Tissue Sodium in Autoimmune Disease

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

Study Overview

• Status: Withdrawn
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Dietary supplement: Low Dietary Sodium; Dietary supplement: High Dietary Sodium

Detailed 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Vanderbilt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low Dietary Sodium; 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).	Dietary supplement: Low Dietary Sodium; 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).
Experimental: High Dietary Sodium; 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).	Dietary supplement: High Dietary Sodium; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	3 months

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Investigators: Principal Investigator: Charles M Stein, MD, Vanderbilt University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2018
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: August 13, 2015
• First Submitted That Met QC Criteria: August 14, 2015
• First Posted (Estimate): August 17, 2015

Study Record Updates

• Last Update Posted (Actual): September 25, 2018
• Last Update Submitted That Met QC Criteria: September 21, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic; Autoimmune Diseases
• Other Study ID Numbers: 150713

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No