Tissue Sodium in Autoimmune Disease

Systemic Lupus Erythematosus Clinical Trial

Official title:

Tissue Sodium in Autoimmune Disease

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02525835
• Other study ID #: 150713
• Status: Withdrawn
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: August 2020

Study information

• Verified date: September 2018
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases
• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

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).
• 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).

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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