The Effect of Omega-3 Fatty Acids in Patients With Rheumatoid Arthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Omega-3 Supplementation, Placebo.
- Who it may be relevant to
- Registry conditions: Rheumatoid Arthritis (RA). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Tunisia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Omega-3 Fatty Acids in Patients With Rheumatoid Arthritis: A Study Protocol of a Double-blinded Randomized Controlled Trial
Overview
The aim of this double-blinded randomized controlled trial (RCT) was to assess the effect of omega-3 intake versus placebo among patients with RA on the primary outcome of disease activity, and the secondary outcomes of function, fatigue and sleep. This is a prospective, comparative, randomized study, that will be conducted in a single centre (the Rheumatology Department of Charles Nicolle Hospital) during a period of 10 months. This double-blinded RCT will include adult patients diagnosed with RA according to the Association of Rheumatology America (ACR) criteria, attending the Rheumatology Department of Charles Nicolle Hospital. All included patients will be randomized into two groups: an intervention group who will receive omega-3 supplementation and a control group who will receive placebo supplementation, over a period of 3 months. The placebo capsules will be olive oil-based and will have the same visual as the omega-3 capsules. They will be developed by Vital Company. Patients in the intervention group will consume 2 omega-3 capsules daily, which contain 36% and 24% of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), respectively. The dose of omega-3 and placebo will be constant throughout the study period. Patients will be evaluated at baseline and after 3 months of omega-3 or placebo intake, by a questionnaire performed by a research assistant, which contains the following evaluation parameters: * Assessment of dietary and non-study supplemental intakes of marine omega-3 fatty acids * Assessment of disease activity * Assessment of function * Assessment of sleep quality * Assessment of fatigue
Detailed description
Objective:
The aim of this double-blinded randomized controlled trial (RCT) will be to assess the effect of omega-3 intake versus placebo among patients with RA on the primary outcome of disease activity, and the secondary outcomes of function, fatigue and sleep.
Study design This is a prospective, comparative, randomized study, that will be conducted in a single centre (the Rheumatology Department of Charles Nicolle Hospital) during a period of 10 months (from May 2025 to February 2026).
Patients This double-blinded RCT will include adult patients diagnosed with RA according to the Association of Rheumatology America (ACR) criteria, attending the Rheumatology Department of Charles Nicolle Hospital. Concomitant use of synthetic and/or biologic disease modifying antirheumatic drugs (DMARDs) and symptomatic treatments (low dose of corticosteroids, non-steroid anti-inflammatory drugs (NSAIDs)) is permitted by maintaining a stable dose during the study period.
Non-inclusion criteria will be allergy to fish and seafood, treatment with anticoagulants and coagulation disorders, severe hypertriglyceridemia associated with pancreatitis, severe hepatic impairment, severe renal impairment, and current pregnancy or breastfeeding.
Study intervention All included patients will be randomized into two groups: an intervention group who will receive omega-3 supplementation and a control group who will receive placebo supplementation, over a period of 3 months.
The placebo capsules will be olive oil-based and will have the same visual as the omega-3 capsules. They will be developed by Vital Company.
Patients in the intervention group will consume 2 omega-3 capsules daily, which contain 36% and 24% of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), respectively.
The dose of omega-3 and placebo will be constant throughout the study period. Outcome Measures
Patients will be evaluated at baseline and after 3 months of omega-3 or placebo intake, by a questionnaire performed by a research assistant, which contains the following evaluation parameters:
* Assessment of dietary and non-study supplemental intakes of marine omega-3 fatty acids * Assessment of disease activity * Assessment of function * Assessment of sleep quality * Assessment of fatigue
Interventions
- Dietary supplement Omega-3 Supplementation
Patients in the intervention group will consume 2 omega-3 capsules (Omevie) daily, which contain 36% and 24% of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), respectively, during a period of 3 months. - Other Placebo
The control group who will receive placebo supplementation, over a period of 3 months.The placebo capsules will be olive oil-based and will have the same visual as the omega-3 capsules. They will be developed by Vital Company.
Primary outcome measures
- impact of omega3 supplementation on rheumatoid arthritis activity [Time frame: Rheumatoid arthritis activity will be evaluated at baseline and at the end of the protocol (3 months of supplementation)]
Secondary outcome measures (3)
- effect of omega3 supplementation on rheumatoid arthritis function [Time frame: Function in rheumatoid arthrtis will be evaluated at baseline and then 3 months later]
- effect of omega3 supplementation on fatigue during rheumatoid arthritis [Time frame: Fatigue will be assessed at baseline, and then 3 months after the omega3 supplementation]
- Effect of omega3 supplementation on sleep quality during rheumatoid arthrtis [Time frame: Sleep quality during rheumatoid arthritis will be assessed at baseline and then 3 months after omega3 supplementation]
Eligibility criteria
Inclusion criteria
- Adult patients ≥ 18 years
- Patients diagnosed with RA according to the Association of Rheumatology America (ACR) criteria, attending the Rheumatology Department of Charles Nicolle Hospital.
Exclusion criteria
- Patients with allergy to fish and seafood
- Patients treated with anticoagulants and coagulation disorders
- Patients with severe hypertriglyceridemia associated with pancreatitis
- Patients with severe hepatic impairment
- Patients with severe renal impairment
- Current pregnancy or breastfeeding.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Tunisia · 1 center
- Charles Nicolle Hospital — Tunis
Identifiers
NCT: NCT06881966 · ECR-OMG-2025-01 · ECR-OMG-2025-01