Clinical Trial: Effect of Zinc on Barrett's Metaplasia
Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Effect of Zinc on Barrett's Metaplasia
Brief Summary:
Using orally administered zinc to patients already diagnosed with the pre-cancerous condition, Barrett's Esophagus, this study is asking two questions:
- can this zinc administration cause molecular-level changes in the Barrett's tissue?
- are the changes measured indicative of chemopreventive action by zinc regarding cancer progression?
Detailed Summary: 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.
Sponsor: Main Line Health
Current Primary Outcome: Changes in zinc-regulated cellular proteins within Barrett's tissue [ Time Frame: in biopsy tissue after 14 days of Zn exposure ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Changes in cellular microRNA profile; changes in protein cancer biomarkers [ Time Frame: in biopsy tissue after 14 days of Zn exposure ]
Original Secondary Outcome: Same as current
Information By: Main Line Health
Dates:
Date Received: November 8, 2013
Date Started: April 2011
Date Completion: December 2015
Last Updated: November 8, 2013
Last Verified: November 2013
