The Effect of Vitamin D Substitution on the Development of Chronic Pancreatitis

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

Official Title
-----------------
The Effect of Vitamin D Substitution on Pancreatic Parenchyma and Development of Fibrosis After First Acute Alcoholic Pancreatitis: A Randomized Prospective Trial

Conditions
-----------------
Chronic Pancreatitis

Intervention / Treatment
-----------------
* Dietary Supplement: Vitamin D 100ug
* Dietary Supplement: Vitamin D 10ug


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 101 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin D 100ug<br>The highest safest dose. Expected to lower risk of chronic pancreatitis after acute pancreatitis. | Dietary Supplement: Vitamin D 100ug<br>* Vitamin D 100 ug from Orion Pharma. Safest highest daily dose of vitamin D.<br>|
| Placebo Comparator: Vitamin D 10ug<br>Placebo dose. Minimal recommended dose | Dietary Supplement: Vitamin D 10ug<br>* Placebo dose. Minimal recommended dose.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 years | 
| The development of complications related to chronic pancreatitis | The complications are registered from the participants medical records. | 3 years | 
| Mortality related to chronic pancreatitis | The mortality is registered from the participants medical records. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic pancreatitis, vitamin d, pancreatitis, Pancreatic stellate cell, rct