High Dose Vitamin D Study

University of British Columbia

Status and phase

Completed

Phase 2

Phase 1

Conditions

Colorectal Cancer

Treatments

Drug: Vitamin D

Study type

Interventional

Funder types

Other

Identifiers

NCT01150877

H10-00028

Details and patient eligibility

About

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?

Full description

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)