NCT01984580

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. 1.can this zinc administration cause molecular-level changes in the Barrett's tissue?
  2. 2.are the changes measured indicative of chemopreventive action by zinc regarding cancer progression?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2011

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 14, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

November 14, 2013

Status Verified

November 1, 2013

Enrollment Period

3.9 years

First QC Date

November 8, 2013

Last Update Submit

November 8, 2013

Conditions

Barrett's Metaplasia

Keywords

Barrett's esophagusEsophagusAdenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Changes in zinc-regulated cellular proteins within Barrett's tissue

    in biopsy tissue after 14 days of Zn exposure

Secondary Outcomes (1)

  • Changes in cellular microRNA profile; changes in protein cancer biomarkers

    in biopsy tissue after 14 days of Zn exposure

Study Arms (2)

Zinc

EXPERIMENTAL
Drug: zinc gluconate

sodium

PLACEBO COMPARATOR

Interventions

zinc gluconateDRUG

26.6 mg zinc BID (as zinc gluconate)

Zinc

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lankenau Institute for Medical Research

Wynnewood, Pennsylvania, 19096, United States

RECRUITING

MeSH Terms

Conditions

Barrett EsophagusAdenocarcinoma

Interventions

gluconic acid

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Central Study Contacts

James M Mullin, Ph.D.

CONTACT

484-476-2708mullinj@mlhs.org

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 8, 2013

First Posted

November 14, 2013

Study Start

April 1, 2011

Primary Completion

March 1, 2015

Study Completion

December 1, 2015

Last Updated

November 14, 2013

Record last verified: 2013-11

Locations

US(1)