High Dose Vitamin D Study - Clinical Trail registered July 2010
false;" title="Historical versions of study NCT01150877 on ClinicalTrials.gov
Archive Site" href="http://clinicaltrials.gov/ct2/archive/NCT01150877">History of Changes| Sponsor: | University of British Columbia |
|---|---|
| Collaborator: | Lotte and John Hecht Memorial Foundation |
| Information provided by: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT01150877 |
PurposeThe 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?
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Control: Active Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Study of High-dose Vitamin D Supplementation in Stage-4 Colorectal Cancer Patients |
return false" title="MedlinePlussite" href="http://www.nlm.nih.gov/medlineplus/">MedlinePlus
related topics: click="openNewWindow('/ct2/bye/uQoPWw4lZX-i-iSxudhWudNzlXNiZip9m67PvQ7xzwhaLwS90B7x061nuQoPmdt.');return false" title="Cancer at MedlinePlus site" href="http://clinicaltrials.gov/ct2/bye/uQoPWw4lZX-i-iSxudhWudNzlXNiZip9m67PvQ7xzwhaLwS90B7x061nuQoPmdt." style="padding-left: 0.5em;">Cancer click="openNewWindow('/ct2/bye/OQoPWw4lZX-i-iSxudhWudNzlXNiZip9m67PvQ7xzwhaLwS90dcaZwNH0ihGvBcGuBcHSXNkWd7E.');return false" title="Colorectal Cancer at MedlinePlus site" href="http://clinicaltrials.gov/ct2/bye/OQoPWw4lZX-i-iSxudhWudNzlXNiZip9m67PvQ7xzwhaLwS90dcaZwNH0ihGvBcGuBcHSXNkWd7E." style="padding-left: 0.5em;">Colorectal Cancer click="openNewWindow('/ct2/bye/rQoPWw4lZX-i-iSxudhWudNzlXNiZip9m67PvQ7xzwhaLwS95Q7HWB1yxw-HEwhazd7HuioRuQoPmdt.');return false" title="Dietary Supplements at MedlinePlus site" href="http://clinicaltrials.gov/ct2/bye/rQoPWw4lZX-i-iSxudhWudNzlXNiZip9m67PvQ7xzwhaLwS95Q7HWB1yxw-HEwhazd7HuioRuQoPmdt." style="padding-left: 0.5em;">Dietary Supplements click="openNewWindow('/ct2/bye/EQoPWw4lZX-i-iSxudhWudNzlXNiZip9m67PvQ7xzwhaLwS9cQ1Pkd7zu6YxlihLv.');return false" title="Vitamin D at MedlinePlus site" href="http://clinicaltrials.gov/ct2/bye/EQoPWw4lZX-i-iSxudhWudNzlXNiZip9m67PvQ7xzwhaLwS9cQ1Pkd7zu6YxlihLv." style="padding-left: 0.5em;">Vitamin Dreturn false" title="Drug Information Portal" href="http://druginfo.nlm.nih.gov/drugportal/drugportal.jsp">Drug Information
available for: click="openNewWindow('/ct2/bye/YQoPWw4lZXcPSi7iedN6ZXNxvdDxuQ7Ju6c9cXcPSi7iEd-yWB7EZ6o35Q1yzB-VuQUgEscxkd789HNzWB7Ledpmj.');return false" title="Vitamin D at ChemIDplus site" href="http://clinicaltrials.gov/ct2/bye/YQoPWw4lZXcPSi7iedN6ZXNxvdDxuQ7Ju6c9cXcPSi7iEd-yWB7EZ6o35Q1yzB-VuQUgEscxkd789HNzWB7Ledpmj." style="padding-left: 0.5em;">Vitamin D- 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 Designated as safety issue: No
- 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 Designated as safety issue: No
- Patient survival with regards to high-dose vitamin D supplementation. Time Frame: After 16 months of intervention Designated as safety issue: No
- Patient survival with regards to high-dose vitamin D supplementation. Time Frame: After 12 months of follow-up Designated as safety issue: No
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| click="openPopupWindow('/ct2/help/arm_group_desc',false); return false;" title="Help on Arm Group field" href="http://clinicaltrials.gov/ct2/help/arm_group_desc"> Arms | click="openPopupWindow('/ct2/help/interventions_desc',false); return false;" title="Help on Interventions field" href="http://clinicaltrials.gov/ct2/help/interventions_desc"> Assigned Interventions |
|---|---|
| Experimental Dietary Supplement (e.g., vitamins, minerals): Experimental Experimental arm is supplemented with high-dose of vitamin D. | 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 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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)
Contacts and Locations| Contact: Julius Halaschek-Wiener, PhD | 604-734-7125 | [email protected] |
| Canada, British Columbia | |
| InspireHealth | |
| Vancouver, British Columbia, Canada, V6H 4A6 | |
| Principal Investigator: | Hal Gunn, MD | University of British Columbia |
More Information Additional Information:
No publications provided
| Responsible Party: | University of British Columbia ( Dr. Hal Gunn ) |
| ClinicalTrials.gov Identifier: | NCT01150877 click="openNewWindow('/ct2/archive/NCT01150877'); return false;" title="Historical versions of study NCT01150877 on ClinicalTrials.gov Archive Site" href="http://clinicaltrials.gov/ct2/archive/NCT01150877">History of Changes |
| Other Study ID Numbers: | H10-00028 |
| Study First Received: | June 22, 2010 |
| Last Updated: | June 24, 2010 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of British Columbia:
| Vitamin D Vitamin D3 colon cancer rectal cancer Cholecalciferol |
Additional relevant MeSH terms:
| Digestive System Neoplasms Gastrointestinal Diseases Growth Substances Physiological Effects of Drugs Colonic Diseases Ergocalciferols Bone Density Conservation Agents Intestinal Diseases Rectal Diseases Pharmacologic Actions | Intestinal Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Vitamin D Vitamins Gastrointestinal Neoplasms Micronutrients Colorectal Neoplasms |
ClinicalTrials.gov processed this record on July 07, 2010