Dietary Salt in Rheumatoid Arthritis

NCT03649178 | Completed Results

• 2 other identifiers: 141610R01HL140145
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Change in Tissue Sodium

  Investigators will measure change in tissue (skin) sodium using 3.0 T MRI equipped with a 23Na coil.

  2 scans, one at end of week 8, and one at end of week 20

Secondary Outcomes (2)

• Change in DAS28-CRP

  Measured at beginning and end of each diet period at weeks 0, 8, and 12, 20

• Change in Blood Pressure

  Measured at beginning and end of each diet period at weeks 0,8 and 12, 20

Study Arms (2)

low salt diet

OTHER

low-sodium diet (50mmol/24hours x 8 weeks ) Subjects will choose a rotation of low-sodium meals from a predetermined list from a commercial vendor (Mom's Meals) that will be used to provide 2 meals (lunch and dinner)/day that the vendor will deliver at approximately 7 day intervals. Staff of the Vanderbilt Diet,Body Composition, and Human Metabolism Core determine breakfast and snacks appropriate for theHS andLS diets and provide instructions to subjects.

Other: salt

high salt diet

OTHER

high-sodium diet (200mmol/24hours x 8weeks) Subjects will choose a rotation of low-sodium meals from a predetermined list from a commercial vendor (Mom's Meals) that will be used to provide 2 meals (lunch and dinner)/day that the vendor will deliver at approximately 7 day intervals. Staff of the Vanderbilt Diet,Body Composition, and Human Metabolism Core determine breakfast and snacks appropriate for theHS andLS diets and provide instructions to subjects.

Other: salt

Interventions

salt OTHER

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

high salt diet; low salt diet

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Salts

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Limitations and Caveats

Enrollment was impeded by COVID19.

Results Point of Contact

• Title: C. Michael Stein MD
• Organization: Vanderbilt University Medical Center

michael.stein@vumc.org

615-936-3420

Study Officials

• Charles M Stein, MBChB

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dan May Professor of Medicine, Professor of Pharmacology

Model Details: This will be a random-order, 2 period crossover study with washout

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 28, 2018
• Study Start: January 2, 2020
• Primary Completion: September 30, 2024
• Study Completion: December 30, 2024
• Last Updated: October 24, 2025
• Results First Posted: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: starting 6 months after publication
• Access Criteria: IPD will be shared on request made to the PI. Criteria: Data is not to be shared. Data should only be used for biomedical research. Researchers requesting access will need appropriate IRB approval and sign a data use agreement.

Locations

US (1)