The Effect of Vitamin D Substitution on Pancreatic Parenchyma and Development of Fibrosis After First Acute Alcoholic Pancreatitis: A Randomized Prospective Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tampere University Hospital
- Enrollment
- 260
- Locations
- 1
- Primary Endpoint
- The development of parenchymal changes possibly related to fibrosis after acute pancreatitis analysed by magnetic resonance cholangiopancreatography imaging texture analysis
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 101 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Vitamin D 100ug
The highest safest dose. Expected to lower risk of chronic pancreatitis after acute pancreatitis.
Intervention: Vitamin D 100ug (Dietary Supplement)
Vitamin D 10ug
Placebo dose. Minimal recommended dose
Intervention: Vitamin D 10ug (Dietary Supplement)
Outcomes
Primary Outcomes
The development of parenchymal changes possibly related to fibrosis after acute pancreatitis analysed by magnetic resonance cholangiopancreatography imaging texture analysis
Time Frame: 3 years
A radiologist analyses the pancreatic parenchymal changes from MRCP images
Secondary Outcomes
- The development of complications related to chronic pancreatitis(3 years)
- The development of chronic pancreatitis (CP) with Mannheim criteria(3 years)
- Mortality related to chronic pancreatitis(3 years)
Investigators
Mikael Parhiala
PhD canditate
Tampere University Hospital