Effect of Melatonin Administration on the Clinical Outcomes of Systemic Lupus Erythematosus Patients
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Serum Interleukin- 6 (IL-6)
研究概览
简要总结
The aim of the current study is to evaluate the effect of melatonin administration on circulating levels of inflammatory mediators, oxidative stress, sleep quality, fatigue and quality of life in patients with SLE. To the best of our knowledge, this is the first randomized-controlled trial to evaluate the impact of melatonin on sleep quality and assess fatigue and quality of life in SLE adult patients. Moreover, the impact of melatonin on serum concentrations of Interleukin-6 and superoxide dismutase SOD will be evaluated.
详细描述
Systemic lupus erythematosus (SLE) is a multisystem chronic autoimmune disease with a relapsing and remitting course. Its prevalence is higher in women of childbearing age of non-white ethnicity. It has a broad spectrum of clinical features ranging from mild cutaneous involvement to severe organ damage, such as kidney failure, pulmonary hypertension, and cardiac failure. The exact etiology of the disease is not well understood well. However, inflammation and oxidative stress are among the most important targets for the management of SLE. Elevated circulating IL-6 concentrations have been consistently observed in patients with systemic lupus erythematosus (SLE) relative to healthy controls, underscoring its pathogenic relevance. In systemic lupus erythematosus (SLE), excessive oxidative stress arising from chronic inflammation and immune complex deposition leads to depletion of endogenous antioxidants, including SOD.
Moreover, diminished SOD activity correlates with disease activity indices such as SLEDAI, suggesting its potential utility as a biomarker for oxidative stress-related disease burden.
melatonin has anti-inflammatory and anti-oxidant characteristics that may aid in the management of autoimmune diseases. In different animal models, melatonin has demonstrated to ameliorate lupus nephritis, reduce inflammation, and improve overall disease pathology. However, these studies have their limitations of being performed in vitro.Only one randomized controlled trial (RCT) was conducted on adult SLE patients and showed improvement in oxidative stress markers, namely malondialdehyde and total antioxidant capacity but no effect on disease activity.
The aim of the current study is to evaluate the effect of melatonin administration on circulating levels of inflammatory mediators, oxidative stress, sleep quality, fatigue and quality of life in patients with SLE. To the best of our knowledge, this is the first randomized-controlled trial to evaluate the impact of melatonin on sleep quality and assess fatigue and quality of life in SLE adult patients. Moreover, the impact of melatonin on serum concentrations of Interleukin-6 and superoxide dismutase SOD will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male and female patients with active SLE aged 18-60 years
- •Active SLE patients defined on SLEDAI-2K score to be (more than or equal 4 up to 11) according to the classification of SLE as suggested by the American Rheumatology Association (American College of Rheumatology)
- •Have had non-life-threatening disease
- •Taking stable doses of medications for SLE treatment in the last three months
- •Ability and willingness to cooperate in the study
排除标准
- •Other autoimmune diseases
- •Uncontrolled hypertension or Uncontrolled DM
- •Severe renal (GFR < 30 ml/min ) or severe liver diseases (ALT or AST <3 times ULN or total bilirubin > 2 times ULN)
- •Life-threatening SLE including
- •Severe hemolysis (reticulocyte count >8%)
- •Severe thrombocytopenia (platelet count <40 000)
- •Endocarditis
- •Lupus pneumonia
- •Alveolar hemorrhage
- •Using sedations, antidepressants, contraceptives, antioxidant and/or omega-3-fatty acid supplements one month prior to or during the study
- •Smoking and/ or alcohol intake
- •Allergy to melatonin
- •Pregnancy, pregnancy plans and lactation.
- •Having active infectious diseases
- •poor patient compliance
- •Any sleeping pills two weeks prior to the study
- •Malabsorption syndromes
- •Malignancy
- •Warfarin or heparin use or high-dose aspirin (more than 325 mg/day)
结局指标
主要结局
Serum Interleukin- 6 (IL-6)
时间窗: at baseline and then after 12 weeks
Blood samples will be drawn from the patients at baseline and after 12 weeks of intervention. Blood samples will be collected at baseline, centrifuged and stored as serum at - 80°C or -20°C until analysis. Enzyme-linked immunosorbent assay (ELISA) method will be used to measure Interleukin 6 concentrations
次要结局
- SLEDAI -2K Score(at baseline and then after 12 weeks)
- Serum SOD(at baseline and after 12 weeks)
- Arabic version form of Systemic Lupus Erythematosus-Specific Quality of Life Questionnaire (SLEQOL-Arabic Version)(at baseline -1st Month-2nd Month-3rd Month)
- Arabic version of Fatigue Severity Scale (FSS)(at baseline -1st Month-2nd Month-3rd Month)
- Arabic Version of the Pittsburgh Sleep Quality Index (PSQI)(at baseline- 1st Month-2nd Month-3rd Month)
- Incidence of Adverse Effects and Medication Adherence & Modifications(weekly up to 12 weeks)
研究者
nirmeen amr habib
Nirmeen Amr
Ain Shams University