Multiple SclerosisSALTNCT01846234
Sodium Intake in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia at 1 site in Argentina.
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). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 132 participants
- Where
- 1 siteArgentina
- Study dates
- Nov 2010to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- 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.
Who may be able to join
- Subject is between 18 and 50 years old
- Subject has diagnosis of relapsing-remitting MS according to McDonald criteria (2010)
Who cannot join
- Patient who had hyponatremia in the last 90 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Salt
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MS patients | MS patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exacerbation rate
Number of disease relapses during follow up time according to salt consumption
Measured: 2 years
Secondary outcomes (1)
Radiological activity
Number of new lesions in MRI
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startNov 2010
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauricio F. Farez, Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia
- Investigators
- Mauricio F Farez, MD MPH, Principal investigator, Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01846234
- Sponsor's protocol ID
- Salt
- Other IDs
- Salt-1
- Acronym
- SALT
- Status last verified
- Oct 2013
- First submitted
- 1 May 2013
- Last updated
- 22 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sodium Intake in Multiple Sclerosis Disease Activity
- ClinicalTrials.gov ID
- NCT01846234
- Acronym / sponsor ID
- SALT / Salt
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Salt
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Fundación para la Lucha contra las Enfermedades Neurológicas de la InfanciaUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 3 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MS patients | – | –MS patients |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- Subject is between 18 and 50 years old
- Subject has diagnosis of relapsing-remitting MS according to McDonald criteria (2010)
Key exclusion criteria (1 listed)
- Patient who had hyponatremia in the last 90 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Exacerbation rate
Time frame: 2 years
Number of disease relapses during follow up time according to salt consumption
1 secondary outcome
Radiological activity
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mauricio F Farez, MD MPH principal investigator
Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exacerbation rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2013.