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Completed

NCT Number: NCT03649178

Dietary Salt in Rheumatoid Arthritis

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

salt

Other

Participants will randomly eat a high salt diet for 8 weeks and a low salt diet for 8 weeks

Primary outcomes

  1. Change in Tissue Sodium

    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.

Secondary outcomes

  1. Change in DAS28-CRP

    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

  2. Change in Blood Pressure

    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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)

Registry information

Official study title

Inflammatory and Vascular Response to Dietary Salt in Rheumatoid Arthritis

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Aug 28, 2018
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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