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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL140145 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| salt | Other | Participants will randomly eat a high salt diet for 8 weeks and a low salt diet for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Tissue Sodium | Investigators will measure change in tissue (skin) sodium using 3.0 T MRI equipped with a 23Na coil. | 2 scans, one at end of week 8, and one at end of week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 at beginning and end of each diet period at weeks 0, 8, and 12, 20 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles M Stein, MBChB | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
all IDP that underlie results in a publication
starting 6 months after publication
IPD will be shared on request made to the PI. Criteria: Data is not to be shared. Data should only be used for biomedical research. Researchers requesting access will need appropriate IRB approval and sign a data use agreement.
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18 of screened participants were randomized. Of the 16 not randomized, 15 did not meet inclusion criteria and 1 declined to participate.
34 patients were screened for eligibility between January 2020 to June 2024 at Vanderbilt University Medical Center Rheumatology Clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | High Sodium Diet, Then Low Sodium Diet | Participants first received high-sodium diet (HSD, 200 mmol/24 hours) for 8 weeks in addition to their baseline DMARD therapy at unchanged doses. After a washout period of 4 weeks, they then received low-sodium diet (LSD, 50 mmol/24 hours) for 8 weeks. |
| FG001 | Low Sodium Diet, Then High Sodium Diet | Participants first received low-sodium diet (LSD, 50 mmol/24 hours) for 8 weeks in addition to their baseline DMARD therapy at unchanged doses. After a washout period of 4 weeks, they then received high-sodium diet (HSD, 200 mmol/24 hours) for 8 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
One participant randomized to sequence A was withdrawn prior to starting diet due to COVID restrictions which halted the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence A: High Sodium Diet, Then Low Sodium Diet | A high-sodium diet (200mmol/24hours) will be provided to participants for 8 weeks. Then participants will have a 4-week washout in which they eat their typical diet. Then a low sodium diet (50mmol/24hours) will be provided to participants for 8 weeks. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Tissue Sodium | Investigators will measure change in tissue (skin) sodium using 3.0 T MRI equipped with a 23Na coil. | Combined from Sequence A and B. | Posted | Mean | Standard Deviation | mmol/L | 2 scans, one at end of week 8, and one at end of week 20 |
|
20 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Sodium Diet | This will use data from Sequence A and B during high sodium diet. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscular pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
Enrollment was impeded by COVID19.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| C. Michael Stein MD | Vanderbilt University Medical Center | 615-936-3420 | michael.stein@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 30, 2023 | Aug 16, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 7, 2023 | Mar 31, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D012492 | Salts |
| ID | Term |
|---|---|
| D007287 | Inorganic Chemicals |
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This will be a random-order, 2 period crossover study with washout
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Participants and nutrition staff will know when participants are on a high salt or low salt diet. Outcomes Assessor will be kept blinded. Participants will be told not to inform outcomes assessor what diet they are on.
| Change in Blood Pressure | Investigators will measure change in systolic blood pressure. | Measured at beginning and end of each diet period at weeks 0,8 and 12, 20 |
| COVID regulation required halt in protocol |
|
| Sequence B: Low Sodium Diet, Then High Sodium Diet |
A low sodium diet (50mmol/24hours) will be provided to participants for 8 weeks. Then participants will have a 4-week washout in which they eat their typical diet. Then a high-sodium diet (200mmol/24hours) will be provided to participants for 8 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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 | Median | Inter-Quartile Range | units on a scale |
|
| Systolic blood pressure | Median | Inter-Quartile Range | mmHg |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | 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 | Combined from Sequence A and B. | Posted | Mean | Standard Deviation | units on a scale | Measured at beginning and end of each diet period at weeks 0, 8, and 12, 20 |
|
|
|
|
| Secondary | Change in Blood Pressure | Investigators will measure change in systolic blood pressure. | Combined from Sequence A and B. | Posted | Mean | Standard Deviation | mmHg | Measured at beginning and end of each diet period at weeks 0,8 and 12, 20 |
|
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 3 |
| 17 |
| EG001 | Low Sodium Diet | This will use data from Sequence A and B during low sodium diet. | 0 | 17 | 0 | 17 | 7 | 17 |
| RA flare | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Carpal tunnel syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Trochanteric bursitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Baker cyst rupture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Dental infection | Infections and infestations | Systematic Assessment |
|
| High blood pressure | Vascular disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |