Seal Oil for Rheumatoid Arthritis

Overseen by Alain Doyen, PhD

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. ^{1 2 3 4 5}

Is 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. ^{1 2 6 7 8}

How 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. ^{1 5 7 8 9}

Research Team

Alain Doyen, PhD

Principal Investigator

Laval University

Eligibility 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.

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.

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

Treatment Details

Interventions

• Control (Behavioural Intervention)
• Seal oil (Omega-3 Fatty Acids)

Trial Overview 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.

Participant Groups

Group I: Seal oil Experimental Treatment 1 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: Control Active Control 1 Intervention

Daily intake of vegetable oil during 12 weeks

Who Is Running the Clinical Trial?

Laval University

Lead Sponsor

Trials

439

Recruited

178,000+

Dr. Pedro O de Campos-Lima

Laval University

Chief Medical Officer since 1998

MD from Federal University of Juiz de Fora, PhD in Tumor Biology from Karolinska Institute

Dr. Manuel Caruso

Laval University

Chief Executive Officer since 1998

PhD in Virology from Pierre and Marie Curie University

Ministry of Agriculture, Fisheries and Food, Quebec

Collaborator

Trials

4

Recruited

450+

Groupe De Recherche En Rhumatologie Et Maladies Osseuses Inc.

Industry Sponsor

Trials

2

Recruited

180+

Findings from Research

Marine n-3 polyunsaturated fatty acids (PUFAs), such as EPA and DHA, have been shown to provide a modest benefit in reducing joint swelling, pain, and morning stiffness in patients with rheumatoid arthritis (RA), based on a systematic review of 23 studies.

These fatty acids work by decreasing the levels of inflammatory eicosanoids derived from arachidonic acid, suggesting a mechanism of action that helps to alleviate inflammation and improve overall disease activity in RA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of marine n-3 polyunsaturated fatty acids on immune function and a systematic review of their effects on clinical outcomes in rheumatoid arthritis. Miles, EA., Calder, PC.[2018]

In a study of patients with early rheumatoid arthritis (RA) who were new to disease-modifying anti-rheumatic drugs (DMARDs), high-dose fish oil (5.5 g/day) significantly reduced the failure rate of triple DMARD therapy compared to a low-dose control group (0.4 g/day), with a hazard ratio of 0.28, indicating a strong protective effect.

Patients receiving high-dose fish oil also had a significantly higher rate of achieving remission according to the American College of Rheumatology criteria, with a hazard ratio of 2.17, suggesting that fish oil may enhance the effectiveness of standard RA treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fish oil in recent onset rheumatoid arthritis: a randomised, double-blind controlled trial within algorithm-based drug use. Proudman, SM., James, MJ., Spargo, LD., et al.[2018]

A meta-analysis and re-analysis of data from 395 patients confirmed that fish oil supplementation significantly reduces tender joint count and morning stiffness in rheumatoid arthritis patients after 3 months of treatment.

The study highlights the benefits of using fish oil as a dietary supplement for improving symptoms of rheumatoid arthritis, with significant reductions in joint tenderness and stiffness compared to control oils.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of a meta-analysis: the effects of fish oil in rheumatoid arthritis. Fortin, PR., Lew, RA., Liang, MH., et al.[2019]

In a study of 43 rheumatoid arthritis patients taking 10 g/day of fish oil, those in the fish oil group showed a significant decrease in NSAID consumption and improved global arthritic activity after 3 months, suggesting some therapeutic benefits.

Despite these improvements, fish oil did not significantly change pain levels, morning stiffness, or functional capacity, indicating that while it may have small anti-inflammatory effects, its overall impact on symptoms is limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of six months of fish oil supplementation in stable rheumatoid arthritis. A double-blind, controlled study. Sköldstam, L., Börjesson, O., Kjällman, A., et al.[2019]

In a clinical trial with 67 patients suffering from active rheumatoid arthritis, those receiving omega-3 fatty acids along with naproxen showed significant improvements in morning stiffness and overall health assessments compared to those on placebo and naproxen.

Patients who received omega-3 fatty acids alone experienced a deterioration in symptoms, but the deterioration was less severe when combined with naproxen, suggesting that omega-3 supplementation may enhance the effects of traditional anti-inflammatory medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary omega-3 fatty acid supplementation and naproxen treatment in patients with rheumatoid arthritis. Kjeldsen-Kragh, J., Lund, JA., Riise, T., et al.[2013]

Dietary supplementation with n-3 polyunsaturated fatty acids (PUFA), such as fish oils, shows a modest beneficial effect on disease parameters in patients with active rheumatoid arthritis, based on a review of ten double-blind studies.

The studies indicated that fish oil supplementation does not lead to serious side effects, suggesting it is a safe adjunct treatment, but further long-term research is needed to explore optimal dosages and its effects in combination with standard therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Fish oils and rheumatoid arthritis]. Ernst, E., Nielsen, GL., Schmidt, EB.[2006]

In a study involving 51 patients with active rheumatoid arthritis, dietary supplementation with n-3 polyunsaturated fatty acids (n-3 PUFA) for 12 weeks led to small but significant improvements in morning stiffness, joint tenderness, and C-reactive protein levels.

The supplementation was found to be safe, with no serious side effects reported, although it only had a modest effect on a few disease variables and did not impact other traditional measures of disease activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Fish oils and rheumatoid arthritis. A randomized and double-blind study]. Faarvang, KL., Nielsen, GL., Thomsen, BS., et al.[2006]

A study involving 324 women with rheumatoid arthritis and 1,245 controls found that consuming broiled or baked fish is linked to a reduced risk of developing rheumatoid arthritis, with adjusted odds ratios indicating a significant protective effect.

The protective association was particularly strong among women who tested positive for rheumatoid factor, suggesting that omega-3 fatty acids from fish may play a role in preventing this autoimmune disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet and rheumatoid arthritis in women: a possible protective effect of fish consumption. Shapiro, JA., Koepsell, TD., Voigt, LF., et al.[2019]

In a trial involving 16 patients with rheumatoid arthritis, dietary supplementation with fish oil significantly reduced joint swelling and the duration of early morning stiffness compared to a placebo, indicating its efficacy in managing symptoms.

Fish oil supplementation led to increased levels of beneficial fatty acids (eicosapentaenoic acid and docosahexaenoic acid) in the body and reduced the production of inflammatory compounds, suggesting a mechanism of action that may help alleviate rheumatoid arthritis symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of fish oil supplementation in rheumatoid arthritis. van der Tempel, H., Tulleken, JE., Limburg, PC., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

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]

2. England pubmed.ncbi.nlm.nih.gov

Fish oil in recent onset rheumatoid arthritis: a randomised, double-blind controlled trial within algorithm-based drug use. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Validation of a meta-analysis: the effects of fish oil in rheumatoid arthritis. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Effect of six months of fish oil supplementation in stable rheumatoid arthritis. A double-blind, controlled study. [2019]

5. Canada pubmed.ncbi.nlm.nih.gov

Dietary omega-3 fatty acid supplementation and naproxen treatment in patients with rheumatoid arthritis. [2013]

6. Denmark pubmed.ncbi.nlm.nih.gov

[Fish oils and rheumatoid arthritis]. [2006]

7. Denmark pubmed.ncbi.nlm.nih.gov

[Fish oils and rheumatoid arthritis. A randomized and double-blind study]. [2006]

8. United States pubmed.ncbi.nlm.nih.gov

Diet and rheumatoid arthritis in women: a possible protective effect of fish consumption. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Effects of fish oil supplementation in rheumatoid arthritis. [2022]