N/A N=145 Randomized Quadruple-blind Prevention

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

Psoriatic Arthritis

Bottom Line

View on ClinicalTrials.gov: NCT01818804 ↗

Enrolled (actual)

145

Serious AEs

2.8%

Results posted

Jun 2020

Primary outcome: Primary: Change in Heart Rate Variability (HRV) Measure — 13.38; -13.48 ms

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: n-3PUFA (Dietary_supplement); olive oil (Dietary_supplement)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Aalborg University Hospital
Primary completion: Dec 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Heart Rate Variability (HRV) Measure	13.38; -13.48	—
SECONDARY Change in PWV	0.01; 0.08	—

Summary

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

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01818804). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.