Trials / Completed
CompletedNCT03649178
Dietary Salt in Rheumatoid Arthritis
Inflammatory and Vascular Response to Dietary Salt in Rheumatoid Arthritis
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Vanderbilt University Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | salt | Participants will randomly eat a high salt diet for 8 weeks and a low salt diet for 8 weeks |
Timeline
- Start date
- 2020-01-02
- Primary completion
- 2024-09-30
- Completion
- 2024-12-30
- First posted
- 2018-08-28
- Last updated
- 2025-10-24
- Results posted
- 2025-10-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03649178. Inclusion in this directory is not an endorsement.