Effects of EED on Zn Absorption and Retention in Children From a Standard Dose
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Food Studies, Ocular, Metabolic |
| Therapuetic Areas: | Ophthalmology, Pharmacology / Toxicology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 5/23/2018 |
| Start Date: | November 2015 |
| End Date: | June 2019 |
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
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.
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.
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.
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.
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
We found this trial at
2
sites
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68 Shaheed Tajuddin Ahmed Avenue
Dhaka, 1212
Dhaka, 1212
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