NCT02758444

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

Effects of Environmental Enteric Dysfunction (EED) on Zinc (Zn) Absorption and Retention in Young Children: Study 2 - Absorption of Zn From a Multi-micronutrient Powder (MNP)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• 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 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..

Detailed description

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.

Conditions

• Environmental Enteric Dysfunction
• Zinc Deficiency

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Micronutrient Powder (MNP) + 15 mg 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.
DIETARY_SUPPLEMENT	MNP + 10 mg Zn	Same as above except MNP will contain 10 mg Zn
DIETARY_SUPPLEMENT	MNP + 5 mg Zn	Same as above except MNP will contain 5 mg Zn
DIETARY_SUPPLEMENT	MNP without Zn	Same as above except MNP will not contain Zn

Timeline

• Start date: 2015-11-01
• Primary completion: 2018-03-01
• Completion: 2019-02-01
• First posted: 2016-05-02
• Last updated: 2019-07-05

Locations

2 sites across 2 countries: United States, Bangladesh