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Will increasing vitamin D in blood to 100 ng reduce deaths of colon cancer patients- July 2010


High Dose Vitamin D Study - Clinical Trail registered July 2010

This study is not yet open for participant recruitment.
Verified by University of British Columbia, June 2010
Sponsor: University of British Columbia
Collaborator: Lotte and John Hecht Memorial Foundation
Information provided by: University of British Columbia
ClinicalTrials.gov Identifier: NCT01150877
Image   Purpose

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?



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

Resource links provided by NLM:

click="openNewWindow('http://www.nlm.nih.gov/medlineplus/');

return false" title="MedlinePlus site" 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 D

Further study details as provided by University of British Columbia:

Primary Outcome Measures:

Secondary Outcome Measures:

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  

Detailed 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.

Image   Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
Image   Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01150877

Contacts
Contact: Julius Halaschek-Wiener, PhD 604-734-7125 jhalaschek-wiener@inspirehealth.ca

Locations
Canada, British Columbia
InspireHealth
Vancouver, British Columbia, Canada, V6H 4A6
Sponsors and Collaborators
University of British Columbia
Lotte and John Hecht Memorial Foundation
Investigators
Principal Investigator: Hal Gunn, MD University of British Columbia
Image   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

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