[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623189":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":28,"locations":11,"responsibleParty":34,"collaborators":11,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":46,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":11,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":11,"overallStatus":59,"whyStopped":11,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":11},{"fullName":5,"class":6},"University of Sao Paulo","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Omega-3 Supplementation","EXPERIMENTAL",null,[13],"Dietary Supplement: Omega-3 Fatty Acids (EPA plus DHA)",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Dietary Supplement: Placebo",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DIETARY_SUPPLEMENT","Omega-3 Fatty Acids (EPA plus DHA)","Oral omega-3 fatty acid supplementation (EPA+DHA), 5,400 mg\u002Fday for 12 weeks.",[9],{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":11},"Inert soybean oil capsules identical in appearance to the active supplement.",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},"Carolina Nicoletti Ferreira","CONTACT","+5516991293056","carolnicolettifino@gmail.com",{"type":35,"investigatorFullName":36,"investigatorTitle":37,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Bruno Gualano","PhD","100623189","omega-3-supplementation-in-systemic-lupus-erythematosus-100623189",false,"NCT07393399","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","SLE-OMEGA","Inclusion Criteria:\n\n* Women aged 18 to 45 years\n* Diagnosis of systemic lupus erythematosus (SLE) according to the EULAR\u002FACR classification criteria\n* Remission or low disease activity, defined as SLEDAI-2K ≤ 4\n* On stable doses of hydroxychloroquine and\u002For glucocorticoids (≤10 mg\u002Fday of prednisone or equivalent) for at least 8 weeks prior to enrollment\n* Ability and willingness to provide written informed consent\n* Willingness to maintain usual dietary patterns and physical activity levels throughout the study period\n\nExclusion Criteria:\n\n* Current use of omega-3 fatty acid supplements or use within the previous 3 months\n* Pregnancy or lactation\n* Presence of severe infection, neoplastic disease, or diabetes mellitus\n* Known allergy or intolerance to fish oil or soybean oil\n* Any medical condition or circumstance that, in the investigator's opinion, could interfere with study participation or adherence to the protocol",true,"FEMALE","18 Years","45 Years",{"count":51,"type":52},80,"ESTIMATED","INTERVENTIONAL",[55],"NA","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\u002Fday 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\u002FS 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\u002FLOX 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.",[58],"Lupus Erythematosus, Systemic","NOT_YET_RECRUITING","2026-01-30",{"date":62,"type":63},"2026-02-06","ACTUAL",{"date":65,"type":52},"2026-07",{"date":67,"type":52},"2028-07",{"name":5,"class":6}]