Tampere University Hospital
Tampere, 33520, Finland
NCT Number: NCT02965898
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
Looking for future studies?
Notify Me18 year–101 year
All sexes
Interventional
Not applicable
Tampere, 33520, Finland
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Vitamin D 100 ug from Orion Pharma. Safest highest daily dose of vitamin D.
Placebo dose. Minimal recommended dose.
Time frame: 3 years
A radiologist analyses the pancreatic parenchymal changes from MRCP images
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.
Time frame: 3 years
The complications are registered from the participants medical records.
Time frame: 3 years
The mortality is registered from the participants medical records.
Tampere University Hospital
Other
The Effect of Vitamin D Substitution on Pancreatic Parenchyma and Development of Fibrosis After First Acute Alcoholic Pancreatitis: A Randomized Prospective Trial
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.
Published trials that share one or more normalized conditions with this study.
NCT03707431
Acute Recurrent Pancreatitis, Chronic Disease
Seattle, Washington, United States
View Trial DetailsNCT06721572
Abdominal Pain, Chronic Disease
Ann Arbor, Michigan, United States
View Trial DetailsNCT06230120
Chronic Disease, Chronic Pain
Aalborg, Denmark
View Trial DetailsNCT03283566
Autoimmune Diseases, Chronic Disease
Cleveland, Ohio, United States
View Trial Details