Omega-3 Supplementation in Women With Systemic Lupus Erythematosus: Protocol for a Randomized, Double-blind, Placebo-controlled Trial
| Registry | NCT07393399, acronym SLE-OMEGA |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: triple, basic science |
| Enrollment | 80 (Estimated) |
| Sponsor | University of Sao Paulo (Other) |
| Conditions | Lupus Erythematosus, Systemic |
| Interventions | Omega-3 Fatty Acids (EPA plus DHA), Placebo (Dietary supplement) |
| Dates | start 2026-07-01 (estimated), primary completion 2026-07-01 (estimated), completion 2028-07-01 (estimated), first posted 2026-02-06, last updated 2026-07-17 |
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All trials for Lupus Erythematosus, Systemic All trials of Omega-3 Fatty Acids (EPA plus DHA) All trials of Placebo
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Omega-3 Supplementation | Experimental | Dietary Supplement: Omega-3 Fatty Acids (EPA plus DHA) | |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Sex: Female, ages: 18 Years to 45 Years, 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