High Dose Vitamin D Study

This study is currently recruiting participants.
Verified March 2014 by University of British Columbia
Sponsor:
Collaborator:
Lotte and John Hecht Memorial Foundation
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01150877
First received: June 22, 2010
Last updated: March 19, 2014
Last verified: March 2014
  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?


Condition Intervention Phase
Colorectal Cancer
Drug: Vitamin D
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
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:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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: July 2017
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Dietary Supplement (e.g., vitamins, minerals)
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.

  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)
  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 Recruiting
Vancouver, British Columbia, Canada, V6H 4A6
Contact: Julius Halaschek-Wiener, PhD    604-734-7125    jhalaschek-wiener@inspirehealth.ca   
Sponsors and Collaborators
University of British Columbia
Lotte and John Hecht Memorial Foundation
Investigators
Principal Investigator: Hal Gunn, MD University of British Columbia
  More Information

Additional Information:
No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01150877     History of Changes
Other Study ID Numbers: H10-00028
Study First Received: June 22, 2010
Last Updated: March 19, 2014
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:
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
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 17, 2014