Environmental Enteric DysfunctionZEED1NCT02760095
Effects of EED on Zn Absorption and Retention in Children From a Standard Dose
An observational study of Environmental Enteric Dysfunction and Zinc Deficiency, run by University of Colorado, Denver at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Environmental Enteric Dysfunction, Zinc Deficiency, Vitamin A Deficiency
- What is being tested?
- 3 mg zinc sulfate supplement and 0.5 mg of 13C10-retinyl-acetate
- How many people
- 46 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2015to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Toddlers aged 18-24 mos living in Dhaka, Bangladesh
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of Colorado Denver School of Medicine
Aurora, Colorado, 80045
Bangladesh1 site
icddr,b (International Centre for Diarrheal Disease Research, Bangladesh
Dhaka
About this study
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
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.
Read the 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.
- Being tested
- 3 mg zinc sulfate supplement, 0.5 mg of 13C10-retinyl-acetate
- Keywords
- environmental enteric dysfunction, environmental enteropathy, zinc, vitamin A, Bangladesh
- Medical subject headings
- Vitamin A Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 mg zinc sulfate supplementDrug
0.5 mg of 13C10-retinyl-acetateDrug
Also called Vitamin A isotope
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: 3 mg zinc sulfate supplement; Drug: 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). Receives: Drug: 3 mg zinc sulfate supplement; Drug: 0.5 mg of 13C10-retinyl-acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absorption of zinc (AZ) from standard dose
Absorption of zinc from standard 3 mg dose will be measured using zinc isotope tracer methods
Measured: 1 day
Endogenous fecal zinc (EFZ)
EFZ measured from zinc isotope ratios in complete fecal collections
Measured: 4 days
Vitamin A absorption
Absorption efficiency of retinol will be measured by isotope ratios in blood
Measured: 1 day
Secondary outcomes (15)
Plasma zinc
Plasma zinc concentration
Measured: 1 day
Alkaline phosphatase
Measured: 1 day
Serum retinol
Measured: 1 day
Methyl malonic acid
serum
Measured: 1 day
Vitamin B12
Measured: 1 day
Serum ferritin
Measured: 1 day
Soluble transferrin receptors
Measured: 1 day
C-reactive Protein (CRP)
Measured: 1 day
Alpha-Glycoprotein (AGP)
Measured: 1 day
Tumor necrosis factor (TNF) alpha
Measured: 1 day
Serum endocab
Measured: 1 day
Fecal neopterin
Measured: 1 day
Myeloperoxidase
Measured: 1 day
Alpha 1 antitrypsin
Measured: 1 day
Calprotectin
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study startNov 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Environmental Enteric DysfunctionStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Responsible party
- Sponsor
- Investigators
- Nancy F Krebs, MD, MS, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02760095
- Sponsor's protocol ID
- 14-2430A
- Acronym
- ZEED1
- Status last verified
- Jun 2019
- First submitted
- 24 Jul 2015
- Last updated
- 1 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31033623
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02760095
- Acronym / sponsor ID
- ZEED1 / 14-2430A
- Keywords
- environmental enteric dysfunction, environmental enteropathy, zinc, vitamin A, Bangladesh
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Study start
- Nov 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 3 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with EED | – | Drug: 3 mg zinc sulfate supplement, Drug: 0.5 mg of 13C10-retinyl-acetateChildren 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). |
| Children without EED | – | Drug: 3 mg zinc sulfate supplement, Drug: 0.5 mg of 13C10-retinyl-acetateChildren 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). |
Who may qualify
- Ages
- 18 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Toddlers aged 18-24 mos living in Dhaka, Bangladesh
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3 mg zinc sulfate supplement | Drug | Children with EED, Children without EED |
| 0.5 mg of 13C10-retinyl-acetateAlso: Vitamin A isotope | Drug | Children with EED, Children without EED |
Primary outcome
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
15 secondary outcomes
Plasma zinc
Time frame: 1 day
Alkaline phosphatase
Time frame: 1 day
Serum retinol
Time frame: 1 day
Methyl malonic acid
Time frame: 1 day
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2019.
- Derived from this study: PubMed 31033623Mondal 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.
- Individual participant dataSharing planned: No
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Effect of Hygiene and Menstrual Hygiene Interventions on Learning and Psychosocial Wellbeing in Madagascar
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Not yet recruitingPhase 2
Glucagon-like Peptide 2 (GLP-2) in Undernourished Women Improving From Histology-Confirmed Environmental Enteric Dysfunction (EED)
Environmental Enteric Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy F Krebs, MD, MS principal investigator
University of Colorado, Denver
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Environmental Enteric Dysfunction and Zinc Deficiency, run by University of Colorado, Denver at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absorption of zinc (AZ) from standard dose (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02760095, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2019.