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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

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


Condition or disease Intervention/treatment Phase
Chronic Pancreatitis Dietary Supplement: Vitamin D 100ug Dietary Supplement: Vitamin D 10ug Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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 Start Date : September 2016
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Active Comparator: Vitamin D 100ug
The highest safest dose. Expected to lower risk of chronic pancreatitis after acute pancreatitis.
Dietary Supplement: Vitamin D 100ug
Vitamin D 100 ug from Orion Pharma. Safest highest daily dose of vitamin D.

Placebo Comparator: Vitamin D 10ug
Placebo dose. Minimal recommended dose
Dietary Supplement: Vitamin D 10ug
Placebo dose. Minimal recommended dose.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. The development of complications related to chronic pancreatitis [ Time Frame: 3 years ]
    The complications are registered from the participants medical records.

  3. Mortality related to chronic pancreatitis [ Time Frame: 3 years ]
    The mortality is registered from the participants medical records.



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Ages Eligible for Study:   18 Years to 101 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02965898


Contacts
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Contact: Johanna Laukkarinen, Ass professor johanna.laukkarinen@pshp.fi
Contact: Mikael Parhiala mikael.parhiala@fimnet.fi

Locations
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Finland
Tampere University Hospital Recruiting
Tampere, Finland, 33520
Contact: Johanna Laukkarinen, Ass professor       johanna.laukkarinen@pshp.fi   
Contact: Mikael Parhiala    +358443097406    mikael.parhiala@fimnet.fi   
Sponsors and Collaborators
Tampere University Hospital
Orion Corporation, Orion Pharma

Additional Information:
Publications:
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Responsible Party: Mikael Parhiala, PhD canditate, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT02965898     History of Changes
Other Study ID Numbers: R16004
First Posted: November 17, 2016    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
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.
Keywords provided by Mikael Parhiala, Tampere University Hospital:
chronic pancreatitis
vitamin d
pancreatitis
Pancreatic stellate cell
rct
Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents