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

NCT ID: NCT01976481

Last Updated: 2016-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-08-31

Brief Summary

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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

Detailed Description

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

Conditions

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Skin Toxicity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Sunbed

sunbed exposure

Group Type EXPERIMENTAL

sunbed exposure

Intervention Type DEVICE

exposure to sunbed ultraviolet radiation

Observation

only observation of subjects recruited after randomization

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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sunbed exposure

exposure to sunbed ultraviolet radiation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guenther Hofbauer, Prof MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Division of Dermatology

Locations

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University Hospital Zurich, Division of Dermatology

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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sunbed study

Identifier Type: -

Identifier Source: org_study_id

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