Multiple SclerosisNCT02282878
The Effect of Dietary Salt Intake on Immune Function in Patients With Multiple Sclerosis
A study testing High/Low Sodium Diet in people with Multiple Sclerosis, run by Yale University at 1 site in United States.
Trial summary
The purpose of this work is to investigate the influence of dietary salt intake on immune function in multiple sclerosis (MS) subjects and healthy controls. This study primarily tests the hypothesis that higher dietary salt intake will be associated with a higher frequency of pathogenic Th17 cells and impaired… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- High/Low Sodium Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to 8 Dec 2019
- Phase
- Interventional
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or Female adult subjects
- Ages 18-60, inclusive
- diagnosis of CIS or MS by 2010 McDonald Criteria (in the case of MS subjects)
- Naive to FDA- approved MS therapies such as glatiramer acetate, interferon-beta, natalizumab, fingolimod, tecfidera, or teriflunomide
Who cannot join
- Secondary or primary progressive MS
- Prior exposure to FDA-approved MS therapies or chemotherapies of any kind
- Known history of autoimmune disease besides MS
- Known history of renal disease, hypertension or congestive heart failure
- Currently taking medications that could affect urine sodium excretion (e.g. diuretics or others that act on the renin-angiotensins-aldosterone system)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this work is to investigate the influence of dietary salt intake on immune function in multiple sclerosis (MS) subjects and healthy controls. This study primarily tests the hypothesis that higher dietary salt intake will be associated with a higher frequency of pathogenic Th17 cells and impaired function of protective regulatory T cells. If a relationship between dietary salt intake and immune function is observed, this study will also test: a) whether this relationship is unique to MS subjects or whether it is also present in healthy controls, and b) whether healthier immune function can be restored by restricting dietary salt intake.
Read the detailed description
The purpose of this work is to investigate the influence of dietary salt intake on immune function in MS subjects and healthy controls. This study primarily tests the hypothesis that higher dietary salt intake will be associated with a higher frequency of pathogenic Th17 cells and impaired function of protective regulatory T cells. If a relationship between dietary salt intake and immune function is observed, this study will also test: a) whether this relationship is unique to MS subjects or whether it is also present in healthy controls, and b) whether healthier immune function can be restored by restricting dietary salt intake. This is a 5-week pilot study of a dietary intervention of 25 subjects with MS or Clinically Isolated Syndrome (CIS) by 2010 Diagnostic Criteria who will be identified and recruited from the Yale MS Center and/or referred from outside MS centers. 25 age-matched healthy controls will be recruited from friends, family members, spouses and the patient waiting room at the Yale MS Center.
- Conditions
- Multiple Sclerosis
- Being tested
- High/Low Sodium Diet
- Keywords
- High Sodium Diet, Low Sodium Diet, MS
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High/Low Sodium DietDietary supplement
All patients will receive 2 weeks of the high sodium diet followed by a 1 week washout and then 2 weeks of the low sodium diet
| Study group | Role | What they receive |
|---|---|---|
| High/Low Sodium Diet | Experimental | All MS patients will receive 2 weeks of controlled high sodium diet followed by a 1 week washout and 2 weeks of low sodium diet. Receives: Dietary Supplement: High/Low Sodium Diet |
| High/Low Sodium Diet Control | Active comparator | Age matched controls will receive two weeks of controlled high sodium diet followed by a 1 week washout and 2 weeks of low sodium diet. Receives: Dietary Supplement: High/Low Sodium Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Th17 cells
Frequency of Th17 cells will be measured by flow cytometry through blood samples taken before and after each of the two week low sodium and high sodium diets
Measured: Change from baseline at 2 weeks
Secondary outcomes (1)
Regulatory T cell function
Frequency of regulatory T cells as measured by flow cytometry through blood samples taken before and after each of the two week low sodium and high sodium diets
Measured: Change from baseline at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study startSep 2014
- Primary completion19 Dec 2018
- Study completion8 Dec 2019
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.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Hafler, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02282878
- Sponsor's protocol ID
- 1406014201
- Status last verified
- Apr 2021
- First submitted
- 31 Oct 2014
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dietary Salt Intake on Immune Function in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02282878
- Acronym / sponsor ID
- 1406014201
- Conditions
- Multiple Sclerosis
- Keywords
- High Sodium Diet, Low Sodium Diet, MS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- 19 Dec 2018 (actual)
- Study completion
- 8 Dec 2019 (actual)
- First posted
- 5 Nov 2014 (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.
The purpose of this work is to investigate the influence of dietary salt intake on immune function in multiple sclerosis (MS) subjects and healthy controls. This study primarily tests the hypothesis that higher dietary salt intake will be associated with a higher frequency of pathogenic Th17 cells and impaired function of protective regulatory T cells. If a relationship between dietary salt intake and immune function is observed, this study will also test: a) whether this relationship is unique to MS subjects or whether it is also present in healthy controls, and b) whether healthier immune function can be restored by restricting dietary salt intake.
Detailed description
The purpose of this work is to investigate the influence of dietary salt intake on immune function in MS subjects and healthy controls. This study primarily tests the hypothesis that higher dietary salt intake will be associated with a higher frequency of pathogenic Th17 cells and impaired function of protective regulatory T cells. If a relationship between dietary salt intake and immune function is observed, this study will also test: a) whether this relationship is unique to MS subjects or whether it is also present in healthy controls, and b) whether healthier immune function can be restored by restricting dietary salt intake. This is a 5-week pilot study of a dietary intervention of 25 subjects with MS or Clinically Isolated Syndrome (CIS) by 2010 Diagnostic Criteria who will be identified and recruited from the Yale MS Center and/or referred from outside MS centers. 25 age-matched healthy controls will be recruited from friends, family members, spouses and the patient waiting room at the Yale MS Center.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High/Low Sodium Diet | Experimental | Dietary Supplement: High/Low Sodium DietAll MS patients will receive 2 weeks of controlled high sodium diet followed by a 1 week washout and 2 weeks of low sodium diet. |
| High/Low Sodium Diet Control | Active comparator | Dietary Supplement: High/Low Sodium DietAge matched controls will receive two weeks of controlled high sodium diet followed by a 1 week washout and 2 weeks of low sodium diet. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or Female adult subjects
- Ages 18-60, inclusive
- diagnosis of CIS or MS by 2010 McDonald Criteria (in the case of MS subjects)
- Naive to FDA- approved MS therapies such as glatiramer acetate, interferon-beta, natalizumab, fingolimod, tecfidera, or teriflunomide
Key exclusion criteria (5 listed)
- Secondary or primary progressive MS
- Prior exposure to FDA-approved MS therapies or chemotherapies of any kind
- Known history of autoimmune disease besides MS
- Known history of renal disease, hypertension or congestive heart failure
- Currently taking medications that could affect urine sodium excretion (e.g. diuretics or others that act on the renin-angiotensins-aldosterone system)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High/Low Sodium DietAll patients will receive 2 weeks of the high sodium diet followed by a 1 week washout and then 2 weeks of the low sodium diet | Dietary supplement | High/Low Sodium Diet, High/Low Sodium Diet Control |
Primary outcome
Number of Th17 cells
Time frame: Change from baseline at 2 weeks
Frequency of Th17 cells will be measured by flow cytometry through blood samples taken before and after each of the two week low sodium and high sodium diets
1 secondary outcome
Regulatory T cell function
Time frame: Change from baseline at 2 weeks
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 19 Apr 2021.
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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.
David Hafler, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High/Low Sodium Diet in people with Multiple Sclerosis, run by Yale University at 1 site in United States.
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 4 inclusion and 5 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 19 Apr 2021. 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 United States. 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?
Number of Th17 cells (time frame: Change from baseline at 2 weeks). 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 19 Apr 2021.