- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01101243
Maintenance of Vitamin D Level by UVB Radiation
April 8, 2010 updated by: Bispebjerg Hospital
How Much UVB Radiation is Necessary to Maintain Summer Vitamin D Level During Winter?
The purpose of the study is to determine the frequency of UVB radiations necessary to maintain the Vitamin D level during winter time.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The work is addressing vitamin D production after UVB exposure and explore how much UVB radiation which is necessary to maintain a sufficient vitamin D level during the winter period in Denmark. 4 different UVB exposure times and 2 different UVB doses to 2 different body surface areas.
Study Type
Interventional
Enrollment (Actual)
75
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
-
-
NV
-
Copenhagen, NV, Denmark, 2400
- 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 to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18-65 years
- Healthy
Exclusion Criteria:
- Sun bed use
- Holiday or business travel south of 45 degrees latitude during trial
- Illness
- Drug addiction
- Pregnancy
- Lactating
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: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group 1
Body surface area: 88 %
|
UVB dose: 1 SED every week
UVB dose: 4 SED every second week
UVB dose: 1 SED every second week
UVB dose: 1 SED every month
|
Active Comparator: Group 2
Body surface area: 22 %
|
UVB dose: 1 SED every week
UVB dose: 4 SED every second week
UVB dose: 1 SED every second week
UVB dose: 1 SED every month
|
Active Comparator: Group 3
Body surface area: 88 %
|
UVB dose: 1 SED every week
UVB dose: 4 SED every second week
UVB dose: 1 SED every second week
UVB dose: 1 SED every month
|
Active Comparator: Group 4
Body surface area: 88 %
|
UVB dose: 1 SED every week
UVB dose: 4 SED every second week
UVB dose: 1 SED every second week
UVB dose: 1 SED every month
|
No Intervention: Group 5
Body surface area: 0 %
|
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vitamin D (nmol/l)
Time Frame: Monthly during 4 months
|
Vitamin D measured in a blood sample to define the relationship between frequency of UVB radiations and the Vitamin D level.
|
Monthly during 4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parathyroideahormone (pmol/l)
Time Frame: 4 months
|
To investigate whether parathyroideahormone is influenced by the UVB radiations.
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Hans Christian Wulf, Professor, Bispebjerg Hospital, Department of Dermatology
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
October 1, 2008
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
April 1, 2010
Study Registration Dates
First Submitted
April 8, 2010
First Submitted That Met QC Criteria
April 8, 2010
First Posted (Estimate)
April 9, 2010
Study Record Updates
Last Update Posted (Estimate)
April 9, 2010
Last Update Submitted That Met QC Criteria
April 8, 2010
Last Verified
April 1, 2010
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- H-C-2008-072
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.
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