Effect of Zinc on Barrett's Metaplasia
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?
|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|
- 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 ]
- 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 ]
|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)|
Drug: zinc gluconate
26.6 mg zinc BID (as zinc gluconate)
|Placebo Comparator: sodium|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01984580
|Contact: James M Mullin, Ph.D.||firstname.lastname@example.org|
|United States, Pennsylvania|
|Lankenau Institute for Medical Research||Recruiting|
|Wynnewood, Pennsylvania, United States, 19096|