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Completed

NCT Number: NCT02760095

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

The overall objective is to determine the impact of EED on zinc absorption and homeostasis, and its impact on the absorptive capacity of vitamin A absorption of young 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

Observational

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. All participants will be given standard, physiological dose of 3 mg zinc sulfate with a zinc stable isotope tracer on study day 8.

On study day 11, 0.5 mg of 13C10-retinyl-acetate will be administered orally to all participants.

Spot urine samples will be collected twice daily from study days 11-14. Complete fecal collections will be obtained for days 11-14. Duplicate diets of all foods consumed will be collected on days 11-14. On study day 14, a blood sample will be taken for analysis of vitamin A isotope status.

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-score (LAZ) between -1.5 to -3.0
  • Hemoglobin (Hgb) ≥ 8

Exclusion criteria

  • Outside age range
  • Hgb < 8
  • Chronic illness
  • Recent diarrhea (within past 2 weeks, treated with supplemental zinc)
  • Severe stunting and/or severe acute malnutrition (SAM): LAZ <-3; Weight-for-age Z-score (WHZ) <-3 or mid-upper arm circumference (MUAC) < 115 or edema

Treatment and study plan

3 mg zinc sulfate supplement

Drug

0.5 mg of 13C10-retinyl-acetate

Drug

Other names: Vitamin A isotope

Primary outcomes

  1. Absorption of zinc (AZ) from standard dose

    Time frame: 1 day

    Absorption of zinc from standard 3 mg dose will be measured using zinc isotope tracer methods

  2. Endogenous fecal zinc (EFZ)

    Time frame: 4 days

    EFZ measured from zinc isotope ratios in complete fecal collections

  3. Vitamin A absorption

    Time frame: 1 day

    Absorption efficiency of retinol will be measured by isotope ratios in blood

Secondary outcomes

  1. Plasma zinc

    Time frame: 1 day

    Plasma zinc concentration

  2. Alkaline phosphatase

    Time frame: 1 day

  3. Serum retinol

    Time frame: 1 day

  4. Methyl malonic acid

    Time frame: 1 day

    serum

  5. Vitamin B12

    Time frame: 1 day

  6. Serum ferritin

    Time frame: 1 day

  7. Soluble transferrin receptors

    Time frame: 1 day

  8. C-reactive Protein (CRP)

    Time frame: 1 day

  9. Alpha-Glycoprotein (AGP)

    Time frame: 1 day

  10. Tumor necrosis factor (TNF) alpha

    Time frame: 1 day

  11. Serum endocab

    Time frame: 1 day

  12. Fecal neopterin

    Time frame: 1 day

  13. Myeloperoxidase

    Time frame: 1 day

  14. Alpha 1 antitrypsin

    Time frame: 1 day

  15. Calprotectin

    Time frame: 1 day

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 1 - Absorption of Zn and Vitamin A From a Standard Dose

Acronym: ZEED1

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 3, 2016
Registry last updated
Jul 1, 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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