Clinical trial · Observational
Calcium/Vitamin D, Biomarkers & Colon Polyp Prevention
NCT00399607CI-TRIAL-00025086PPS4BcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 who are at higher than average risk for colon cancer (ie, have already undergone the removal of colon growths, called adenomatous polyps, which are known to be precursors to developing colon cancer), and 2) whether effects on the biomarkers predict who will get new colon polyps or not.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Adenomatous Polyps | Colon Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsies during colonoscopy | Procedure | — | UNRESOLVED |
| Rectal biopsy at 1 year | Procedure | — | UNRESOLVED |
| Rectal biopsy at randomization | Procedure | — | UNRESOLVED |
| Rectal biopsy during colonoscopy | Procedure | — | UNRESOLVED |
| Rectal biopsy prior to colonoscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Aim 1
- description
- Participants previously randomized for the parent study will be eligible for a portion of the adjunct biomarker study.
- interventionNames
- Procedure: Rectal biopsy during colonoscopy
- label
- All aims
- description
- Participants entering the parent study will be eligible for all sample collections of the adjunct biomarker study.
- interventionNames
- Procedure: Rectal biopsy at randomization
- Procedure: Rectal biopsy at 1 year
- Procedure: Rectal biopsy prior to colonoscopy
- Procedure: Biopsies during colonoscopy
Primary outcomes (10)
- measure
- COX-2 Levels
- timeFrame
- Baseline to end of intervention (up to 5 years)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.