Omega-3 Supplementation in Systemic Lupus Erythematosus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Omega-3 Fatty Acids (EPA plus DHA), Placebo.
- Who it may be relevant to
- Registry conditions: Lupus Erythematosus, Systemic. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Omega-3 Supplementation in Women With Systemic Lupus Erythematosus: Protocol for a Randomized, Double-blind, Placebo-controlled Trial
Overview
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.
Interventions
- Dietary supplement Omega-3 Fatty Acids (EPA plus DHA)
Oral omega-3 fatty acid supplementation (EPA+DHA), 5,400 mg/day for 12 weeks. - Dietary supplement Placebo
Inert soybean oil capsules identical in appearance to the active supplement.
Primary outcome measures
- Telomere length [Time frame: Baseline and 12 weeks]
Secondary outcome measures (4)
- Inflammatory markers [Time frame: Baseline and 12 weeks]
- Oxidative stress markers [Time frame: Baseline and 12 weeks]
- Lipid profile [Time frame: Baseline and 12 weeks]
- Fatty acid profiles [Time frame: Baseline and 12 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Basic science
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07393399 · SLE_Omega3_RCT