NCT03649178

Dietary Salt in Rheumatoid Arthritis

Completed NA Results posted Last updated 24 October 2025

What this trial tests

NA trial testing salt in Rheumatoid Arthritis in 18 participants. Completed in 30 December 2024.

Timeline

2 January 2020

Primary endpoint
30 September 2024

30 December 2024

Quick facts

Lead sponsor	Vanderbilt University Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	other
Enrollment	18
Start date	2 January 2020
Primary completion	30 September 2024
Estimated completion	30 December 2024
Sites	1 location across United States

Drugs / interventions tested

• salt

Conditions studied

• Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →

Sponsor

Vanderbilt University Medical Center

Who can join

Adults 18 to 80, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Tissue Sodium Primary · 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.

Group	Value	95% CI
High Sodium Diet	17.1	± 5.1
Low Sodium Diet	16.7	± 8.2

Change in DAS28-CRP Secondary · Measured at beginning and end of each diet period at weeks 0, 8, and 12, 20

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

Group	Value	95% CI
High Sodium Diet Baseline	4.50	± 0.65
High Sodium Diet After 8 Weeks	4.47	± 0.91
Low Sodium Diet Baseline	4.70	± 1.21
Low Sodium Diet After 8 Weeks	4.21	± 1.23

Change in Blood Pressure Secondary · Measured at beginning and end of each diet period at weeks 0,8 and 12, 20

Investigators will measure change in systolic blood pressure.

Group	Value	95% CI
High Sodium Diet Baseline	125	± 10
High Sodium Diet After 8 Weeks	122	± 10
Low Sodium Diet Baseline	124	± 14
Low Sodium Diet After 8 Weeks	114	± 11

Adverse events — posted to ClinicalTrials.gov

Time frame: 20 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

High Sodium Diet

Serious: 0/17 (0%)

Deaths: 0/17

Low Sodium Diet

Serious: 0/17 (0%)

Deaths: 0/17

Other adverse events (9 terms — click to expand)

Reaction	System	High Sodium Diet	Low Sodium Diet
Muscular pain	Musculoskeletal and connective tissue disorders	—	—
RA flare	Musculoskeletal and connective tissue disorders	—	—
Carpal tunnel syndrome	Musculoskeletal and connective tissue disorders	—	—
Trochanteric bursitis	Musculoskeletal and connective tissue disorders	—	—
Baker cyst rupture	Musculoskeletal and connective tissue disorders	—	—
Respiratory tract infection	Infections and infestations	—	—
Dental infection	Infections and infestations	—	—
High blood pressure	Vascular disorders	—	—
Dizziness	Nervous system disorders	—	—

Data from ClinicalTrials.gov NCT03649178 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.