Serum 25-OH Vitamin D Modulation by Sunbed Use According to EU Guideline EN 60335-2-27

University of Zurich (UZH)

Status: Completed

Conditions: Skin Toxicity

Treatments: Device: sunbed exposure

Study type: Interventional

Funder types: Other

Identifiers

NCT01976481

sunbed study

Details and patient eligibility

About

Our study aims to clarify the impact of the use of a standard sunbed according to new EU guideline EN 60335-2-27 and possibly discount the positive effects of tanning beds. We plan to investigate the serum elevation of 25(OH)D under sunbed use, respecting the new recommendations for the exposure plan for different skin types according to EN 60335-2-27.

The use of a sunbed will be compared to a control group not using a sunbed in the observation period.

• Trial with medical device

Full description

We will compare to baseline changes in serum vitamin D and health-related quality of life using a control group and an intervention group.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria: Probands intending to use a commercial sunbed :

1. Age 18 years or older
2. Regular use of commercial sunbeds
3. Oral and written informed consent

Exclusion criteria: 1. Skin type I according to Fitzpatrick according to EU guideline EN 60335-2-27 2. Sunbed use within the last three months 3. Use of vitamin D supplements or multivitamin supplements 4. Any medical condition which renders them unfit for sunbed use in the judgment of the investigator 5. Inability to provide oral and written consent to participate

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Sunbed

Experimental group

Description:

sunbed exposure

Treatment:

Device: sunbed exposure

Observation

No Intervention group

Description:

only observation of subjects recruited after randomization