Colorectal CancerPhase 2NCT01574027
Efficacy of Vitamin D in Colorectal Cancer Chemoprevention
A Phase 2 study testing Vitamin D3 (cholecalciferol) in people with Colorectal Cancer, run by University of Illinois Chicago at 1 site in United States.
Trial summary
Vitamin D's ability to prevent colorectal cancer (CRC) has been suspected for nearly 30 years, but has never been directly studied in humans. The biologically active version of vitamin D, 1,25(OH)2D3, cannot be readily used in humans because of its tendency to cause serum calcium levels to rise. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Vitamin D3 (cholecalciferol)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Oct 2011
- Phase
- Phase 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All non-pregnant patients 50 years of age or older with 10 or more ACFs.
Who cannot join
- The following will be specifically looked for, and result in patients not being eligible for study enrollment:
- Use of non-steroidal anti-inflammatory drugs or glucocorticosteroids within 60 days of study entry.
- History of chronic IBD or prior pelvic radiation (inflammation distorts crypt pattern).
- Intake of any vitamin D or calcium supplements within 60 days of study entry.
- Patients with increased bleeding risk from biopsy protocol (i.e. renal failure, decompensated cirrhosis, blood dyscrasia
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago Medical Center
Chicago, Illinois, 60612
About this study
Vitamin D's ability to prevent colorectal cancer (CRC) has been suspected for nearly 30 years, but has never been directly studied in humans. The biologically active version of vitamin D, 1,25(OH)2D3, cannot be readily used in humans because of its tendency to cause serum calcium levels to rise. In contrast, 25(OH)D3 (ie calcifediol) does not have this side effect. The investigators previous research suggests that the enzyme necessary to convert 25(OH)D3 (calcifediol) into active 1,25(OH)D3 is present in cells lining the large intestine (colon).
Aberrant crypt foci (ACF) are very small (ie microscopic) collections of abnormally shaped cells that are a commonly used marker of CRC risk. Screening colonoscopy at UIC routinely uses methods that allow ACF counting to be done as a part of standard practice. ACF's are not fixed, like polyps or cancers, but can disappear as a person's risk for developing CRC decreases.
The investigators propose giving patient's with 10 or more ACF's 25(OH)D3 (calcifediol) or placebo, and determining if there is a drug-dependant decrease in ACF number. The primary objective is to determine whether 25(OH)D3 (calcifediol) supplementation, compared to placebo, causes significant reduction of ACF number from baseline levels. The primary endpoint will be change in ACF number.
Read the detailed description
Patients will be offered participation in this study at the time of their regularly scheduled visit to the UIC Colorectal Cancer Screening Clinic. Those agreeing will have indicated their understanding that participation will be conditional upon their having 10+ ACF at the time of their screening colonoscopy. If at screening colonoscopy 10+ ACF are found patients will:
- undergo 3 endoscopic mucosal biopsies of the distal colon; and
- undergo a blood draw from an i.v. already in place for sedative-narcotic administration for serum 25(OH)D3 and serum ionized calcium; and
- be given either placebo or calcifediol and instructed to take daily for 6 months.
- provide urine for calcium/creatine spot ratio.
At 7 and 14 days after the screening colonoscopy patients will be called on the telephone by the clinical research nurse assigned to this study to follow-up and note 25(OH)D3 (calcifediol) toxicity, if any (note that toxicity has not been described except in the case of overdose). Signs specifically looked for will include: headache, increased urination, nausea, vomiting, abdominal pain, weakness, constipation, and anorexia. If present, patient will be advised to present immediately to the UIC GCRC for physical and serological evaluation.
At 30, 90 and 120 days the patient will have agreed to present to the GCRC clinic for:
- Capsule retrieval/count (80% compliance will be required to remain in study); and
- Detailed history and physical, focusing specifically on signs and symptoms of hypercalcemia.
- At day 90 only - provide urine for calcium/creatine spot ratio.
