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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 from the Rheumatoid Arthritis Disease Activity Index (RADAI) questionnaire, in patients suffering from this disease. The secondary objectives are to evaluate the effect of DPA-rich seal oil on: the degree of disease activity as measured by a joint examination performed by the physician the patient's overall health, quality of life and level of fatigue blood biomarkers of inflammation (CRP: c-reactive protein, TNF-: tumor necrosis factor, IL-1, IL-6 and IL-17: interleukin); the use of non-steroidal anti-inflammatory drugs (NSAIDs); the occurrence of side effects. To do so, the proposed study is a multi-center, randomized, double-blind, parallel-designed study involving 130 participants with a previous diagnosis of RA from two research and treatment centers in Quebec: the Groupe de recherche en rhumatologie et maladies osseuses (GRMO Inc.) from Québec and the Centre de recherche musculo-squelettique (CRMS) from Centre du Québec. Rheumatologists from each of the centers, as well as research nurses, will be involved in this project, which will be coordinated by a research professional from the Institut sur la nutrition et les aliments fonctionnels (INAF) at Université Laval. Half of the participants (n=65) will randomly receive the experimental treatment (marine seal oil) while the other half will receive the control treatment (vegetable oil). In order to reach a minimum blood concentration of omega-3 fatty acids for measurable effects, the experimental and control treatments will be administered over a 12-week period.

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

Conditions
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Polyarthritis

Intervention / Treatment
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* Dietary Supplement: Seal oil
* Dietary Supplement: Control


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Seal oil<br>Daily intake of 15 ml of seal oil containing 534 mg of EPA + 1129 mg of DHA + 530 mg of DPA during 12 weeks | Dietary Supplement: Seal oil<br>* Consumption of seal oil once per day (at breakfast)<br>|
| Active Comparator: Control<br>Daily intake of vegetable oil during 12 weeks | Dietary Supplement: Control<br>* Consumption of vegetable oil once per day (at breakfast)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Overall inflammation | Measured via blood CRP. | One year after the beginning of the study | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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seal oil, inflammation