CClinicalTrials.gg
CompletedNCT01846234SALTUpdated Oct 22, 2013

Sodium Intake in Multiple Sclerosis

An observational study in Multiple Sclerosis, sponsored by Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia. Completed at 1 site in Argentina. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2013-10-22.

Sponsored by Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
132
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Multiple Sclerosis

Keywords

  • Multiple Sclerosis
  • Salt
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 132 is above the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patient who had hyponatremia in the last 90 days
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
132 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • MS patients

    MS patients

06

What researchers measure

Primary outcomes

  1. Exacerbation rate

    Number of disease relapses during follow up time according to salt consumption

    Time frame: 2 years

Secondary outcomes

  1. Radiological activity

    Number of new lesions in MRI

    Time frame: One year

07

Study locations

1 site
  • FLENI
    Buenos Aires, 1428, Argentina
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01846234
Lead sponsor
Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia
Responsible party
Mauricio F. Farez (Research Associate, Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia) — Principal investigator
First posted
May 3, 2013
Start date
Nov 2010
Primary completion
Jul 2013
Completion
Jul 2013
Last update
Oct 22, 2013

Study contacts

Mauricio F Farez, MD MPH
principal investigator · Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion