Study Results
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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UNKNOWN
EARLY_PHASE1
50 participants
INTERVENTIONAL
2010-12-31
2016-12-31
Brief Summary
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ACF's are very small (i.e., microscopic) collections of abnormally shaped cells that are a commonly used marker of CRC risk. Screening colonoscopy at UIC routinely uses methods that allow ACF counting to be done as a part of standard practice. ACF's are not fixed, like polyps or cancers, but can disappear as a person's risk for developing CRC decreases.
The investigators propose giving patient's with 6 or more ACF's 200 mcg selenized yeast or placebo, and determining if there is a drug-dependant decrease in ACF number. The primary objective is to determine whether selenized yeast supplementation, compared to placebo, causes significant reduction of ACF number from baseline levels. The primary endpoint will be change in ACF number
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
DOUBLE
Study Groups
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Selenium, selenomethionine
Selenium, selenomethionine
Patients will receive one 200 ug pill of Selenomethionine
placebo
placebo
Patients will be given one 200 ug placebo pill each day for 6 months
Interventions
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Selenium, selenomethionine
Patients will receive one 200 ug pill of Selenomethionine
placebo
Patients will be given one 200 ug placebo pill each day for 6 months
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Use of non-steroidal anti-inflammatory drugs or glucocorticosteroids within 60 days of study entry.
* History of chronic IBD or prior pelvic radiation (inflammation distorts crypt pattern).
* Intake of any selenium supplements within 60 days of study entry, including vitamins.
* Patients with increased bleeding risk from biopsy protocol (i.e. renal failure, decompensated cirrhosis, blood dyscrasia).
50 Years
ALL
Yes
Sponsors
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University of Illinois at Chicago
OTHER
Responsible Party
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University of Illinois
Principal Investigators
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Richard V Benya, MD
Role: PRINCIPAL_INVESTIGATOR
University of Illinois at Chicago
Locations
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University of Illinois at Chicago Medical Center
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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John OToole, BA
Role: primary
Other Identifiers
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2008-1122
Identifier Type: -
Identifier Source: org_study_id