Spondyloarthritis, AxialSALTNCT06259890
Influence of Sodium Intake in spondyLoarthriTes
A study testing measurement of salt intake in people with Spondyloarthritis, Axial and Arthritis, Psoriatic, run by Centre Hospitalier Universitaire de Besancon at 4 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spondyloarthritis, Axial, Arthritis, Psoriatic
- What is being tested?
- measurement of salt intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 4 sitesFrance
- Study dates
- 30 Jan 2024to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
CHU Besançon
Besançon, 25000
Eric Toussirot, MD PhD
- Recruiting
CHD Vendée
La Roche-sur-Yon, 85000
- Recruiting
CHU St Etienne
Saint-Etienne, 42000
- Recruiting
Hôpital Nord Franche-Comté
Trévenans, 90400
About this study
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.
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.
- Conditions
- Spondyloarthritis, Axial, Arthritis, Psoriatic
- Being tested
- measurement of salt intake
- Keywords
- Sodium intake
- Medical subject headings
- Axial Spondyloarthritis, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of salt intakeOther
measurement of salt intake without intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: measurement of salt intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
sodium intake
average sodium concentration in urine for the week
Measured: day of inclusion, monday and tuesday following
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start30 Jan 2024
- Primary completionNov 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spondyloarthritis, AxialStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- French Society of Rheumatology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259890
- Sponsor's protocol ID
- 2023/807
- Acronym
- SALT
- Status last verified
- Nov 2024
- First submitted
- 31 Jan 2024
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06259890
- Acronym / sponsor ID
- SALT / 2023/807
- Conditions
- Spondyloarthritis, Axial, Arthritis, Psoriatic
- Keywords
- Sodium intake
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- French Society of Rheumatology
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with radiographic/non-radiographic Axial Spondylitis or psoriatic arthritis | Other | Other: measurement of salt intakePatients with radiographic/non-radiographic Axial Spondylitis or psoriatic arthritis managed in the rheumatology departments of the study centres. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measurement of salt intakemeasurement of salt intake without intervention | Other | Patients with radiographic/non-radiographic Axial Spondylitis or psoriatic arthritis |
Primary outcome
sodium intake
Time frame: day of inclusion, monday and tuesday following
average sodium concentration in urine for the week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing measurement of salt intake in people with Spondyloarthritis, Axial and Arthritis, Psoriatic, run by Centre Hospitalier Universitaire de Besancon at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume BOITEUX, PhD (+33381218957, gboiteux@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sodium intake (time frame: day of inclusion, monday and tuesday following). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.