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Omega-3 Supplementation in Systemic Lupus Erythematosus

Sponsored by University of Sao Paulo

About this trial

Last updated 4 months ago

Study ID

SLE_Omega3_RCT

Status

Not yet recruiting

Type

Interventional

Phase

N/A

Placebo

Yes

Accepting

18 to 45 Years
Female

Trial Timing

Starts in a month

What is this trial 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.

What are the participation requirements?

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