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

Description

The purpose of this work is to investigate the influence of dietary salt intake on immune function in newly diagnosed, untreated 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.

Study Start Date

September 2014

Estimated Completion Date

January 2017

Interventions

  • Dietary Supplement: Low Sodium Diet
  • Dietary Supplement: High/Low Sodium Diet
  • Dietary Supplement: High Sodium Diet

Specialties

  • Nursing: Neurology
  • Neurology: Demyelinating Disorders
  • Family Medicine: Preventive/Nutrition
  • Physician Assistant: Neurology

MeSH Terms

  • High Sodium Diet
  • Multiple Sclerosis
  • Sclerosis

Study ID

Yale University -- 1406014201

Status

Unknown

Trial ID

NCT02282878

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

25

Sponsor

Yale University

Inclusion Criteria

  • Male or Female adult subjects
  • Ages 18-60, inclusive
  • New diagnosis (<1year) 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-angiotensis-aldosterone system)

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Yale MS Center - New Haven, Connecticut 17.3 miles Joan Nye BS 203-737-7095 joan.nye@yale.edu

ClinicalTrialsLocator.com provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from ClinicalTrials.gov. This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.