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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High/Low Sodium Diet
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Multiple Sclerosis focused on measuring High Sodium Diet, Low Sodium Diet, MS

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Yale MS Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High/Low Sodium Diet

High/Low Sodium Diet Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of Th17 cells
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

Regulatory T cell function
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

Full Information

First Posted
October 31, 2014
Last Updated
April 16, 2021
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT02282878
Brief Title
The Effect of Dietary Salt Intake on Immune Function in Patients With Multiple Sclerosis
Official Title
The Effect of Dietary Salt Intake on Immune Function in Patients With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 19, 2018 (Actual)
Study Completion Date
December 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
High Sodium Diet, Low Sodium Diet, MS

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High/Low Sodium Diet
Arm Type
Experimental
Arm Description
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.
Arm Title
High/Low Sodium Diet Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
High/Low Sodium Diet
Intervention Description
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 Measure Information:
Title
Number of Th17 cells
Description
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
Time Frame
Change from baseline at 2 weeks
Secondary Outcome Measure Information:
Title
Regulatory T cell function
Description
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
Time Frame
Change from baseline at 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Hafler, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale MS Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

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

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