Effect of Zinc on Barrett's Metaplasia

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01984580

Enrollment

120

Registered

2013-11-14

Start date

2011-04-30

Completion date

2015-12-31

Last updated

2013-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Barrett's Metaplasia

Keywords

Barrett's esophagus, Esophagus, Adenocarcinoma

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?

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.

Interventions

DRUGzinc gluconate

26.6 mg zinc BID (as zinc gluconate)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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) \-

Design outcomes

Primary

Measure	Time frame
Changes in zinc-regulated cellular proteins within Barrett's tissue	in biopsy tissue after 14 days of Zn exposure

Secondary

Measure	Time frame
Changes in cellular microRNA profile; changes in protein cancer biomarkers	in biopsy tissue after 14 days of Zn exposure

Countries

United States

Contacts

Primary ContactJames M Mullin, Ph.D.

mullinj@mlhs.org484-476-2708

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026