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

  • STATUS
    Recruiting
  • End date
    Jan 2, 2027
  • participants needed
    260
  • sponsor
    Tampere University Hospital
Updated on 27 January 2022
abdominal pain
acute pancreatitis
pancreatic insufficiency
mrcp

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 ) or a largest safe dose (100 g). 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

Details
Condition Chronic Pancreatitis
Treatment Vitamin D 100ug, Vitamin D 10ug
Clinical Study IdentifierNCT02965898
SponsorTampere University Hospital
Last Modified on27 January 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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