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

January 11, 2010 updated by: Bispebjerg Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

92

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

  • Denmark
    • Copenhagen
      • Copenhagen Nv, Copenhagen, Denmark, 2400
        • Bispebjerg Hospital, Department of Dermatology D92, Bispebjerg Bakke 23,

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:

  • 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

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: 2
Body surface area: 12 %
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: 1
Body surface area: 6 %
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: 3
Body surface area: 24 %
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: 4
Body surface area: 6 %
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: 5
Body surface area: 12 %
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: 6
Body surface area: 24 %
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: 7
Body surface area: 6 %
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: 8
Body surface area: 12 %
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: 9
Body surface area: 24 %
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Before and 2 days after the last UVB session.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Collaborators

Vejle Hospital

Investigators

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

January 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

January 4, 2010

First Submitted That Met QC Criteria

January 4, 2010

First Posted (Estimate)

January 5, 2010

Study Record Updates

Last Update Posted (Estimate)

January 12, 2010

Last Update Submitted That Met QC Criteria

January 11, 2010

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H-B-2007-100

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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