Psoriasis VulgarisNCT05892640
Low-Salt Diet Effect on Th17-Mediated Inflammation and Vascular Reactivity in Psoriasis
A study testing Low-Salt Diet in people with Psoriasis Vulgaris, run by Josip Juraj Strossmayer University of Osijek at 1 site in Croatia.
Trial summary
Psoriasis presents an independent cardiovascular risk factor characterized by chronic low-grade systemic inflammation and oxidative stress which altogether might lead to endothelial dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Low-Salt Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Sep 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with diagnosed psoriasis vulgaris
- subjects do not use topical corticosteroid therapy for at least 2 weeks before inclusion in the study and 2 weeks during the study
- subjects do not use systemic or biological therapy for at least 3 months before and 2 weeks during the study.
Who cannot join
- age < 18 years
- existence of other immune-mediated diseases (with the exception of autoimmune thyroid diseases and psoriatic arthritis - people with these comorbidities can be included)
- malignant diseases
- current infectious diseases and allergic reactions within 6 weeks before the start of the study
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
University Hospital Osijek
Osijek, 31000
Martina Mihalj, MD, PhD, +385 31 512 426, martina.mihalj@gmail.com
Ivana Krajina, MD, krajina.ivana91@gmail.com
About this study
Official title: Effects of Low Salt Dietary Intake on Th17-Mediated Inflammation and Vascular Reactivity in Patients With Psoriasis
Psoriasis presents an independent cardiovascular risk factor characterized by chronic low-grade systemic inflammation and oxidative stress which altogether might lead to endothelial dysfunction. It has been reported that increased oxidative stress has a pivotal role in high dietary sodium-induced endothelial dysfunction. Previous studies on sodium accumulation in psoriatic skin lesions and the sodium-induced augmentation in Th17 immune response, raise the question on the complex interplay between sodium and psoriasis, especially in the context of cardiovascular morbidity.
This study aimed to investigate the effect of a 2-week low-salt diet on endothelium-dependent and endothelium-independent cutaneous microvascular vasodilation and Th17-Mediated Inflammation in patients with psoriasis vulgaris.
- Conditions
- Psoriasis Vulgaris
- Being tested
- Low-Salt Diet
- Keywords
- Diet, Sodium-Restricted, Psoriasis, Laser-Doppler Flowmetry, Microcirculation, Endothelium
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Salt DietOther
Low-salt diet (LS diet) according to DASH eating plan, with sodium intake of 1500 mg (3.75 g of salt), within the period of 14 days
| Study group | Role | What they receive |
|---|---|---|
| Low-Salt Diet | Experimental | Low-salt diet (LS diet) according to DASH eating plan, with sodium intake of 1500 mg (3.75 g of salt), within the period of 14 days Receives: Other: Low-Salt Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microvascular endothelial function
Cutaneous microvascular blood flow will be measured by Laser Doppler Flowmetry in response to vascular occlusion (post occlusive reactive hyperaemia - PORH), in response to iontophoresis of acetylcholine (ACh) and local thermal hyperemia (LTH) before and after LS diet protocol
Measured: 2 weeks
Frequency of peripheral T helper 17 (Th17) and regulatory lymphocytes (Treg) among parent lymphocytes sub-population
Flow cytometry assessment of the frequencies of peripheral Treg and Th17 lymphocytes before and after LS diet protocol
Measured: 2 weeks
Secondary outcomes (4)
Microvascular non-endothelial function
Cutaneous microvascular blood flow will be measured by Laser Doppler Flowmetry in response to iontophoresis of sodium nitroprusside (SNP) before and after LS diet protocol
Measured: 2 weeks
Relative amount of serum- and glucocorticoid-induced kinase 1 (SGK1) in peripheral blood mononuclear cells
Relative amount of total serum- and glucocorticoid regulated kinase 1 (SGK1) in cultured cells will be measured by commercially available cell-based enzyme-linked immuno-sorbent assay (ELISA) kit before and after LS diet protocol
Measured: 2 weeks
Serum Protein Concentration of Pro- and Anti-Inflammatory Cytokines
Serum protein concentrations (pg/mL) of pro-inflammatory and anti-inflammatory cytokines will be measured with panel for multiplex protein quantitation before and after LS diet protocol
Measured: 2 weeks
24-hour natriuresis
A 24-h urinary sodium excretion will be measured in each participant before and after LS diet protocol in order to assess compliance to the given dietary protocol
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start1 Sep 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Josip Juraj Strossmayer University of Osijek
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ines Drenjancevic, Josip Juraj Strossmayer University of Osijek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892640
- Sponsor's protocol ID
- 215861462341
- Status last verified
- Jun 2023
- First submitted
- 27 May 2023
- Last updated
- 9 Jun 2023
- 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 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low Salt Dietary Intake on Th17-Mediated Inflammation and Vascular Reactivity in Patients With Psoriasis
- ClinicalTrials.gov ID
- NCT05892640
- Acronym / sponsor ID
- 215861462341
- Conditions
- Psoriasis Vulgaris
- Keywords
- Diet, Sodium-Restricted, Psoriasis, Laser-Doppler Flowmetry, Microcirculation, Endothelium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Josip Juraj Strossmayer University of OsijekUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 7 Jun 2023 (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.
Psoriasis presents an independent cardiovascular risk factor characterized by chronic low-grade systemic inflammation and oxidative stress which altogether might lead to endothelial dysfunction. It has been reported that increased oxidative stress has a pivotal role in high dietary sodium-induced endothelial dysfunction. Previous studies on sodium accumulation in psoriatic skin lesions and the sodium-induced augmentation in Th17 immune response, raise the question on the complex interplay between sodium and psoriasis, especially in the context of cardiovascular morbidity.
This study aimed to investigate the effect of a 2-week low-salt diet on endothelium-dependent and endothelium-independent cutaneous microvascular vasodilation and Th17-Mediated Inflammation in patients with psoriasis vulgaris.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low-Salt Diet | Experimental | Other: Low-Salt DietLow-salt diet (LS diet) according to DASH eating plan, with sodium intake of 1500 mg (3.75 g of salt), within the period of 14 days |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with diagnosed psoriasis vulgaris
- subjects do not use topical corticosteroid therapy for at least 2 weeks before inclusion in the study and 2 weeks during the study
- subjects do not use systemic or biological therapy for at least 3 months before and 2 weeks during the study.
Key exclusion criteria (4 listed)
- age < 18 years
- existence of other immune-mediated diseases (with the exception of autoimmune thyroid diseases and psoriatic arthritis - people with these comorbidities can be included)
- malignant diseases
- current infectious diseases and allergic reactions within 6 weeks before the start of the study
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 |
|---|---|---|
| Low-Salt DietLow-salt diet (LS diet) according to DASH eating plan, with sodium intake of 1500 mg (3.75 g of salt), within the period of 14 days | Other | Low-Salt Diet |
Primary outcome
Microvascular endothelial function
Time frame: 2 weeks
Cutaneous microvascular blood flow will be measured by Laser Doppler Flowmetry in response to vascular occlusion (post occlusive reactive hyperaemia - PORH), in response to iontophoresis of acetylcholine (ACh) and local thermal hyperemia (LTH) before and after LS diet protocol
Frequency of peripheral T helper 17 (Th17) and regulatory lymphocytes (Treg) among parent lymphocytes sub-population
Time frame: 2 weeks
Flow cytometry assessment of the frequencies of peripheral Treg and Th17 lymphocytes before and after LS diet protocol
4 secondary outcomes
Microvascular non-endothelial function
Time frame: 2 weeks
Relative amount of serum- and glucocorticoid-induced kinase 1 (SGK1) in peripheral blood mononuclear cells
Time frame: 2 weeks
Serum Protein Concentration of Pro- and Anti-Inflammatory Cytokines
Time frame: 2 weeks
24-hour natriuresis
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Salt Diet in people with Psoriasis Vulgaris, run by Josip Juraj Strossmayer University of Osijek at 1 site in Croatia.
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 3 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: status not confirmed, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ines Drenjančević, MD, PhD (+38531512800, ines.drenjancevic@mefos.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microvascular endothelial function (time frame: 2 weeks). The study lists 2 primary outcomes in all. 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 Jun 2023.