Colorectal CancerPhase 1/2NCT01150877
High Dose Vitamin D Study
A Phase 1/2 study testing Vitamin D in people with Colorectal Cancer, run by University of British Columbia at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2011to 23 Apr 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- Vitamin D
- Keywords
- Vitamin D, Vitamin D3, colon cancer, rectal cancer, Cholecalciferol
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Dietary Supplement (e.g., vitamins, minerals) | Experimental | Experimental arm is supplemented with high-dose of vitamin D. Receives: Drug: Vitamin D |
| No Intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The metabolic consequences, including tolerability and toxicity, of prolonged, high-dose physiological vitamin D in patients with colorectal cancer.
Measured: After 16 months of intervention
The metabolic consequences, including tolerability and toxicity, of prolonged, high-dose physiological vitamin D in patients with colorectal cancer.
Measured: After 12 months of follow-up
Secondary outcomes (2)
Patient survival with regards to high-dose vitamin D supplementation.
Measured: After 16 months of intervention
Patient survival with regards to high-dose vitamin D supplementation.
Measured: After 12 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2010 (estimated)
- Study startJan 2011
- Primary completion23 Apr 2014
- Study completion23 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Lotte & John Hecht Memorial Foundation
- Responsible party
- Sponsor
- Investigators
- Hal Gunn, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150877
- Sponsor's protocol ID
- H10-00028
- Status last verified
- Mar 2017
- First submitted
- 22 Jun 2010
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of High-dose Vitamin D Supplementation in Stage-4 Colorectal Cancer Patients
- ClinicalTrials.gov ID
- NCT01150877
- Acronym / sponsor ID
- H10-00028
- Conditions
- Colorectal Cancer
- Keywords
- Vitamin D, Vitamin D3, colon cancer, rectal cancer, Cholecalciferol
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Lotte & John Hecht Memorial Foundation
- Study start
- Jan 2011
- Primary completion
- 23 Apr 2014 (actual)
- Study completion
- 23 Apr 2014 (actual)
- First posted
- 25 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Dietary Supplement (e.g., vitamins, minerals) | Experimental | Drug: Vitamin DExperimental arm is supplemented with high-dose of vitamin D. |
| No Intervention | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DWe 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. | Drug | Experimental Dietary Supplement (e.g., vitamins, minerals) |
Primary outcome
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
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
2 secondary outcomes
Patient survival with regards to high-dose vitamin D supplementation.
Time frame: After 16 months of intervention
Patient survival with regards to high-dose vitamin D supplementation.
Time frame: After 12 months of follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hal Gunn, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vitamin D in people with Colorectal Cancer, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.