NCT07393399Not yet recruiting
Omega-3 Supplementation in Systemic Lupus Erythematosus
Omega-3 Supplementation in Women With Systemic Lupus Erythematosus: Protocol for a Randomized, Double-blind, Placebo-controlled Trial
Source: ClinicalTrials.gov · Last updated 17 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 30 Jan 2026
- Start date
- Jul 2026
- Primary completion date
- Jul 2026
- Lead sponsor
- University of Sao Paulo
- Diseases
- Lupus (SLE)
- NCT number
- NCT07393399
What you commit to
- Study type: Interventional
- Planned participants: 80
- From Jul 2026 to the primary completion date, Jul 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of omega-3 fatty acid supplements or use within the previous 3 months
Other illness
- 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
Other
- Pregnancy or lactation
Who the study is looking for
- 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
Age in the registry: 18 years to 45 years · Sex: Female · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.