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

NCT01818804 | Completed Results DMC

• 1 other identifier: N-20120076
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Psoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

• Change in Heart Rate Variability (HRV) Measure

  Heart Rate variability, non-invasive measurement for the autonom regulation of the heart associated with risk of cardiovascular disease

  24 week

Secondary Outcomes (1)

• Change in PWV

  24 weeks

Other Outcomes (1)

• Change in Disease Activity

  24 weeks

Study Arms (2)

n-3PUFA

ACTIVE COMPARATOR

n-3 polyunsaturated fattyacids from fish oil

Dietary Supplement: n-3PUFA

olive oil

PLACEBO COMPARATOR

Olive oil

Dietary Supplement: olive oil

Interventions

n-3PUFA DIETARY_SUPPLEMENT

Also known as: n-3 polyunsaturated fattyacids from fishoil

n-3PUFA

olive oil DIETARY_SUPPLEMENT

olive oil

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Treatment with biological drugs
• Treatment with oral corticosteroids
• cardiac arrhythmias

Sponsors & Collaborators

• Aalborg University Hospital: lead

Study Sites (2)

Aalborg University Hospital, Department of Rheumatology

Aalborg, 9000, Denmark

Location

Vendsyssel Hospital in Region Northern Denmark, Department of Rheumatology

Hjørring, 9800, Denmark

Location

Related Publications (2)

• Holm Nielsen S, Sardar S, Siebuhr AS, Schlemmer A, Schmidt EB, Bay-Jensen AC, Karsdal MA, Christensen JH, Kristensen S. Effect of n-3 PUFA on extracellular matrix protein turnover in patients with psoriatic arthritis: a randomized, double-blind, placebo-controlled trial. Rheumatol Int. 2021 Jun;41(6):1065-1077. doi: 10.1007/s00296-021-04861-z. Epub 2021 Apr 22.

  PMID: 33885930 DERIVED

• Kristensen S, Schmidt EB, Schlemmer A, Rasmussen C, Lindgreen E, Johansen MB, Christensen JH. The effect of marine n-3 polyunsaturated fatty acids on cardiac autonomic and hemodynamic function in patients with psoriatic arthritis: a randomised, double-blind, placebo-controlled trial. Lipids Health Dis. 2016 Dec 12;15(1):216. doi: 10.1186/s12944-016-0382-5.

  PMID: 27955663 DERIVED

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

Olive Oil

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Salome Kristensen, MD. PhD
• Organization: Aalborg University hospital

sakr@rn.dk

+45 97664015

Study Officials

• Salome Kristensen, MD

  Aalborg Universityhospital, Department og Rheumatology

  PRINCIPAL INVESTIGATOR

• Jeppe H Christensen, Professor

  Aalborg University Hospital, Department of Nephrology

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 20, 2013
• First Posted: March 27, 2013
• Study Start: March 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 9, 2020
• Results First Posted: June 9, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share

Locations

DK (2)