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Dietary Salt in Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

salt

About this trial

This is an interventional other trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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).

Sites / Locations

Vanderbilt University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

low salt diet

high salt diet

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Tissue sodium

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

Secondary Outcome Measures

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.

Change in blood pressure

Investigators will measure change in blood pressure, blood pressure will be measured over a 24 hour period.

Full Information

NCT ID

NCT03649178

First Posted

August 23, 2018

Last Updated

October 20, 2022

Sponsor

Vanderbilt University Medical Center

Collaborators

National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT03649178

Brief Title

Dietary Salt in Rheumatoid Arthritis

Official Title

Inflammatory and Vascular Response to Dietary Salt in Rheumatoid Arthritis

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 2, 2020 (Actual)

Primary Completion Date

October 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vanderbilt University Medical Center

Collaborators

National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

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

Masking

InvestigatorOutcomes 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.

Allocation

Randomized

Enrollment

22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

low salt diet

Arm Type

Other

Arm Description

Arm Title

high salt diet

Arm Type

Other

Arm Description

Intervention Type

Other

Intervention Name(s)

salt

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Tissue sodium

Description

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

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

Secondary Outcome Measure Information:

Title

Change in DAS 28

Description

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.

Time Frame

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

Title

Change in blood pressure

Description

Investigators will measure change in blood pressure, blood pressure will be measured over a 24 hour period.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Charles M Stein, MBChB

Phone

615-936-3420

mike.stein@vumc.org

First Name & Middle Initial & Last Name or Official Title & Degree

Annette M Oeser, MLAS, CCRP

Phone

615-322-3778

annette.oeser@vumc.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Charles M Stein, MBChB

Organizational Affiliation

Vanderbilt University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vanderbilt University Medical Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Annette Oeser

Phone

615-322-3778

annette.oeser@Vumc.org

First Name & Middle Initial & Last Name & Degree

Charles M Stein, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

all IDP that underlie results in a publication

IPD Sharing Time Frame

starting 6 months after publication

IPD Sharing 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.

Learn more about this trial

Dietary Salt in Rheumatoid Arthritis

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