Effect of Zinc on Barrett's Metaplasia

NCT01984580 — Phase 1, Unknown, 120 participants, Main Line Health

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Registry	NCT01984580
Status	Unknown
Phase	Phase 1
Study type	Interventional; randomized, parallel, masking: single, prevention
Enrollment	120 (Estimated)
Sponsor	Main Line Health (Other); collaborators: Sharpe-Strumia Research Foundation
Conditions	Barrett's Metaplasia
Interventions	zinc gluconate (Drug)
Dates	start 2011-04-01, primary completion 2015-03-01 (estimated), completion 2015-12-01 (estimated), first posted 2013-11-14, last updated 2013-11-14
Locations	1 site in United States

-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?

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Zinc	Experimental	Drug: zinc gluconate
sodium	Placebo comparator

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

+Outcome measures

Primary outcomes

Changes in zinc-regulated cellular proteins within Barrett's tissue [in biopsy tissue after 14 days of Zn exposure]

Secondary outcomes

Changes in cellular microRNA profile; changes in protein cancer biomarkers [in biopsy tissue after 14 days of Zn exposure]

+Eligibility

Sex: All, ages: 18 Years to 80 Years

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)

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+Locations (1)

Facility	City	Country	Status
Lankenau Institute for Medical Research	Wynnewood, Pennsylvania	United States	Recruiting