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Tissue Sodium in Autoimmune Disease

Primary Purpose

Systemic Lupus Erythematosus

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low Dietary Sodium
High Dietary Sodium
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Vanderbilt University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low Dietary Sodium

High Dietary Sodium

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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

Full Information

First Posted
August 13, 2015
Last Updated
September 21, 2018
Sponsor
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT02525835
Brief Title
Tissue Sodium in Autoimmune Disease
Official Title
Tissue Sodium in Autoimmune Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Withdrawn
Why Stopped
funding
Study Start Date
December 1, 2018 (Anticipated)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
August 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Dietary Sodium
Arm Type
Experimental
Arm Description
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).
Arm Title
High Dietary Sodium
Arm Type
Experimental
Arm Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Low Dietary Sodium
Intervention Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
High Dietary Sodium
Intervention Description
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).
Primary Outcome Measure Information:
Title
sodium concentration in skin
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
SLEDAI
Description
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
Time Frame
3 months
Title
blood pressure
Description
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
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles M Stein, MD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States

12. IPD Sharing Statement

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Tissue Sodium in Autoimmune Disease

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