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OpenTrials
Completed

NCT Number: NCT02758444

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

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..

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Key information

Age range

18 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Micronutrient Powder (MNP) + 15 mg Zn

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

Dietary Supplement

Same as above except MNP will contain 10 mg Zn

MNP + 5 mg Zn

Dietary Supplement

Same as above except MNP will contain 5 mg Zn

MNP without Zn

Dietary Supplement

Same as above except MNP will not contain Zn

Primary outcomes

  1. Total daily absorbed zinc (TAZ)

    Time frame: 1 day

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

Secondary outcomes

  1. Exchangeable zinc pool (EZP)

    Time frame: 1 day

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

  2. Plasma zinc

    Time frame: 1 day

    Measured prior to the meal.

  3. Alkaline phosphatase

    Time frame: 1 day

    Measured prior to the meal.

  4. Serum retinol

    Time frame: 1 day

    Measured prior to the meal.

  5. Methyl malonic acid

    Time frame: 1 day

    Measured prior to the meal.

  6. Vitamin B12

    Time frame: 1 day

    Measured prior to the meal.

  7. Serum ferritin

    Time frame: 1 day

    Measured prior to the meal.

  8. Soluble transferrin receptors

    Time frame: 1 day

    Measured prior to the meal.

  9. CRP

    Time frame: 1 day

    Measured prior to the meal.

  10. AGP

    Time frame: 1 day

    Measured prior to the meal.

  11. TNF alpha

    Time frame: 1 day

    Measured prior to the meal.

  12. Serum endocab

    Time frame: 1 day

    Measured prior to the meal.

  13. Neopterin

    Time frame: 1 day

    Measured prior to the meal.

  14. Myeloperoxidase

    Time frame: 1 day

    Measured prior to the meal.

  15. Calprotectin

    Time frame: 1 day

    Measured prior to the meal.

  16. alpha 1 antitrypsin

    Time frame: 1 day

    Measured prior to the meal.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

Registry information

Official study 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)

Acronym: ZEED2

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
May 2, 2016
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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