Effects of EED on Zn Absorption and Retention in Children From a Standard Dose (ZEED1)

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status

Completed

Conditions

Vitamin A Deficiency
Zinc Deficiency
Environmental Enteric Dysfunction

Treatments

Drug: 3 mg zinc sulfate supplement
Drug: 0.5 mg of 13C10-retinyl-acetate

Study type

Observational

Funder types

Other

Identifiers

NCT02760095
14-2430A

Details and patient eligibility

About

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.

Full description

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.

Enrollment

46 patients

Sex

All

Ages

18 to 24 months old

Volunteers

Accepts Healthy Volunteers

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

Trial design

46 participants in 2 patient groups

Children with EED
Description:
Children are placed in this arm if they screen positive for EED using the urinary lactulose:mannitol (L:M) recovery ratio. Children will receive a one-time 3 mg standard dose of zinc sulfate with stable isotope zinc tracer and 0.5 mg standard dose of 13C10-retinyl-acetate (vitamin A isotope).
Treatment:
Drug: 0.5 mg of 13C10-retinyl-acetate
Drug: 3 mg zinc sulfate supplement
Children without EED
Description:
Children are placed in this arm if they screen negative for EED using the urinary lactulose:mannitol (L:M) recovery ratio. Children will receive a one-time 3 mg standard dose of zinc sulfate with stable isotope zinc tracer and 0.5 mg standard dose of 13C10-retinyl-acetate (vitamin A isotope).
Treatment:
Drug: 0.5 mg of 13C10-retinyl-acetate
Drug: 3 mg zinc sulfate supplement

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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