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

Zinc Deficiency Clinical Trial

— ZEED2  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02758444
• Other study ID #: 14-2430B
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: February 2019

Study information

• Verified date: July 2019
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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..

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2019
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Environmental Enteric Dysfunction
• Zinc Deficiency

Intervention

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.
• MNP + 10 mg Zn
Same as above except MNP will contain 10 mg Zn
• MNP + 5 mg Zn
Same as above except MNP will contain 5 mg Zn
• MNP without Zn
Same as above except MNP will not contain Zn

Locations

Country	Name	City	State
Bangladesh	icddr,b (International Centre for Diarrheal Disease Research, Bangladesh	Dhaka
United States	University of Colorado Denver	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	International Centre for Diarrhoeal Disease Research, Bangladesh

Countries where clinical trial is conducted

United States,  Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total daily absorbed zinc (TAZ)	Measured during the meal to determine the effects of EED on zinc absorption.	1 day
Secondary	Exchangeable zinc pool (EZP)	Size of exchangeable Zn pool (EZP) measured with zinc isotope methods prior to the meal.	1 day
Secondary	Plasma zinc	Measured prior to the meal.	1 day
Secondary	Alkaline phosphatase	Measured prior to the meal.	1 day
Secondary	Serum retinol	Measured prior to the meal.	1 day
Secondary	Methyl malonic acid	Measured prior to the meal.	1 day
Secondary	Vitamin B12	Measured prior to the meal.	1 day
Secondary	Serum ferritin	Measured prior to the meal.	1 day
Secondary	Soluble transferrin receptors	Measured prior to the meal.	1 day
Secondary	CRP	Measured prior to the meal.	1 day
Secondary	AGP	Measured prior to the meal.	1 day
Secondary	TNF alpha	Measured prior to the meal.	1 day
Secondary	Serum endocab	Measured prior to the meal.	1 day
Secondary	Neopterin	Measured prior to the meal.	1 day
Secondary	Myeloperoxidase	Measured prior to the meal.	1 day
Secondary	Calprotectin	Measured prior to the meal.	1 day
Secondary	alpha 1 antitrypsin	Measured prior to the meal.	1 day