The Effect of n-3 Polyunsaturated Fatty Acids in Patients With Psoriatic Arthritis

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Aalborg Universitetshospital
Sponsor:
Information provided by (Responsible Party):
Salome Kristensen, Aalborg Universityhospital
ClinicalTrials.gov Identifier:
NCT01818804
First received: March 20, 2013
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

Background: There is evidence for a high cardiovascular risk in rheumatic and inflammatory diseases . Recent evidence suggest that psoriatic arthritis is also associated with an increased cardiovascular risk with accelerated atherosclerosis and increased cardiovascular risk. However, data regarding cardiovascular comorbidity and cardiovascular risk factors in patients with psoriatic arthritis are limited.

Objective: The aim of this study is to investigate the effect of daily supplementation with 3 g n-3 polyunsaturated fatty acids on risk markers for cardiovascular disease and inflammation in patients with psoriatic arthritis.

Design: Randomized double-blind, placebo-controlled, multicenter trial with n-3 polyunsaturated fatty acids in patient with psoriatic arthritis.

Setting: Departments of Rheumatology, Nephrology and Cardiology at Aalborg University Hospital and Vendsyssel Hospital in Region Northern Denmark

Participants: 156 men and women aged > 18 years with psoriatic arthritis classified by the CASPAR criteria will be included. Exclusion criteria: cardiac arrhythmias, conduction disturbances, treatment with biological drugs or oral corticosteroids. Inclusion time: spring 2013 to spring 2015.

Method: The following data will be collected for each participant: Interview including dietary records, assessment of tender and swollen joints, enthesitis, dactylitis, patient global assessment of disease activity (Visual Analogue Scale ), global assessment of pain (Visual Analogue Scale), psoriatic skin involvement by Psoriatic Area and Severity Index (PASI), laboratory parameters of disease activity and risk markers of cardiovascular disease.

For detection of early cardiovascular risk markers Heart Rate Variability (HRV) and Pulse Wave Velocity (PWV) will be performed.

Main outcome measures: The primary endpoint will be HRV and secondary endpoints will be PWV, inflammatory activity and use of analgesics.

The trial is approved by The local Ethics Committee, registration number N20120076


Condition Intervention
Psoriatic Arthritis
Dietary Supplement: n-3PUFA
Dietary Supplement: olive oil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of n-3 Polyunsaturated Fatty Acids on Risk Markers for Cardiovascular Disease and Inflammation in Patients With Psoriatic Arthritis

Resource links provided by NLM:


Further study details as provided by Aalborg Universitetshospital:

Primary Outcome Measures:
  • Change in HRV measure [ Time Frame: Baseline and 24 week ] [ Designated as safety issue: No ]
    Heart Rate Velocity, non-invasive measurement for the autonom regulation of the heart associated with risk of cardiovascular disease


Secondary Outcome Measures:
  • Change in PWV [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    Pulse wave Velocity, non-invasive measurement for arterioscleroses


Other Outcome Measures:
  • Change in Inflammation parameters [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    Disease activity score for psoriatic arthritis, Psoriasis area severity index, enthesitis score, CRP


Estimated Enrollment: 156
Study Start Date: March 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: n-3PUFA
n-3 polyunsaturated fattyacids from fish oil
Dietary Supplement: n-3PUFA
Other Name: n-3 polyunsaturated fattyacids from fishoil
Placebo Comparator: olive oil
Olive oil
Dietary Supplement: olive oil

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women aged > 18 years with
  • Psoriatic arthritis classified by the CASPAR criteria
  • written informed consent

Exclusion Criteria:

  • Treatment with biological drugs
  • Treatment with oral corticosteroids
  • cardiac arrhythmias
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01818804

Contacts
Contact: Salome Kristensen, MD + 45 99 32 81 83 sakr@rn.dk
Contact: Jeppe H Christensen, Professor + 45 99 32 66 30 Jeppe.hagstrup.christensen@rn.dk

Locations
Denmark
Aalborg University Hospital, Department of Rheumatology Recruiting
Aalborg, Denmark, 9000
Contact: Salome Kristensen, MD    + 45 99 32 81 83    sakr@rn.dk   
Contact: Jeppe H Christensen, MD professor    + 45 99 32 66 30    jeppe.hagstrup.christensen@rn.dk   
Principal Investigator: Salome Kristensen, MD         
Vendsyssel Hospital in Region Northern Denmark, Department of Rheumatology Recruiting
Hjørring, Denmark, 9800
Contact: Salome Kristensen, MD    + 45 99 32 81 83    sakr@rn.dk   
Contact: Claus Rasmussen, MD    + 45 97 64 16 51    clara@rn.dk   
Principal Investigator: Salome Kristensen, MD         
Sponsors and Collaborators
Aalborg Universitetshospital
Investigators
Principal Investigator: Salome Kristensen, MD Aalborg Universityhospital, Department og Rheumatology
Study Director: Jeppe H Christensen, Professor Aalborg University Hospital, Department of Nephrology
  More Information

No publications provided

Responsible Party: Salome Kristensen, MD, Aalborg Universityhospital
ClinicalTrials.gov Identifier: NCT01818804     History of Changes
Other Study ID Numbers: N-20120076
Study First Received: March 20, 2013
Last Updated: August 19, 2014
Health Authority: Denmark: Danish Health and Medicines Authority

Additional relevant MeSH terms:
Arthritis, Psoriatic
Arthritis
Bone Diseases
Joint Diseases
Musculoskeletal Diseases
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Spinal Diseases
Spondylarthritis
Spondylarthropathies
Spondylitis

ClinicalTrials.gov processed this record on October 30, 2014