High Dose Vitamin D Study

Study of High-dose Vitamin D Supplementation in Stage-4 Colorectal Cancer Patients

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 Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Vitamin D

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 4A6
      • InspireHealth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No Intervention
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The metabolic consequences, including tolerability and toxicity, of prolonged, high-dose physiological vitamin D in patients with colorectal cancer.	After 16 months of intervention
The metabolic consequences, including tolerability and toxicity, of prolonged, high-dose physiological vitamin D in patients with colorectal cancer.	After 12 months of follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
Patient survival with regards to high-dose vitamin D supplementation.	After 16 months of intervention
Patient survival with regards to high-dose vitamin D supplementation.	After 12 months of follow-up

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Lotte & John Hecht Memorial Foundation
• Investigators: Principal Investigator: Hal Gunn, MD, University of British Columbia

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): April 23, 2014
• Study Completion (Actual): April 23, 2014

Study Registration Dates

• First Submitted: June 22, 2010
• First Submitted That Met QC Criteria: June 24, 2010
• First Posted (Estimate): June 25, 2010

Study Record Updates

• Last Update Posted (Actual): March 3, 2017
• Last Update Submitted That Met QC Criteria: March 1, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Vitamin D; rectal cancer; colon cancer; Vitamin D3; Cholecalciferol
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: H10-00028