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
  Purpose

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 Intervention
Vitamin D Status
Radiation: Broadband UVB

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Interdependence Between Body Surface Area and UVB Dose in Vitamin D Production: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • 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 ]

Enrollment: 92
Study Start Date: January 2008
Study Completion Date: December 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01042197

Locations
Denmark
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
  More Information

No publications provided

Responsible Party: Morten Bogh M.D., Bispebjerg Hospital, Department of Dermatology
ClinicalTrials.gov Identifier: NCT01042197     History of Changes
Other Study ID Numbers: H-B-2007-100
Study First Received: January 4, 2010
Last Updated: January 11, 2010
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Bispebjerg Hospital:
Vitamin D
UVB
Dose-Response
Body surface area

Additional relevant MeSH terms:
Vitamin D
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 18, 2014