Tests omega-3 fatty acids in adults with rheumatoid arthritis
Compares omega-3 capsules with placebo in adults with rheumatoid arthritis.
Plain-language title generated from the registry record
Registry title: The Effect of Omega-3 Fatty Acids in Patients With Rheumatoid Arthritis
Key facts
- Where
- Tunis, TunisiaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with rheumatoid arthritis who attend the Rheumatology Department of Charles Nicolle Hospital. It compares omega-3 capsules with placebo capsules over 3 months.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Rheumatoid arthritis diagnosed by the Association of Rheumatology America (ACR) criteria. No stage or severity is named.
Main reasons for not taking part
- Allergy to fish and seafood
- Treatment with anticoagulants, or coagulation disorders
- Severe hypertriglyceridemia associated with pancreatitis
- Severe hepatic impairment or severe renal impairment
- Current pregnancy or breastfeeding
Read by machine on 9 November 2026.
Where in Tunisia
- Charles Nicolle hospitalTunis, TunisiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hopital Charles Nicolle
- Trial code
- NCT06881966
- Record updated
- 10 June 2025
- Original description
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.Read full original descriptionShow less
The Effect of Omega-3 Fatty Acids in Patients With Rheumatoid Arthritis: A Study Protocol of a Double-blinded Randomized Controlled Trial
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
Inclusion: 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: Patients treated with anticoagulants and coagulation disorders; Patients with allergy to fish and seafood; Patients with severe hepatic impairment; Patients with severe renal impairment; Patients with severe hypertriglyceridemia associated with pancreatitis; Current pregnancy or breastfeeding.