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

Vitamin D Status Clinical Trial

Official title:

Interdependence Between Body Surface Area and UVB Dose in Vitamin D Production: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01042197
• Other study ID #: H-B-2007-100
• Status: Completed
• Phase: N/A
• First received: January 4, 2010
• Last updated: January 11, 2010
• Start date: January 2008
• Est. completion date: December 2009

Study information

• Verified date: December 2007
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: December 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Vitamin D Status

Intervention

Radiation:
• Broadband UVB
UVB dose: 0.75 SED. Four UVB sessions with 2 days in between.
• Broadband UVB
UVB dose: 0.75 SED. Four UVB sessions with 2 days in between.
• Broadband UVB
UVB dose: 0.75 SED. Four UVB sessions with 2 days in between.
• Broadband UVB
UVB dose: 1.5 SED. Four UVB sessions with 2 days in between.
• Broadband UVB
UVB dose: 1.5 SED. Four UVB sessions with 2 days in between.
• Broadband UVB
UVB dose: 1.5 SED. Four UVB sessions with 2 days in between.
• Broadband UVB
UVB dose: 3.0 SED. Four UVB sessions with 2 days in between.
• Broadband UVB
UVB dose: 3.0 SED. Four UVB sessions with 2 days in between.
• Broadband UVB
UVB dose: 3.0 SED. Four UVB sessions with 2 days in between.

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital, Department of Dermatology D92, Bispebjerg Bakke 23,	Copenhagen Nv	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Bispebjerg Hospital	Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes