Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
NCT Number: NCT03649178
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.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Nashville, Tennessee, 37232, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will randomly eat a high salt diet for 8 weeks and a low salt diet for 8 weeks
Time frame: 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.
Time frame: 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
Time frame: Measured at beginning and end of each diet period at weeks 0,8 and 12, 20
Investigators will measure change in systolic blood pressure.
Vanderbilt University Medical Center
Other
Inflammatory and Vascular Response to Dietary Salt in Rheumatoid Arthritis
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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