Efficacy of Vitamin D in Colorectal Cancer Chemoprevention
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01574027|
Recruitment Status : Completed
First Posted : April 10, 2012
Last Update Posted : April 10, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: Vitamin D3 (cholecalciferol) Drug: Placebo||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
Placebo Comparator: Placebo
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.
One capsule per day for six months
Experimental: 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.
Drug: Vitamin D3 (cholecalciferol)
One capsule per day for six months
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574027
|United States, Illinois|
|University of Illinois at Chicago Medical Center|
|Chicago, Illinois, United States, 60612|
|Principal Investigator:||Richard V Benya, M.D.||University of Illinois at Chicago|