Evidence on exam, or laboratory, of hypercalcemia will result in an adverse event reporting and immediate patient discharge from this study. Signs specifically looked for include: headache, increased urination, nausea, vomiting, abdominal pain, weakness, constipation, and anorexia.
At 180 days the patient will have agreed to undergo:
- Repeat endoscopic exam limited to the recto-sigmoid colon, also known as a "flexible sigmoidoscopy"; and
- repeat blood draw for serum 25(OH)D3 and serum ionized calcium
- Conditions
- Colorectal Cancer
- Being tested
- Vitamin D3 (cholecalciferol), Placebo
- Keywords
- Assess the efficacy of vitamin D for preventing colorectal cancer and identifying the populations likely (or unlikely) to benefit from vitamin D-based therapy., Evaluate the ability of Vitamin D3 (cholecalciferol) to reduce ACF's in humans.
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 (cholecalciferol)Drug
One capsule per day for six months
PlaceboDrug
One capsule per day for six months
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Some participants were given a placebo pill to take daily for the length of the study. The placebo patients were used as a control group to compare against those taking the Vitamin D supplement. Receives: Drug: Placebo |
| Vitamin D3 (cholecalciferol) | Experimental | Other participants were administered Vitamin D3 (cholecalciferol) for the six month study duration to determine if it would decrease the number of aberrant crypt foci in the colon as compared to the baseline number. Receives: Drug: Vitamin D3 (cholecalciferol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in ACF biomarkers
The investigators propose giving patient's with 10 or more ACF's 25(OH)D3 (calcifediol) or placebo, and determining if there is a drug-dependant decrease in ACF number. The primary objective is to determine whether 25(OH)D3 (calcifediol) supplementation, compared to placebo, causes significant reduction of ACF number from baseline levels. The primary endpoint will be change in ACF number.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startApr 2008
- Primary completionOct 2011
- Study completionOct 2011
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 Illinois ChicagoThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Benya, M.D., University of Illinois Chicago
- Investigators
- Richard V Benya, M.D., Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574027
- Sponsor's protocol ID
- R01CA122299
- Status last verified
- Apr 2012
- First submitted
- 30 Mar 2012
- Last updated
- 10 Apr 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Vitamin D in Colorectal Cancer Chemoprevention
- ClinicalTrials.gov ID
- NCT01574027
- Acronym / sponsor ID
- R01CA122299
- Conditions
- Colorectal Cancer
- Keywords
- Assess the efficacy of vitamin D for preventing colorectal cancer and identifying the populations likely (or unlikely) to benefit from vitamin D-based therapy., Evaluate the ability of Vitamin D3 (cholecalciferol) to reduce ACF's in humans.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 10 Apr 2012 (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.
Vitamin D's ability to prevent colorectal cancer (CRC) has been suspected for nearly 30 years, but has never been directly studied in humans. The biologically active version of vitamin D, 1,25(OH)2D3, cannot be readily used in humans because of its tendency to cause serum calcium levels to rise. In contrast, 25(OH)D3 (ie calcifediol) does not have this side effect. The investigators previous research suggests that the enzyme necessary to convert 25(OH)D3 (calcifediol) into active 1,25(OH)D3 is present in cells lining the large intestine (colon).
Aberrant crypt foci (ACF) are very small (ie microscopic) collections of abnormally shaped cells that are a commonly used marker of CRC risk. Screening colonoscopy at UIC routinely uses methods that allow ACF counting to be done as a part of standard practice. ACF's are not fixed, like polyps or cancers, but can disappear as a person's risk for developing CRC decreases.
The investigators propose giving patient's with 10 or more ACF's 25(OH)D3 (calcifediol) or placebo, and determining if there is a drug-dependant decrease in ACF number. The primary objective is to determine whether 25(OH)D3 (calcifediol) supplementation, compared to placebo, causes significant reduction of ACF number from baseline levels. The primary endpoint will be change in ACF number.
