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Tissue Sodium in Autoimmune Disease

NCT02525835 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-09-25

No results posted yet for this study

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

Interventions

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).

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).

Sponsors & Collaborators

  • Vanderbilt University

    lead OTHER

Principal Investigators

  • Charles M Stein, MD · Vanderbilt University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2020-08-31
Completion
2020-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02525835 on ClinicalTrials.gov