Tissue Sodium in Autoimmune Disease

Sponsor

Vanderbilt University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02525835

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Erythematosus	Dietary Supplement: Low Dietary Sodium Dietary Supplement: High Dietary Sodium	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Tissue Sodium in Autoimmune Disease

Anticipated Study Start Date :

Dec 1, 2018

Anticipated Primary Completion Date :

Aug 1, 2020

Anticipated Study Completion Date :

Aug 1, 2020

Arms and Interventions

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).

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

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).

Outcome Measures

Primary Outcome Measures

sodium concentration in skin [3 months]
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

Secondary Outcome Measures

SLEDAI [3 months]
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
blood pressure [3 months]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University	Nashville	Tennessee	United States	37203

Sponsors and Collaborators

Vanderbilt University

Investigators

Principal Investigator: Charles M Stein, MD, Vanderbilt University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

C. Michael Stein, Dan May Professor of Medicine and Pharmacology, Assc. Director Division of Clinical Pharmacology, Vanderbilt University

ClinicalTrials.gov Identifier:

NCT02525835

Other Study ID Numbers:

150713

First Posted:

Aug 17, 2015

Last Update Posted:

Sep 25, 2018

Last Verified:

Sep 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lupus Erythematosus, Systemic

Autoimmune Diseases

Study Results

No Results Posted as of Sep 25, 2018