Influence of Sodium Intake in spondyLoarthriTes (SALT)

July 4, 2025 updated by: Centre Hospitalier Universitaire de Besancon

Sodium Intake in spondyLoarthriTes: Analysis of the Influence on the Activity of the Disease and the Therapeutic Response to Anti IL-17A Agents.

The aim of the SALT study is to analyze the relationship between dietary sodium intake and disease activity in patients with axial spondyloarthritis (radiographic or non-radiographic) or psoriatic arthritis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Besancon, France, 25000
        • Recruiting
        • CHU Besançon
        • Principal Investigator:
          • Eric Toussirot, MD PhD
      • La Roche-sur-Yon, France, 85000
        • Recruiting
        • CHD Vendée
      • St Etienne, France, 42000
        • Recruiting
        • CHU St Etienne
      • Trévenans, France, 90400
        • Recruiting
        • Hôpital Nord Franche-Comté

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients with axial spondyloarthritis (radiographic or non-radiographic) or psoriatic arthritis
  • women who have been menopausal for at least 24 months, surgically sterilized, or, for women of childbearing potentiale, use an effective method of contraception (oral contraceptives, contraceptive injections, intrauterine devices, double-barrier method, contraceptive patches)

Exclusion Criteria:

  • patient treated by cyclosporine, diuretics, angiotensin-converting enzyme inhibitors or angiotensin II receptor antagonists.
  • current treatment with an anti-IL-17A agent (secukinumab or ixekizumab or bimekizumab or brodalumab) or with an anti-IL23 agent (ustekinumab, guselkumab, risankizumab or tildrakizumab) or previous treatment less than 6 months old.
  • patients on systemic corticosteroids with corticosteroid therapy > 10 mg prednisone equivalent
  • pregnant woman

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients with radiographic/non-radiographic Axial Spondylitis or psoriatic arthritis
Patients with radiographic/non-radiographic Axial Spondylitis or psoriatic arthritis managed in the rheumatology departments of the study centres.
Other: measurement of salt intake
measurement of salt intake without intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sodium intake
Time Frame: day of inclusion, monday and tuesday following
average sodium concentration in urine for the week
day of inclusion, monday and tuesday following

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Collaborators

French Society of Rheumatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

January 31, 2024

First Submitted That Met QC Criteria

February 7, 2024

First Posted (Actual)

February 14, 2024

Study Record Updates

Last Update Posted (Actual)

July 9, 2025

Last Update Submitted That Met QC Criteria

July 4, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/807

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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