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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The metabolic consequences, including tolerability and toxicity, of prolonged, high-dose physiological vitamin D in patients with colorectal cancer.
After 16 months of intervention
Hal Gunn, MD
University of British Columbia
Canada: Health Canada