Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Selenium's ability to prevent colorectal cancer (CRC) has been suspected for nearly 30 years, but has never been directly studied in humans. The investigators will directly assess selenium's ability to prevent CRC by measuring alterations in aberrant crypt foci (ACF), an accepted surrogate marker for CRC.
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selenium, selenomethionine | Experimental |
| |
| placebo | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selenium, selenomethionine | Drug | Patients will receive one 200 ug pill of Selenomethionine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in ACF biomarkers | 6 months |
Not provided
Not provided
Inclusion Criteria:
- All non-pregnant patients >50 years of age
Exclusion Criteria:
The following will be specifically looked for, and result in patients not being eligible for study enrollment:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| John A O'Toole, BA | Contact | 312-413-2446 | jotool2@uic.edu |
| Name | Affiliation | Role |
|---|---|---|
| Richard V Benya, MD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago Medical Center | Chicago | Illinois | 60612 | United States |
Not provided
| ID | Term |
|---|---|
| D012643 | Selenium |
| D012645 | Selenomethionine |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008903 | Minerals |
| D016566 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo | Drug | Patients will be given one 200 ug placebo pill each day for 6 months |
|
| Organoselenium Compounds |
| D009930 | Organic Chemicals |
| D008715 | Methionine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |