Status:
COMPLETED
Calcium/Vitamin D, Biomarkers & Colon Polyp Prevention
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Adenomatous Polyps
Eligibility:
All Genders
45-75 years
Brief Summary
The study team has developed a set of biomarkers of risk for colon cancer; this study tests 1) whether or not calcium and/or vitamin D supplementation can favorably affect these biomarkers in persons ...
Detailed Description
This study is an add-on study ('adjunct study') to a clinical trial that is already being conducted (the 'parent study'). Study participants will be composed of persons who are already participating i...
Eligibility Criteria
Inclusion
- Currently participating in the parent study. Not open to people not already enrolled in the parent study. This sub-study is for the collection of biopsies only, while the parent study is for calcium and vitamin D to prevent reoccurrence of colon polyps.
- Inclusion Criteria for the parent study:
- 45 - 75 years old.
- ≥ 1 histologically-verified neoplastic polyps, ≥ 2 mm in diameter, removed from the large bowel within 4 months of study entry, with entire large bowel examined by colonoscopy and documented free of further polyps.
- Willing to follow the study protocol, as indicated by the subject's informed consent to participate.
- Good general health, with no severely debilitating diseases or active malignancy that might compromise the patient's ability to complete the study.
- Anticipated colonoscopic follow up three years or five years after the qualifying colonoscopy.
- Exclusion Criteria for the parent study:
- Invasive carcinoma in any colonic polyp removed.
- Familial colonic polyposis syndromes.
- Ulcerative colitis or Crohn's disease.
- Malabsorption syndrome (e.g., pancreatic insufficiency).
- History of large bowel resection for any reason.
- Diagnosed narcotic or alcohol dependence.
- Elevated serum calcium or creatinine, or supraphysiologic levels of 25(OH) vitamin D at study entry.
- Current use of thiazide diuretic in amount greater than the equivalent of 50 mg of hydrochlorothiazide.
- New York Heart Association Cardiovascular Disease functional class 3 or 4.
- On renal dialysis.
- History of kidney stones, unexplained hematuria, or sarcoidosis in the previous 20 years.
- Any history of hypo- or hyperparathyroidism.
- Unwilling to forgo individual calcium and vitamin D supplementation during the trial.
- Unwilling to forgo daily intake of more than a quart of milk (or equivalent in other dairy products) or daily dietary intake of vitamin D estimated to be greater than 400 IU.
- History of osteoporosis or other medical condition that may require supplemental calcium or vitamin D.
- Current use of bisphosphonates (eg, alendronate \[Fosamax\], risendronate \[Actonel\]).
- Current use of calcitonins (eg, Miacalcin).
- Additional exclusion criteria for the adjunct biomarker study are:
- Unable to be off aspirin for 7 days.
- History of bleeding disorder or current use of anticoagulant medication.
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT00399607
Start Date
June 1 2006
End Date
August 1 2016
Last Update
December 8 2016
Active Locations (9)
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1
USC/Norris Comprehensice Cancer Center
Los Angeles, California, United States, 90089
2
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80220
3
Emory University
Atlanta, Georgia, United States, 30322
4
University of Iowa Hospitals & Clinic
Iowa City, Iowa, United States, 52242