Tissue Sodium in Autoimmune Disease

Vanderbilt University

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Systemic Lupus Erythematosus

Interventions

Low Dietary SodiumDIETARY_SUPPLEMENT

Participants will be randomized to a low sodium diet (50 mmol/24 hours) for 28 days (range allowed 25-31 days) with a 4 week washout period between (range 2-3 weeks).

High Dietary SodiumDIETARY_SUPPLEMENT

Participants will be randomized to a high sodium diet (250 mmol/24 hours) for 28 days (range allowed 25-31 days) with a 4 week washout period between (range 2-3 weeks).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Vanderbilt University

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

sodium concentration in skin

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

Time frame: 3 months

Secondary Outcomes

SLEDAI

SLEDAI stands for Systemic Lupus Erythematosus Disease Activity Index, a list of 24 items that covers clinical findings and laboratory tests that combined indicate how active a participant's disease is. SLEDAI after 1 month low salt diet will be compared to SLEDAI after 1 month high sodium diet, with 2 week wash out between

Time frame: 3 months

blood pressure

Blood pressure after 1 month low salt diet will be compared to blood pressure after 1 month high sodium diet, with 2 week wash out between

Time frame: 3 months

Data from ClinicalTrials.gov

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