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OpenTrials
Completed

NCT Number: NCT02965898

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

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

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Key information

Age range

18 year–101 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tampere University Hospital

Tampere, 33520, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D 100ug

Dietary Supplement

Vitamin D 100 ug from Orion Pharma. Safest highest daily dose of vitamin D.

Vitamin D 10ug

Dietary Supplement

Placebo dose. Minimal recommended dose.

Primary outcomes

  1. 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

  1. 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.

  2. The development of complications related to chronic pancreatitis

    Time frame: 3 years

    The complications are registered from the participants medical records.

  3. Mortality related to chronic pancreatitis

    Time frame: 3 years

    The mortality is registered from the participants medical records.

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Collaborators

  • Orion Corporation, Orion Pharma

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
Nov 17, 2016
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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