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Low-Salt Diet for Rheumatoid Arthritis

N/A

Waitlist Available

Led By Charles M Stein, MBChB

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Must not have

Organ or bone marrow transplant

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up will be measured at beginning and end of each diet period at weeks 0,8 and 12, 20

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether reducing dietary sodium intake can help manage RA by reducing inflammation, blood pressure, and tissue sodium levels.

Who is the study for?

This trial is for adults over 18 with rheumatoid arthritis who meet specific diagnostic criteria, have stable disease activity without recent changes in medication, and at least 3 swollen and tender joints. It's not for those with recent major surgery, uncontrolled high blood pressure, severe edema, diabetes on an insulin pump, or conditions making blood pressure monitoring difficult.

What is being tested?

The study tests if reducing dietary salt can lower inflammation and blood pressure in rheumatoid arthritis patients. It also looks at whether less salt affects tissue sodium levels. Participants will follow a low-sodium diet to see these potential effects.

What are the potential side effects?

While the trial involves dietary changes rather than medication, possible side effects may include altered taste preference, mild discomfort from diet adjustment or cravings for salty foods. No significant medical side effects are expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have at least 3 swollen and tender joints.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had an organ or bone marrow transplant.

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I am taking diuretics, have high blood pressure (>160/100 mmHg), or need treatment for heart failure.

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I manage my diabetes with an insulin pump.

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I am currently on dialysis.

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I have not had major surgery in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ will be measured at beginning and end of each diet period at weeks 0,8 and 12, 20

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~will be measured at beginning and end of each diet period at weeks 0,8 and 12, 20

This trial's timeline: 3 weeks for screening, Varies for treatment, and will be measured at beginning and end of each diet period at weeks 0,8 and 12, 20 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Tissue sodium

Secondary study objectives

Change in DAS 28

Change in blood pressure

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: low salt dietExperimental Treatment1 Intervention

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.

Group II: high salt dietExperimental Treatment1 Intervention

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.

0 / 6Eligibility criteria met