A large body of evidence suggests that high blood levels of Vitamin D decreases the risk of developing cancer, especially colorectal cancer. Very little is known about what role optimum blood levels of Vitamin D can play in the treatment of cancer. The purpose of this clinical trial is to study the therapeutic effect and the safety of high-dose vitamin D supplementation in stage 4 (metastatic) colorectal cancer patients.
Who is eligible to participate?
Anyone who has a stage four colorectal cancer diagnosis, living in Ontario or British Columbia, may be eligible to participate. All participants need to have access to a Lifelabs facility for blood and urine collections.
What is involved?
This 40 month study involves regular lab tests and follow up phone calls. Participation is fully voluntary and participants may withdraw at any time. Participants will be randomized into either a high-dose vitamin D treatment group or a control group. Participants in both groups may continue all other cancer treatments including chemotherapy.
Participants in the treatment group receive daily oral high dose Vitamin D supplementation provided free of charge through the clinical study. They also receive daily calcium supplementation 1000mg daily as per guidelines, provided free through the clinical study. Participants will have monthly blood and urine tests for monitoring purposes. All laboratory tests are free of charge. Participants also need to be available for a 15 minute phone consultation with a study coordinator every 2 months.
Participants in the control group will continue their usual amount of Vitamin D and/or calcium if they wish to do so. No supplements will be provided through the study. Participants will be asked to provide a small blood and urine sample at the beginning of the study, every 8 months and at the end of the study. These blood and urine tests will be free of charge.
If you have any further questions regarding this study or you are interested in participating in this study, please contact us:
British Columbia: 604-734-7125, toll free 1- 888-734-7125 or email Dstudy@inspirehealth.ca
Ontario: 613-792-1222, toll free 1-855-546-1244 or firstname.lastname@example.org