Effect of Zinc on Barrett's Metaplasia

November 8, 2013 updated by: James M. Mullin, Ph.D., Main Line Health

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. are the changes measured indicative of chemopreventive action by zinc regarding cancer progression?

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Wynnewood, Pennsylvania, United States, 19096
        • Recruiting
        • Lankenau Institute for Medical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Zinc
Drug: zinc gluconate
26.6 mg zinc BID (as zinc gluconate)
PLACEBO_COMPARATOR: sodium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in zinc-regulated cellular proteins within Barrett's tissue
Time Frame: in biopsy tissue after 14 days of Zn exposure
in biopsy tissue after 14 days of Zn exposure

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in cellular microRNA profile; changes in protein cancer biomarkers
Time Frame: in biopsy tissue after 14 days of Zn exposure
in biopsy tissue after 14 days of Zn exposure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Main Line Health

Collaborators

Sharpe-Strumia Research Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (ANTICIPATED)

March 1, 2015

Study Completion (ANTICIPATED)

December 1, 2015

Study Registration Dates

First Submitted

November 8, 2013

First Submitted That Met QC Criteria

November 8, 2013

First Posted (ESTIMATE)

November 14, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 14, 2013

Last Update Submitted That Met QC Criteria

November 8, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F/N-R-11-3038L

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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