High Dose Vitamin D Study

Phase 1

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: Vitamin D

• Registration Number: NCT01150877
• Lead Sponsor: University of British Columbia

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.

Study Timeline

• Study First Submitted: 2010-06-22
• Study First Submitted QC: 2010-06-24
• Study First Posted: 2010-06-25
• Study Start: 2011-01
• Primary Completion: 2014-04-23
• Study Completion: 2014-04-23
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-01
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Dietary Supplement (e.g., vitamins, minerals)	Vitamin D	Experimental arm is supplemented with high-dose of vitamin D.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Patient survival with regards to high-dose vitamin D supplementation.	After 12 months of follow-up

Trial Locations

Locations (1)

InspireHealth; 🇨🇦 Vancouver, British Columbia, Canada