The Effect of n-3 Polyunsaturated Fatty Acids in Patients With Psoriatic Arthritis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01818804|
Recruitment Status : Completed
First Posted : March 27, 2013
Results First Posted : June 9, 2020
Last Update Posted : June 9, 2020
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 or disease||Intervention/treatment||Phase|
|Psoriatic Arthritis||Dietary Supplement: n-3PUFA Dietary Supplement: olive oil||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||145 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effect of n-3 Polyunsaturated Fatty Acids on Risk Markers for Cardiovascular Disease and Inflammation in Patients With Psoriatic Arthritis|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
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
- Change in Heart Rate Variability (HRV) Measure [ Time Frame: 24 week ]Heart Rate variability, non-invasive measurement for the autonom regulation of the heart associated with risk of cardiovascular disease
- Change in PWV [ Time Frame: 24 weeks ]Pulse wave Velocity, non-invasive measurement for arterioscleroses
- Change in Disease Activity [ Time Frame: 24 weeks ]
Disease activity score (DAS-28) is a system developed and validated by the EULAR (European League Against Rheumatism) to measure the progress and improvement of Rheumatoid Arthritis. DAS28 is often used in clinical trials for arthritis
DAS28 values range from 2.0 to 10.0 while higher values mean a higher disease activity. A DAS 28 below the value of 2.6 is interpreted as Remission.
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): 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|