The Effect of Vitamin D Substitution on the Development of Chronic Pancreatitis
Primary Purpose
Chronic Pancreatitis
Status
Active
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Vitamin D 100ug
Vitamin D 10ug
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Pancreatitis focused on measuring chronic pancreatitis, vitamin d, pancreatitis, Pancreatic stellate cell, rct
Eligibility 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
Sites / Locations
- Tampere University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Vitamin D 100ug
Vitamin D 10ug
Arm Description
The highest safest dose. Expected to lower risk of chronic pancreatitis after acute pancreatitis.
Placebo dose. Minimal recommended dose
Outcomes
Primary Outcome Measures
The development of parenchymal changes possibly related to fibrosis after acute pancreatitis analysed by magnetic resonance cholangiopancreatography imaging texture analysis
A radiologist analyses the pancreatic parenchymal changes from MRCP images
Secondary Outcome Measures
The development of chronic pancreatitis (CP) with Mannheim criteria
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
The complications are registered from the participants medical records.
Mortality related to chronic pancreatitis
The mortality is registered from the participants medical records.
Full Information
NCT ID
NCT02965898
First Posted
September 23, 2016
Last Updated
November 29, 2022
Sponsor
Tampere University Hospital
Collaborators
Orion Corporation, Orion Pharma
1. Study Identification
Unique Protocol Identification Number
NCT02965898
Brief Title
The Effect of Vitamin D Substitution on the Development of Chronic Pancreatitis
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 Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2016 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
January 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University Hospital
Collaborators
Orion Corporation, Orion Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pancreatitis
Keywords
chronic pancreatitis, vitamin d, pancreatitis, Pancreatic stellate cell, rct
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
260 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D 100ug
Arm Type
Active Comparator
Arm Description
The highest safest dose. Expected to lower risk of chronic pancreatitis after acute pancreatitis.
Arm Title
Vitamin D 10ug
Arm Type
Placebo Comparator
Arm Description
Placebo dose. Minimal recommended dose
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D 100ug
Intervention Description
Vitamin D 100 ug from Orion Pharma. Safest highest daily dose of vitamin D.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D 10ug
Intervention Description
Placebo dose. Minimal recommended dose.
Primary Outcome Measure Information:
Title
The development of parenchymal changes possibly related to fibrosis after acute pancreatitis analysed by magnetic resonance cholangiopancreatography imaging texture analysis
Description
A radiologist analyses the pancreatic parenchymal changes from MRCP images
Time Frame
3 years
Secondary Outcome Measure Information:
Title
The development of chronic pancreatitis (CP) with Mannheim criteria
Description
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
Title
The development of complications related to chronic pancreatitis
Description
The complications are registered from the participants medical records.
Time Frame
3 years
Title
Mortality related to chronic pancreatitis
Description
The mortality is registered from the participants medical records.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
101 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33520
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be written into an article, which shall be displayed in a national and international forum.
Citations:
PubMed Identifier
25259922
Citation
Sherman MH, Yu RT, Engle DD, Ding N, Atkins AR, Tiriac H, Collisson EA, Connor F, Van Dyke T, Kozlov S, Martin P, Tseng TW, Dawson DW, Donahue TR, Masamune A, Shimosegawa T, Apte MV, Wilson JS, Ng B, Lau SL, Gunton JE, Wahl GM, Hunter T, Drebin JA, O'Dwyer PJ, Liddle C, Tuveson DA, Downes M, Evans RM. Vitamin D receptor-mediated stromal reprogramming suppresses pancreatitis and enhances pancreatic cancer therapy. Cell. 2014 Sep 25;159(1):80-93. doi: 10.1016/j.cell.2014.08.007.
Results Reference
background
PubMed Identifier
26005021
Citation
Blauer M, Sand J, Laukkarinen J. Physiological and clinically attainable concentrations of 1,25-dihydroxyvitamin D3 suppress proliferation and extracellular matrix protein expression in mouse pancreatic stellate cells. Pancreatology. 2015 Jul-Aug;15(4):366-71. doi: 10.1016/j.pan.2015.05.044. Epub 2015 May 14.
Results Reference
background
PubMed Identifier
17209171
Citation
Hathcock JN, Shao A, Vieth R, Heaney R. Risk assessment for vitamin D. Am J Clin Nutr. 2007 Jan;85(1):6-18. doi: 10.1093/ajcn/85.1.6.
Results Reference
background
PubMed Identifier
21400196
Citation
Steffensen LH, Jorgensen L, Straume B, Mellgren SI, Kampman MT. Can vitamin D supplementation prevent bone loss in persons with MS? A placebo-controlled trial. J Neurol. 2011 Sep;258(9):1624-31. doi: 10.1007/s00415-011-5980-6. Epub 2011 Mar 13.
Results Reference
background
PubMed Identifier
24988118
Citation
Stallings VA, Schall JI, Hediger ML, Zemel BS, Tuluc F, Dougherty KA, Samuel JL, Rutstein RM. High-dose vitamin D3 supplementation in children and young adults with HIV: a randomized, placebo-controlled trial. Pediatr Infect Dis J. 2015 Feb;34(2):e32-40. doi: 10.1097/INF.0000000000000483.
Results Reference
background
Links:
URL
http://www.efsa.europa.eu/en/efsajournal/pub/2813
Description
Scientific Opinion on the Tolerable Upper Intake Level of vitamin D
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The Effect of Vitamin D Substitution on the Development of Chronic Pancreatitis
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