Recruiting
Phase 1

Zinc

Sponsor:

Main Line Health

Code:

NCT01984580

Conditions

Barrett's Metaplasia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

zinc gluconate

Study Details

Brief 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?

Conditions

Barrett's Metaplasia

Study ID

NCT01984580

Start date

Apr, 2011

Status verified date

Nov, 2013

Completion date

Dec, 2015

Anticipated

Primary completion date

Mar, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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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Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Zinc

placebo comparator: sodium

Interventions

zinc gluconate

26.6 mg zinc BID (as zinc gluconate)

Primary outcome measure

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

Central Contacts and Locations

Central contacts

James M Mullin, Ph.D.

484-476-2708mullinj@mlhs.org

Locations

Lankenau Institute for Medical Research

Recruiting

Wynnewood, Pennsylvania, United States, 19096

More Information

Sponsor

Main Line Health

Last update posted

Nov 14, 2013

Last verified

Nov, 2013

Keywords

  • Barrett's esophagus
  • Esophagus
  • Adenocarcinoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Main Line Health on 2013-11-14.