50 Years
N/A
Both
Colorectal Cancer
Trial Information
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
Inclusion Criteria:
- All non-pregnant patients 50 years of age or older with 10 or more ACFs.
Exclusion Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Outcome Measure:
Reduction in ACF biomarkers
Outcome Description:
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.
Outcome Time Frame:
6 months
Safety Issue:
No
Principal Investigator
Richard V Benya, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Illinois
Authority:
United States: Institutional Review Board
Study ID:
R01CA122299
NCT ID:
NCT01574027
Start Date:
April 2008
Completion Date:
October 2011
Related Keywords:
- Colorectal Cancer
- 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.
- Colorectal Neoplasms
Name | Location |
|---|---|
| University of Illinois at Chicago Medical Center | Chicago, Illinois 60612 |
