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

Chronic Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02965898
• Other study ID #: R16004
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2016
• Est. completion date: January 2027

Study information

• Verified date: November 2022
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 260
• Est. completion date: January 2027
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 101 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Pancreatitis
• Pancreatitis, Chronic

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (2)

Lead Sponsor	Collaborator
Tampere University Hospital	Orion Corporation, Orion Pharma

Country where clinical trial is conducted

Finland, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 years
Secondary	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.	3 years
Secondary	The development of complications related to chronic pancreatitis	The complications are registered from the participants medical records.	3 years
Secondary	Mortality related to chronic pancreatitis	The mortality is registered from the participants medical records.	3 years

External Links

•   Scientific Opinion on the Tolerable Upper Intake Level of vitamin D