Clinical trial NCT06881966: The Effect of Omega-3 Fatty Acids in Patients With Rheumatoid Arthritis
Official title: The Effect of Omega-3 Fatty Acids in Patients With Rheumatoid Arthritis: A Study Protocol of a Double-blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rheumatoid Arthritis (RA)
Keywords: rheumatoid arthritis
omega3
supplementation
efficacy
Lead sponsor: Hopital Charles Nicolle
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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

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.

Primary outcomes:
measure: impact of omega3 supplementation on rheumatoid arthritis activity
timeFrame: Rheumatoid arthritis activity will be evaluated at baseline and at the end of the protocol (3 months of supplementation)
Secondary outcomes:
measure: effect of omega3 supplementation on rheumatoid arthritis function
timeFrame: Function in rheumatoid arthrtis will be evaluated at baseline and then 3 months later
measure: effect of omega3 supplementation on fatigue during rheumatoid arthritis
timeFrame: Fatigue will be assessed at baseline, and then 3 months after the omega3 supplementation
measure: Effect of omega3 supplementation on sleep quality during rheumatoid arthrtis
timeFrame: Sleep quality during rheumatoid arthritis will be assessed at baseline and then 3 months after omega3 supplementation
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Charles Nicolle Hospital
state: Bab Saadoun
Study officials:
References: