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

NCT02965898 | Completed

• 1 other identifier: R16004
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Pancreatitis

Keywords

chronic pancreatitis; vitamin d; pancreatitis; Pancreatic stellate cell; rct

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The development of chronic pancreatitis (CP) with Mannheim criteria

  3 years

• The development of complications related to chronic pancreatitis

  3 years

• Mortality related to chronic pancreatitis

  3 years

Study Arms (2)

Vitamin D 100ug

ACTIVE COMPARATOR

The highest safest dose. Expected to lower risk of chronic pancreatitis after acute pancreatitis.

Dietary Supplement: Vitamin D 100ug

Vitamin D 10ug

PLACEBO COMPARATOR

Placebo dose. Minimal recommended dose

Dietary Supplement: Vitamin D 10ug

Interventions

Vitamin D 100ug DIETARY_SUPPLEMENT

Vitamin D 100 ug from Orion Pharma. Safest highest daily dose of vitamin D.

Vitamin D 100ug

Vitamin D 10ug DIETARY_SUPPLEMENT

Placebo dose. Minimal recommended dose.

Vitamin D 10ug

Eligibility Criteria

• Age: 18 Years - 101 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First alcohol induced acute pancreatitis
• Willing to participate in a 3 year RCT

You may not qualify if:

• Renal failure
• Hypercalcemia
• High serum levels of vitamin D
• Unwilling to participate

Sponsors & Collaborators

• Tampere University Hospital: lead
• Orion Corporation, Orion Pharma: collaborator

Study Sites (1)

Tampere University Hospital

Tampere, 33520, Finland

Location

Related Publications (6)

• 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.

  PMID: 25259922 BACKGROUND

• 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.

  PMID: 26005021 BACKGROUND

• 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.

  PMID: 17209171 BACKGROUND

• 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.

  PMID: 21400196 BACKGROUND

• 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.

  PMID: 24988118 BACKGROUND

• Parhiala M, Aronen A, Ukkonen M, Haukijarvi E, Pappinen P, Rinta-Kiikka I, Laukkarinen J. High-Dose Vitamin D and Early Chronic Pancreatitis-Related Changes After Acute Pancreatitis: A Randomized Dose Controlled Trial. Dig Dis Sci. 2026 Jan 26. doi: 10.1007/s10620-026-09688-x. Online ahead of print.

  PMID: 41588283 DERIVED

Related Links

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

MeSH Terms

Conditions

Pancreatitis, Chronic; Pancreatitis

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD canditate

Study Record Dates

• First Submitted: September 23, 2016
• First Posted: November 17, 2016
• Study Start: September 1, 2016
• Primary Completion: March 10, 2024
• Study Completion: March 10, 2024
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

FI (1)