Detailed description
Patients will be offered participation in this study at the time of their regularly scheduled visit to the UIC Colorectal Cancer Screening Clinic. Those agreeing will have indicated their understanding that participation will be conditional upon their having 10+ ACF at the time of their screening colonoscopy. If at screening colonoscopy 10+ ACF are found patients will:
- undergo 3 endoscopic mucosal biopsies of the distal colon; and
- undergo a blood draw from an i.v. already in place for sedative-narcotic administration for serum 25(OH)D3 and serum ionized calcium; and
- be given either placebo or calcifediol and instructed to take daily for 6 months.
- provide urine for calcium/creatine spot ratio.
At 7 and 14 days after the screening colonoscopy patients will be called on the telephone by the clinical research nurse assigned to this study to follow-up and note 25(OH)D3 (calcifediol) toxicity, if any (note that toxicity has not been described except in the case of overdose). Signs specifically looked for will include: headache, increased urination, nausea, vomiting, abdominal pain, weakness, constipation, and anorexia. If present, patient will be advised to present immediately to the UIC GCRC for physical and serological evaluation.
At 30, 90 and 120 days the patient will have agreed to present to the GCRC clinic for:
- Capsule retrieval/count (80% compliance will be required to remain in study); and
- Detailed history and physical, focusing specifically on signs and symptoms of hypercalcemia.
- At day 90 only - provide urine for calcium/creatine spot ratio.
Evidence on exam, or laboratory, of hypercalcemia will result in an adverse event reporting and immediate patient discharge from this study. Signs specifically looked for include: headache, increased urination, nausea, vomiting, abdominal pain, weakness, constipation, and anorexia.
At 180 days the patient will have agreed to undergo:
- Repeat endoscopic exam limited to the recto-sigmoid colon, also known as a "flexible sigmoidoscopy"; and
- repeat blood draw for serum 25(OH)D3 and serum ionized calcium
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboSome participants were given a placebo pill to take daily for the length of the study. The placebo patients were used as a control group to compare against those taking the Vitamin D supplement. |
| Vitamin D3 (cholecalciferol) | Experimental | Drug: Vitamin D3 (cholecalciferol)Other participants were administered Vitamin D3 (cholecalciferol) for the six month study duration to determine if it would decrease the number of aberrant crypt foci in the colon as compared to the baseline number. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All non-pregnant patients 50 years of age or older with 10 or more ACFs.
Key exclusion criteria (5 listed)
- The following will be specifically looked for, and result in patients not being eligible for study enrollment:
- Use of non-steroidal anti-inflammatory drugs or glucocorticosteroids within 60 days of study entry.
- History of chronic IBD or prior pelvic radiation (inflammation distorts crypt pattern).
- Intake of any vitamin D or calcium supplements within 60 days of study entry.
- Patients with increased bleeding risk from biopsy protocol (i.e. renal failure, decompensated cirrhosis, blood dyscrasia
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 D3 (cholecalciferol)One capsule per day for six months | Drug | Vitamin D3 (cholecalciferol) |
| PlaceboOne capsule per day for six months | Drug | Placebo |
Primary outcome
Reduction in ACF biomarkers
Time frame: 6 months
The investigators propose giving patient's with 10 or more ACF's 25(OH)D3 (calcifediol) or placebo, and determining if there is a drug-dependant decrease in ACF number. The primary objective is to determine whether 25(OH)D3 (calcifediol) supplementation, compared to placebo, causes significant reduction of ACF number from baseline levels. The primary endpoint will be change in ACF number.
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 10 Apr 2012.
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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.
Richard V Benya, M.D. principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin D3 (cholecalciferol) in people with Colorectal Cancer, run by University of Illinois Chicago at 1 site in United States.
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 1 inclusion and 5 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 10 Apr 2012. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
Reduction in ACF biomarkers (time frame: 6 months). 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 10 Apr 2012.