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NCT01984580 Clinical Trial

Effect of Zinc on Barrett's Metaplasia

Barrett's Metaplasia Clinical Trial

Official title:
Effect of Zinc on Barrett's Metaplasia

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01984580
Other study ID # F/N-R-11-3038L
Secondary ID
Status Recruiting
Phase Phase 1
First received November 8, 2013
Last updated November 8, 2013
Start date April 2011
Est. completion date December 2015

Study information
Verified date November 2013
Source Main Line Health
Contact James M Mullin, Ph.D.
Phone 484-476-2708
Email mullinj@mlhs.org
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date December 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• zinc gluconate
26.6 mg zinc BID (as zinc gluconate)

Locations
Country Name City State
United States Lankenau Institute for Medical Research Wynnewood Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
Main Line Health Sharpe-Strumia Research Foundation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in zinc-regulated cellular proteins within Barrett's tissue in biopsy tissue after 14 days of Zn exposure No
Secondary Changes in cellular microRNA profile; changes in protein cancer biomarkers in biopsy tissue after 14 days of Zn exposure No