Environmental Enteric DysfunctionZEED2NCT02758444
Effects of EED on Zn Absorption and Retention in Children From a MNP
A study testing Micronutrient Powder (MNP) + 15 mg Zn, MNP + 10 mg Zn and MNP + 5 mg Zn in people with 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 total daily zinc absorption of young Bangladeshi 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
- What is being tested?
- Micronutrient Powder (MNP) + 15 mg Zn, MNP + 10 mg Zn and MNP + 5 mg Zn
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2015to Feb 2019
- Phase
- Interventional
- 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
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 (LAZ) score between -1.5 to -3.0
- Hg ≥ 8
Who cannot join
- Outside age range
- Hb < 8
- Chronic illness
- Zinc supplement within past 2 weeks (including for treatment of diarrhea or MNP containing zinc)
- Severe stunting and/or severe acute malnutrition (SAM): LAZ <-3; WHZ <-3 or 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
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 2 - Absorption of Zn From a Multi-micronutrient Powder (MNP)
The overall objective is to determine the impact of EED on total daily zinc absorption of young Bangladeshi 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. After assignment to one of the two groups, proposed subjects will be randomized to one of four supplement groups: Micronutrient powder (MNP) with 15 mg Zn, MNP with 10 mg Zn, MNP with 5 mg Zn, and MNP with 0 mg Zn. Children will receive the supplement once with a meal on Day 8 of the study. Absorption of zinc from the supplement and from other non-supplemented meals will be determined using zinc stable isotope technology.
- Conditions
- Environmental Enteric Dysfunction, Zinc Deficiency
- Being tested
- Micronutrient Powder (MNP) + 15 mg Zn, MNP + 10 mg Zn, MNP + 5 mg Zn, MNP without Zn
- Keywords
- environmental enteric dysfunction, environmental enteropathy, zinc absorption, Bangladesh, toddlers, zinc isotope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micronutrient Powder (MNP) + 15 mg ZnDietary supplement
Children will have the supplement powder added to one meal on study day 1. Absorption of zinc from this meal will be measured using zinc stable isotope techniques.
MNP + 10 mg ZnDietary supplement
Same as above except MNP will contain 10 mg Zn
MNP + 5 mg ZnDietary supplement
Same as above except MNP will contain 5 mg Zn
MNP without ZnDietary supplement
Same as above except MNP will not contain Zn
| Study group | Role | What they receive |
|---|---|---|
| Micronutrient Powder (MNP) + 15 mg Zn | Active comparator | 1 sachet of Micronutrient Powder (MNP) + 15 mg Zn will be added to a single meal on study day 8 Receives: Dietary Supplement: Micronutrient Powder (MNP) + 15 mg Zn |
| MNP + 10 mg Zn | Active comparator | 1 sachet of MNP + 10 mg Zn will be added to a single meal on study day 8 Receives: Dietary Supplement: MNP + 10 mg Zn |
| MNP + 5 mg Zn | Active comparator | 1 sachet of MNP + 5 mg Zn will be added to a single meal on study day 8 Receives: Dietary Supplement: MNP + 5 mg Zn |
| MNP without Zn | Placebo comparator | 1 sachet of MNP without Zn will be added to a single meal on study day 8 Receives: Dietary Supplement: MNP without Zn |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total daily absorbed zinc (TAZ)
Measured during the meal to determine the effects of EED on zinc absorption.
Measured: 1 day
Secondary outcomes (16)
Exchangeable zinc pool (EZP)
Size of exchangeable Zn pool (EZP) measured with zinc isotope methods prior to the meal.
Measured: 1 day
Plasma zinc
Measured prior to the meal.
Measured: 1 day
Alkaline phosphatase
Measured prior to the meal.
Measured: 1 day
Serum retinol
Measured prior to the meal.
Measured: 1 day
Methyl malonic acid
Measured prior to the meal.
Measured: 1 day
Vitamin B12
Measured prior to the meal.
Measured: 1 day
Serum ferritin
Measured prior to the meal.
Measured: 1 day
Soluble transferrin receptors
Measured prior to the meal.
Measured: 1 day
CRP
Measured prior to the meal.
Measured: 1 day
AGP
Measured prior to the meal.
Measured: 1 day
TNF alpha
Measured prior to the meal.
Measured: 1 day
Serum endocab
Measured prior to the meal.
Measured: 1 day
Neopterin
Measured prior to the meal.
Measured: 1 day
Myeloperoxidase
Measured prior to the meal.
Measured: 1 day
Calprotectin
Measured prior to the meal.
Measured: 1 day
alpha 1 antitrypsin
Measured prior to the meal.
