The Effect of Vitamin D Substitution on the Development of Chronic Pancreatitis
NCT ID: NCT02965898
Last Updated: 2025-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
260 participants
INTERVENTIONAL
2016-09-30
2024-03-10
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Vitamin D 100ug
The highest safest dose. Expected to lower risk of chronic pancreatitis after acute pancreatitis.
Vitamin D 100ug
Vitamin D 100 ug from Orion Pharma. Safest highest daily dose of vitamin D.
Vitamin D 10ug
Placebo dose. Minimal recommended dose
Vitamin D 10ug
Placebo dose. Minimal recommended dose.
Interventions
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Vitamin D 100ug
Vitamin D 100 ug from Orion Pharma. Safest highest daily dose of vitamin D.
Vitamin D 10ug
Placebo dose. Minimal recommended dose.
Eligibility Criteria
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Inclusion Criteria
* Willing to participate in a 3 year RCT
Exclusion Criteria
* Hypercalcemia
* High serum levels of vitamin D
* Unwilling to participate
18 Years
101 Years
ALL
No
Sponsors
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Orion Corporation, Orion Pharma
INDUSTRY
Tampere University Hospital
OTHER
Responsible Party
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Mikael Parhiala
PhD canditate
Locations
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Tampere University Hospital
Tampere, , Finland
Countries
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References
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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.
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.
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.
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.
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.
Related Links
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Scientific Opinion on the Tolerable Upper Intake Level of vitamin D
Other Identifiers
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R16004
Identifier Type: -
Identifier Source: org_study_id
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