Omega-3 Supplementation in Systemic Lupus Erythematosus (SLE-OMEGA)

University of Sao Paulo

Status

Begins enrollment in 4 months

Conditions

Lupus Erythematosus, Systemic

Treatments

Dietary Supplement: Placebo

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

Study type

Interventional

Funder types

Other

Identifiers

NCT07393399

SLE_Omega3_RCT

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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