Dietary Salt in Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Inflammatory and Vascular Response to Dietary Salt in Rheumatoid Arthritis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03649178
• Other study ID #: 141610
• Secondary ID: R01HL140145
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2, 2020
• Est. completion date: December 30, 2024

Study information

• Verified date: June 2024
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: December 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Male and female patients older than 18 years who are willing to participate.

2. Satisfy the ACR criteria for the diagnosis of RA.

3. Have stable disease activity as evidenced by no clinically meaningful change in immunomodulating or corticosteroid therapy in the past 1 month.

4. Have moderate disease activity as reflected by a minimum of 3 swollen and tender joints.

Exclusion Criteria:

1. Pregnancy

2. Receiving dialysis

3. Organ or bone marrow transplant

4. Taking diuretics, uncontrolled hypertension (>160/100 mmHg), or cardiac failure requiring treatment.

5. Severe edema (as judged by the investigator)

6. Diabetes mellitus treated with an insulin pump

7. Major surgery within the previous 3 months

8. Severe co-morbid conditions such as active cancer likely to compromise study participation

9. Unwillingness, or other inability, to cooperate

10. Contraindication to MRI

11. 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).

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Tissue sodium	Investigators will measure change in tissue sodium using 3.0 T MRI equipped with a 23Na coil.	2 scans, one at end of low salt diet at week 8, and one at end of high salt diet at week 20
Secondary	Change in DAS 28	Investigators will measure change in DAS28, a measurement of disease activity that includes 28 joint count of tenderness and swelling, a disease activity scale (0-100), and sedimentation rate.	Will be measured at beginning and end of each diet period at weeks 0, 8, and 12, 20
Secondary	Change in blood pressure	Investigators will measure change in blood pressure, blood pressure will be measured over a 24 hour period.	will be measured at beginning and end of each diet period at weeks 0,8 and 12, 20