Clinical Trial: The Effect of Vitamin D Substitution on the Development of Chronic Pancreatitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 3 years.

The enrollment will begin 26.9.2016


Detailed Summary:
Sponsor: Tampere University Hospital

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The development of chronic pancreatitis (CP) with Mannheim criteria [ Time Frame: 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 [ Time Frame: 3 years ]
    The complications are registered from the participants medical records.
  • Mortality related to chronic pancreatitis [ Time Frame: 3 years ]
    The mortality is registered from the participants medical records.


Original Secondary Outcome: Same as current

Information By: Tampere University Hospital

Dates:
Date Received: September 23, 2016
Date Started: September 2016
Date Completion: January 2021
Last Updated: November 14, 2016
Last Verified: November 2016