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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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26 April 2021 |
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Main ID: |
NCT02282878 |
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Date of registration:
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31/10/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Effect of Dietary Salt Intake on Immune Function in Patients With Multiple Sclerosis
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Scientific title:
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The Effect of Dietary Salt Intake on Immune Function in Patients With Multiple Sclerosis |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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14 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02282878 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
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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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David Hafler, 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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Yale University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male or Female adult subjects
- Ages 18-60, inclusive
- diagnosis of CIS or MS by 2010 McDonald Criteria (in the case of MS subjects)
- Naive to FDA- approved MS therapies such as glatiramer acetate, interferon-beta,
natalizumab, fingolimod, tecfidera, or teriflunomide
Exclusion Criteria:
- Secondary or primary progressive MS
- Prior exposure to FDA-approved MS therapies or chemotherapies of any kind
- Known history of autoimmune disease besides MS
- Known history of renal disease, hypertension or congestive heart failure
- Currently taking medications that could affect urine sodium excretion (e.g. diuretics
or others that act on the renin-angiotensins-aldosterone system)
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Dietary Supplement: High/Low Sodium Diet
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Primary Outcome(s)
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Number of Th17 cells
[Time Frame: Change from baseline at 2 weeks]
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Secondary Outcome(s)
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Regulatory T cell function
[Time Frame: Change from baseline at 2 weeks]
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Secondary ID(s)
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1406014201
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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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