Study of the Impact of Fatty Acids From Seal Oil on the Relief of Symptoms Associated With Rheumatoid Arthritis
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Polyarthritis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Double-blindPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The main objective of this project is to measure the efficacy of DPA-rich marine wolfish oil compared to a DPA-free marine oil in improving the clinical signs and symptoms associated with rheumatoid arthritis through the score calculated from the Rheumatoid Arthritis Disease Activity Index (RADAI) q...
The main objective of this project is to measure the efficacy of DPA-rich marine wolfish oil compared to a DPA-free marine 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 doctor 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 three research and treatment centers in Quebec: the Centre de l'ostéoporose et de rhumatologie de Québec, the Clinique de rhumatologie/physiatrie du Centre du Québec and the Institut de rhumatologie de Montréal. 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 while the other half will receive the control treatment. In order to reach a minimum blood concentration of DPA for measurable effects, the experimental and control treatments will be administered over a 12-week period.
Tracking Information
- NCT #
- NCT04688398
- Collaborators
- Ministry of Agriculture, Fisheries and Food, Quebec
- Groupe De Recherche En Rhumatologie Et Maladies Osseuses Inc.
- Investigators
- Principal Investigator: Alain Doyen, PhD Laval University
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