Clinical trial · Interventional
Cholecalciferol and Calcium Carbonate in Treating Patients With Colon Cancer That Has Been Removed by Surgery
A Pilot Study of Low and High Dose Vitamin Cholecalciferol (D3) With Pharmacokinetic and Pharmacodynamic Correlates in Patients With Resected Colon Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Withdrawn due to poor accrual/lack of funding
Summary
Brief summary (as posted)
RATIONALE: The use of cholecalciferol and calcium carbonate may keep colon cancer from coming back in patients with colon cancer that has been removed by surgery. PURPOSE: This randomized clinical trial is studying two different doses of cholecalciferol to compare how well they work when given together with calcium carbonate in treating patients with colon cancer that has been removed by surgery.
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 Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsy | Procedure | — | UNRESOLVED |
| calcium carbonate | Dietary Supplement | — | UNRESOLVED |
| cholecalciferol | Dietary Supplement | — | UNRESOLVED |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Change in proliferative labeling index of normal rectal mucosa as measured by Ki67 IHC staining
Secondary outcomes (3)
- measure
- Changes in serum levels of 25-OH-D3, 1,25-OH-D3, 24,25-OH-D3, calcium, and parathyroid hormone
- measure
- Safety of high-dose cholecalciferol supplementation as measured over 2 years
- timeFrame
- over 2 years
- measure
- Effects of cholecalciferol on biological markers of proliferation (i.e., cyclin D1, protein kinase C, vitamin D receptor, p21, and p27) as measured by IHC at baseline and after 6 months of study treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * History of colon cancer * Underwent resection and has been in clinical remission for ≥ 1 year * No inflammatory bowel disease * No familial adenomatous polyposis PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy \> 1 year * No genitourinary stones within the past 5 years * No severe comorbid conditions, such as uncompensated heart failure or active uncontrolled infection * No history of hypercalcemia * No active colostomy * No contraindications to sigmoidoscopy or mucosal biopsies PRIOR CONCURRENT THERAPY: * No prior rectal surgery or abdominoperineal resection * At least 1 month since prior vitamin D or calcium supplementation * Prior vitamin D supplemental intake ≤ 800 IU per day * At least 1 year since prior chemotherapy * No prior radiotherapy to the pelvis * No concurrent active anticoagulation * Patients who stop anticoagulation therapy at the time of mucosal biopsy are eligible * No other concurrent supplemental calcium or vitamin D
References
Publications (0)
Data not yet available