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

NCT06881966 | Not Yet Recruiting

• 1 other identifier: ECR-OMG-2025-01
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Conditions

Rheumatoid Arthritis (RA)

Keywords

rheumatoid arthritis; omega3; supplementation; efficacy

Outcome Measures

Primary Outcomes (1)

• 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.

  Rheumatoid arthritis activity will be evaluated at baseline and at the end of the protocol (3 months of supplementation)

Secondary Outcomes (3)

• effect of omega3 supplementation on rheumatoid arthritis function

  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 at baseline, and then 3 months after the omega3 supplementation

• Effect of omega3 supplementation on sleep quality during rheumatoid arthrtis

  Sleep quality during rheumatoid arthritis will be assessed at baseline and then 3 months after omega3 supplementation

Study Arms (2)

omega3 group

EXPERIMENTAL

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

control group

PLACEBO COMPARATOR

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

Interventions

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.

omega3 group

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.

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hopital Charles Nicolle: lead

Study Sites (1)

Charles Nicolle Hospital

Tunis, Bab Saadoun, 1006, Tunisia

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

selma bouden, Assistant doctor

CONTACT

0021624685748; selma.bouden@fmt.utm.tn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Doctor

Model Details: 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.

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 18, 2025
• Study Start: September 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: June 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)