Viewing Study NCT02760095



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Last Modification Date: 2024-10-26 @ 12:01 PM
Study NCT ID: NCT02760095
Status: COMPLETED
Last Update Posted: 2019-07-01
First Post: 2015-07-24

Brief Title: Effects of EED on Zn Absorption and Retention in Children From a Standard Dose
Sponsor: University of Colorado Denver
Organization: University of Colorado Denver

Study Overview

Official Title: Effects of Environmental Enteric Dysfunction EED on Zinc Zn Absorption and Retention in Young Children Study 1 - Absorption of Zn and Vitamin A From a Standard Dose
Status: COMPLETED
Status Verified Date: 2019-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ZEED1
Brief Summary: 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
Detailed Description: Participating children are screened for EED using the lactulosemannitol 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 05 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None