Effect of Zinc on Barrett's Metaplasia

Phase 1

• Conditions: Barrett's Metaplasia
• Interventions: Drug: zinc gluconate

• Registration Number: NCT01984580
• Lead Sponsor: Main Line Health

Brief 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?

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 Timeline

• Study Start: 2011-04
• Status Verified: 2013-11
• Study First Submitted: 2013-11-08
• Study First Submitted QC: 2013-11-08
• Last Update Submitted: 2013-11-08
• Study First Posted: 2013-11-14
• Last Update Posted: 2013-11-14
• Primary Completion: 2015-03
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zinc	zinc gluconate	-

Primary Outcome Measures

Name	Time	Method
Changes in zinc-regulated cellular proteins within Barrett's tissue	in biopsy tissue after 14 days of Zn exposure

Secondary Outcome Measures

Name	Time	Method
Changes in cellular microRNA profile; changes in protein cancer biomarkers	in biopsy tissue after 14 days of Zn exposure

Trial Locations

Locations (1)

Lankenau Institute for Medical Research; 🇺🇸 Wynnewood, Pennsylvania, United States