NCT02760095

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2015

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 3, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

July 1, 2019

Status Verified

June 1, 2019

Enrollment Period

1.6 years

First QC Date

July 24, 2015

Last Update Submit

June 27, 2019

Conditions

Environmental Enteric DysfunctionZinc DeficiencyVitamin A Deficiency

Keywords

environmental enteric dysfunctionenvironmental enteropathyzincvitamin ABangladesh

Outcome Measures

Primary Outcomes (3)

  • 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

  • Endogenous fecal zinc (EFZ)

    EFZ measured from zinc isotope ratios in complete fecal collections

    4 days

  • Vitamin A absorption

    Absorption efficiency of retinol will be measured by isotope ratios in blood

    1 day

Secondary Outcomes (15)

  • Plasma zinc

    1 day

  • Alkaline phosphatase

    1 day

  • Serum retinol

    1 day

  • Methyl malonic acid

    1 day

  • Vitamin B12

    1 day

  • +10 more secondary outcomes

Study Arms (2)

Children with EED

Children are placed in this arm if they screen positive for EED using the urinary lactulose:mannitol (L:M) recovery ratio. Children will receive a one-time 3 mg standard dose of zinc sulfate with stable isotope zinc tracer and 0.5 mg standard dose of 13C10-retinyl-acetate (vitamin A isotope).

Drug: 3 mg zinc sulfate supplementDrug: 0.5 mg of 13C10-retinyl-acetate

Children without EED

Children are placed in this arm if they screen negative for EED using the urinary lactulose:mannitol (L:M) recovery ratio. Children will receive a one-time 3 mg standard dose of zinc sulfate with stable isotope zinc tracer and 0.5 mg standard dose of 13C10-retinyl-acetate (vitamin A isotope).

Drug: 3 mg zinc sulfate supplementDrug: 0.5 mg of 13C10-retinyl-acetate

Interventions

3 mg zinc sulfate supplementDRUG
Children with EEDChildren without EED
0.5 mg of 13C10-retinyl-acetateDRUG
Also known as: Vitamin A isotope
Children with EEDChildren without EED

Eligibility Criteria

Age18 Months - 24 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Toddlers aged 18-24 mos living in Dhaka, Bangladesh

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Colorado Denver School of Medicine

Aurora, Colorado, 80045, United States

Location

icddr,b (International Centre for Diarrheal Disease Research, Bangladesh

Dhaka, Bangladesh

Location

Related Publications (1)

  • 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.

    PMID: 31033623DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Spot urine samples x 4 days; complete fecal collections x 4 days; blood sample

MeSH Terms

Conditions

Vitamin A Deficiency

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Nancy F Krebs, MD, MS

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2015

First Posted

May 3, 2016

Study Start

November 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

July 1, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)BA(1)