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

NCT ID: NCT02758444

Last Updated: 2019-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2019-02-28

Brief Summary

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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

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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

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Environmental Enteric Dysfunction Zinc Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Micronutrient Powder (MNP) + 15 mg Zn

Intervention Type DIETARY_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 Zn

1 sachet of MNP + 10 mg Zn will be added to a single meal on study day 8

Group Type ACTIVE_COMPARATOR

MNP + 10 mg Zn

Intervention Type DIETARY_SUPPLEMENT

Same as above except MNP will contain 10 mg Zn

MNP + 5 mg Zn

1 sachet of MNP + 5 mg Zn will be added to a single meal on study day 8

Group Type ACTIVE_COMPARATOR

MNP + 5 mg Zn

Intervention Type DIETARY_SUPPLEMENT

Same as above except MNP will contain 5 mg Zn

MNP without Zn

1 sachet of MNP without Zn will be added to a single meal on study day 8

Group Type PLACEBO_COMPARATOR

MNP without Zn

Intervention Type DIETARY_SUPPLEMENT

Same as above except MNP will not contain Zn

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

MNP + 10 mg Zn

Same as above except MNP will contain 10 mg Zn

Intervention Type DIETARY_SUPPLEMENT

MNP + 5 mg Zn

Same as above except MNP will contain 5 mg Zn

Intervention Type DIETARY_SUPPLEMENT

MNP without Zn

Same as above except MNP will not contain Zn

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Months

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nancy F Krebs, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Denver

Aurora, Colorado, United States

Site Status

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

Dhaka, , Bangladesh

Site Status

Countries

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United States Bangladesh

References

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Long JM, Mondal P, Westcott JE, Miller LV, Islam MM, Ahmed M, Mahfuz M, Ahmed T, Krebs NF. Zinc Absorption from Micronutrient Powders Is Low in Bangladeshi Toddlers at Risk of Environmental Enteric Dysfunction and May Increase Dietary Zinc Requirements. J Nutr. 2019 Jan 1;149(1):98-105. doi: 10.1093/jn/nxy245.

Reference Type DERIVED
PMID: 30624753 (View on PubMed)

Other Identifiers

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14-2430B

Identifier Type: -

Identifier Source: org_study_id

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