PolyarthritisNCT04688398
Study of the Impact of Fatty Acids From Seal Oil on the Relief of Symptoms Associated With Rheumatoid Arthritis
A study testing Seal oil in people with Polyarthritis, run by Laval University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polyarthritis
- What is being tested?
- Seal oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteCanada
- Study dates
- 20 Jan 2022to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
GRMO
Québec, G1V 3M7
Chantal Jacques, 418-650-0698, chantal.jacques@grmo.ca
About this study
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.
Read the detailed 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:
- the degree of disease activity as measured by a joint examination performed by the physician
- 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 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.
- Conditions
- Polyarthritis
- Being tested
- Seal oil, Control
- Keywords
- seal oil, inflammation
- Medical subject headings
- Arthritis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seal oilDietary supplement
Consumption of seal oil once per day (at breakfast)
ControlDietary supplement
Consumption of vegetable oil once per day (at breakfast)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Seal oil |
| Control | Active comparator | Daily intake of vegetable oil during 12 weeks Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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.
Measured: One year after the beginning of the study
Overall inflammation
Measured via blood CRP.
Measured: 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.
Measured: One year after the beginning of the study
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: One year after the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start20 Jan 2022
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolyarthritisStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Agriculture, Fisheries and Food, Quebec, Groupe De Recherche En Rhumatologie Et Maladies Osseuses Inc.
- Responsible party
- Principal investigator, Alain Doyen, Laval University
- Investigators
- Alain Doyen, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04688398
- Sponsor's protocol ID
- 2019101
- Status last verified
- Mar 2024
- First submitted
- 14 Dec 2020
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Impact of Fatty Acids From Seal Oil on the Relief of Symptoms Associated With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT04688398
- Acronym / sponsor ID
- 2019101
- Conditions
- Polyarthritis
- Keywords
- seal oil, inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Ministry of Agriculture, Fisheries and Food, Quebec, Groupe De Recherche En Rhumatologie Et Maladies Osseuses Inc.
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- the degree of disease activity as measured by a joint examination performed by the physician
- 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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Seal oil | Experimental | Dietary Supplement: Seal oilDaily intake of 15 ml of seal oil containing 534 mg of EPA + 1129 mg of DHA + 530 mg of DPA during 12 weeks |
| Control | Active comparator | Dietary Supplement: ControlDaily intake of vegetable oil during 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seal oilConsumption of seal oil once per day (at breakfast) | Dietary supplement | Seal oil |
| ControlConsumption of vegetable oil once per day (at breakfast) | Dietary supplement | Control |
Primary outcome
Efficacy of DPA-rich seal oil in improving the clinical signs and symptoms associated with rheumatoid arthritis
Time frame: One year after the beginning of the study
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.
8 secondary outcomes
Degree of disease activity through the 66/68-swollen and tender joint count (SJC66/TJC68)
Time frame: One year after the beginning of the study
Overall blood biomarkers of inflammation (cytokines)
Time frame: One year after the beginning of the study
Overall inflammation
Time frame: One year after the beginning of the study
Patient's overall health
Time frame: One year after the beginning of the study
Patient's quality of life measured with MOS 36-item short-form health survey (SF36)
Time frame: One year after the beginning of the study
Patient's level of fatigue
Time frame: One year after the beginning of the study
Change in the use of non-steroidal anti-inflammatory drugs
Time frame: One year after the beginning of the study
Rate of occurrence of side effects between experimental group and control group.
Time frame: One year after the beginning of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain Doyen, PhD principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seal oil in people with Polyarthritis, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Louise Corneau, MSc (418-656-2131 ext. 408412, louise.corneau@fsaa.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of DPA-rich seal oil in improving the clinical signs and symptoms associated with rheumatoid arthritis (time frame: One year after the beginning of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.