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

NCT02282878 | Completed

• 1 other identifier: 1406014201
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

High Sodium Diet; Low Sodium Diet; MS

Outcome Measures

Primary Outcomes (1)

• 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

  Change from baseline at 2 weeks

Secondary Outcomes (1)

• Regulatory T cell function

  Change from baseline at 2 weeks

Study Arms (2)

High/Low Sodium Diet

EXPERIMENTAL

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

High/Low Sodium Diet Control

ACTIVE COMPARATOR

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

Interventions

High/Low Sodium Diet DIETARY_SUPPLEMENT

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

High/Low Sodium Diet; High/Low Sodium Diet Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale MS Center

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• David Hafler, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2014
• First Posted: November 5, 2014
• Study Start: September 1, 2014
• Primary Completion: December 19, 2018
• Study Completion: December 8, 2019
• Last Updated: April 19, 2021

Record last verified: 2021-04

Locations

US (1)