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NCT06259890 Clinical Trial

Influence of Sodium Intake in spondyLoarthriTes

Arthritis, Psoriatic Clinical Trial

— SALT  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06259890
Other study ID # 2023/807
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 30, 2024
Est. completion date May 2027

Study information
Verified date October 2023
Source Centre Hospitalier Universitaire de Besancon
Contact Guillaume BOITEUX, PhD
Phone +33381218957
Email gboiteux@chu-besancon.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 250
Est. completion date May 2027
Est. primary completion date November 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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: - catient 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• measurement of salt intake
measurement of salt intake without intervention

Locations
Country Name City State
France CHUBEsancon Besancon

Sponsors (2)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon French Society of Rheumatology

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary sodium intake average sodium concentration in urine for the week day of inclusion, monday and tuesday following
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