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The Effect of Dietary Salt Intake on Immune Function in Patients With Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT02282878
Recruitment Status : Recruiting
First Posted : November 5, 2014
Last Update Posted : October 19, 2017
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Dietary Supplement: High/Low Sodium Diet Not Applicable

Detailed Description:
The purpose of this work is to investigate the influence of dietary salt intake on immune function in 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. This is a 5-week pilot study of a dietary intervention of 25 subjects with MS or Clinically Isolated Syndrome (CIS) by 2010 Diagnostic Criteria who will be identified and recruited from the Yale MS Center and/or referred from outside MS centers. 25 age-matched healthy controls will be recruited from friends, family members, spouses and the patient waiting room at the Yale MS Center.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effect of Dietary Salt Intake on Immune Function in Patients With Multiple Sclerosis
Study Start Date : September 2014
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High/Low Sodium Diet
All MS patients will receive 2 weeks of controlled high sodium diet followed by a 1 week washout and 2 weeks of low sodium diet.
Dietary Supplement: High/Low Sodium Diet
All patients will receive 2 weeks of the high sodium diet followed by a 1 week washout and then 2 weeks of the low sodium diet

Active Comparator: High/Low Sodium Diet Control
Age matched controls will receive two weeks of controlled high sodium diet followed by a 1 week washout and 2 weeks of low sodium diet.
Dietary Supplement: High/Low Sodium Diet
All patients will receive 2 weeks of the high sodium diet followed by a 1 week washout and then 2 weeks of the low sodium diet




Primary Outcome Measures :
  1. Number of Th17 cells [ Time Frame: Change from baseline at 2 weeks ]
    Frequency of Th17 cells will be measured by flow cytometry through blood samples taken before and after each of the two week low sodium and high sodium diets


Secondary Outcome Measures :
  1. Regulatory T cell function [ Time Frame: Change from baseline at 2 weeks ]
    Frequency of regulatory T cells as measured by flow cytometry through blood samples taken before and after each of the two week low sodium and high sodium diets



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02282878


Contacts
Contact: Joan Nye, BS (203) 737-7095 joan.nye@yale.edu

Locations
United States, Connecticut
Yale MS Center Recruiting
New Haven, Connecticut, United States, 06519
Contact: Joan Nye, BS    203-737-7095    joan.nye@yale.edu   
Principal Investigator: David Hafler, MD         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: David Hafler, MD Yale University

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02282878     History of Changes
Other Study ID Numbers: 1406014201
First Posted: November 5, 2014    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: June 2017

Keywords provided by Yale University:
High Sodium Diet
Low Sodium Diet
MS

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases