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

Polyarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04688398
• Other study ID #: 2019101
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: March 2024
• Source: Laval University
• Contact: Louise Corneau, MSc
• Phone: 418-656-2131
• Email: louise.corneau[@]fsaa.ulaval.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• 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).

Related Conditions & MeSH terms

• Arthritis
• Polyarthritis

Intervention

Dietary Supplement:
• Seal oil
Consumption of seal oil once per day (at breakfast)
• Control
Consumption of vegetable oil once per day (at breakfast)

Locations

Country	Name	City	State
Canada	GRMO	Québec

Sponsors (3)

Lead Sponsor	Collaborator
Laval University	Groupe De Recherche En Rhumatologie Et Maladies Osseuses Inc., Ministry of Agriculture, Fisheries and Food, Quebec

Country where clinical trial is conducted

Canada, 

Outcome

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