A PiLot ClinicaL TrIal of ParicAlcitol for ChroNiC PancrEatitis
Cedars-Sinai Medical Center
Summary
The purpose of this pilot study to examine the feasibility and acceptability of paricalcitol in adults with Chronic Pancreatitis (CP).
Description
Examine the feasibility of a trial to test the effect of paricalcitol through health-related quality of life, imaging, and biomarker analysis in patients with chronic pancreatitis (CP). The study hopes the proposed intervention will improve symptoms based on preclinical evidence that vitamin D analogues have significant and beneficial effects on pancreatitis cancer by blocking certain signaling proteins to reduce pain. Medical history, concomitant medications, and laboratory test results will be reviewed at all visits by one of the study physicians. In addition, at the beginning and end of th…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged 18-75 at time of enrollment * Diagnosis of Chronic Pancreatitis episode is not attributable to gallstones (i.e. suspected or definite biliary etiology), medications, trauma or autoimmune pancreatitis. * Ability to take oral medication and be willing to adhere to the dosing regimen * Normal Calcium levels- 8.5 to 10.2 mg/dL * Normal Phosphate levels- 2.8 to 4.5 mg/dL * Normal Parathyroid hormone…
Interventions
- DrugParicalcitol
2 MCG Oral Capsule
- DrugPlacebo
Matching capsule to 2 MCG Paricalcitol Oral Capsule
Location
- Cedars-Sinai Medical CenterLos Angeles, California