NCT01150877

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_1 colorectal-cancer

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 25, 2010

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2014

Completed
Last Updated

March 3, 2017

Status Verified

March 1, 2017

Enrollment Period

3.3 years

First QC Date

June 22, 2010

Last Update Submit

March 1, 2017

Conditions

Colorectal Cancer

Keywords

Vitamin DVitamin D3colon cancerrectal cancerCholecalciferol

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • 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

Study Arms (2)

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

EXPERIMENTAL

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

Drug: Vitamin D

No Intervention

NO INTERVENTION

Interventions

Vitamin DDRUG

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.

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

InspireHealth

Vancouver, British Columbia, V6H 4A6, Canada

Location

Related Links

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Hal Gunn, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2010

First Posted

June 25, 2010

Study Start

January 1, 2011

Primary Completion

April 23, 2014

Study Completion

April 23, 2014

Last Updated

March 3, 2017

Record last verified: 2017-03

Locations

CA(1)