RecruitingNot ApplicableNCT04688398
Study of the Impact of Fatty Acids From Seal Oil on the Relief of Symptoms Associated With Rheumatoid Arthritis
Sponsor
Laval University
Enrollment
130 participants
Start Date
Jan 20, 2022
Study Type
INTERVENTIONAL
Conditions
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. This unique approach will allow to clinically evaluate the benefits of sea bass oil on the relief of rheumatoid arthritis-related pain in a population suffering from inflammatory arthritis.
Eligibility
Min Age: 18 Years
Inclusion Criteria8
- 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 Criteria10
- 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).
Interventions
DIETARY_SUPPLEMENTSeal oil
Consumption of seal oil once per day (at breakfast)
DIETARY_SUPPLEMENTControl
Consumption of vegetable oil once per day (at breakfast)
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04688398