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.
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: 1. the degree of disease activity as measured by a joint examination performed by the physician 2. the patient's overall health, quality of life and level of fatigue 3. blood biomarkers of inflammation (CRP: c-reactive protein, TNF-: tumor necrosis factor, IL-1, IL-6 and IL-17: interleukin); 4. the use of non-steroidal anti-inflammatory drugs (NSAIDs); 5. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
130
GRMO
Québec, Canada
RECRUITINGEfficacy 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.
Time frame: One year after the beginning of the study
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.
Time frame: 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.
Time frame: One year after the beginning of the study
Overall inflammation
Measured via blood CRP.
Time frame: 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.
Time frame: One year after the beginning of the study
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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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: One year after the beginning of the study