NCT01846234

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

October 22, 2013

Status Verified

October 1, 2013

Enrollment Period

2.7 years

First QC Date

May 1, 2013

Last Update Submit

October 21, 2013

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisSalt

Outcome Measures

Primary Outcomes (1)

  • Exacerbation rate

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

    2 years

Secondary Outcomes (1)

  • Radiological activity

    One year

Study Arms (1)

MS patients

MS patients

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Patient who had hyponatremia in the last 90 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FLENI

Buenos Aires, 1428, Argentina

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, urine

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Mauricio F Farez, MD MPH

    Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate

Study Record Dates

First Submitted

May 1, 2013

First Posted

May 3, 2013

Study Start

November 1, 2010

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

October 22, 2013

Record last verified: 2013-10

Locations

AR(1)