNP + 5 mg Zn will be added to a single meal on study day 8
Dietary Supplement: MNP + 5 mg Zn
1 sachet of MNP without Zn will be added to a single meal on study day 8
Dietary Supplement: MNP without Zn
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.
Same as above except MNP will contain 10 mg Zn
Same as above except MNP will contain 5 mg Zn
Same as above except MNP will not contain Zn
Total daily absorbed zinc (TAZ)
Measured during the meal to determine the effects of EED on zinc absorption.
Time frame: 1 day
Exchangeable zinc pool (EZP)
Size of exchangeable Zn pool (EZP) measured with zinc isotope methods prior to the meal.
Time frame: 1 day
Plasma zinc
Measured prior to the meal.
Time frame: 1 day
Alkaline phosphatase
Measured prior to the meal.
Time frame: 1 day
Serum retinol
Measured prior to the meal.
Time frame: 1 day
Methyl malonic acid
Measured prior to the meal.
Time frame: 1 day
Vitamin B12
Measured prior to the meal.
Time frame: 1 day
Serum ferritin
Measured prior to the meal.
Time frame: 1 day
Soluble transferrin receptors
Measured prior to the meal.
Time frame: 1 day
CRP
Measured prior to the meal.
Time frame: 1 day
AGP
Measured prior to the meal.
Time frame: 1 day
TNF alpha
Measured prior to the meal.
Time frame: 1 day
Serum endocab
Measured prior to the meal.
Time frame: 1 day
Neopterin
Measured prior to the meal.
Time frame: 1 day
Myeloperoxidase
Measured prior to the meal.
Time frame: 1 day
Calprotectin
Measured prior to the meal.
Time frame: 1 day
alpha 1 antitrypsin
Measured prior to the meal.
Time frame: 1 day
Plan to share: Yes
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver