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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02525835 |
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Date of registration:
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13/08/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Tissue Sodium in Autoimmune Disease
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Scientific title:
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Tissue Sodium in Autoimmune Disease |
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Date of first enrolment:
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December 1, 2018 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT02525835 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Charles M Stein, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Vanderbilt University |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Systemic Lupus Erythematosus
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Intervention(s)
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Dietary Supplement: High Dietary Sodium
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Dietary Supplement: Low Dietary Sodium
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Primary Outcome(s)
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sodium concentration in skin
[Time Frame: 3 months]
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Secondary Outcome(s)
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SLEDAI
[Time Frame: 3 months]
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blood pressure
[Time Frame: 3 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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