An interventional study of Omega-3 Supplementation and Placebo in Rheumatoid Arthritis (RA), sponsored by Hopital Charles Nicolle. Not yet recruiting at 1 site in Tunisia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-10.
Sponsored by Hopital Charles Nicolle · Not applicable, Interventional, and Treatment
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:
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:
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's planned enrollment of 180 is above the median of 96 across 2,220 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Hopital Charles Nicolle is the lead sponsor of 11 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
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, during a period of 3 months. The dose of omega-3 will be constant throughout the study period.
Dietary Supplement: Omega-3 Supplementation
The control group 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. The dose of placebo will be constant throughout the study period.
Other: Placebo
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.
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.
impact of omega3 supplementation on rheumatoid arthritis activity
Patients will be evaluated by the disease Activity Score (DAS28). This combined index measures disease activity in patients with RA. It includes a 28 tender joint count, a 28 swollen joint count, a general assessment of the patient's general health status and the level of CRP. The score is interpreted as follow: less than 2.6: RA is in remission, 2.6 to 3.2: a low level of disease activity, more than 3.2: moderate disease activity, more than 5.1: very active disease.
Time frame: Rheumatoid arthritis activity will be evaluated at baseline and at the end of the protocol (3 months of supplementation)
effect of omega3 supplementation on rheumatoid arthritis function
Function will be evaluated by the Health Assessment Questionnaire (HAQ), which is one of the most widely used measures of patient's function, with an acceptable validity and reliability. It contains 8 domains including: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Each domain is noted 0 to 3 (0=No assistance is needed, 1=A special device is used by the patient in his/her usual activities. 2=The patient usually needs help from another person, 3=The patient usually needs both a special device and help from another person). The final score is the sum of the ratings of the various domains divided by the number of domains evaluated. The score obtained in this way is between 0 and 3, with a higher score indicating a higher disability.
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
Fatigue will be assessed by the Functional Assessment of Chronic Illness Therapy Fatigue Subscale (FACIT-Fatigue). It is a 13-item measure that assesses physical and functional impact of fatigue. Scores range from 0 to 52, with higher scores indicating less fatigue.
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
Sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI), which is a self-report questionnaire that assesses sleep quality over a one-month time interval. It is composed of 19 items that measure seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping medications and daytime dysfunction. Scores range from 0 to 21, with higher scores indicating poorer sleep quality.
Time frame: Sleep quality during rheumatoid arthritis will be assessed at baseline and then 3 months after omega3 supplementation
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2025; primary completion for Dec 2025, 3 months later.
Of 292 non-industry interventional studies with no phase under Arthritis, Rheumatoid, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 39. This study's planned 3 months is below that.
Counting every sponsor, half of 348 studies reached it within 27 months; a quarter within 13 and three quarters within 47.
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This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Omega-3 fatty acid
Hopital Charles Nicolle