Trial results for the study "Dietary Salt in Rheumatoid Arthritis" were posted on ClinicalTrials.gov on 2025-10-24. The study found that a low sodium diet significantly reduced blood pressure in patients with rheumatoid arthritis, with a p-value of 0.02 for the change in blood pressure.
Background
Rheumatoid Arthritis (RA) is a chronic autoimmune disease characterized by inflammation of the joints, leading to pain, swelling, and potential joint damage. Managing inflammation is a primary goal of RA treatment. This study investigated whether dietary sodium reduction could impact inflammation, blood pressure, and tissue sodium levels in RA patients, addressing potential non-pharmacological approaches to disease management and associated comorbidities.
Trial design
This completed study, designated as Phase NA, enrolled 18 participants with Rheumatoid Arthritis. The trial aimed to address three hypotheses: 1) Reduction in dietary sodium would decrease inflammation in patients with RA, 2) Reduction in dietary sodium would decrease blood pressure in patients with RA, and 3) Reduction in dietary sodium would decrease tissue sodium in patients with RA. The study compared the effects of a high sodium diet versus a low sodium diet on these parameters.
Key results
The study reported several key measurements and analyses:
- Change in Tissue Sodium:
- For the High Sodium Diet group, the mean change was 17.1 mmol/L (Standard Deviation 5.1).
- For the Low Sodium Diet group, the mean change was 16.7 mmol/L (Standard Deviation 8.2).
A Mixed Models Analysis for tissue sodium change reported a p-value of 0.55.
- Change in DAS28-CRP (a measure of inflammation):
- In the High Sodium Diet group, the mean DAS28-CRP was 4.50 (Standard Deviation 0.65) at baseline and 4.47 (Standard Deviation 0.91) after 8 weeks.
- In the Low Sodium Diet group, the mean DAS28-CRP was 4.70 (Standard Deviation 1.21) at baseline and 4.21 (Standard Deviation 1.23) after 8 weeks.
A Mixed Models Analysis for DAS28-CRP change reported a p-value of 0.76.
- Change in Blood Pressure:
- For the High Sodium Diet group, the mean blood pressure was 125 mmHg (Standard Deviation 10) at baseline and 122 mmHg (Standard Deviation 10) after 8 weeks.
- For the Low Sodium Diet group, the mean blood pressure was 124 mmHg (Standard Deviation 14) at baseline and 114 mmHg (Standard Deviation 11) after 8 weeks.
A Mixed Models Analysis for blood pressure change reported a p-value of 0.02.
What this means
The results indicate that a reduction in dietary sodium significantly decreased blood pressure in patients with rheumatoid arthritis, as evidenced by a p-value of 0.02. This suggests that dietary modifications could be a valuable non-pharmacological strategy for managing blood pressure in this patient population. However, the study did not find a statistically significant impact of dietary sodium reduction on tissue sodium levels (p-value 0.55) or inflammation as measured by DAS28-CRP (p-value 0.76). Therefore, while a low sodium diet may offer cardiovascular benefits for RA patients, its direct effect on RA disease activity or tissue sodium was not demonstrated in this study.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03649178, titled "Dietary Salt in Rheumatoid Arthritis", were posted on 2025-10-24 on clinicaltrials.gov.