The Vitamin D Dose-Response Relationship

This study has been completed.
Sponsor:
Collaborator:
The Danish Medical Research Council
Information provided by:
Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT01074541
First received: February 23, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted

February 23, 2010
February 23, 2010
January 2008
March 2008   (final data collection date for primary outcome measure)
Vitamin D (nmol/l) [ Time Frame: 2 days after exposure ] [ Designated as safety issue: Yes ]
Vitamin D measured in a blood sample to define the dose-response relationship between UVB dose, UV intensity and Vitamin D production in the skin after UVB exposure.
Same as current
No Changes Posted
Other parameters [ Time Frame: 2 days after radiation ] [ Designated as safety issue: Yes ]
To invesitage whether other parameters like sex, BMI, Diet etc. influences the vitamin D production after UVB exposure.
Same as current
Not Provided
Not Provided
 
The Vitamin D Dose-Response Relationship
Vitamin D Production Depends on Ultraviolet-B Dose But Not on UV-intensity. A Randomized Controlled Trial

The purpose of the study is to determine the importance of the UV intensity and the UVB dose on the Vitamin D response after UVB.

The work is addressing vitamin D production after UVB exposure and explore the importance of UVB dose and UV intensity. Four different UVB doses and four different UV intensities are used to explore these relationships.

Many assumptions have been made concerning the vitamin D production after UVB exposure but only few studies exist.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Vitamin D Status
  • Radiation: UVB
    0.375 SED x 4 in a week
    Other Name: UVB radiation
  • Radiation: UVB
    0.75 SED x 4 in a week
    Other Name: UVB radiation
  • Radiation: UVB
    1.5 SED x 4 in a week
    Other Name: UVB radiation
  • Radiation: UVB
    3.0 SED x 4 in a week
    Other Name: UVB radiation
  • Active Comparator: Group 1
    UV intensity 10 MIN
    Interventions:
    • Radiation: UVB
    • Radiation: UVB
    • Radiation: UVB
    • Radiation: UVB
  • Active Comparator: Group 2
    UV intensity 5 MIN
    Interventions:
    • Radiation: UVB
    • Radiation: UVB
    • Radiation: UVB
    • Radiation: UVB
  • Active Comparator: Group 3
    UV intensity 1 MIN
    Intervention: Radiation: UVB
  • Active Comparator: Group 4
    UV intensity 20 MIN
    Interventions:
    • Radiation: UVB
    • Radiation: UVB
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
February 2010
March 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01074541
271-08-0461
No
Morten Bogh MD, Bispebjerg Hospital, Department of Dermatology
Bispebjerg Hospital
The Danish Medical Research Council
Study Chair: Hans Christian Wulf, Professor Bispebjerg Hospital, Deparment of Dermatology
Bispebjerg Hospital
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP