Actively Recruiting
A Pilot Clinical Trial of Paricalcitol for Chronic Pancreatitis
Led by Cedars-Sinai Medical Center · Updated on 2025-11-14
24
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
C
Cedars-Sinai Medical Center
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to explore the feasibility and acceptability of using paricalcitol in adults diagnosed with Chronic Pancreatitis (CP). The study evaluates the potential impact of paricalcitol on patients' health-related quality of life, imaging results, and biomarker analysis. It is based on early evidence suggesting that vitamin D analogues may influence pancreatitis symptoms by blocking certain proteins involved in pain. Participants are randomly assigned to receive either a daily 2 mcg capsule of paricalcitol or a matching placebo for 12 months. The study includes several assessments such as MRI scans to evaluate pancreatic condition and DEXA scans to monitor bone mineral density at the beginning and end of the treatment period. Routine laboratory tests will also be performed to check for any safety concerns during the trial. Throughout the study, medical history and medications will be reviewed at each visit. Blood and other mechanistic research specimens will be collected at screening/randomization, 6 months, and 12 months visits. Researchers will assess changes in quality of life over 12 months, monitor bone density, and watch for adverse effects. The total participation time is 12 months, with multiple in-person visits and ongoing safety monitoring.
CONDITIONS
Brief Title
A PiLot ClinicaL TrIal of ParicAlcitol for ChroNiC PancrEatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to follow all study procedures and be available for the study duration
- Male or female aged 18 to 75 years at enrollment
- Diagnosis of Chronic Pancreatitis not caused by gallstones, medications, trauma, or autoimmune pancreatitis
- Ability to take oral medication and follow dosing schedule
- Normal calcium levels (8.5 to 10.2 mg/dL)
- Normal phosphate levels (2.8 to 4.5 mg/dL)
- Normal parathyroid hormone levels (10 to 65 pg/mL)
- For females of reproductive potential: use of effective contraception before and during study and for 1 week after treatment
- For males of reproductive potential: use of condoms or other effective contraception
- No prior pancreatic surgery
- Pancreatic necrosis less than 50% if present
- No participation in other interventional trials currently or within 6 months
You will not qualify if you...
- Pregnancy or breastfeeding
- History of autoimmune or traumatic pancreatitis or acute necrotizing pancreatitis with suspected disconnected duct syndrome
- Presence of primary pancreatic tumors or pancreatic metastasis
- History of solid organ transplant or HIV/AIDS
- Abnormal calcium, phosphate, or parathyroid hormone lab values
- Known isolated pancreatic exocrine insufficiency without meeting inclusion criteria
- Medical or psychiatric illnesses or substance abuse that affect study participation
- Known abnormal kidney function (GFR < 30) or renal failure
- Known pregnancy or positive pregnancy test within 2 days prior to research procedures
- Currently incarcerated
- Inability to tolerate MRI
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 months
Participants take a daily oral capsule of paricalcitol or placebo for 12 months to assess effects on chronic pancreatitis symptoms and safety.
In-person visits at Screening/Randomization, Month 6, and Month 12
Trial Site Locations
Total: 1 location
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
Research Team
A
Arax Shanlian
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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