Barrett's MetaplasiaPhase 1NCT01984580
Effect of Zinc on Barrett's Metaplasia
A Phase 1 study testing zinc gluconate in people with Barrett's Metaplasia, run by Main Line Health at 1 site in United States.
Trial summary
Using orally administered zinc to patients already diagnosed with the pre-cancerous condition, Barrett's Esophagus, this study is asking two questions: 1. can this zinc administration cause molecular-level changes in the Barrett's tissue? 2. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Barrett's Metaplasia
- What is being tested?
- zinc gluconate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Dec 2015
- Phase
- Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:ages 18-80; prior diagnosis of Barrett's esophagus -
Exclusion Criteria:unable to provide written, informed consent; prior history of Barrett's dysplasia or esophageal adenocarcinoma; drug exclusions: hormone replacement therapy, cholestyramine, amiloride diuretics, oral quinolone antibiotics, glucocorticoids, corticosteroids, anticoagulants (other than aspirin)
-
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, 19096
About this study
Using orally administered zinc to patients already diagnosed with the pre-cancerous condition, Barrett's Esophagus, this study is asking two questions:
- can this zinc administration cause molecular-level changes in the Barrett's tissue?
- are the changes measured indicative of chemopreventive action by zinc regarding cancer progression?
Read the detailed description
14 days prior to already-scheduled upper endoscopy (EGD) procedures for routine surveillance of Barrett's tissue, patients who have given written, informed consent are randomized (sealed envelope method) and placed on an oral dose of zinc gluconate (26.6 mg zinc BID) or a placebo (molar equivalent of sodium gluconate BID) for 14 days. At the time of endoscopy, 4 biopsies are taken (and pooled) from the Barrett's tissue and 4 from proximal normal esophageal tissue. Biopsies are flash frozen for later analyses by atomic absorption spectroscopy, PAGE and Western immunoblot or RNA microarray.
- Conditions
- Barrett's Metaplasia
- Being tested
- zinc gluconate
- Keywords
- Barrett's esophagus, Esophagus, Adenocarcinoma
- Medical subject headings
- Barrett Esophagus, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zinc gluconateDrug
26.6 mg zinc BID (as zinc gluconate)
| Study group | Role | What they receive |
|---|---|---|
| Zinc | Experimental | Not described Receives: Drug: zinc gluconate |
| sodium | Placebo comparator | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in zinc-regulated cellular proteins within Barrett's tissue
Measured: in biopsy tissue after 14 days of Zn exposure
Secondary outcomes (1)
Changes in cellular microRNA profile; changes in protein cancer biomarkers
Measured: in biopsy tissue after 14 days of Zn exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startApr 2011
- Primary completionMar 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett's MetaplasiaStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Main Line Health
- Sponsor type
- University, hospital or other
- Collaborators
- Sharpe-Strumia Research Foundation
- Responsible party
- Principal investigator, James M. Mullin, Ph.D., Main Line Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01984580
- Sponsor's protocol ID
- F/N-R-11-3038L
- Status last verified
- Nov 2013
- First submitted
- 8 Nov 2013
- Last updated
- 14 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Zinc on Barrett's Metaplasia
- ClinicalTrials.gov ID
- NCT01984580
- Acronym / sponsor ID
- F/N-R-11-3038L
- Conditions
- Barrett's Metaplasia
- Keywords
- Barrett's esophagus, Esophagus, Adenocarcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Main Line HealthUniversity, hospital or other
- Collaborators
- Sharpe-Strumia Research Foundation
- Study start
- Apr 2011
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 14 Nov 2013 (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.
Using orally administered zinc to patients already diagnosed with the pre-cancerous condition, Barrett's Esophagus, this study is asking two questions:
- can this zinc administration cause molecular-level changes in the Barrett's tissue?
- are the changes measured indicative of chemopreventive action by zinc regarding cancer progression?
Detailed description
14 days prior to already-scheduled upper endoscopy (EGD) procedures for routine surveillance of Barrett's tissue, patients who have given written, informed consent are randomized (sealed envelope method) and placed on an oral dose of zinc gluconate (26.6 mg zinc BID) or a placebo (molar equivalent of sodium gluconate BID) for 14 days. At the time of endoscopy, 4 biopsies are taken (and pooled) from the Barrett's tissue and 4 from proximal normal esophageal tissue. Biopsies are flash frozen for later analyses by atomic absorption spectroscopy, PAGE and Western immunoblot or RNA microarray.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zinc | Experimental | Drug: zinc gluconate |
| sodium | Placebo comparator | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| zinc gluconate26.6 mg zinc BID (as zinc gluconate) | Drug | Zinc |
Primary outcome
Changes in zinc-regulated cellular proteins within Barrett's tissue
Time frame: in biopsy tissue after 14 days of Zn exposure
1 secondary outcome
Changes in cellular microRNA profile; changes in protein cancer biomarkers
Time frame: in biopsy tissue after 14 days of Zn exposure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing zinc gluconate in people with Barrett's Metaplasia, run by Main Line Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 14 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James M Mullin, Ph.D. (484-476-2708, mullinj@mlhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in zinc-regulated cellular proteins within Barrett's tissue (time frame: in biopsy tissue after 14 days of Zn exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Nov 2013.