Dietary Salt in Rheumatoid Arthritis
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Rheumatoid Arthritis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: This will be a random-order, 2 period crossover study with washoutMasking: Double (Investigator, Outcomes Assessor)Masking Description: Participants and nutrition staff will know when participants are on a high salt or low salt diet. Outcomes Assessor will be kept blinded. Participants will be told not to inform outcomes assessor what diet they are on.Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
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 windo...
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.
Tracking Information
- NCT #
- NCT03649178
- Collaborators
- National Institutes of Health (NIH)
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Principal Investigator: Charles M Stein, MBChB Vanderbilt University Medical Center
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