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Effect of Zinc on Barrett's Metaplasia

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Main Line Health
Sponsor:
Collaborator:
Sharpe-Strumia Research Foundation
Information provided by (Responsible Party):
James M. Mullin, Ph.D., Main Line Health
ClinicalTrials.gov Identifier:
NCT01984580
First received: November 8, 2013
Last updated: NA
Last verified: November 2013
History: No changes posted
  Purpose

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?

Condition Intervention Phase
Barrett's Metaplasia
Drug: zinc gluconate
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Effect of Zinc on Barrett's Metaplasia

Resource links provided by NLM:


Further study details as provided by Main Line Health:

Primary Outcome Measures:
  • Changes in zinc-regulated cellular proteins within Barrett's tissue [ Time Frame: in biopsy tissue after 14 days of Zn exposure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in cellular microRNA profile; changes in protein cancer biomarkers [ Time Frame: in biopsy tissue after 14 days of Zn exposure ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: April 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zinc Drug: zinc gluconate
26.6 mg zinc BID (as zinc gluconate)
Placebo Comparator: sodium

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01984580

Contacts
Contact: James M Mullin, Ph.D. 484-476-2708 mullinj@mlhs.org

Locations
United States, Pennsylvania
Lankenau Institute for Medical Research Recruiting
Wynnewood, Pennsylvania, United States, 19096
Sponsors and Collaborators
Main Line Health
Sharpe-Strumia Research Foundation
  More Information

No publications provided

Responsible Party: James M. Mullin, Ph.D., Professor, Main Line Health
ClinicalTrials.gov Identifier: NCT01984580     History of Changes
Other Study ID Numbers: F/N-R-11-3038L
Study First Received: November 8, 2013
Last Updated: November 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Main Line Health:
Barrett's esophagus
Esophagus
Adenocarcinoma

Additional relevant MeSH terms:
Barrett Esophagus
Metaplasia
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Pathologic Processes
Zinc
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Trace Elements

ClinicalTrials.gov processed this record on November 25, 2014