Does Sunbed Radiation With Mainly UVA Provoke Cutaneous V... | NCT00516867

Studies
Does Sunbed Radiation With Mainly UVA Provoke Cutaneous Vitamin D Synthesis in Humans?

NCT00516867

Sponsor

Bispebjerg Hospital

Status

Completed

Last Update Posted

Aug 16, 2007Estimated

Enrollment

41Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

UV radiation
UV radiation

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2006

Primary Completion Date

Not provided

Completion Date

Apr 2006Actual

First Submitted Date

Aug 14, 2007

First Submission Date that Met QC Criteria

Aug 15, 2007

First Posted Date

Aug 16, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 15, 2007

Last Update Posted Date

Aug 16, 2007Estimated

Name	Class
Hvidovre University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

We would investigate in a controlled, randomized open study in the winter season: 1) If serum levels of vitamin D (25(OH)D) increase in subjects treated with sunbed with sunlamps emitting mainly UVA and only 0·5% or 1·4% UVB compared to non-sunbed treated controls 2) If yes, are the 25(OH)D serum levels then dependent on the UVB dose?

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

41Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
UVB 0.5%	Active Comparator	Radiation: UV radiation
Controls	No Intervention
UVB 1.4%	Active Comparator	Radiation: UV radiation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
UV radiation	Radiation	UV radiation with 99.5% UVA and 0.5%UVB	UVB 0.5%

Measure	Description	Time Frame
Serum concentration of 25(OH)D		18 Days

Measure	Description	Time Frame
Serum concentration of PTH		18 Days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy
Females
Above 50 years
Younger with serum concentration of 25(OH)D below 50nmol/l

Exclusion Criteria:

No sunbed use last ½ year
No sun holiday last ½ year
No intake of vitamin D above 10 microgram/day

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hans C Wulf, MD, DSc	Bispebjerg Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bispebjerg Hospital		Copenhagen		DK-2000 NV	Denmark

Intervention Browse Module

MeSH Terms

ID	Term
D014466	Ultraviolet Rays

Ancestor Terms

ID	Term
D008027	Light
D060733	Electromagnetic Radiation
D055590	Electromagnetic Phenomena
D060328	Magnetic Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided