Ignite Creation Date:
2024-05-06 @ 8:33 AM
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
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