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

• ClinicalTrials.gov Identifier: NCT02282878
• Recruitment Status: Completed
• First Posted: November 5, 2014
• Last Update Posted: April 19, 2021
• Sponsor: Yale University
• Information provided by (Responsible Party): Yale University

Study Description

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 14 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
• Actual Primary Completion Date: December 19, 2018
• Actual Study Completion Date: December 8, 2019

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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)

Contacts and Locations

Locations

United States, Connecticut

Yale MS Center

New Haven, Connecticut, United States, 06519

Sponsors and Collaborators

Yale University

Investigators

• Principal Investigator: David Hafler, MD; Yale University

More Information

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT02282878
• Other Study ID Numbers: 1406014201
• First Posted: November 5, 2014
• Last Update Posted: April 19, 2021
• Last Verified: April 2021

Keywords provided by Yale University:

High Sodium Diet; Low Sodium Diet; MS

Additional relevant MeSH terms:

Multiple Sclerosis; Sclerosis; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases