Impact of seal oil on rheumatoid arthritis symptoms

Study of the Impact of Fatty Acids From Seal Oil on the Relief of Symptoms Associated With Rheumatoid Arthritis

This study is testing if taking seal oil can help people with rheumatoid arthritis feel better and improve their quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 130 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Laval University (Academic / other)
• Drugs / interventions: prednisone
• Locations: 1 site (Québec)
• Trial ID: NCT04688398 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of DPA-rich seal oil in alleviating symptoms associated with rheumatoid arthritis. It is a multi-center, randomized, double-blind study involving 130 participants diagnosed with rheumatoid arthritis. The study will assess various outcomes, including disease activity, quality of life, and inflammatory biomarkers, using established clinical measures and questionnaires. Participants will be randomly assigned to receive either the seal oil treatment or a control, allowing for a robust comparison of results.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with a diagnosis of rheumatoid arthritis for at least one year and stable disease status.

Not a fit: Patients with other rheumatologic autoimmune diseases or those consuming omega-3 supplements outside the study may not benefit.

Why it matters

Potential benefit: If successful, this study could provide a novel dietary intervention for managing rheumatoid arthritis symptoms.

How similar studies have performed: While this approach is novel, similar studies exploring dietary interventions for inflammatory conditions have shown promising results.

Eligibility criteria

Inclusion Criteria:

* Have been diagnosed with RA after the age of 18;
* Have had RA for at least 1 year;
* Meet the 2010 ACR/EULAR criteria;
* Stable disease status for at least 3 months:

  * Low to moderate activity as measured by the Clinical Disease Activity Index (CDAI);
  * Stable dose of DMARD (conventional synthetic Disease Modifying Anti-Rheumatic Drug) for at least 3 months;
  * Stable dose of NSAIDs and corticosteroids for at least 1 month;
  * Do not take \> 10 mg per day of prednisone.

Exclusion Criteria:

* Have been diagnosed with another rheumatologic autoimmune disease;
* Have been diagnosed with inflammatory bowel disease (ulcerative colitis or Crohn's disease);
* Have a disease that may interfere with the physician's assessment (e.g. severe osteoarthritis);
* Have fibromyalgia;
* Consume omega-3 fatty acid supplements other than those given during the project;
* Have an allergy or intolerance to seafood;
* Consume natural health products that may potentially affect inflammation (e.g. glucosamine, chondroitin, devil's claw, curcumin products) during the project;
* Consume more than two servings (1 serving = 90 g or 3 ounces) of fish and seafood per week for the duration of the study;
* Take anticoagulant medication;
* Be treated or have previously received biological agents or inhibitors of JAK (Janus kinase) (family of tyrosine kinases).

Where this trial is running

Québec

• Grmo — Québec, Canada (Recruiting)

Study contacts

• Principal investigator: Alain Doyen, PhD — Laval University
• Study coordinator: Louise Corneau, MSc

Conditions Polyarthritis; seal oil; inflammation