Environmental Enteric Dysfunction, Vitamin A Deficiency, Zinc Deficiency
Conditions
Keywords
environmental enteric dysfunction, environmental enteropathy, zinc, vitamin A, Bangladesh
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.
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.
Interventions
DRUG3 mg zinc sulfate supplement
DRUG0.5 mg of 13C10-retinyl-acetate
Sponsors
International Centre for Diarrhoeal Disease Research, Bangladesh
University of Colorado, Denver
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Months to 24 Months
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Endogenous fecal zinc (EFZ) | 4 days | EFZ measured from zinc isotope ratios in complete fecal collections |
| Vitamin A absorption | 1 day | Absorption efficiency of retinol will be measured by isotope ratios in blood |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum ferritin | 1 day | — |
| Soluble transferrin receptors | 1 day | — |
| C-reactive Protein (CRP) | 1 day | — |
| Alpha-Glycoprotein (AGP) | 1 day | — |
| Tumor necrosis factor (TNF) alpha | 1 day | — |
| Serum endocab | 1 day | — |
| Serum retinol | 1 day | — |
| Myeloperoxidase | 1 day | — |
| Alpha 1 antitrypsin | 1 day | — |
| Calprotectin | 1 day | — |
| Plasma zinc | 1 day | Plasma zinc concentration |
| Alkaline phosphatase | 1 day | — |
| Fecal neopterin | 1 day | — |
| Methyl malonic acid | 1 day | serum |
| Vitamin B12 | 1 day | — |
Countries
Bangladesh, United States
Outcome results
None listed