Status:
RECRUITING
Study of the Impact of Fatty Acids From Seal Oil on the Relief of Symptoms Associated With Rheumatoid Arthritis
Lead Sponsor:
Laval University
Collaborating Sponsors:
Ministry of Agriculture, Fisheries and Food, Quebec
Groupe De Recherche En Rhumatologie Et Maladies Osseuses Inc.
Conditions:
Polyarthritis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This project proposes to conduct the first fully controlled and randomized clinical study demonstrating the impact of DPA-rich sea bass oil on the reduction of symptoms related to rheumatoid arthritis...
Detailed Description
The main objective of this project is to measure the efficacy of DPA-rich marine seal oil in improving the clinical signs and symptoms associated with rheumatoid arthritis through the score calculated...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2025
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT04688398
Start Date
January 20 2022
End Date
March 31 2025
Last Update
March 15 2024
Active Locations (1)
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1
GRMO
Québec, Canada, G1V 3M7