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

Not Applicable

Completed

• Conditions: Chronic Pancreatitis
• Interventions: Dietary Supplement: Vitamin D 100ug; Dietary Supplement: Vitamin D 10ug

• Registration Number: NCT02965898
• Lead Sponsor: Tampere University Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-23
• Study First Submitted QC: 2016-11-14
• Study First Posted: 2016-11-17
• Primary Completion: 2024-03-10
• Study Completion: 2024-03-10
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D 100ug	Vitamin D 100ug	The highest safest dose. Expected to lower risk of chronic pancreatitis after acute pancreatitis.
Vitamin D 10ug	Vitamin D 10ug	Placebo dose. Minimal recommended dose

Primary Outcome Measures

Name	Time	Method
The development of parenchymal changes possibly related to fibrosis after acute pancreatitis analysed by magnetic resonance cholangiopancreatography imaging texture analysis	3 years	A radiologist analyses the pancreatic parenchymal changes from MRCP images

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Finland