Sodium Intake in Multiple Sclerosis | NCT01846234

Studies
Sodium Intake in Multiple Sclerosis

NCT01846234

Sponsor

Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia

Status

Completed

Last Update Posted

Oct 22, 2013Estimated

Enrollment

132Actual

Phase

Not provided

Conditions

Multiple Sclerosis

Interventions

Not provided

Countries

Argentina

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Salt-1	Other Grant/Funding Number	FLENI

Status Module

Record Verification Date

Oct 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Jul 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

May 1, 2013

First Submission Date that Met QC Criteria

May 1, 2013

First Posted Date

May 3, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 21, 2013

Last Update Posted Date

Oct 22, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mauricio F. Farez, Research Associate, Fundación para la Lucha contra las Enfermedades Neurológicas de la InfanciaPrincipal Investigator

Lead Sponsor

Fundación para la Lucha contra las Enfermedades Neurológicas de la InfanciaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

132Actual

Label	Type	Description	Intervention Names
MS patients		MS patients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mauricio F Farez, MD MPH	Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
FLENI		Buenos Aires		1428	Argentina

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided