The Effect of Dietary Salt Intake on Immune Function in Patients With
The Effect of Dietary Salt Intake on Immune Function in Patients With Multiple Sclerosis
What it found
We found no results in the registry or in papers.
This trial finished 7 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- High/Low Sodium Diet
What it measured
Main measures
Number of Th17 cells
Change from baseline at 2 weeks
Other measures (1)
Regulatory T cell function
Change from baseline at 2 weeks
Who could take part
Early (CIS/RIS) · 18 to 60
Show the full criteria
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)
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of this work is to investigate the influence of dietary salt intake on immune function in multiple sclerosis (MS) subjects and healthy controls. This study primarily tests the hypothesis that higher dietary salt intake will be associated with a higher frequency of pathogenic Th17 cells and impaired function of protective regulatory T cells. If a relationship between dietary salt intake and immune function is observed, this study will also test: a) whether this relationship is unique to MS subjects or whether it is also present in healthy controls, and b) whether healthier immune function can be restored by restricting dietary salt intake.
Papers
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History
Started
Sept 2014
Main results due
Dec 2018
Finished
Dec 2019