Polyarthritis Clinical Trial
Official title:
Study of the Impact of Fatty Acids From Seal Oil on the Relief of Symptoms Associated With Rheumatoid Arthritis
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.
Status | Recruiting |
Enrollment | 130 |
Est. completion date | March 31, 2025 |
Est. primary completion date | August 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Canada | GRMO | Québec |
Lead Sponsor | Collaborator |
---|---|
Laval University | Groupe De Recherche En Rhumatologie Et Maladies Osseuses Inc., Ministry of Agriculture, Fisheries and Food, Quebec |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy of DPA-rich seal oil in improving the clinical signs and symptoms associated with rheumatoid arthritis | Change in the RADAI (Rheumatoid Arthritis Disease Activity Index) score post intervention is measured with a self-administrated questionnaire of 5 questions. Total score can vary from 0 to 10. Higher the score, higher the signs and symptoms. | One year after the beginning of the study | |
Secondary | Degree of disease activity through the 66/68-swollen and tender joint count (SJC66/TJC68) | Measured by doctor's joint examination on 66/68 joints (number of painful and swollen joints). The 66/68-swollen and tender joint count (SJC66/TJC68) is a common questionnaire used for rheumatoid arthritis. The joints count is scored as a sum of the tender joints and the sum of the swollen joints. Higher the score, higher the disease activity. | One year after the beginning of the study | |
Secondary | Overall blood biomarkers of inflammation (cytokines) | Measured via TNF-alpha, IL-1, IL-6 and IL-17 through a kit. | One year after the beginning of the study | |
Secondary | Overall inflammation | Measured via blood CRP. | One year after the beginning of the study | |
Secondary | Patient's overall health | Measured by a self-administrated questionnaire called Health Assessment Questionnaire (HAQ). Each question asks on a scale ranging from 0 to 3 if the categories can be performed without any difficulty (scale 0) up to cannot be done at all (scale 3). Result of this questionnaire is a mean score between 0 to 3. Higher the score, higher the difficulties related to the overall health issues. | One year after the beginning of the study | |
Secondary | Patient's quality of life measured with MOS 36-item short-form health survey (SF36) | Measured by a self-administrated questionnaire called Medical Outcome Study Short Form-36 or MOS 36-item short-form health survey (SF36). The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The higher the score the less disability. | One year after the beginning of the study | |
Secondary | Patient's level of fatigue | Measured with the FACIT fatigue-scale (version 4) which is a self-administrated questionnaire. Each of the 13 questions is scaled from 0 to 4. After summing all the items, the total is reported on 100. The higher the score, the better the quality of life. | One year after the beginning of the study | |
Secondary | Change in the use of non-steroidal anti-inflammatory drugs | Self-reported by the participant by filling a daily form reporting the consumption of non-steroidal anti-inflammatory drugs. The use of these drugs during study will be compared to the use of these drugs during the washout phase. | One year after the beginning of the study | |
Secondary | Rate of occurrence of side effects between experimental group and control group. | Self-reported by the participant. | One year after the beginning of the study |
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