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CompletedNCT04095130TSS1Updated Sep 19, 2019

Tissue Sodium in Patients With Psoriasis

An observational study in Psoriasis Vulgaris and Healthy, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-09-19.

Sponsored by Charite University, Berlin, Germany · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
56
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Sodium can be buffered in the skin, which mechanism is altered during aging and in certain diseases such as hypertension. High salt environment can promote autoimmunity by expanding pathogenic IL-17 producing T helper (Th17) cells. Psoriasis is a relapsing and remitting inflammatory autoimmune disease affecting the skin and joints and involves proinflammatory Th17 cells. Here we tested the hypothesis if psoriatic skin has a higher sodium content in humans.

Read the detailed description

The cytokine interleukin-17A (IL-17A) is a crucial player in the pathogenesis of the autoimmune disease of psoriasis. This neutrophil recruiting cytokine is produced by IL-17A producing CD4+ T cells (Th17) and gamma/delta T cells of the skin and evokes an inflammation circuit finally leading to the classical clinical picture of psoriasis with hyper- and parakeratosis, erythema, scaling and neutrophil abscess formation.

Besides genetic factors, lifestyle factors are relevant and decide if an autoimmune disease becomes manifest. It was shown previously that increased salt (sodium chloride, NaCl) concentrations boost the induction of murine and human Th17 cells. However, more - and also clinical - studies are needed to understand the correlation between salt content and IL-17A in autoimmune diseases.

This study investigates the hypothesis if skin sodium content in human psoriasis is increased in order to get further insight into the IL-17A-salt-interplay.

02

Conditions studied

  • Psoriasis Vulgaris
  • Healthy

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Keywords

  • Psoriasis
  • Sodium
  • Skin
03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 56 is below the median of 200 across 396 observational studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Healthy patients recruited locally (invitation to volunteer sent to workers of the Charié University Clinic and the Max Delbrück Center for Molecular Medicine).

Psoriasis patients are recruited who are treated at the Department of Dermatology, Venerology and Allergology, Charité Medical Faculty, Berlin, Germany, Immanuel Krankenhaus Berlin, Medical Centre for Rheumatology and Clinical Immunology, Berlin, Germany and the Helios Clinic Berlin-Buch, Berlin, Germany.

Inclusion criteria

  • Age: 18-80
  • Body mass index (BMI) 18.5- 40 kg/m2
  • Glomerular filtration rate >60 ml/min/1.73m2

Exclusion criteria

Exclusion Criteria:

  • Diagnosed or treated hypertension and/or blood pressure above 140/90 at screening
  • Palpable peripheral oedema during phyisical examination at screening
  • Any type of diabetes mellitus and/or HgbA1c>6.5% at screening
  • Subjects with a thyroid-stimulating hormone >4.2 mU/L at screening
  • Psoriasis patients treated with systemic corticosteroids, chemotherapy agent (methothrexate) or with any kind of biologics/biosimilars
  • Subjects with acute disease
  • Pregnant or lactating women
  • Metal or medical device implant in the body
  • Tattoo on the lower extremities
  • Subjects with a history of drug or alcohol abuse
  • Subjects who are legal incapacitated or their circumstances do not enable the patient to fully understand the nature, significance and scope of this study.
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
56 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Healthy subjects

    those without a condition

    Diagnostic Test: 23Na Magnetic resonance imaging

  • Psoriasis patients

    those with a condition

    Diagnostic Test: 23Na Magnetic resonance imaging

Interventions

  • Diagnostic test23Na Magnetic resonance imaging

    Measurement of skin sodium content by non-invasive 23Na Magnetic resonance imaging.

06

What researchers measure

Primary outcomes

  1. Non-invasive sodium measurement in the skin

    Sodium measured in the skin by 23Na-MRI is higher in psoriasis patients vs. matched healthy individuals.

    Time frame: 4 years

07

Study locations

1 site
  • Experimental and Clinical Research Center, Clinical Research Unit
    Berlin, 13125, Germany
08

References and documents

Publications

  • Kopp C, Linz P, Dahlmann A, Hammon M, Jantsch J, Muller DN, Schmieder RE, Cavallaro A, Eckardt KU, Uder M, Luft FC, Titze J. 23Na magnetic resonance imaging-determined tissue sodium in healthy subjects and hypertensive patients. Hypertension. 2013 Mar;61(3):635-40. doi: 10.1161/HYPERTENSIONAHA.111.00566. Epub 2013 Jan 21. PubMed 23339169 ↗
  • Kleinewietfeld M, Manzel A, Titze J, Kvakan H, Yosef N, Linker RA, Muller DN, Hafler DA. Sodium chloride drives autoimmune disease by the induction of pathogenic TH17 cells. Nature. 2013 Apr 25;496(7446):518-22. doi: 10.1038/nature11868. Epub 2013 Mar 6. PubMed 23467095 ↗

Individual participant data

Plan to share: Undecided — Planned to share all IPD that underlie results in a publication.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04095130
Lead sponsor
Charite University, Berlin, Germany
Collaborators
German Heart Center
Responsible party
Dr. Lajos Marko (Principal Investigator, Charite University, Berlin, Germany) — Principal investigator
First posted
Sep 19, 2019
Start date
Jul 1, 2015
Primary completion
Mar 16, 2018
Completion
Sep 17, 2019
Last update
Sep 19, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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