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

• Sponsor: University of Colorado, Denver (Other)
• Overall Status: Completed
• CT.gov ID: NCT02760095
• Collaborator: International Centre for Diarrhoeal Disease Research, Bangladesh (Other)
• Enrollment: 46
• Locations: 2
• Actual Duration (Months): 19
• Patients Per Site: 23
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Environmental Enteric Dysfunction; Zinc Deficiency; Vitamin A Deficiency	Drug: 3 mg zinc sulfate supplement; Drug: 0.5 mg of 13C10-retinyl-acetate

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 46 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official 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
• Actual Study Start Date: Nov 1, 2015
• Actual Primary Completion Date: Jun 1, 2017
• Actual Study Completion Date: Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Children with EED 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).	Drug: 3 mg zinc sulfate supplement; Drug: 0.5 mg of 13C10-retinyl-acetate; Other Names: Vitamin A isotope
Children without EED 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).	Drug: 3 mg zinc sulfate supplement; Drug: 0.5 mg of 13C10-retinyl-acetate; Other Names: Vitamin A isotope

Outcome Measures

Primary Outcome Measures

1. Absorption of zinc (AZ) from standard dose [1 day]

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

2. Endogenous fecal zinc (EFZ) [4 days]

   EFZ measured from zinc isotope ratios in complete fecal collections

3. Vitamin A absorption [1 day]

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

Secondary Outcome Measures

1. Plasma zinc [1 day]

   Plasma zinc concentration

2. Alkaline phosphatase [1 day]

3. Serum retinol [1 day]

4. Methyl malonic acid [1 day]

   serum

5. Vitamin B12 [1 day]

6. Serum ferritin [1 day]

7. Soluble transferrin receptors [1 day]

8. C-reactive Protein (CRP) [1 day]

9. Alpha-Glycoprotein (AGP) [1 day]

10. Tumor necrosis factor (TNF) alpha [1 day]

11. Serum endocab [1 day]

12. Fecal neopterin [1 day]

13. Myeloperoxidase [1 day]

14. Alpha 1 antitrypsin [1 day]

15. Calprotectin [1 day]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Months to 24 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Denver School of Medicine	Aurora	Colorado	United States	80045
2	icddr,b (International Centre for Diarrheal Disease Research, Bangladesh	Dhaka		Bangladesh

Sponsors and Collaborators

• University of Colorado, Denver
• International Centre for Diarrhoeal Disease Research, Bangladesh

Investigators

• Principal Investigator: Nancy F Krebs, MD, MS, University of Colorado, Denver

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT02760095
• Other Study ID Numbers: 14-2430A
• First Posted: May 3, 2016
• Last Update Posted: Jul 1, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by University of Colorado, Denver: environmental enteric dysfunction; environmental enteropathy; zinc; vitamin A; Bangladesh
• Additional relevant MeSH terms: Night Blindness; Vitamin A Deficiency; Vitamin A; Acetic Acid; Retinol acetate; Zinc Sulfate

Study Results

No Results Posted as of Jul 1, 2019