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Seal Oil for Rheumatoid Arthritis

N/A

Recruiting

Led By Alain Doyen, PhD

Research Sponsored by Laval University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have had RA for at least 1 year

Have been diagnosed with RA after the age of 18

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year after the beginning of the study

Awards & highlights

Study Summary

This trial will test whether DPA-rich sea bass oil can help relieve symptoms of rheumatoid arthritis in a controlled and randomized study.

Who is the study for?

This trial is for adults who've had rheumatoid arthritis (RA) for at least a year, meet specific RA criteria, and have low to moderate disease activity. Participants must be on stable doses of certain RA medications and not consume much fish or omega-3 supplements. Those with severe osteoarthritis, other autoimmune diseases, seafood allergies, fibromyalgia, or taking anticoagulants can't join.Check my eligibility

What is being tested?

The study tests the effects of seal oil rich in DPA (a type of fatty acid) on reducing symptoms like pain in people with rheumatoid arthritis. It's a controlled study where participants are randomly assigned to receive either seal oil or a control substance to compare outcomes.See study design

What are the potential side effects?

While the side effects aren't specified here, typical concerns when consuming fish oils may include an upset stomach, bad breath, heartburn, nausea. Allergic reactions could occur in those sensitive to seafood products.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had rheumatoid arthritis for at least one year.

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I was diagnosed with rheumatoid arthritis after turning 18.

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I take 10 mg or less of prednisone daily.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year after the beginning of the study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year after the beginning of the study

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year after the beginning of the study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Efficacy of DPA-rich seal oil in improving the clinical signs and symptoms associated with rheumatoid arthritis

Secondary outcome measures

Change in the use of non-steroidal anti-inflammatory drugs

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

Overall blood biomarkers of inflammation (cytokines)

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Seal oilExperimental Treatment1 Intervention

Daily intake of 15 ml of seal oil containing 534 mg of EPA + 1129 mg of DHA + 530 mg of DPA during 12 weeks

Group II: ControlActive Control1 Intervention

Daily intake of vegetable oil during 12 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Seal oil

2008

Completed Phase 1

~420

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Laval UniversityLead Sponsor

417 Previous Clinical Trials

172,142 Total Patients Enrolled

Ministry of Agriculture, Fisheries and Food, QuebecOTHER_GOV

3 Previous Clinical Trials

318 Total Patients Enrolled

Groupe De Recherche En Rhumatologie Et Maladies Osseuses Inc.Industry Sponsor

1 Previous Clinical Trials

50 Total Patients Enrolled

Media Library

Control Clinical Trial Eligibility Overview. Trial Name: NCT04688398 — N/A

Polyarthritis Research Study Groups: Seal oil, Control

Polyarthritis Clinical Trial 2023: Control Highlights & Side Effects. Trial Name: NCT04688398 — N/A

Control 2023 Treatment Timeline for Medical Study. Trial Name: NCT04688398 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the researchers investigating in this clinical trial?

"The primary objective of this study, which will be evaluated after one year, is to measure the efficacy of DPA-rich seal oil in reducing clinical symptoms associated with rheumatoid arthritis. Additionally, the study sponsor wishes to assess secondary outcomes surrounding the use of non-steroidal anti-inflammatory drugs (self reported via daily journal), patient quality of life (measured with SF36) and level of fatigue (measured with FACIT)."

Answered by AI

Can we still enroll in this experiment?

"The clinicaltrials.gov website indicates that this trial is presently seeking patients. This study was originally posted on 1/20/2022 and was most recently updated on 8/24/2022."

Answered by AI

How many volunteers are needed for this research project?

"Yes, the information on clinicaltrials.gov point out that this study is actively searching for patients. The clinical trial was originally posted on 1/20/2022 and was last edited on 8/24/2022. The clinical trial is searching for 130 patients across 1 locations"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Alain Doyen 2022. "Study of the Impact of Fatty Acids From Seal Oil on the Relief of Symptoms Associated With Rheumatoid Arthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04688398.

All > Rheumatoid Arthritis > Ra