NCT02965898

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: Tampere University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 101 Years
• Healthy volunteers: Not accepted

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

Conditions

• Chronic Pancreatitis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin D 100ug	Vitamin D 100 ug from Orion Pharma. Safest highest daily dose of vitamin D.
DIETARY_SUPPLEMENT	Vitamin D 10ug	Placebo dose. Minimal recommended dose.

Timeline

• Start date: 2016-09-01
• Primary completion: 2024-03-10
• Completion: 2024-03-10
• First posted: 2016-11-17
• Last updated: 2025-04-16

Locations

1 site across 1 country: Finland