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 Universityhospital
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

March 20, 2013
August 19, 2014
March 2013
December 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01818804 on ClinicalTrials.gov Archive Site
Change in PWV [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
Pulse wave Velocity, non-invasive measurement for arterioscleroses
Same as current
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
Same as current
 
The Effect of n-3 Polyunsaturated Fatty Acids in Patients With Psoriatic Arthritis
The Effect of n-3 Polyunsaturated Fatty Acids on Risk Markers for Cardiovascular Disease and Inflammation in Patients With Psoriatic Arthritis

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Psoriatic Arthritis
  • Dietary Supplement: n-3PUFA
    Other Name: n-3 polyunsaturated fattyacids from fishoil
  • Dietary Supplement: olive oil
  • Active Comparator: n-3PUFA
    n-3 polyunsaturated fattyacids from fish oil
    Intervention: Dietary Supplement: n-3PUFA
  • Placebo Comparator: olive oil
    Olive oil
    Intervention: Dietary Supplement: olive oil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
156
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
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
Denmark
 
NCT01818804
N-20120076
Yes
Salome Kristensen, Aalborg Universityhospital
Aalborg Universityhospital
Not Provided
Principal Investigator: Salome Kristensen, MD Aalborg Universityhospital, Department og Rheumatology
Study Director: Jeppe H Christensen, Professor Aalborg University Hospital, Department of Nephrology
Aalborg Universityhospital
August 2014

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