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

NCT04688398 | Recruiting

• 1 other identifier: 2019101
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Polyarthritis

Keywords

seal oil; inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Degree of disease activity through the 66/68-swollen and tender joint count (SJC66/TJC68)

  One year after the beginning of the study

• Overall blood biomarkers of inflammation (cytokines)

  One year after the beginning of the study

• Overall inflammation

  One year after the beginning of the study

• Patient's overall health

  One year after the beginning of the study

• Patient's quality of life measured with MOS 36-item short-form health survey (SF36)

  One year after the beginning of the study

Study Arms (2)

Seal oil

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

Daily intake of vegetable oil during 12 weeks

Dietary Supplement: Control

Interventions

Seal oil DIETARY_SUPPLEMENT

Consumption of seal oil once per day (at breakfast)

Seal oil

Control DIETARY_SUPPLEMENT

Consumption of vegetable oil once per day (at breakfast)

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Laval University: lead
• Ministry of Agriculture, Fisheries and Food, Quebec: collaborator
• Groupe De Recherche En Rhumatologie Et Maladies Osseuses Inc.: collaborator

Study Sites (1)

GRMO

Québec, G1V 3M7, Canada

RECRUITING

MeSH Terms

Conditions

Arthritis; Inflammation

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alain Doyen, PhD

  Laval University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Louise Corneau, MSc

CONTACT

418-656-2131; louise.corneau@fsaa.ulaval.ca

Sonia Pomerleau, MSc

CONTACT

418-656-2131; sonia.pomerleau@fsaa.ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 30, 2020
• Study Start: January 20, 2022
• Primary Completion: August 31, 2024
• Study Completion: March 31, 2025
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

CA (1)