Sodium Intake in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— SALT  

Official title:

Effect of Sodium Intake in Multiple Sclerosis Disease Activity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01846234
• Other study ID #: Salt
• Secondary ID: Salt-1
• Status: Completed
• Phase: N/A
• First received: May 1, 2013
• Last updated: October 21, 2013
• Start date: November 2010
• Est. completion date: July 2013

Study information

• Verified date: October 2013
• Source: Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
Argentina	FLENI	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exacerbation rate	Number of disease relapses during follow up time according to salt consumption	2 years	No
Secondary	Radiological activity	Number of new lesions in MRI	One year	No