Trial Outcomes & Findings for The Effect of n-3 Polyunsaturated Fatty Acids in Patients With Psoriatic Arthritis (NCT NCT01818804)

NCT ID: NCT01818804

Last Updated: 2020-06-09

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 145 participants
• Primary outcome timeframe: 24 week
• Results posted on: 2020-06-09

Participant Flow

Participant milestones

Measure	n-3PUFA n-3 polyunsaturated fattyacids from fish oil 3 g of n-3PUFA pr day	Olive Oil Olive oil 3 g of olive oil pr day
Overall Study STARTED	73	72
Overall Study COMPLETED	68	65
Overall Study NOT COMPLETED	5	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	n-3PUFA n=73 Participants n-3 polyunsaturated fattyacids from fish oil n-3PUFA	Olive Oil n=72 Participants Olive oil olive oil	Total n=145 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	64 Participants n=5 Participants	62 Participants n=7 Participants	126 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Age, Continuous	53.2 years STANDARD_DEVIATION 11.4 • n=5 Participants	50.7 years STANDARD_DEVIATION 11.5 • n=7 Participants	52 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	43 Participants n=7 Participants	83 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	29 Participants n=7 Participants	62 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	73 Participants n=5 Participants	72 Participants n=7 Participants	145 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Denmark	73 participants n=5 Participants	72 participants n=7 Participants	145 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 week

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

Outcome measures

Measure	n-3PUFA n=68 Participants n-3 polyunsaturated fattyacids from fish oil n-3PUFA	Olive Oil n=60 Participants Olive oil olive oil
Change in Heart Rate Variability (HRV) Measure	13.38 ms Interval -5.06 to 31.83	-13.48 ms Interval -35.0 to -8.69

SECONDARY outcome

Timeframe: 24 weeks

Pulse wave Velocity, non-invasive measurement for arterioscleroses

Outcome measures

Measure	n-3PUFA n=68 Participants n-3 polyunsaturated fattyacids from fish oil n-3PUFA	Olive Oil n=60 Participants Olive oil olive oil
Change in PWV	0.01 m/s Interval -0.44 to 0.46	0.08 m/s Interval -0.33 to 0.49

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	n-3PUFA n=63 Participants n-3 polyunsaturated fattyacids from fish oil n-3PUFA	Olive Oil n=67 Participants Olive oil olive oil
Change in Disease Activity	-0.22 units on a scale Interval -0.38 to -0.05	-0.05 units on a scale Interval -0.25 to 0.15

Adverse Events

n-3PUFA

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Olive Oil

Serious events: 3 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	n-3PUFA n=73 participants at risk n-3 polyunsaturated fattyacids from fish oil n-3PUFA	Olive Oil n=72 participants at risk Olive oil olive oil
Infections and infestations Infection	1.4% 1/73 • Number of events 1	0.00% 0/72
Musculoskeletal and connective tissue disorders Joint inflammation	0.00% 0/73	2.8% 2/72 • Number of events 2
Ear and labyrinth disorders vertigo	0.00% 0/73	1.4% 1/72 • Number of events 1

Other adverse events

Measure	n-3PUFA n=73 participants at risk n-3 polyunsaturated fattyacids from fish oil n-3PUFA	Olive Oil n=72 participants at risk Olive oil olive oil
Gastrointestinal disorders nausea	0.00% 0/73	2.8% 2/72 • Number of events 2

Additional Information

Salome Kristensen, MD. PhD

Aalborg University hospital

Phone: +45 97664015

Email: sakr@rn.dk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place