NCT02760095

Effects of EED on Zn Absorption and Retention in Children From a Standard Dose

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
• Phase: —
• Study type: Observational
• Enrollment: 46 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Months – 24 Months
• Healthy volunteers: Accepted

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.

Conditions

• Environmental Enteric Dysfunction
• Zinc Deficiency
• Vitamin A Deficiency

Interventions

Type	Name	Description
DRUG	3 mg zinc sulfate supplement
DRUG	0.5 mg of 13C10-retinyl-acetate

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2016-05-03
• Last updated: 2019-07-01

Locations

2 sites across 2 countries: United States, Bangladesh