The Relation Between Vitamin D Production and UVB Exposed Body Surface Area

This study has been completed.
Sponsor:
Collaborator:
Vejle Hospital
Information provided by:
Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT01042197
First received: January 4, 2010
Last updated: January 11, 2010
Last verified: December 2007

January 4, 2010
January 11, 2010
January 2008
April 2009   (final data collection date for primary outcome measure)
Vitamin D (nmol/l) measured in a blood sample to define just how much sun exposure is necessary to obtain a sufficient vitamin D production. [ Time Frame: Before and 2 days after the last UVB session. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01042197 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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The Relation Between Vitamin D Production and UVB Exposed Body Surface Area
Interdependence Between Body Surface Area and UVB Dose in Vitamin D Production: A Randomized Controlled Trial

The purpose of this study is to investigate the relation between vitamin D production after UVB and exposed body surface areas with different UVB doses.

Vitamin D deficiency is very common. Rachitis, osteoporosis, cancer, sclerosis as well as cardiovascular diseases are related to vitamin D deficiency. Elderly people, immigrants as well as patients with malabsorption diseases often have vitamin D deficiency. 90-95 % of the total vitamin D requirements are obtained from the ultraviolet (UV) radiation of the skin.In spite of the risk of skin-cancer, treatment with sunlight radiation is often recommended against vitamin D deficiency. This fact has raised a scientific debate, where concern has been expressed with regard to the risk of skin-cancer. This dilemma should also be examined as no human studies are available on the vitamin D production in the skin after UV-radiation showing the frequency and dose necessary for sufficient production of vitamin D. The lowest exposure frequency, the smallest body surface area and the lowest UV dose should therefore be established to be exposed in order to minimize the risk of skin-cancer by unnecessary UV-radiation. The purpose of the project is therefore to clarify which factors there are of importance for the production of vitamin D in the skin after UVB radiation.

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: Broadband UVB
    UVB dose: 0.75 SED. Four UVB sessions with 2 days in between.
  • Radiation: Broadband UVB
    UVB dose: 1.5 SED. Four UVB sessions with 2 days in between.
  • Radiation: Broadband UVB
    UVB dose: 3.0 SED. Four UVB sessions with 2 days in between.
  • Active Comparator: 2
    Body surface area: 12 %
    Intervention: Radiation: Broadband UVB
  • Active Comparator: 1
    Body surface area: 6 %
    Intervention: Radiation: Broadband UVB
  • Active Comparator: 3
    Body surface area: 24 %
    Intervention: Radiation: Broadband UVB
  • Active Comparator: 4
    Body surface area: 6 %
    Intervention: Radiation: Broadband UVB
  • Active Comparator: 5
    Body surface area: 12 %
    Intervention: Radiation: Broadband UVB
  • Active Comparator: 6
    Body surface area: 24 %
    Intervention: Radiation: Broadband UVB
  • Active Comparator: 7
    Body surface area: 6 %
    Intervention: Radiation: Broadband UVB
  • Active Comparator: 8
    Body surface area: 12 %
    Intervention: Radiation: Broadband UVB
  • Active Comparator: 9
    Body surface area: 24 %
    Intervention: Radiation: Broadband UVB
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
92
December 2009
April 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy individuals between 18 - 65 years of age.
  • Avoidance of sun bed exposure
  • Not Holidaying south of 45 degrees latitude 3 months before
  • Avoiding vitamin D supplementation during and two months before

Exclusion Criteria:

  • Illness as well as age above 65 years.
  • Skin diseases
  • Psychiatric diseases
  • Drug addiction
  • Intake of photosensitive medicine.
  • Intake of cholesterol-lowering medicine.
  • Pregnancy
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01042197
H-B-2007-100
Yes
Morten Bogh M.D., Bispebjerg Hospital, Department of Dermatology
Bispebjerg Hospital
Vejle Hospital
Study Chair: Hans Christian Wulf, Full Prof. Bispebjerg Hospital
Bispebjerg Hospital
December 2007

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