Tissue Sodium in Autoimmune Disease

Withdrawn before enrolling · Not applicable

Conditions studied: Systemic Lupus Erythematosus

In brief

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

Key facts

Study ID

NCT02525835

Run by

Vanderbilt University

People needed

0

Starts

2018-12-01

Expected to finish

2020-08-01

Last updated by the study team

2018-09-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Vanderbilt University — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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