Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2011-01-31
2014-04-23
Brief Summary
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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?
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental Dietary Supplement (e.g., vitamins, minerals)
Experimental arm is supplemented with high-dose of vitamin D.
Vitamin D
We propose to study high-dose, oral vitamin D supplementation, raising serum 25-hydroxy-vitamin D (25(OH)D) concentrations to 200 -250 nmol/L, in metastatic colorectal cancer patients with safety, tolerability and survival as the main outcome measurements. The dose is not pre-set and will depend on the individual subjects' serum 25(OH)D concentration. Subjects will be supplemented for 16 months with a daily oral dose, followed by a 12 months follow-up period.
No Intervention
No interventions assigned to this group
Interventions
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Vitamin D
We propose to study high-dose, oral vitamin D supplementation, raising serum 25-hydroxy-vitamin D (25(OH)D) concentrations to 200 -250 nmol/L, in metastatic colorectal cancer patients with safety, tolerability and survival as the main outcome measurements. The dose is not pre-set and will depend on the individual subjects' serum 25(OH)D concentration. Subjects will be supplemented for 16 months with a daily oral dose, followed by a 12 months follow-up period.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Lotte & John Hecht Memorial Foundation
OTHER
University of British Columbia
OTHER
Responsible Party
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Principal Investigators
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Hal Gunn, MD
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Locations
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InspireHealth
Vancouver, British Columbia, Canada
Countries
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Related Links
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Related Info
Other Identifiers
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H10-00028
Identifier Type: -
Identifier Source: org_study_id
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