Tissue Sodium in Autoimmune Disease

NCT02525835 | Withdrawn

• 1 other identifier: 150713
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• SLEDAI

  3 months

• blood pressure

  3 months

Study Arms (2)

Low Dietary Sodium

EXPERIMENTAL

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

High Dietary Sodium

EXPERIMENTAL

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

Interventions

Low Dietary Sodium DIETARY_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).

Low Dietary Sodium

High Dietary Sodium DIETARY_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).

High Dietary Sodium

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Charles M Stein, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dan May Professor of Medicine and Pharmacology, Assc. Director Division of Clinical Pharmacology

Study Record Dates

• First Submitted: August 13, 2015
• First Posted: August 17, 2015
• Study Start: December 1, 2018
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: September 25, 2018

Record last verified: 2018-09

Locations

US (1)