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High Dose Vitamin D Study

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Vitamin D
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Vitamin D, Vitamin D3, colon cancer, rectal cancer, Cholecalciferol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • InspireHealth

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Dietary Supplement (e.g., vitamins, minerals)

No Intervention

Arm Description

Experimental arm is supplemented with high-dose of vitamin D.

Outcomes

Primary Outcome Measures

The metabolic consequences, including tolerability and toxicity, of prolonged, high-dose physiological vitamin D in patients with colorectal cancer.
The metabolic consequences, including tolerability and toxicity, of prolonged, high-dose physiological vitamin D in patients with colorectal cancer.

Secondary Outcome Measures

Patient survival with regards to high-dose vitamin D supplementation.
Patient survival with regards to high-dose vitamin D supplementation.

Full Information

First Posted
June 22, 2010
Last Updated
March 1, 2017
Sponsor
University of British Columbia
Collaborators
Lotte & John Hecht Memorial Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01150877
Brief Title
High Dose Vitamin D Study
Official Title
Study of High-dose Vitamin D Supplementation in Stage-4 Colorectal Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
April 23, 2014 (Actual)
Study Completion Date
April 23, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
Collaborators
Lotte & John Hecht Memorial Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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?
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Vitamin D, Vitamin D3, colon cancer, rectal cancer, Cholecalciferol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Dietary Supplement (e.g., vitamins, minerals)
Arm Type
Experimental
Arm Description
Experimental arm is supplemented with high-dose of vitamin D.
Arm Title
No Intervention
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
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
Secondary Outcome Measure Information:
Title
Patient survival with regards to high-dose vitamin D supplementation.
Time Frame
After 16 months of intervention
Title
Patient survival with regards to high-dose vitamin D supplementation.
Time Frame
After 12 months of follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hal Gunn, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
InspireHealth
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 4A6
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.inspirehealth.ca
Description
Related Info

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High Dose Vitamin D Study

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