High Dose Vitamin D Study
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| ClinicalTrials.gov Identifier: NCT01150877 |
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Recruitment Status :
Completed
First Posted : June 25, 2010
Last Update Posted : March 3, 2017
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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?
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Colorectal Cancer | Drug: Vitamin D | Phase 1 Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 40 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Study of High-dose Vitamin D Supplementation in Stage-4 Colorectal Cancer Patients |
| Study Start Date : | January 2011 |
| Actual Primary Completion Date : | April 23, 2014 |
| Actual Study Completion Date : | April 23, 2014 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Experimental Dietary Supplement (e.g., vitamins, minerals)
Experimental arm is supplemented with high-dose of vitamin D.
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Drug: 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 Intervention |
- The metabolic consequences, including tolerability and toxicity, of prolonged, high-dose physiological vitamin D in patients with colorectal cancer. [ Time Frame: After 16 months of intervention ]
- The metabolic consequences, including tolerability and toxicity, of prolonged, high-dose physiological vitamin D in patients with colorectal cancer. [ Time Frame: After 12 months of follow-up ]
- Patient survival with regards to high-dose vitamin D supplementation. [ Time Frame: After 16 months of intervention ]
- Patient survival with regards to high-dose vitamin D supplementation. [ Time Frame: After 12 months of follow-up ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01150877
| Canada, British Columbia | |
| InspireHealth | |
| Vancouver, British Columbia, Canada, V6H 4A6 | |
| Principal Investigator: | Hal Gunn, MD | University of British Columbia |
| Responsible Party: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT01150877 |
| Other Study ID Numbers: |
H10-00028 |
| First Posted: | June 25, 2010 Key Record Dates |
| Last Update Posted: | March 3, 2017 |
| Last Verified: | March 2017 |
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Vitamin D Vitamin D3 colon cancer rectal cancer Cholecalciferol |
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Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases |
Colonic Diseases Intestinal Diseases Rectal Diseases Vitamin D Vitamins Micronutrients Physiological Effects of Drugs Bone Density Conservation Agents |