Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Laval University
Must be taking: DMARDs, NSAIDs, Corticosteroids
Must not be taking: Anticoagulants, Biologicals, JAK inhibitors
Disqualifiers: Other autoimmune, IBD, Fibromyalgia, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial tests if sea bass oil rich in DPA can reduce pain and inflammation in people with rheumatoid arthritis. The study involves 130 patients who will receive either the sea bass oil or another substance for a period of time. Researchers will measure improvements in symptoms and overall health. Fish oil, including DPA, has been shown to reduce symptoms in rheumatoid arthritis and reduce cardiovascular risk.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications, but you must have a stable dose of DMARDs, NSAIDs, and corticosteroids before joining. You cannot take more than 10 mg of prednisone daily or consume certain supplements and natural health products during the study.
What data supports the effectiveness of seal oil as a treatment for rheumatoid arthritis?
Research shows that marine n-3 polyunsaturated fatty acids (found in fish oils) can help reduce joint swelling and pain in rheumatoid arthritis. Seal oil, which is rich in these fatty acids, may have similar benefits.
12345Is seal oil safe for humans?
Research on fish oils, which are similar to seal oil, shows they are generally safe for humans, with studies reporting no serious side effects when used for conditions like rheumatoid arthritis.
12678How does seal oil treatment for rheumatoid arthritis differ from other treatments?
Seal oil, rich in omega-3 fatty acids, may help reduce inflammation in rheumatoid arthritis by decreasing the production of inflammatory substances in the body. This is similar to fish oil, but seal oil is unique due to its specific composition, which includes DPA (docosapentaenoic acid), potentially offering additional anti-inflammatory benefits.
15789Eligibility Criteria
This trial is for adults who've had rheumatoid arthritis (RA) for at least a year, meet specific RA criteria, and have low to moderate disease activity. Participants must be on stable doses of certain RA medications and not consume much fish or omega-3 supplements. Those with severe osteoarthritis, other autoimmune diseases, seafood allergies, fibromyalgia, or taking anticoagulants can't join.Inclusion Criteria
I have had rheumatoid arthritis for at least one year.
Meet the 2010 ACR/EULAR criteria
I have been on a stable dose of my rheumatism medication for at least 3 months.
+4 more
Exclusion Criteria
Consume omega-3 fatty acid supplements other than those given during the project
I have been diagnosed with inflammatory bowel disease.
I have been treated with drugs targeting JAK enzymes.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive daily intake of 15 ml of seal oil or vegetable oil for 12 weeks
12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
40 weeks
Participant Groups
The study tests the effects of seal oil rich in DPA (a type of fatty acid) on reducing symptoms like pain in people with rheumatoid arthritis. It's a controlled study where participants are randomly assigned to receive either seal oil or a control substance to compare outcomes.
2Treatment groups
Experimental Treatment
Active Control
Group I: Seal oilExperimental Treatment1 Intervention
Daily intake of 15 ml of seal oil containing 534 mg of EPA + 1129 mg of DHA + 530 mg of DPA during 12 weeks
Group II: ControlActive Control1 Intervention
Daily intake of vegetable oil during 12 weeks
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
GRMOQuébec, Canada
Loading ...
Who Is Running the Clinical Trial?
