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

University of Colorado, Denver80 enrolled

Overview

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..

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Environmental Enteric Dysfunction Zinc Deficiency

Interventions

Micronutrient Powder (MNP) + 15 mg ZnDIETARY_SUPPLEMENT

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 ZnDIETARY_SUPPLEMENT

Same as above except MNP will contain 10 mg Zn

MNP + 5 mg ZnDIETARY_SUPPLEMENT

Same as above except MNP will contain 5 mg Zn

Eligibility

Sex: ALLMin age: 18 MonthsMax age: 24 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

University of Colorado Denver

Aurora, Colorado, United States

icddr,b (International Centre for Diarrheal Disease Research, Bangladesh

Dhaka, Bangladesh

Outcomes

Primary Outcomes

Total daily absorbed zinc (TAZ)

Measured during the meal to determine the effects of EED on zinc absorption.

Time frame: 1 day

Secondary Outcomes

Exchangeable zinc pool (EZP)

Size of exchangeable Zn pool (EZP) measured with zinc isotope methods prior to the meal.

Time frame: 1 day

Plasma zinc

Measured prior to the meal.

Time frame: 1 day

Alkaline phosphatase

Measured prior to the meal.

Time frame: 1 day

Serum retinol

Measured prior to the meal.

Time frame: 1 day

Methyl malonic acid

Measured prior to the meal.

Time frame: 1 day

Vitamin B12

Measured prior to the meal.

Time frame: 1 day

Serum ferritin

Measured prior to the meal.

Time frame: 1 day

Soluble transferrin receptors

Measured prior to the meal.

Time frame: 1 day

CRP

Measured prior to the meal.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.