What side effects are associated with this type of intervention?

Common treatments for polyarthritis with anti-inflammatory properties, such as NSAIDs, omega-3 fatty acid supplements like cod liver oil, and green-lipped mussel extracts, have varying side effects. NSAIDs can cause gastrointestinal issues, cardiovascular risks, and renal impairment. Omega-3 supplements are generally well-tolerated but may cause mild gastrointestinal discomfort and a fishy aftertaste. Green-lipped mussel supplements have shown promise with minimal reported side effects, though further research is needed to fully understand their safety profile.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of polyarthritis, focusing on their anti-inflammatory properties. Notable examples include nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen, which are commonly used to reduce inflammation and pain. Additionally, disease-modifying antirheumatic drugs (DMARDs) such as methotrexate and biologic agents like TNF inhibitors (e.g., etanercept, adalimumab) have been approved for their efficacy in managing symptoms and slowing disease progression. These treatments share anti-inflammatory properties similar to those being studied in DPA-rich sea bass oil.

What other types of research exist?

Promising novel alternatives to DPA-rich sea bass oil for polyarthritis patients include: 1) SKI306X, which has shown anti-inflammatory and analgesic effects comparable to celecoxib in rheumatoid arthritis patients. 2) Green-lipped mussel extract, which retains significant anti-inflammatory activity. 3) Cod liver oil, which has been effective as an NSAID-sparing agent in rheumatoid arthritis patients. These alternatives have demonstrated potential in clinical studies and may offer effective treatment options in 2024.

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Seal Oil for Rheumatoid Arthritis

N/A

Recruiting

Led By Alain Doyen, PhD

Research Sponsored by Laval University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have had RA for at least 1 year

Have been diagnosed with RA after the age of 18

Must not have

Have been diagnosed with inflammatory bowel disease (ulcerative colitis or Crohn's disease)

Be treated or have previously received biological agents or inhibitors of JAK (Janus kinase) (family of tyrosine kinases)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year after the beginning of the study

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the side effects aren't specified here, typical concerns when consuming fish oils may include an upset stomach, bad breath, heartburn, nausea. Allergic reactions could occur in those sensitive to seafood products.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had rheumatoid arthritis for at least one year.

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I was diagnosed with rheumatoid arthritis after turning 18.

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I take 10 mg or less of prednisone daily.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with inflammatory bowel disease.

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I have been treated with drugs targeting JAK enzymes.

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I have been diagnosed with an autoimmune disease affecting my joints.

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I have fibromyalgia.

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I take blood thinner medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year after the beginning of the study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year after the beginning of the study

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year after the beginning of the study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy of DPA-rich seal oil in improving the clinical signs and symptoms associated with rheumatoid arthritis

Secondary study objectives

Change in the use of non-steroidal anti-inflammatory drugs

Degree of disease activity through the 66/68-swollen and tender joint count (SJC66/TJC68)

Overall blood biomarkers of inflammation (cytokines)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Seal oil

2008

Completed Phase 1

~420

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for polyarthritis often focus on reducing inflammation and managing pain. Nonsteroidal anti-inflammatory drugs (NSAIDs) inhibit cyclooxygenase enzymes (COX-1 and COX-2), reducing the production of prostaglandins that cause inflammation and pain. Disease-modifying antirheumatic drugs (DMARDs) like methotrexate suppress the immune system to slow disease progression. Biologic DMARDs, such as TNF inhibitors, target specific components of the immune system to reduce inflammation. DPA-rich sea bass oil, similar to other omega-3 fatty acids, may reduce inflammation by inhibiting the production of pro-inflammatory cytokines. These treatments are crucial for polyarthritis patients as they help manage symptoms, improve quality of life, and prevent joint damage.

Anti-inflammatory activity in fractionated extracts of the green-lipped mussel.Anti-inflammatory and antioxidant potential of alginic acid isolated from the marine algae, Sargassum wightii on adjuvant-induced arthritic rats.Effects of photobiomodulation therapy, pharmacological therapy, and physical exercise as single and/or combined treatment on the inflammatory response induced by experimental osteoarthritis.