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

Sponsor
Bispebjerg Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01042197
Collaborator
Vejle Hospital (Other)
92
Enrollment
1
Location
9
Arms
23
Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Broadband UVB
  • Radiation: Broadband UVB
  • Radiation: Broadband UVB
  • Radiation: Broadband UVB
  • Radiation: Broadband UVB
  • Radiation: Broadband UVB
  • Radiation: Broadband UVB
  • Radiation: Broadband UVB
  • Radiation: Broadband UVB
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
92 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
Interdependence Between Body Surface Area and UVB Dose in Vitamin D Production: A Randomized Controlled Trial
Study Start Date :
Jan 1, 2008
Actual Primary Completion Date :
Apr 1, 2009
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 2

Body surface area: 12 %

Radiation: Broadband UVB
UVB dose: 0.75 SED. Four UVB sessions with 2 days in between.
Active Comparator: 1

Body surface area: 6 %

Radiation: Broadband UVB
UVB dose: 0.75 SED. Four UVB sessions with 2 days in between.
Active Comparator: 3

Body surface area: 24 %

Radiation: Broadband UVB
UVB dose: 0.75 SED. Four UVB sessions with 2 days in between.
Active Comparator: 4

Body surface area: 6 %

Radiation: Broadband UVB
UVB dose: 1.5 SED. Four UVB sessions with 2 days in between.
Active Comparator: 5

Body surface area: 12 %

Radiation: Broadband UVB
UVB dose: 1.5 SED. Four UVB sessions with 2 days in between.
Active Comparator: 6

Body surface area: 24 %

Radiation: Broadband UVB
UVB dose: 1.5 SED. Four UVB sessions with 2 days in between.
Active Comparator: 7

Body surface area: 6 %

Radiation: Broadband UVB
UVB dose: 3.0 SED. Four UVB sessions with 2 days in between.
Active Comparator: 8

Body surface area: 12 %

Radiation: Broadband UVB
UVB dose: 3.0 SED. Four UVB sessions with 2 days in between.
Active Comparator: 9

Body surface area: 24 %

Radiation: Broadband UVB
UVB dose: 3.0 SED. Four UVB sessions with 2 days in between.

Outcome Measures

Primary Outcome Measures

  1. 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. [Before and 2 days after the last UVB session.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bispebjerg Hospital, Department of Dermatology D92, Bispebjerg Bakke 23, Copenhagen Nv Copenhagen Denmark 2400

Sponsors and Collaborators

  • Bispebjerg Hospital
  • Vejle Hospital

Investigators

  • Study Chair: Hans Christian Wulf, Full Prof., Bispebjerg Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01042197
Other Study ID Numbers:
  • H-B-2007-100
First Posted:
Jan 5, 2010
Last Update Posted:
Jan 12, 2010
Last Verified:
Dec 1, 2007
Keywords provided by , ,
Vitamin D
UVB
Dose-Response
Body surface area

Study Results

No Results Posted as of Jan 12, 2010