Laval UniversityLead Sponsor
Ministry of Agriculture, Fisheries and Food, QuebecCollaborator
Groupe De Recherche En Rhumatologie Et Maladies Osseuses Inc.Industry Sponsor
References
Influence of marine n-3 polyunsaturated fatty acids on immune function and a systematic review of their effects on clinical outcomes in rheumatoid arthritis. [2018]Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disease of the joints and bones. The n-6 polyunsaturated fatty acid (PUFA) arachidonic acid (ARA) is the precursor of inflammatory eicosanoids which are involved in RA. Some therapies used in RA target ARA metabolism. Marine n-3 PUFAs (eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)) found in oily fish and fish oils decrease the ARA content of cells involved in immune responses and decrease the production of inflammatory eicosanoids from ARA. EPA gives rise to eicosanoid mediators that are less inflammatory than those produced from ARA and both EPA and DHA give rise to resolvins that are anti-inflammatory and inflammation resolving, although little is known about these latter mediators in RA. Marine n-3 PUFAs can affect other aspects of immunity and inflammation relevant to RA, including dendritic cell and T cell function and production of inflammatory cytokines and reactive oxygen species, although findings for these outcomes are not consistent. Fish oil has been shown to slow the development of arthritis in animal models and to reduce disease severity. A number of randomised controlled trials of marine n-3 PUFAs have been performed in patients with RA. A systematic review included 23 studies. Evidence is seen for a fairly consistent, but modest, benefit of marine n-3 PUFAs on joint swelling and pain, duration of morning stiffness, global assessments of pain and disease activity, and use of non-steroidal anti-inflammatory drugs.
Fish oil in recent onset rheumatoid arthritis: a randomised, double-blind controlled trial within algorithm-based drug use. [2018]The effects of fish oil (FO) in rheumatoid arthritis (RA) have not been examined in the context of contemporary treatment of early RA. This study examined the effects of high versus low dose FO in early RA employing a 'treat-to-target' protocol of combination disease-modifying anti-rheumatic drugs (DMARDs).
Validation of a meta-analysis: the effects of fish oil in rheumatoid arthritis. [2019]The purpose of this study was to validate the results of a meta-analysis showing the efficacy of fish oil in rheumatoid arthritis with the results of a re-analysis of the complete primary data set. A Medline search yielded seven published papers. Three additional trials were found by contacting authorities in the field. Inclusion criteria included (1) a double-blind, placebo-controlled study, (2) use of at least one of seven predetermined outcome measures, (3) results reported for both placebo and treatment groups at baseline and follow-up, (4) randomization, and (5) parallel or cross-over design. Papers were scored for quality. Demographic and outcomes variables were collected. For the re-analysis of the primary data, the same variables were abstracted for the 395 individual patients randomized. The meta-analysis demonstrated that dietary fish oil supplementation for 3 months significantly reduced tender joint count (rate difference [RD] [95% CI] = -2.9 [-3.8 to -2.1] [p = 0.001]) and morning stiffness (RD [95% CI] = -25.9 [-44.3 to -7.5] [p
Effect of six months of fish oil supplementation in stable rheumatoid arthritis. A double-blind, controlled study. [2019]Therapeutic effects of fish oil (10 g/day) in rheumatoid arthritis were investigated in a randomized, controlled, double-blind study. Forty-three patients completing the study were evaluated at 0, 3 and 6 months. The nutrient intake in the fish oil group and in the control group was essentially similar. In the fish oil group, the percentage of n-3 fatty acids in serum phosphatidylcholine increased by 9.6 (range 2.6-16.1). Patients in the fish oil group reported a significantly decreased consumption of NSAID at 3 and 6 months, and the status of global arthritic activity improved at 3 months in physician's assessment. Control patients reported an increased global arthritic activity at 6 months. No change was found in patient assessment of pain, duration of morning stiffness or functional capacity. Essentially no change occurred in biochemical markers of inflammation. We conclude that fish oil has small anti-inflammatory effects with at most a NSAID-saving potential. The value of prolonged supplementation remains to be evaluated.
Dietary omega-3 fatty acid supplementation and naproxen treatment in patients with rheumatoid arthritis. [2013]In a controlled, double blind, clinical trial we tested the effect of dietary omega-3 fatty acid supplementation with and without naproxen and placebo, respectively, in 67 patients with active rheumatoid arthritis. The patients were randomized into 3 groups that received the following treatment: Group 1, corn oil ("placebo omega-3 fatty acids"), 7 g/day for 16 weeks, and naproxen, 750 mg/day for 10 weeks followed by a stepwise reduction to 0 mg/day during the following 3 weeks; Group 2, omega-3 fatty acids, 3.8 g of eicosapentaenoic acid plus 2.0 g of docosahexaenoic acid, and naproxen, 750 mg/day for 16 weeks; and Group 3, omega-3 fatty acids as Group 2 and naproxen as Group 1. At the end of the trial, patients in Group 2 had improved with respect to duration of morning stiffness and global assessment by physician and patient. In Groups 1 and 3 there was a significant deterioration for most of the variables measured. However, for duration of morning stiffness the deterioration was significantly less pronounced in Group 3 compared with Group 1. These effects might be ascribed to the dietary omega-3 fatty acid supplementation.
