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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
Sponsor:
Collaborator:
Orion Corporation, Orion Pharma
Information provided by (Responsible Party):
Mikael Parhiala, Tampere University Hospital

Tracking Information
First Submitted Date  ICMJE September 23, 2016
First Posted Date  ICMJE November 17, 2016
Last Update Posted Date October 8, 2019
Study Start Date  ICMJE September 2016
Estimated Primary Completion Date September 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02965898 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2016)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Vitamin D Substitution on the Development of Chronic Pancreatitis
Official Title  ICMJE The Effect of Vitamin D Substitution on Pancreatic Parenchyma and Development of Fibrosis After First Acute Alcoholic Pancreatitis: A Randomized Prospective Trial
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 3 years.

The enrollment will begin 26.9.2016

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Chronic Pancreatitis
Intervention  ICMJE
  • Dietary Supplement: Vitamin D 100ug
    Vitamin D 100 ug from Orion Pharma. Safest highest daily dose of vitamin D.
  • Dietary Supplement: Vitamin D 10ug
    Placebo dose. Minimal recommended dose.
Study Arms  ICMJE
  • Active Comparator: Vitamin D 100ug
    The highest safest dose. Expected to lower risk of chronic pancreatitis after acute pancreatitis.
    Intervention: Dietary Supplement: Vitamin D 100ug
  • Placebo Comparator: Vitamin D 10ug
    Placebo dose. Minimal recommended dose
    Intervention: Dietary Supplement: Vitamin D 10ug
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 14, 2016)
260
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2026
Estimated Primary Completion Date September 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 101 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Johanna Laukkarinen, Ass professor johanna.laukkarinen@pshp.fi
Contact: Mikael Parhiala mikael.parhiala@fimnet.fi
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02965898
Other Study ID Numbers  ICMJE R16004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: The data will be written into an article, which shall be displayed in a national and international forum.
Responsible Party Mikael Parhiala, Tampere University Hospital
Study Sponsor  ICMJE Tampere University Hospital
Collaborators  ICMJE Orion Corporation, Orion Pharma
Investigators  ICMJE Not Provided
PRS Account Tampere University Hospital
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP