Rheumatoid ArthritisNCT03649178
Dietary Salt in Rheumatoid Arthritis
A study testing salt in people with Rheumatoid Arthritis, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
In this study investigators propose to address the following hypotheses: 1) Reduction in dietary sodium will decrease inflammation in patients with rheumatoid arthritis (RA). 2) Reduction in dietary sodium will decrease blood pressure in patients with RA. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- salt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2020to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients older than 18 years who are willing to participate.
- Satisfy the ACR criteria for the diagnosis of RA.
- Have stable disease activity as evidenced by no clinically meaningful change in immunomodulating or corticosteroid therapy in the past 1 month.
- Have moderate disease activity as reflected by a minimum of 3 swollen and tender joints.
Who cannot join
- Pregnancy
- Receiving dialysis
- Organ or bone marrow transplant
- Taking diuretics, uncontrolled hypertension (>160/100 mmHg), or cardiac failure requiring treatment.
- Severe edema (as judged by the investigator)
- Diabetes mellitus treated with an insulin pump
Show all 11Show fewer
- Major surgery within the previous 3 months
- Severe co-morbid conditions such as active cancer likely to compromise study participation
- Unwillingness, or other inability, to cooperate
- Contraindication to MRI
- Presence of a condition that could make 24-hour blood pressure monitoring difficult: atrial fibrillation, inability to operate machine, receiving anticoagulants, presence of a condition that in the opinion of the investigator may be exacerbated by blood pressure cuff inflation (e.g., lymphedema).
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Inflammatory and Vascular Response to Dietary Salt in Rheumatoid Arthritis
In this study investigators propose to address the following hypotheses: 1) Reduction in dietary sodium will decrease inflammation in patients with rheumatoid arthritis (RA). 2) Reduction in dietary sodium will decrease blood pressure in patients with RA. 3) Reduction in dietary sodium will decrease tissue sodium in patients with RA.
Read the detailed description
The study is a random-order, 2 period crossover study with washout. Participants will be randomly assigned to be on the high-sodium diet (200mmol/24hours x 8weeks) or low-sodium diet (50mmol/24hours x 8 weeks ) with crossover separated by 4-week washout period. Investigators will allow a 7-day window on the diet (i.e., to facilitate scheduling the diet can be between 7-9 weeks), and investigators will allow a 1-week window for the washout (i.e., washout can be 3-5 weeks).
Investigators will measure changes in inflammation (as measured by DAS28 (using tender and swollen joint count, disease activity and sedimentation rate)), blood pressure measured over a 24 hour period, and tissue sodium (using Magnetic Resonance Imaging (MRI)).
If a relatively simple dietary modification has a clinically important effect on inflammation and blood pressure regulation in vivo in patients with RA, this will have far-reaching implications for the treatment of RA and prevention of Cardiovascular disease in this population.
- Conditions
- Rheumatoid Arthritis
- Being tested
- salt
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
saltOther
Participants will randomly eat a high salt diet for 8 weeks and a low salt diet for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| low salt diet | Other | low-sodium diet (50mmol/24hours x 8 weeks ) Subjects will choose a rotation of low-sodium meals from a predetermined list from a commercial vendor (Mom's Meals) that will be used to provide 2 meals (lunch and dinner)/day that the vendor will deliver at approximately 7 day intervals. Staff of the Vanderbilt Diet,Body Composition, and Human Metabolism Core determine breakfast and snacks appropriate for theHS andLS diets and provide instructions to subjects. Receives: Other: salt |
| high salt diet | Other | high-sodium diet (200mmol/24hours x 8weeks) Subjects will choose a rotation of low-sodium meals from a predetermined list from a commercial vendor (Mom's Meals) that will be used to provide 2 meals (lunch and dinner)/day that the vendor will deliver at approximately 7 day intervals. Staff of the Vanderbilt Diet,Body Composition, and Human Metabolism Core determine breakfast and snacks appropriate for theHS andLS diets and provide instructions to subjects. Receives: Other: salt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tissue Sodium
Investigators will measure change in tissue (skin) sodium using 3.0 T MRI equipped with a 23Na coil.
Measured: 2 scans, one at end of week 8, and one at end of week 20
Secondary outcomes (2)
Change in DAS28-CRP
DAS28-CRP score is a disease activity score based on 28 joints and C-reactive protein. Lower is better. Range= 0.96 units to 10.
DAS28-CRP = 0.56 x sqrt(tender joint count) + 0.28 x sqrt(swollen joint count) + 0.36 x ln(C-reactive protein + 1) + 0.014 x global health score + 0.96
Measured: Measured at beginning and end of each diet period at weeks 0, 8, and 12, 20
Change in Blood Pressure
Investigators will measure change in systolic blood pressure.
Measured: Measured at beginning and end of each diet period at weeks 0,8 and 12, 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start2 Jan 2020
- Primary completion30 Sep 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Randomised
- Intervention model
- Crossover
- Model description
- This will be a random-order, 2 period crossover study with washout
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, C. Michael Stein, Vanderbilt University Medical Center
- Investigators
- Charles M Stein, MBChB, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03649178
- Sponsor's protocol ID
- 141610
- Other IDs
- R01HL140145
- Status last verified
- Jul 2026
- First submitted
- 23 Aug 2018
- Last updated
- 30 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IDP that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory and Vascular Response to Dietary Salt in Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT03649178
- Acronym / sponsor ID
- 141610
- Conditions
- Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 28 Aug 2018 (actual)
- Results
- Posted 24 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study investigators propose to address the following hypotheses: 1) Reduction in dietary sodium will decrease inflammation in patients with rheumatoid arthritis (RA). 2) Reduction in dietary sodium will decrease blood pressure in patients with RA. 3) Reduction in dietary sodium will decrease tissue sodium in patients with RA.
Detailed description
The study is a random-order, 2 period crossover study with washout. Participants will be randomly assigned to be on the high-sodium diet (200mmol/24hours x 8weeks) or low-sodium diet (50mmol/24hours x 8 weeks ) with crossover separated by 4-week washout period. Investigators will allow a 7-day window on the diet (i.e., to facilitate scheduling the diet can be between 7-9 weeks), and investigators will allow a 1-week window for the washout (i.e., washout can be 3-5 weeks).
Investigators will measure changes in inflammation (as measured by DAS28 (using tender and swollen joint count, disease activity and sedimentation rate)), blood pressure measured over a 24 hour period, and tissue sodium (using Magnetic Resonance Imaging (MRI)).
If a relatively simple dietary modification has a clinically important effect on inflammation and blood pressure regulation in vivo in patients with RA, this will have far-reaching implications for the treatment of RA and prevention of Cardiovascular disease in this population.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This will be a random-order, 2 period crossover study with washout
| Arm | Type | Receives |
|---|---|---|
| low salt diet | Other | Other: saltlow-sodium diet (50mmol/24hours x 8 weeks ) Subjects will choose a rotation of low-sodium meals from a predetermined list from a commercial vendor (Mom's Meals) that will be used to provide 2 meals (lunch and dinner)/day that the vendor will deliver at approximately 7 day intervals. Staff of the Vanderbilt Diet,Body Composition, and Human Metabolism Core determine breakfast and snacks appropriate for theHS andLS diets and provide instructions to subjects. |
| high salt diet | Other | Other: salthigh-sodium diet (200mmol/24hours x 8weeks) Subjects will choose a rotation of low-sodium meals from a predetermined list from a commercial vendor (Mom's Meals) that will be used to provide 2 meals (lunch and dinner)/day that the vendor will deliver at approximately 7 day intervals. Staff of the Vanderbilt Diet,Body Composition, and Human Metabolism Core determine breakfast and snacks appropriate for theHS andLS diets and provide instructions to subjects. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients older than 18 years who are willing to participate.
- Satisfy the ACR criteria for the diagnosis of RA.
- Have stable disease activity as evidenced by no clinically meaningful change in immunomodulating or corticosteroid therapy in the past 1 month.
- Have moderate disease activity as reflected by a minimum of 3 swollen and tender joints.
Key exclusion criteria (11 listed)
- Pregnancy
- Receiving dialysis
- Organ or bone marrow transplant
- Taking diuretics, uncontrolled hypertension (>160/100 mmHg), or cardiac failure requiring treatment.
- Severe edema (as judged by the investigator)
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 |
|---|---|---|
| saltParticipants will randomly eat a high salt diet for 8 weeks and a low salt diet for 8 weeks | Other | high salt diet, low salt diet |
Primary outcome
Change in Tissue Sodium
Time frame: 2 scans, one at end of week 8, and one at end of week 20
Investigators will measure change in tissue (skin) sodium using 3.0 T MRI equipped with a 23Na coil.
2 secondary outcomes
Change in DAS28-CRP
Time frame: Measured at beginning and end of each diet period at weeks 0, 8, and 12, 20
Change in Blood Pressure
Time frame: Measured at beginning and end of each diet period at weeks 0,8 and 12, 20
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. all IDP that underlie results in a publication
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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.
Charles M Stein, MBChB principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing salt in people with Rheumatoid Arthritis, run by Vanderbilt University Medical Center 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 11 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 30 Jul 2026. 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?
Yes. Results are posted in the registry (first posted 24 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Tissue Sodium (time frame: 2 scans, one at end of week 8, and one at end of week 20). 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 30 Jul 2026.