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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
260
Vitamin D 100 ug from Orion Pharma. Safest highest daily dose of vitamin D.
Placebo dose. Minimal recommended dose.
Tampere University Hospital
Tampere, Finland
The development of parenchymal changes possibly related to fibrosis after acute pancreatitis analysed by magnetic resonance cholangiopancreatography imaging texture analysis
A radiologist analyses the pancreatic parenchymal changes from MRCP images
Time frame: 3 years
The development of chronic pancreatitis (CP) with Mannheim criteria
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.
Time frame: 3 years
The development of complications related to chronic pancreatitis
The complications are registered from the participants medical records.
Time frame: 3 years
Mortality related to chronic pancreatitis
The mortality is registered from the participants medical records.
Time frame: 3 years
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