[Fish oils and rheumatoid arthritis]. [2006]Dietary supplementation with polyunsaturated fatty acids--n-3 PUFA or fish oils--has gained increasing interest among patients suffering from rheumatoid arthritis. The biochemical background for the beneficial effects of fish oils in modulating the inflammatory response is briefly described and is partly based on findings from experimental animal models. Ten published double-blind studies evaluating the effect of a daily supplement with three to six grams of n-3 PUFA to patients with active rheumatoid arthritis are reviewed. The studies support a modest effect of fish oil on patient-reported disease parameters without serious side effects. Future research should evaluate effect, tolerance and side effects in long term studies with different daily intakes of n-3 PUFA and should also focus on the effect of n-3 PUFA in combination with standard therapy in patients with rheumatoid arthritis.
[Fish oils and rheumatoid arthritis. A randomized and double-blind study]. [2006]The effect of dietary supplementation with n-3 polyunsaturated fatty acids (n-3 PUFA) on disease variables in patients with active rheumatoid arthritis was evaluated in a multicentre, randomized and double blind study. Fifty-one patients with active rheumatoid arthritis were included from three Danish hospital Departments of Rheumatology. The patients were allocated to 12 weeks of treatment with either six n-3 PUFA capsules (3.6 g) or six capsules with a fat composition averaging the Danish diet. Small but significant improvements in morning stiffness, joint tenderness and C-reactive protein were observed. There were no serious side-effects. Dietary supplementation with n-3 PUFA in patients with active rheumatoid arthritis has a modest effect on three out of eight disease variables, without effect on other traditional parameters for monitoring disease activity.
Diet and rheumatoid arthritis in women: a possible protective effect of fish consumption. [2019]Some researchers have hypothesized that omega-3 fatty acids, found primarily in fish oils, may protect against the development of rheumatoid arthritis. We conducted a population-based case-control study in women, comparing 324 incident rheumatoid arthritis cases with 1,245 controls. We used a food frequency questionnaire to ascertain diet during a 1-year period 5 years before a reference date (first physician visit for joint-symptoms). Consumption of broiled or baked fish, but not of other types of fish, was associated with a decreased risk of rheumatoid arthritis. The adjusted odds ratios (OR) for 1- or = 2 servings of broiled or baked fish per week, compared with
Effects of fish oil supplementation in rheumatoid arthritis. [2022]Sixteen patients with rheumatoid arthritis entered a trial to determine the clinical and biochemical effects of dietary supplementation with fractionated fish oil fatty acids. A randomised, double blind, placebo controlled crossover design with 12 week treatment periods was used. Treatment with non-steroidal anti-inflammatory drugs and with disease modifying drugs was continued throughout the study. Placebo consisted of fractionated coconut oil. The following results favoured fish oil rather than placebo: joint swelling index and duration of early morning stiffness. Other clinical indices improved but did not reach statistical significance. During fish oil supplementation relative amounts of eicosapentaenoic acid and docosahexaenoic acid in the plasma cholesterol ester and neutrophil membrane phospholipid fractions increased, mainly at the expense of the omega-6 fatty acids. The mean neutrophil leucotriene B4 production in vitro showed a reduction after 12 weeks of fish oil supplementation. Leucotriene B5 production, which could not be detected either in the control or in the placebo period, rose to substantial quantities during fish oil treatment. This study shows that dietary fish oil supplementation is effective in suppressing clinical symptoms of rheumatoid arthritis.