NCT01984580

Effect of Zinc on Barrett's Metaplasia

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Main Line Health · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Barrett's Metaplasia

Interventions

Type	Name	Description
DRUG	zinc gluconate	26.6 mg zinc BID (as zinc gluconate)

Timeline

• Start date: 2011-04-01
• Primary completion: 2015-03-01
• Completion: 2015-12-01
• First posted: 2013-11-14
• Last updated: 2013-11-14

Locations

1 site across 1 country: United States