Examining how sodium intake affects spondyloarthritis
Sodium Intake in spondyLoarthriTes: Analysis of the Influence on the Activity of the Disease and the Therapeutic Response to Anti IL-17A Agents.
NA · Centre Hospitalier Universitaire de Besancon · NCT06259890
This study is testing how changing salt intake might affect the symptoms of people with spondyloarthritis or psoriatic arthritis.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Besancon (other) |
| Drugs / interventions | secukinumab, ixekizumab, bimekizumab, brodalumab, ustekinumab, guselkumab, risankizumab, tildrakizumab, prednisone |
| Locations | 4 sites (Besançon and 3 other locations) |
| Trial ID | NCT06259890 on ClinicalTrials.gov |
What this trial studies
The SALT study aims to investigate the relationship between dietary sodium intake and disease activity in patients diagnosed with axial spondyloarthritis (both radiographic and non-radiographic) or psoriatic arthritis. Participants will have their salt intake measured to assess its influence on their condition. This interventional approach seeks to provide insights into dietary modifications that could potentially improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include women who are menopausal or surgically sterilized, or women of childbearing potential using effective contraception, who have axial spondyloarthritis or psoriatic arthritis.
Not a fit: Patients currently treated with specific immunosuppressive therapies or systemic corticosteroids may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to dietary recommendations that help manage disease activity in patients with spondyloarthritis.
How similar studies have performed: While the relationship between sodium intake and arthritis has been explored, this specific approach is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Besançon and 3 other locations
- CHU Besançon — Besançon, France (RECRUITING)
- CHD Vendée — La Roche-sur-Yon, France (RECRUITING)
- CHU St Etienne — Saint-Etienne, France (RECRUITING)
- Hôpital Nord Franche-Comté — Trévenans, France (RECRUITING)
Study contacts
- Study coordinator: Guillaume BOITEUX, PhD
- Email: gboiteux@chu-besancon.fr
- Phone: +33381218957
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Spondyloarthritis, Axial, Arthritis, Psoriatic, Sodium intake