Tissue Sodium in Autoimmune Disease

Vanderbilt University

Status: Withdrawn

Conditions: Systemic Lupus Erythematosus

Treatments: Dietary Supplement: Low Dietary Sodium; Dietary Supplement: High Dietary Sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT02525835

150713

Details and patient eligibility

About

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

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Low Dietary Sodium

Experimental group

Description:

Participants will be randomized to a low sodium diet (50 mmol/24 hours) for 28 days (range allowed 25-31 days) or 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).

Treatment:

Dietary Supplement: Low Dietary Sodium

High Dietary Sodium

Experimental group

Description:

Participants will be randomized to a low sodium diet (50 mmol/24 hours) for 28 days (range allowed 25-31 days) or 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).

Treatment:

Dietary Supplement: High Dietary Sodium