Clinical trial NCT02760095: Effects of EED on Zn Absorption and Retention in Children From a Standard Dose
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Environmental Enteric Dysfunction
Zinc Deficiency
Vitamin A Deficiency
Keywords: environmental enteric dysfunction
environmental enteropathy
zinc
vitamin A
Bangladesh
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: International Centre for Diarrhoeal Disease Research, Bangladesh
First posted: 2016-05-03
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Toddlers aged 18-24 mos living in Dhaka, 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.

Eligibility criteria: 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

Primary outcomes:
measure: Absorption of zinc (AZ) from standard dose
timeFrame: 1 day
measure: Endogenous fecal zinc (EFZ)
timeFrame: 4 days
measure: Vitamin A absorption
timeFrame: 1 day
Secondary outcomes:
measure: Plasma zinc
timeFrame: 1 day
measure: Alkaline phosphatase
timeFrame: 1 day
measure: Serum retinol
timeFrame: 1 day
measure: Methyl malonic acid
timeFrame: 1 day
measure: Vitamin B12
timeFrame: 1 day
measure: Serum ferritin
timeFrame: 1 day
measure: Soluble transferrin receptors
timeFrame: 1 day
measure: C-reactive Protein (CRP)
timeFrame: 1 day
measure: Alpha-Glycoprotein (AGP)
timeFrame: 1 day
measure: Tumor necrosis factor (TNF) alpha
timeFrame: 1 day
measure: Serum endocab
timeFrame: 1 day
measure: Fecal neopterin
timeFrame: 1 day
measure: Myeloperoxidase
timeFrame: 1 day
measure: Alpha 1 antitrypsin
timeFrame: 1 day
measure: Calprotectin
timeFrame: 1 day
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver School of Medicine
state: Colorado
city: Dhaka
country: Bangladesh
facility: icddr,b (International Centre for Diarrheal Disease Research, Bangladesh
Study officials:
affiliation: University of Colorado, Denver
name: Nancy F Krebs, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mondal P, Long JM, Westcott JE, Islam MM, Ahmed M, Mahfuz M, Ahmed T, Miller LV, Krebs NF. Zinc Absorption and Endogenous Fecal Zinc Losses in Bangladeshi Toddlers at Risk for Environmental Enteric Dysfunction. J Pediatr Gastroenterol Nutr. 2019 Jun;68(6):874-879. doi: 10.1097/MPG.0000000000002361.