Sodium Intake in Multiple Sclerosis (SALT)

October 21, 2013 updated by: Mauricio F. Farez, Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia

Effect of Sodium Intake in Multiple Sclerosis Disease Activity

Recently, it has been shown that salt (ClNa, sodium chloride) can modulate the differentiation of human and mouse TH17 cells. Indeed, mice feed with high sodium diet were described to develop more aggressive course of EAE (Experimental Autoimmune Encephalitis).

However, the role of sodium intake in MS has not been investigated. In this study we investigate the effect of sodium intake in Multiple Sclerosis (MS) clinical and radiological activity.

Study Overview

Status

Completed

Conditions

Multiple Sclerosis

Study Type

Observational

Enrollment (Actual)

132

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina, 1428
    - Fleni

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A total of 70 patients with relapsing-remitting MS according to McDonald criteria1 were recruited from the MS clinic at FLENI by attending neurologists. A second group of 52 relapsing-remitting MS patients was recluted later.

Description

Inclusion Criteria:

Subject is between 18 and 50 years old
Subject has diagnosis of relapsing-remitting MS according to McDonald criteria (2010)

Exclusion Criteria:

Patient who had hyponatremia in the last 90 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
MS patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exacerbation rate Time Frame: 2 years	Number of disease relapses during follow up time according to salt consumption	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiological activity Time Frame: One year	Number of new lesions in MRI	One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia

Investigators

Principal Investigator: Mauricio F Farez, MD MPH, Fundación para la lucha contra las enfermedades neurológicas de la infancia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

May 1, 2013

First Submitted That Met QC Criteria