Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2026-02-20 @ 4:49 PM
Study NCT ID:
NCT02760095
Status:
COMPLETED
Last Update Posted:
2019-07-01
First Post:
2015-07-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of EED on Zn Absorption and Retention in Children From a Standard Dose
Sponsor:
University of Colorado, Denver
Organization:
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 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.
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.
Study Oversight
Has Oversight DMC:
False
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?: