NCT06259890

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
12mo left

Started Jan 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Jan 2024May 2027

Study Start

First participant enrolled

January 30, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 31, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 14, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

July 9, 2025

Status Verified

November 1, 2024

Enrollment Period

2.8 years

First QC Date

January 31, 2024

Last Update Submit

July 4, 2025

Conditions

Keywords

Sodium intake

Outcome Measures

Primary Outcomes (1)

  • sodium intake

    average sodium concentration in urine for the week

    day of inclusion, monday and tuesday following

Study Arms (1)

Patients with radiographic/non-radiographic Axial Spondylitis or psoriatic arthritis

OTHER

Patients with radiographic/non-radiographic Axial Spondylitis or psoriatic arthritis managed in the rheumatology departments of the study centres.

Other: measurement of salt intake

Interventions

measurement of salt intake without intervention

Patients with radiographic/non-radiographic Axial Spondylitis or psoriatic arthritis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHU Besançon

Besançon, 25000, France

RECRUITING

CHD Vendée

La Roche-sur-Yon, 85000, France

RECRUITING

CHU St Etienne

Saint-Etienne, 42000, France

RECRUITING

Hôpital Nord Franche-Comté

Trévenans, 90400, France

RECRUITING

MeSH Terms

Conditions

Axial SpondyloarthritisArthritis, Psoriatic

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritisPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Guillaume BOITEUX, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2024

First Posted

February 14, 2024

Study Start

January 30, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

July 9, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations