Status:
TERMINATED
Vitamin D Supplement in Preventing Colon Cancer in African Americans With Colon Polyps
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Precancerous Condition
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of vitamin D may keep colorectal cancer from forming in patients with colon polyps. PURPOSE: This randomize...
Detailed Description
OBJECTIVES: Primary * To determine the accrual rate of African Americans with adenomatous polyps to a 6-month randomized intervention trial comprising supplementation with either cholecalciferol (vi...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenomatous polyp
- At least 1 adenoma
- Self-identified as an African American AND undergoing screening or diagnostic colonoscopy at the University of Chicago
- No history of colon or rectal cancer or hereditary or familial colon cancer (e.g., hereditary non-polyposis colon cancer or familial adenomatous polyposis)
- PATIENT CHARACTERISTICS:
- Total bilirubin normal
- AST and ALT ≤ 2.5 times upper limit of normal
- Creatinine normal
- Albumin ≥ 3.0 mg/dL
- Baseline serum calcium level normal
- Not pregnant
- No history of thyroid disease
- No history of renal stones
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No other concurrent vitamin D intake
Exclusion
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00870961
Start Date
February 1 2009
End Date
June 1 2012
Last Update
September 16 2013
Active Locations (2)
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1
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
2
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470