NCT05627609

Brief Summary

Ultraviolet B (UVB) irradiation induces regulatory immune cell types that may transmigrate from the skin to the blood and to the central nervous system and exert regulatory effects. Vitamin D deficiency-associated gene variants should reduce this effect if this is mediated by vitamin D. For this study, participants will be irradiated with UVB for 4 weeks. Single cell RNA Sequencing will be performed on isolated immune cells from skin, blood and Cerebrospinal fluid (CSF), before and after irradiation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable multiple-sclerosis

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 16, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

November 21, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 25, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2023

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

5 months

First QC Date

November 16, 2022

Last Update Submit

May 8, 2023

Conditions

Multiple Sclerosis

Keywords

UVBscRNAseq

Outcome Measures

Primary Outcomes (1)

  • Vitamin D3 serum concentration (ng/mL)

    Changes in Vitamin D3 serum concentration (ng/mL) of RRMS patients with regard to different Vitamin D3 deficit-associated genotypes before and after UVB-narrowband radiation.

    4 weeks

Secondary Outcomes (1)

  • single-cell RNA sequencing

    1 year

Study Arms (2)

Participants with high Vitamin D genotype risk score

EXPERIMENTAL
Device: 311 nm narrowband UVB irradiation

PArticipants with low Vitamin D genotype risk score

EXPERIMENTAL
Device: 311 nm narrowband UVB irradiation

Interventions

311 nm narrowband UVB irradiationDEVICE

Participants will be irradiated with 311nm UVB for 5 days per week and 4 weeks in total.

PArticipants with low Vitamin D genotype risk scoreParticipants with high Vitamin D genotype risk score

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • RRMS according to revised McDonald criteria (2017) or healthy volunteer
  • Patients under treatment of natalizumab, teriflunomide, glatirameracetat or dimethyl fumarate for at least 4 weeks of therapy, or therapy-naïve patients will be included

You may not qualify if:

  • Patients receiving treatment in the last 3 months of interferon-β, fingolimod, alemtuzumab, ocrelizumab, cladribine, ofatumumab, ozanimod, or ponesimod
  • Vitamin D supplementation in the last 8 weeks
  • UVB-narrowband contraindicated skin diseases (e.g., cutaneous neoplasia)
  • Lacking the ability to stand on their own in the treatment chamber
  • Signs of intolerance regarding UVB radiation
  • Intake of UV-sensitive therapeutics
  • Further autoimmune diseases (e.g., Morbus Crohn, psoriasis, neurodermatitis)
  • Additional recreational or therapeutic UV radiation (e.g., solarium)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Muenster

Münster, North Rhine-Westphalia, 48149, Germany

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. rer. nat.

Study Record Dates

First Submitted

November 16, 2022

First Posted

November 25, 2022

Study Start

November 21, 2022

Primary Completion

April 14, 2023

Study Completion

April 14, 2023

Last Updated

May 9, 2023

Record last verified: 2023-05

Locations

DE(1)