Chronic Pancreatitis
Conditions
Keywords
chronic pancreatitis, vitamin d, pancreatitis, Pancreatic stellate cell, rct
Brief summary
Acute pancreatitis (AP) may develop to chronic pancreatitis (CP). In Finland, the ethiology is alcohol in about 80% of the cases. Several symptoms lower the quality of life in CP patients, including abdominal pain, exocrine and endocrine pancreatic insufficiency. Recently, the investigators and others have found that vitamin D may protect from the formation of fibrosis on cellular level. The investigators hypothesized that after the first AP they may be able to protect the formation of fibrosis leading to CP with Vitamin D, and designed this RCT. The aim is to study whether the investigators can prevent CP with vitamin D substitute. In this randomized controlled patient study, the patients after their first AP are randomized to have either a normal recommended (10 μ) or a largest safe dose (100 μg). of vitamin D substitute daily. The patients are examined by MRI/MRCP imaging and laboratory tests at the baseline after recovery from AP and yearly then after. Primary endpoint is the development of parenchymal changes possibly related to fibrosis. Secondary endpoints are the development of CP with Mannheim criteria, CP related complications and mortality. The first analysis will be done after 7 years. The enrollment will begin 26.9.2016
Interventions
DIETARY_SUPPLEMENTVitamin D 100ug
Vitamin D 100 ug from Orion Pharma. Safest highest daily dose of vitamin D.
DIETARY_SUPPLEMENTVitamin D 10ug
Placebo dose. Minimal recommended dose.
Sponsors
Orion Corporation, Orion Pharma
Tampere University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 101 Years
Healthy volunteers
No
Inclusion criteria
* First alcohol induced acute pancreatitis * Willing to participate in a 3 year RCT
Exclusion criteria
* Renal failure * Hypercalcemia * High serum levels of vitamin D * Unwilling to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The development of parenchymal changes possibly related to fibrosis after acute pancreatitis analysed by magnetic resonance cholangiopancreatography imaging texture analysis | 3 years | A radiologist analyses the pancreatic parenchymal changes from MRCP images |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The development of chronic pancreatitis (CP) with Mannheim criteria | 3 years | The diagnostic Mannheim criteria include laboratory tests for measuring the endocrine and exocrine function of the pancreas and MRI/MRCP for measuring pancreatic duct lesions and calcifications. |
| The development of complications related to chronic pancreatitis | 3 years | The complications are registered from the participants medical records. |
| Mortality related to chronic pancreatitis | 3 years | The mortality is registered from the participants medical records. |
Countries
Finland
Outcome results
None listed