Tissue Sodium in Autoimmune Disease



Status:Withdrawn
Conditions:Lupus, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:9/27/2018
Start Date:December 1, 2018
End Date:August 2020

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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

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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
1
site
2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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from
Nashville, TN
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