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 posted2 May 2016 (estimated)
- Study startNov 2015
- Primary completionMar 2018
- Study completionFeb 2019
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
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
- NCT02758444
- Sponsor's protocol ID
- 14-2430B
- Acronym
- ZEED2
- Status last verified
- Jul 2019
- First submitted
- 27 Apr 2016
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Long JM, Mondal P, Westcott JE, Miller LV, Islam MM, Ahmed M, Mahfuz M, Ahmed T, Krebs NF. Zinc Absorption from Micronutrient Powders Is Low in Bangladeshi Toddlers at Risk of Environmental Enteric Dysfunction and May Increase Dietary Zinc Requirements. J Nutr. 2019 Jan 1;149(1):98-105. doi: 10.1093/jn/nxy245.
PubMed 30624753
Study at a glance
From the registry record, last updated by the sponsor on 5 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 2 - Absorption of Zn From a Multi-micronutrient Powder (MNP)
- ClinicalTrials.gov ID
- NCT02758444
- Acronym / sponsor ID
- ZEED2 / 14-2430B
- Conditions
- Environmental Enteric Dysfunction, Zinc Deficiency
- Keywords
- environmental enteric dysfunction, environmental enteropathy, zinc absorption, Bangladesh, toddlers, zinc isotope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Study start
- Nov 2015 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 2 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 total daily zinc absorption of young Bangladeshi 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. After assignment to one of the two groups, proposed subjects will be randomized to one of four supplement groups: Micronutrient powder (MNP) with 15 mg Zn, MNP with 10 mg Zn, MNP with 5 mg Zn, and MNP with 0 mg Zn. Children will receive the supplement once with a meal on Day 8 of the study. Absorption of zinc from the supplement and from other non-supplemented meals will be determined using zinc stable isotope technology.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Micronutrient Powder (MNP) + 15 mg Zn | Active comparator | Dietary Supplement: Micronutrient Powder (MNP) + 15 mg Zn1 sachet of Micronutrient Powder (MNP) + 15 mg Zn will be added to a single meal on study day 8 |
| MNP + 10 mg Zn | Active comparator | Dietary Supplement: MNP + 10 mg Zn1 sachet of MNP + 10 mg Zn will be added to a single meal on study day 8 |
| MNP + 5 mg Zn | Active comparator | Dietary Supplement: MNP + 5 mg Zn1 sachet of MNP + 5 mg Zn will be added to a single meal on study day 8 |
| MNP without Zn | Placebo comparator | Dietary Supplement: MNP without Zn1 sachet of MNP without Zn will be added to a single meal on study day 8 |
Who may qualify
- Ages
- 18 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
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 (LAZ) score between -1.5 to -3.0
- Hg ≥ 8
Key exclusion criteria (5 listed)
- Outside age range
- Hb < 8
- Chronic illness
- Zinc supplement within past 2 weeks (including for treatment of diarrhea or MNP containing zinc)
- Severe stunting and/or severe acute malnutrition (SAM): LAZ <-3; WHZ <-3 or 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 |
|---|---|---|
| Micronutrient Powder (MNP) + 15 mg ZnChildren will have the supplement powder added to one meal on study day 1. Absorption of zinc from this meal will be measured using zinc stable isotope techniques. | Dietary supplement | Micronutrient Powder (MNP) + 15 mg Zn |
| MNP + 10 mg ZnSame as above except MNP will contain 10 mg Zn | Dietary supplement | MNP + 10 mg Zn |
| MNP + 5 mg ZnSame as above except MNP will contain 5 mg Zn | Dietary supplement | MNP + 5 mg Zn |
| MNP without ZnSame as above except MNP will not contain Zn | Dietary supplement | MNP without Zn |
Primary outcome
Total daily absorbed zinc (TAZ)
Time frame: 1 day
Measured during the meal to determine the effects of EED on zinc absorption.
16 secondary outcomes
Exchangeable zinc pool (EZP)
Time frame: 1 day
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
CRP
Time frame: 1 day
AGP
Time frame: 1 day
TNF alpha
Time frame: 1 day
Serum endocab
Time frame: 1 day
Neopterin
Time frame: 1 day
Myeloperoxidase
Time frame: 1 day
Calprotectin
Time frame: 1 day
alpha 1 antitrypsin
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 5 Jul 2019.
- Derived from this study: PubMed 30624753Long JM, Mondal P, Westcott JE, Miller LV, Islam MM, Ahmed M, Mahfuz M, Ahmed T, Krebs NF. Zinc Absorption from Micronutrient Powders Is Low in Bangladeshi Toddlers at Risk of Environmental Enteric Dysfunction and May Increase Dietary Zinc Requirements. J Nutr. 2019 Jan 1;149(1):98-105. doi: 10.1093/jn/nxy245.
- Individual participant dataSharing planned: Yes
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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)
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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?
A study testing Micronutrient Powder (MNP) + 15 mg Zn, MNP + 10 mg Zn and MNP + 5 mg Zn in people with 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 5 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. Some participants in this study may receive a placebo. 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?
Total daily absorbed zinc (TAZ) (time frame: 1 day). 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 NCT02758444, 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 5 Jul 2019.