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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Conditions
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
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
0.5 mg of 13C10-retinyl-acetate
DrugOther names: Vitamin A isotope
Primary outcomes
-
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
-
Endogenous fecal zinc (EFZ)
Time frame: 4 days
EFZ measured from zinc isotope ratios in complete fecal collections
-
Vitamin A absorption
Time frame: 1 day
Absorption efficiency of retinol will be measured by isotope ratios in blood
Secondary outcomes
-
Plasma zinc
Time frame: 1 day
Plasma zinc concentration
-
Alkaline phosphatase
Time frame: 1 day
-
Serum retinol
Time frame: 1 day
-
Methyl malonic acid
Time frame: 1 day
serum
-
Vitamin B12
Time frame: 1 day
-
Serum ferritin
Time frame: 1 day
-
Soluble transferrin receptors
Time frame: 1 day
-
C-reactive Protein (CRP)
Time frame: 1 day
-
Alpha-Glycoprotein (AGP)
Time frame: 1 day
-
Tumor necrosis factor (TNF) alpha
Time frame: 1 day
-
Serum endocab
Time frame: 1 day
-
Fecal neopterin
Time frame: 1 day
-
Myeloperoxidase
Time frame: 1 day
-
Alpha 1 antitrypsin
Time frame: 1 day
-
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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