Omega-3 Supplementation in Systemic Lupus Erythematosus

NCT07393399 | Not Yet Recruiting

• 1 other identifier: SLE_Omega3_RCT
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized, double-blind, placebo-controlled clinical trial aims to evaluate whether oral omega-3 fatty acid supplementation can modulate inflammation, oxidative stress, and telomere maintenance in women with systemic lupus erythematosus (SLE) in remission. Women aged 18-45 years with SLE (SLEDAI-2K ≤ 4) will be allocated to receive either omega-3 (5,400 mg/day of EPA+DHA) or placebo for 12 weeks. A parallel healthy control group will undergo the same intervention scheme. Clinical, biochemical, and molecular assessments including inflammatory cytokines, oxidative stress markers (TBARS, ORAC, T-AOC), and relative telomere length (T/S ratio) will be conducted at baseline and post-intervention. The trial is designed to determine whether omega-3 can attenuate chronic low-grade inflammation and oxidative imbalance, both key drivers of cellular dysfunction and premature immunosenescence in SLE. Omega-3 PUFAs exert anti-inflammatory effects through competition with arachidonic acid for COX/LOX enzymes and by activating GPR120, which inhibits the TAK1-NF-κB-JNK inflammatory cascade. Their antioxidant effects may further reduce reactive oxygen species and support genomic stability. By integrating clinical, biochemical, and molecular outcomes, this study provides a comprehensive evaluation of omega-3 effects on pathways implicated in accelerated cellular aging in autoimmune diseases. The findings are expected to clarify whether omega-3 supplementation represents a safe, low-cost strategy capable of improving inflammatory and oxidative profiles and contributing to telomere preservation in women with SLE, supporting future precision-nutrition approaches in this population.

Conditions

Lupus Erythematosus, Systemic

Outcome Measures

Primary Outcomes (1)

• Telomere length

  Change in leukocyte telomere length assessed by quantitative polymerase chain reaction (qPCR), expressed as the telomere-to-single copy gene (T/S) ratio.

  Baseline and 12 weeks

Secondary Outcomes (3)

• Inflammatory markers

  Baseline and 12 weeks

• Oxidative stress markers

  Baseline and 12 weeks

• Lipid profile

  Baseline and 12 weeks

Study Arms (2)

Omega-3 Supplementation

EXPERIMENTAL

Dietary Supplement: Omega-3 Fatty Acids (EPA plus DHA)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Omega-3 Fatty Acids (EPA plus DHA) DIETARY_SUPPLEMENT

Oral omega-3 fatty acid supplementation (EPA+DHA), 5,400 mg/day for 12 weeks.

Omega-3 Supplementation

Placebo DIETARY_SUPPLEMENT

Inert soybean oil capsules identical in appearance to the active supplement.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 18 to 45 years
• Diagnosis of systemic lupus erythematosus (SLE) according to the EULAR/ACR classification criteria
• Remission or low disease activity, defined as SLEDAI-2K ≤ 4
• On stable doses of hydroxychloroquine and/or glucocorticoids (≤10 mg/day of prednisone or equivalent) for at least 8 weeks prior to enrollment
• Ability and willingness to provide written informed consent
• Willingness to maintain usual dietary patterns and physical activity levels throughout the study period

You may not qualify if:

• Current use of omega-3 fatty acid supplements or use within the previous 3 months
• Pregnancy or lactation
• Presence of severe infection, neoplastic disease, or diabetes mellitus
• Known allergy or intolerance to fish oil or soybean oil
• Any medical condition or circumstance that, in the investigator's opinion, could interfere with study participation or adherence to the protocol

Sponsors & Collaborators

• University of Sao Paulo: lead

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Central Study Contacts

Carolina Nicoletti Ferreira

CONTACT

+5516991293056; carolnicolettifino@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 6, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2028
• Last Updated: February 6, 2026

Record last verified: 2026-01