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

Vitamin A Deficiency Clinical Trial

— ZEED1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02760095
• Other study ID #: 14-2430A
• Status: Completed
• Start date: November 2015
• Est. completion date: June 2017

Study information

• Verified date: June 2019
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Environmental Enteric Dysfunction
• Night Blindness
• Vitamin A Deficiency
• Zinc Deficiency

Intervention

Drug:
• 3 mg zinc sulfate supplement

• 0.5 mg of 13C10-retinyl-acetate

Locations

Country	Name	City	State
Bangladesh	icddr,b (International Centre for Diarrheal Disease Research, Bangladesh	Dhaka
United States	University of Colorado Denver School of Medicine	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	International Centre for Diarrhoeal Disease Research, Bangladesh

Countries where clinical trial is conducted

United States,  Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absorption of zinc (AZ) from standard dose	Absorption of zinc from standard 3 mg dose will be measured using zinc isotope tracer methods	1 day
Primary	Endogenous fecal zinc (EFZ)	EFZ measured from zinc isotope ratios in complete fecal collections	4 days
Primary	Vitamin A absorption	Absorption efficiency of retinol will be measured by isotope ratios in blood	1 day
Secondary	Plasma zinc	Plasma zinc concentration	1 day
Secondary	Alkaline phosphatase		1 day
Secondary	Serum retinol		1 day
Secondary	Methyl malonic acid	serum	1 day
Secondary	Vitamin B12		1 day
Secondary	Serum ferritin		1 day
Secondary	Soluble transferrin receptors		1 day
Secondary	C-reactive Protein (CRP)		1 day
Secondary	Alpha-Glycoprotein (AGP)		1 day
Secondary	Tumor necrosis factor (TNF) alpha		1 day
Secondary	Serum endocab		1 day
Secondary	Fecal neopterin		1 day
Secondary	Myeloperoxidase		1 day
Secondary	Alpha 1 antitrypsin		1 day
Secondary	Calprotectin		1 day