Omega-3 Supplementation in Systemic Lupus Erythematosus

Официальное название

Omega-3 Supplementation in Women With Systemic Lupus Erythematosus: Protocol for a Randomized, Double-blind, Placebo-controlled Trial

Обзор

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.

Вмешательства

• Пищевая добавка Omega-3 Fatty Acids (EPA plus DHA)
  Oral omega-3 fatty acid supplementation (EPA+DHA), 5,400 mg/day for 12 weeks.
• Пищевая добавка Placebo
  Inert soybean oil capsules identical in appearance to the active supplement.

Первичные конечные точки

• Telomere length [Срок оценки: Baseline and 12 weeks]

Вторичные конечные точки (4)

• Inflammatory markers [Срок оценки: Baseline and 12 weeks]
• Oxidative stress markers [Срок оценки: Baseline and 12 weeks]
• Lipid profile [Срок оценки: Baseline and 12 weeks]
• Fatty acid profiles [Срок оценки: Baseline and 12 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Фундаментальное исследование

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07393399 · SLE_Omega3_RCT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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