N/A
N=18
Dietary Salt in Rheumatoid Arthritis
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT03649178 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Change in Tissue Sodium — 17.1; 16.7 mmol/L — p=0.55
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- salt (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Tissue Sodium |
17.1; 16.7 | 0.55 |
| SECONDARY Change in DAS28-CRP |
4.50; 4.47; 4.70; 4.21 | 0.76 |
| SECONDARY Change in Blood Pressure |
125; 122; 124; 114 | 0.02 sig |
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. 3) Reduction in dietary sodium will decrease tissue sodium in patients with RA.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
- 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).
Data sourced from ClinicalTrials.gov (NCT03649178). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.