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Effect of Zinc on Barrett's Metaplasia

NCT ID: NCT01984580

Last Updated: 2013-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2015-12-31

Brief Summary

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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

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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

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Barrett's Metaplasia

Keywords

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Barrett's esophagus Esophagus Adenocarcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Zinc

Group Type EXPERIMENTAL

zinc gluconate

Intervention Type DRUG

26.6 mg zinc BID (as zinc gluconate)

sodium

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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zinc gluconate

26.6 mg zinc BID (as zinc gluconate)

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sharpe-Strumia Research Foundation

OTHER

Sponsor Role collaborator

Main Line Health

OTHER

Sponsor Role lead

Responsible Party

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James M. Mullin, Ph.D.

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Lankenau Institute for Medical Research

Wynnewood, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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James M Mullin, Ph.D.

Role: CONTACT

Phone: 484-476-2708

Email: [email protected]

Other Identifiers

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F/N-R-11-3038L

Identifier Type: -

Identifier Source: org_study_id