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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2022
• Main ID: NCT02965898
• Date of registration: 23/09/2016
• Prospective Registration: No
• Primary sponsor: Tampere University Hospital
• Public title: The Effect of Vitamin D Substitution on the Development of Chronic Pancreatitis
• Scientific title: The Effect of Vitamin D Substitution on Pancreatic Parenchyma and Development of Fibrosis After First Acute Alcoholic Pancreatitis: A Randomized Prospective Trial
• Date of first enrolment: September 2016
• Target sample size: 260
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02965898
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: N/A

Countries of recruitment

Finland

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 101 Years
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Pancreatitis

Intervention(s)

Dietary Supplement: Vitamin D 100ug

Dietary Supplement: Vitamin D 10ug

Primary Outcome(s)

The development of parenchymal changes possibly related to fibrosis after acute pancreatitis analysed by magnetic resonance cholangiopancreatography imaging texture analysis [Time Frame: 3 years]

Secondary Outcome(s)

Mortality related to chronic pancreatitis [Time Frame: 3 years]

The development of chronic pancreatitis (CP) with Mannheim criteria [Time Frame: 3 years]

The development of complications related to chronic pancreatitis [Time Frame: 3 years]

Secondary ID(s)

R16004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Orion Corporation, Orion Pharma