The Effect of Vitamin D Substitution on the Development of Chronic Pancreatitis
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|ClinicalTrials.gov Identifier: NCT02965898|
Recruitment Status : Recruiting
First Posted : November 17, 2016
Last Update Posted : October 8, 2019
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 3 years.
The enrollment will begin 26.9.2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pancreatitis||Dietary Supplement: Vitamin D 100ug Dietary Supplement: Vitamin D 10ug||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||260 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||The Effect of Vitamin D Substitution on Pancreatic Parenchyma and Development of Fibrosis After First Acute Alcoholic Pancreatitis: A Randomized Prospective Trial|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||September 2024|
|Estimated Study Completion Date :||January 2026|
Active Comparator: Vitamin D 100ug
The highest safest dose. Expected to lower risk of chronic pancreatitis after acute pancreatitis.
Dietary Supplement: Vitamin D 100ug
Vitamin D 100 ug from Orion Pharma. Safest highest daily dose of vitamin D.
Placebo Comparator: Vitamin D 10ug
Placebo dose. Minimal recommended dose
Dietary Supplement: Vitamin D 10ug
Placebo dose. Minimal recommended dose.
- 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
- 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.
- The development of complications related to chronic pancreatitis [ Time Frame: 3 years ]The complications are registered from the participants medical records.
- Mortality related to chronic pancreatitis [ Time Frame: 3 years ]The mortality is registered from the participants medical records.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02965898
|Contact: Johanna Laukkarinen, Ass email@example.com|
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