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Low-Salt Diet for Rheumatoid Arthritis
N/A
Recruiting
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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have at least 3 swollen and tender joints.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Tissue sodium
Secondary outcome measures
Change in DAS 28
Change in blood pressure
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.
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Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
857 Previous Clinical Trials
672,171 Total Patients Enrolled
1 Trials studying Rheumatoid Arthritis
32 Patients Enrolled for Rheumatoid Arthritis
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,854 Total Patients Enrolled
9 Trials studying Rheumatoid Arthritis
626 Patients Enrolled for Rheumatoid Arthritis
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,837 Previous Clinical Trials
47,851,572 Total Patients Enrolled
4 Trials studying Rheumatoid Arthritis
563 Patients Enrolled for Rheumatoid Arthritis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had an organ or bone marrow transplant.I do not have severe health issues that could affect my participation.I am taking diuretics, have high blood pressure (>160/100 mmHg), or need treatment for heart failure.I manage my diabetes with an insulin pump.I am willing and able to follow study requirements.I have severe swelling as determined by my doctor.You are pregnant.I am currently on dialysis.I have at least 3 swollen and tender joints.I am over 18 years old and willing to participate.My medication for immune system or steroids hasn't changed in the last month.I have not had major surgery in the last 3 months.You are unable to undergo an MRI for medical reasons.
Research Study Groups:
This trial has the following groups:- Group 1: low salt diet
- Group 2: high salt diet
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment currently ongoing for the trial?
"Affirmative. According to the clinicaltrials.gov listing, this medical study is actively enrolling participants since its posting on February 1st 2020 with a most recent update on October 20th 2022. At present, 22 patients are needed from one trial location."
Answered by AI
Would I be qualified to partake in this clinical research?
"To be eligible for this trial, prospective candidates must have a diagnosis of rheumatoid arthritis and fall within the 18 to 80 year old age bracket. Currently, 22 individuals are being recruited."
Answered by AI
Does the eligibility criteria extend to those aged 75 and above?
"Patients hoping to join this medical experiment must be between 18 and 80 years old. There is a total of 51 studies for younger individuals and 331 trials catered to senior citizens."
Answered by AI
How many participants does this experiment have thus far?
"Affirmative. Clinicaltrials.gov evidences that this investigation is in progress, having been initially posted on the 2nd of January 2020 and recently updated on the 20th of October 2022. 22 test subjects are sought across one medical centre."
Answered by AI
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