Low-Salt Diet Effect on Th17-Mediated Inflammation and Vascular Reactivity in Psoriasis

NCT ID: NCT05892640

Last Updated: 2023-06-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2024-06-30

Brief 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. 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low-Salt Diet

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

Group Type: EXPERIMENTAL

Low-Salt Diet

Intervention Type: OTHER

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

Interventions

Low-Salt Diet

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Josip Juraj Strossmayer University of Osijek

OTHER

Sponsor Role: lead

Responsible Party

Ines Drenjancevic

Vice Dean for Science, Faculty of Medicine Josip Juraj Strossmayer University of Osijek

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital Osijek

Osijek, , Croatia

Site Status: RECRUITING

Countries

Croatia

Central Contacts

Ines Drenjančević, MD, PhD

Role: CONTACT

ines.drenjancevic@mefos.hr

+38531512800

Facility Contacts

Martina Mihalj, MD, PhD

Role: primary

martina.mihalj@gmail.com

+385 31 512 426

Ivana Krajina, MD

Role: backup

krajina.ivana91@gmail.com

Other Identifiers

215861462341

Identifier Type: -

Identifier Source: org_study_id