- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00516867
Does Sunbed Radiation With Mainly UVA Provoke Cutaneous Vitamin D Synthesis in Humans?
August 15, 2007 updated by: Bispebjerg Hospital
Sunbed Radiation Provoke Cutaneous Vitamin D Synthesis in Humans, a Randomized Controlled Trial
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?
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
41
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Copenhagen, Denmark, DK-2000 NV
- Bispebjerg Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Controls
|
|
|
Active Comparator: UVB 0.5%
|
UV radiation with 99.5% UVA and 0.5%UVB
UVB 1.4 % and UVA 98.6
|
|
Active Comparator: UVB 1.4%
|
UV radiation with 99.5% UVA and 0.5%UVB
UVB 1.4 % and UVA 98.6
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Serum concentration of 25(OH)D
Time Frame: 18 Days
|
18 Days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Serum concentration of PTH
Time Frame: 18 Days
|
18 Days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Hans C Wulf, MD, DSc, Bispebjerg Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2006
Study Completion (Actual)
April 1, 2006
Study Registration Dates
First Submitted
August 14, 2007
First Submitted That Met QC Criteria
August 15, 2007
First Posted (Estimate)
August 16, 2007
Study Record Updates
Last Update Posted (Estimate)
August 16, 2007
Last Update Submitted That Met QC Criteria
August 15, 2007
Last Verified
August 1, 2007
More Information
Terms related to this study
Other Study ID Numbers
- KF 01 290815
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.