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

Not Applicable

Completed

• Conditions: Environmental Enteric Dysfunction; Zinc Deficiency
• Interventions: Dietary Supplement: MNP + 10 mg Zn; Dietary Supplement: Micronutrient Powder (MNP) + 15 mg Zn; Dietary Supplement: MNP without Zn; Dietary Supplement: MNP + 5 mg Zn

• Registration Number: NCT02758444
• Lead Sponsor: University of Colorado, Denver

Brief 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.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-04-27
• Study First Submitted QC: 2016-04-28
• Study First Posted: 2016-05-02
• Primary Completion: 2018-03
• Study Completion: 2019-02
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-01
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Absence of apparent health problems that would impair ability to consume regular diet, to tolerate zinc supplements, or to comply with demands of metabolic studies
• Length for age Z (LAZ) score between -1.5 to -3.0
• Hg ≥ 8

Exclusion Criteria

• Outside age range
• Hb < 8
• Chronic illness
• Zinc supplement within past 2 weeks (including for treatment of diarrhea or MNP containing zinc)
• Severe stunting and/or severe acute malnutrition (SAM): LAZ <-3; WHZ <-3 or MUAC < 115 or edema

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MNP + 10 mg Zn	MNP + 10 mg Zn	1 sachet of MNP + 10 mg Zn will be added to a single meal on study day 8
Micronutrient Powder (MNP) + 15 mg Zn	Micronutrient Powder (MNP) + 15 mg Zn	1 sachet of Micronutrient Powder (MNP) + 15 mg Zn will be added to a single meal on study day 8
MNP without Zn	MNP without Zn	1 sachet of MNP without Zn will be added to a single meal on study day 8
MNP + 5 mg Zn	MNP + 5 mg Zn	1 sachet of MNP + 5 mg Zn will be added to a single meal on study day 8

Primary Outcome Measures

Name	Time	Method
Total daily absorbed zinc (TAZ)	1 day	Measured during the meal to determine the effects of EED on zinc absorption.

Secondary Outcome Measures

Name	Time	Method
Soluble transferrin receptors	1 day	Measured prior to the meal.
Plasma zinc	1 day	Measured prior to the meal.
Vitamin B12	1 day	Measured prior to the meal.
TNF alpha	1 day	Measured prior to the meal.
Neopterin	1 day	Measured prior to the meal.
Myeloperoxidase	1 day	Measured prior to the meal.
Serum ferritin	1 day	Measured prior to the meal.
Serum endocab	1 day	Measured prior to the meal.
alpha 1 antitrypsin	1 day	Measured prior to the meal.
Alkaline phosphatase	1 day	Measured prior to the meal.
Calprotectin	1 day	Measured prior to the meal.
Exchangeable zinc pool (EZP)	1 day	Size of exchangeable Zn pool (EZP) measured with zinc isotope methods prior to the meal.
AGP	1 day	Measured prior to the meal.
Serum retinol	1 day	Measured prior to the meal.
Methyl malonic acid	1 day	Measured prior to the meal.
CRP	1 day	Measured prior to the meal.

Trial Locations

Locations (2)

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States

icddr,b (International Centre for Diarrheal Disease Research, Bangladesh; 🇧🇩 Dhaka, Bangladesh