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NCT Number: NCT06881966

The Effect of Omega-3 Fatty Acids in Patients With Rheumatoid Arthritis

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

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Key information

Conditions

Rheumatoid Arthritis (RA) Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Omega-3 supplementation

Dietary Supplement

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.

Placebo

Other

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 outcomes

  1. 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)

    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.

Secondary outcomes

  1. effect of omega3 supplementation on rheumatoid arthritis function

    Time frame: Function in rheumatoid arthrtis will be evaluated at baseline and then 3 months later

    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.

  2. 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

    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.

  3. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

selma bouden, Assistant doctor

CONTACT

[email protected]

0021624685748

Sponsors and collaborators

Lead sponsor

Hopital Charles Nicolle

Other

Registry information

Official study title

The Effect of Omega-3 Fatty Acids in Patients With Rheumatoid Arthritis: A Study Protocol of a Double-blinded Randomized Controlled Trial

Acronym: omega3-RA

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 18, 2025
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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