Effect of Zinc on Barrett's Metaplasia
Primary Purpose
Barrett's Metaplasia
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
zinc gluconate
Sponsored by
About this trial
This is an interventional prevention trial for Barrett's Metaplasia focused on measuring Barrett's esophagus, Esophagus, Adenocarcinoma
Eligibility Criteria
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)
-
Sites / Locations
- Lankenau Institute for Medical ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Zinc
sodium
Arm Description
Outcomes
Primary Outcome Measures
Changes in zinc-regulated cellular proteins within Barrett's tissue
Secondary Outcome Measures
Changes in cellular microRNA profile; changes in protein cancer biomarkers
Full Information
NCT ID
NCT01984580
First Posted
November 8, 2013
Last Updated
November 8, 2013
Sponsor
Main Line Health
Collaborators
Sharpe-Strumia Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01984580
Brief Title
Effect of Zinc on Barrett's Metaplasia
Official Title
Effect of Zinc on Barrett's Metaplasia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
March 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Main Line Health
Collaborators
Sharpe-Strumia Research Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett's Metaplasia
Keywords
Barrett's esophagus, Esophagus, Adenocarcinoma
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Zinc
Arm Type
Experimental
Arm Title
sodium
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
zinc gluconate
Intervention Description
26.6 mg zinc BID (as zinc gluconate)
Primary Outcome Measure Information:
Title
Changes in zinc-regulated cellular proteins within Barrett's tissue
Time Frame
in biopsy tissue after 14 days of Zn exposure
Secondary Outcome Measure Information:
Title
Changes in cellular microRNA profile; changes in protein cancer biomarkers
Time Frame
in biopsy tissue after 14 days of Zn exposure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James M Mullin, Ph.D.
Phone
484-476-2708
Email
mullinj@mlhs.org
Facility Information:
Facility Name
Lankenau Institute for Medical Research
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
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Effect of Zinc on Barrett's Metaplasia
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