Efficacy of EPA and DHA Supplementation in Systemic Lupus Erythematosus and Primary Antiphospholipid Syndrome
试验速览
- 阶段
- 不适用
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Cytokine profile (serum levels of IL-1B, IL-2, IL-4, IL-6, IL-8, IL-10, TNF-alpha, IFN-y)
研究概览
简要总结
It has been demonstrated that EPA and DHA supplementation may have anti-inflammatory properties in several chronic diseases, namely, diabetes, obesity, and in rheumatoid arthritis, although not with controversy. Systemic lupus erythematosus (SLE) and Antiphospholipid Antibody Syndrome (AAS) are autoimmune diseases characterized by a chronic inflammatory state which is associated with the disease´s clinical symptoms. Thus, we hypothesized that EPA and DHA supplementation may beneficially affect the inflammatory cytokine profile and clinical features of LES and AAS patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 7 and 40 years
排除标准
- •Cardiovascular dysfunction
- •Rhythm and conduction disorders
- •Musculoskeletal disturbances
- •Kidney and pulmonary involvements
- •Peripheral neuropathy
- •Use of tobacco
- •Treatment with lipid-lowering or hypoglycemic drugs
- •Fibromyalgia
- •Use of chronotropic or antihypertensive drugs
- •Physically active subjects
结局指标
主要结局
Cytokine profile (serum levels of IL-1B, IL-2, IL-4, IL-6, IL-8, IL-10, TNF-alpha, IFN-y)
时间窗: 4 months
Cytokines´ serum levels (pg/ml) will be assessed by Elisa kits.
Endothelial function
时间窗: 4 months
Endothelial function assessed by flow mediated dilatation (FMD).
次要结局
- Clical features(4 months)
- Clinical features(4 months)
研究者
Fabiana Braga Benatti
PhD
University of Sao Paulo