Trial Outcomes & Findings for Dietary Salt in Rheumatoid Arthritis (NCT NCT03649178)
NCT ID: NCT03649178
Last Updated: 2026-07-30
Results Overview
Investigators will measure change in tissue (skin) sodium using 3.0 T MRI equipped with a 23Na coil.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
2 scans, one at end of week 8, and one at end of week 20
Results posted on
2026-07-30
Participant Flow
34 patients were screened for eligibility between January 2020 to June 2024 at Vanderbilt University Medical Center Rheumatology Clinic.
18 of screened participants were randomized. Of the 16 not randomized, 15 did not meet inclusion criteria and 1 declined to participate.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
8
|
|
Overall Study
End of First Diet
|
9
|
7
|
|
Overall Study
Beginning of Second Diet
|
8
|
5
|
|
Overall Study
COMPLETED
|
8
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
COVID regulation required halt in protocol
|
1
|
0
|
Baseline Characteristics
Dietary Salt in Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Sequence A: High Sodium Diet, Then Low Sodium Diet
n=9 Participants
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.
|
Sequence B: Low Sodium Diet, Then High Sodium Diet
n=8 Participants
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.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55 years
n=20 Participants
|
54 years
n=20 Participants
|
55 years
n=40 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
16 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
14 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=20 Participants
|
8 participants
n=20 Participants
|
17 participants
n=40 Participants
|
|
DAS28-CRP
|
4.56 units on a scale
n=20 Participants
|
4.67 units on a scale
n=20 Participants
|
4.56 units on a scale
n=40 Participants
|
|
Systolic blood pressure
|
129 mmHg
n=20 Participants
|
118 mmHg
n=20 Participants
|
126 mmHg
n=40 Participants
|
PRIMARY outcome
Timeframe: 2 scans, one at end of week 8, and one at end of week 20Population: Combined from Sequence A and B.
Investigators will measure change in tissue (skin) sodium using 3.0 T MRI equipped with a 23Na coil.
Outcome measures
| Measure |
High Sodium Diet
n=17 Participants
This will use data from Sequence A and B after 8 weeks of high sodium (week 8 or 20 depending on sequence).
|
Low Sodium Diet
n=17 Participants
This will use data from Sequence A and B after 8 weeks of low sodium diet (week 8 or 20 depending on sequence).
|
Low Sodium Diet Baseline
This will use data from Sequence A and B prior to starting low salt diet (week 0 or 12 depending on sequence).
|
Low Sodium Diet After 8 Weeks
This will use data from Sequence A and B after 8 weeks of low salt diet (week 8 or 20 depending on sequence).
|
|---|---|---|---|---|
|
Change in Tissue Sodium
|
17.1 mmol/L
Standard Deviation 5.1
|
16.7 mmol/L
Standard Deviation 8.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at beginning and end of each diet period at weeks 0, 8, and 12, 20Population: Combined from Sequence A and B.
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
Outcome measures
| Measure |
High Sodium Diet
n=17 Participants
This will use data from Sequence A and B after 8 weeks of high sodium (week 8 or 20 depending on sequence).
|
Low Sodium Diet
n=17 Participants
This will use data from Sequence A and B after 8 weeks of low sodium diet (week 8 or 20 depending on sequence).
|
Low Sodium Diet Baseline
n=17 Participants
This will use data from Sequence A and B prior to starting low salt diet (week 0 or 12 depending on sequence).
|
Low Sodium Diet After 8 Weeks
n=17 Participants
This will use data from Sequence A and B after 8 weeks of low salt diet (week 8 or 20 depending on sequence).
|
|---|---|---|---|---|
|
Change in DAS28-CRP
|
4.50 units on a scale
Standard Deviation 0.65
|
4.47 units on a scale
Standard Deviation 0.91
|
4.70 units on a scale
Standard Deviation 1.21
|
4.21 units on a scale
Standard Deviation 1.23
|
SECONDARY outcome
Timeframe: Measured at beginning and end of each diet period at weeks 0,8 and 12, 20Population: Combined from Sequence A and B.
Investigators will measure change in systolic blood pressure.
Outcome measures
| Measure |
High Sodium Diet
n=17 Participants
This will use data from Sequence A and B after 8 weeks of high sodium (week 8 or 20 depending on sequence).
|
Low Sodium Diet
n=17 Participants
This will use data from Sequence A and B after 8 weeks of low sodium diet (week 8 or 20 depending on sequence).
|
Low Sodium Diet Baseline
n=17 Participants
This will use data from Sequence A and B prior to starting low salt diet (week 0 or 12 depending on sequence).
|
Low Sodium Diet After 8 Weeks
n=17 Participants
This will use data from Sequence A and B after 8 weeks of low salt diet (week 8 or 20 depending on sequence).
|
|---|---|---|---|---|
|
Change in Blood Pressure
|
125 mmHg
Standard Deviation 10
|
122 mmHg
Standard Deviation 10
|
124 mmHg
Standard Deviation 14
|
114 mmHg
Standard Deviation 11
|
Adverse Events
High Sodium Diet
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Low Sodium Diet
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
High Sodium Diet
n=17 participants at risk
This will use data from Sequence A and B during high sodium diet.
|
Low Sodium Diet
n=17 participants at risk
This will use data from Sequence A and B during low sodium diet.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscular pain
|
5.9%
1/17 • Number of events 1 • 20 weeks
|
11.8%
2/17 • Number of events 2 • 20 weeks
|
|
Musculoskeletal and connective tissue disorders
RA flare
|
5.9%
1/17 • Number of events 1 • 20 weeks
|
5.9%
1/17 • Number of events 1 • 20 weeks
|
|
Musculoskeletal and connective tissue disorders
Carpal tunnel syndrome
|
0.00%
0/17 • 20 weeks
|
5.9%
1/17 • Number of events 1 • 20 weeks
|
|
Musculoskeletal and connective tissue disorders
Trochanteric bursitis
|
0.00%
0/17 • 20 weeks
|
5.9%
1/17 • Number of events 1 • 20 weeks
|
|
Musculoskeletal and connective tissue disorders
Baker cyst rupture
|
0.00%
0/17 • 20 weeks
|
5.9%
1/17 • Number of events 1 • 20 weeks
|
|
Infections and infestations
Respiratory tract infection
|
5.9%
1/17 • Number of events 1 • 20 weeks
|
5.9%
1/17 • Number of events 1 • 20 weeks
|
|
Infections and infestations
Dental infection
|
5.9%
1/17 • Number of events 1 • 20 weeks
|
0.00%
0/17 • 20 weeks
|
|
Vascular disorders
High blood pressure
|
0.00%
0/17 • 20 weeks
|
5.9%
1/17 • Number of events 1 • 20 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/17 • 20 weeks
|
5.9%
1/17 • Number of events 1 • 20 weeks
|
Additional Information
C. Michael Stein MD
Vanderbilt University Medical Center
Phone: 615-936-3420
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place