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
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
- 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
At 180 days the patient will have agreed to undergo:
- Repeat endoscopic exam limited to the recto-sigmoid colon, also known as a "flexible
- repeat blood draw for serum 25(OH)D3 and serum ionized calcium
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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.
Richard V Benya, M.D.
University of Illinois
United States: Institutional Review Board
|University of Illinois at Chicago Medical Center||Chicago, Illinois 60612|