The Effect of n-3 Polyunsaturated Fatty Acids 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
Dietary Supplement: n-3PUFA
Dietary Supplement: olive oil
|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|
- 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
- Change in PWV [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]Pulse wave Velocity, non-invasive measurement for arterioscleroses
- 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
|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)|
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
|Dietary Supplement: olive oil|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01818804
|Aalborg University Hospital, Department of Rheumatology|
|Aalborg, Denmark, 9000|
|Vendsyssel Hospital in Region Northern Denmark, Department of Rheumatology|
|Hjørring, Denmark, 9800|
|Principal Investigator:||Salome Kristensen, MD||Aalborg Universityhospital, Department og Rheumatology|
|Study Director:||Jeppe H Christensen, Professor||Aalborg University Hospital, Department of Nephrology|