High Dose Vitamin D Study

• Status: Completed
• Trial end date: 2014-04-23
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the therapeutic effect and the safety of high-dose vitamin D supplementation in metastatic colorectal cancer patients. We propose to supplement metastatic (stage 4) colorectal cancer patients with oral doses of vitamin D to raise serum 25-hydroxy-vitamin D [25(OH)D] levels to the high normal range of 200-250 nmol/L. The primary objective of this study is to evaluate the metabolic consequences, including tolerability and toxicity, of prolonged, high-dose physiological vitamin D in patients with colorectal cancer. The secondary objective is to evaluate patient survival with regards to high-dose vitamin D supplementation.

Hypothesis:

Whereas low doses of vitamin D reportedly play a significant role in prevention of colorectal cancers, do much larger (pharmacological) doses of vitamin D have a significant therapeutic effect against the same kind of cancer?

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Collaborator: Lotte & John Hecht Memorial Foundation
• Treatments: Ergocalciferols; Vitamin D; Vitamins

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)