ZEED2: Effects of EED on Zn Absorption and Retention in Children From a MNP

Sponsor

University of Colorado, Denver (Other)

Overall Status

Completed

CT.gov ID

NCT02758444

Collaborator

International Centre for Diarrhoeal Disease Research, Bangladesh (Other)

Enrollment

Locations

Arms

Actual Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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..

Condition or Disease	Intervention/Treatment	Phase
Environmental Enteric Dysfunction Zinc Deficiency	Dietary Supplement: Micronutrient Powder (MNP) + 15 mg Zn Dietary Supplement: MNP + 10 mg Zn Dietary Supplement: MNP + 5 mg Zn Dietary Supplement: MNP without Zn	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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)

Actual Study Start Date :

Nov 1, 2015

Actual Primary Completion Date :

Mar 1, 2018

Actual Study Completion Date :

Feb 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	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.
Active Comparator: MNP + 10 mg Zn 1 sachet of MNP + 10 mg Zn will be added to a single meal on study day 8	Dietary Supplement: MNP + 10 mg Zn Same as above except MNP will contain 10 mg Zn
Active Comparator: MNP + 5 mg Zn 1 sachet of MNP + 5 mg Zn will be added to a single meal on study day 8	Dietary Supplement: MNP + 5 mg Zn Same as above except MNP will contain 5 mg Zn
Placebo Comparator: MNP without Zn 1 sachet of MNP without Zn will be added to a single meal on study day 8	Dietary Supplement: MNP without Zn Same as above except MNP will not contain Zn

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Months to 24 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Denver	Aurora	Colorado	United States	80045
2	icddr,b (International Centre for Diarrheal Disease Research, Bangladesh	Dhaka		Bangladesh