Study of High-dose Vitamin D Supplementation in Stage-4 Colorectal Cancer Patients
18 Years
N/A
Both
Colorectal Cancer
Trial Information
Study of High-dose Vitamin D Supplementation in Stage-4 Colorectal Cancer Patients
Metastatic (stage 4) colorectal cancer patients who were randomly assigned to the treatment
arm of this study will be orally supplemented with high doses of vitamin D to achieve serum
25(OH)D concentrations of 200-250 nmol/L (80-100 ng/ml). Therefore, the supplementation
dosage is not pre-set but will be determined on an individual basis. Vitamin D
supplementation will be continued for 16 months, followed by a 12 month follow up period.
Monthly monitoring of serum 25(OH)D and calcium levels will assure the safety of our
treatment protocol. Subjects in the control arm of the study will be receiving standard
cancer care at InspireHealth that includes supplementation with at least 2,000 International
Units of vitamin D.
Inclusion Criteria
Inclusion Criteria (We will recruit stage 4 (metastatic) colorectal cancer patients who
are clients at InspireHealth):
- Age > 18
- Histologically confirmed colon or rectal cancer
- Known metastatic disease (stage-4) confirmed histologically or radiologically
- Life expectancy of >8 months
- May receive anti-neoplastic therapy at the discretion of their physician
- Stable metastatic disease defined as no change in systemic for the month before and
the month after commencing study
- Signed informed consent
Exclusion Criteria(Stage 4 colorectal cancer patients):
- Pregnant / lactating women
- Known hypersensitivity to vitamin D
- Pre-existing renal stone disease based on history
- Pre-existing hypercalcemia
- Severe renal or hepatic dysfunction (≥ 2x of the upper normal range)
- granulomatous disease (TB and sarcoid)
- unable to give informed consent in English (translations of study documents in
languages other than English will not be provided)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The metabolic consequences, including tolerability and toxicity, of prolonged, high-dose physiological vitamin D in patients with colorectal cancer.
Outcome Time Frame:
After 16 months of intervention
Safety Issue:
No
Principal Investigator
Hal Gunn, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of British Columbia
Authority:
Canada: Health Canada
Study ID:
H10-00028
NCT ID:
NCT01150877
Start Date:
January 2011
Completion Date:
October 2013
Related Keywords:
- Colorectal Cancer
- Vitamin D
- Vitamin D3
- colon cancer
- rectal cancer
- Cholecalciferol
- Colorectal Neoplasms
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