The Effect of Omega-3 Fatty Acids in Patients With Rheumatoid Arthritis (omega3-RA)

June 6, 2025 updated by: Selma Bouden, Hopital Charles Nicolle

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Tunisia
    • Bab Saadoun
      • Tunis, Bab Saadoun, Tunisia, 1006
        • Charles Nicolle Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: omega3 group

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
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 Comparator: control group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Rheumatoid arthritis activity will be evaluated at baseline and at the end of the protocol (3 months of supplementation)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
Sleep quality during rheumatoid arthritis will be assessed at baseline and then 3 months after omega3 supplementation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Charles Nicolle

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

March 7, 2025

First Submitted That Met QC Criteria

March 14, 2025

First Posted (Actual)

March 18, 2025

Study Record Updates

Last Update Posted (Actual)

June 10, 2025

Last Update Submitted That Met QC Criteria

June 6, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECR-OMG-2025-01 (Other Identifier: Charles Nicolle Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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