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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02282878
• Other study ID #: 1406014201
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: December 8, 2019

Study information

• Verified date: April 2021
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 8, 2019
• Est. primary completion date: December 19, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
United States	Yale MS Center	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Change from baseline at 2 weeks