Tissue Sodium in Autoimmune Disease
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- sodium concentration in skin
研究概览
简要总结
This pilot study will test the hypothesis that a low sodium diet will decrease sodium (23Na) magnetic resonance imaging-determined skin sodium concentrations in patients with systemic lupus erythematosus (SLE) and improve blood pressure and inflammation
详细描述
This pilot study will test the hypothesis that a low sodium diet will decrease 23Na magnetic resonance imaging-determined skin sodium concentrations in patients with SLE and improve blood pressure and inflammation. Investigators plan to enroll 21 participants who will be randomized to low salt or high salt diet. Participants will eat the first diet for 28 days, and after a 2 week washout, Participants will eat the second diet (whichever the participant was not randomized to for the first phase). Participant will know what diet participant is on, study coordinator who does the assessment will be blinded to diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male and female patients 18 and over
- •meets 2012 International criteria for the diagnosis of SLE
- •have stable disease activity as evidenced by no significant change in immunomodulating therapy in last month
- •provide written informed consent
排除标准
- •Pregnancy
- •Receiving dialysis
- •Organ or bone marrow transplant
- •Uncontrolled hypertension, BP> 160/100 mm Hg at screening
- •Severe edema as judged by investigator
- •Diabetes mellitus requiring drug therapy
- •Major surgery within the previous 3 months
- •Severe co-morbid conditions such as active cancer likely to compromise study participation
- •unwillingness or other inability to cooperate
- •Conditions that alter sodium homeostasis substantially including heart failure, clinically evident liver disease, clinically evident renal dysfunction (creatinine clearance < 50 nl/min or > 2+ proteinuria, or being treated for lupus nephritis
结局指标
主要结局
sodium concentration in skin
时间窗: 3 months
sodium concentration in skin after 1 month low salt diet will be compared to sodium concentration in skin after 1 month high sodium diet, with 2 week wash out between
次要结局
- SLEDAI(3 months)
- blood pressure(3 months)
研究者
C. Michael Stein
Dan May Professor of Medicine and Pharmacology, Assc. Director Division of Clinical Pharmacology
Vanderbilt University