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Dietary Salt in Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT03649178
Recruitment Status : Not yet recruiting
First Posted : August 28, 2018
Last Update Posted : August 28, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
C. Michael Stein, Vanderbilt University Medical Center

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Other: salt Not Applicable

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This will be a random-order, 2 period crossover study with washout
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Other
Official Title: Inflammatory and Vascular Response to Dietary Salt in Rheumatoid Arthritis
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
low salt diet
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
Participants will randomly eat a high salt diet for 8 weeks and a low salt diet for 8 weeks

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




Primary Outcome Measures :
  1. Change in Tissue sodium [ Time Frame: 2 scans, one at end of low salt diet at week 8, and one at end of high salt diet at week 20 ]
    Investigators will measure change in tissue sodium using 3.0 T MRI equipped with a 23Na coil.


Secondary Outcome Measures :
  1. Change in DAS 28 [ Time Frame: Will be measured at beginning and end of each diet period at weeks 0, 8, and 12, 20 ]
    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.

  2. Change in blood pressure [ Time Frame: will be measured at beginning and end of each diet period at weeks 0,8 and 12, 20 ]
    Investigators will measure change in blood pressure, blood pressure will be measured over a 24 hour period.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03649178


Contacts
Contact: Charles M Stein, MBChB 615-936-3420 mike.stein@vumc.org
Contact: Annette M Oeser, MLAS, CCRP 615-322-3778 annette.oeser@vumc.org

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Charles M Stein, MBChB Vanderbilt University Medical Center

Responsible Party: C. Michael Stein, Dan May Professor of Medicine, Professor of Pharmacology, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03649178     History of Changes
Other Study ID Numbers: 141610
R01HL140145 ( U.S. NIH Grant/Contract )
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all IDP that underlie results in a publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases