Fish oil in recent onset rheumatoid arthritis: High versus low dose fish oil on a background of dose-responsive combination disease-modifying anti-rheumatic drugs.

Fish oil in anti-inflammatory doses in recent onset rheumatoid arthritis: A randomized, double-blind controlled trial within algorithm-based drug use with DMARD use as the primary outcome.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000579796

Enrollment

140

Registered

2013-05-23

Start date

2001-09-03

Completion date

2008-12-08

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The omega-3 fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) can suppress synthesis of the omega-6 pro-inflammatory eicosanoids, prostaglandin E2 and leukotriene B4. Meta-analysis of 10 randomised controlled trials (RCTs) in 1995 reported that fish oil supplementation reduced tender joint count and duration of morning stiffness. Meta-analysis in 2007 of 17 RCTs of fish oil in inflammatory joint pain included 14 RA studies and reported a benefit of fish oil for patient assessed pain, morning stiffness, number of painful and/or tender joints and NSAID consumption. Collectively, these studies determined that symptomatic benefits were seen above doses of 2.7g EPA+DHA per day after a delay of 2 to 3 months. There were at least two features common to these RCTs that are problematic for demonstrating the potential for use of fish oil in RA. Firstly, participants had established disease with the average disease duration being 10.2 +/- 5.2 years across all studies. Secondly, DMARD use was not ‘real life’. DMARDs were held constant with the need for change being a withdrawal criterion, or if drug variation was allowed, it was not according to pre-defined rules. This is an investigator-initiated, double-blind RCT with fish oil in recent onset RA with disease duration < 12 months, using a study design which addresses some of the shortcomings of previous RCTs of fish oil in RA. A treatment algorithm for DMARD use that is responsive to disease activity and tolerability / toxicity, according to pre-defined rules, allows the extent of DMARD to be used as an outcome measure.

Interventions

High dose fish oil group receive 10mL / day liquid fish oil concentrate (BLT Incromega TG3525) providing 5.5g/d EPA+DHA. Incromega TG3525 has 35% EPA and 25% DHA. Taken orally. Duration of therapy 3 years. Plasma phospholipids used to monitor adherence to therapy

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Inclusion criteria: subjects must be 18 years or older, have rheumatoid arthritis (RA) according to the 1987 revised ACR criteria with polyarthritis of less than 12 months’ duration, at least 3 swollen joints and ESR greater than 28 mm/hour and/or CRP greater than 10 mg/dL and be DMARD-naive.

Exclusion criteria

Exclusion criteria: use of DMARDs other than antimalarials, use of antimalarials for more than 1 month, recent seroconversion to parvovirus, Ross River, Barmah Forest or rubella viruses, antinuclear antibody titre greater than 1:320, hepatitis B, hepatitis C or human immunodeficiency virus, known sensitivity to methotrexate, sulphasalazine or hydroxychloroquine, or systemic disease likely to increase the risk of toxicity to 1 or more of these drugs.

Outcome results