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

History of Changes

Tracking Information

First Received Date ^ICMJE

January 4, 2010

Last Updated Date

January 11, 2010

Start Date ^ICMJE

January 2008

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01042197 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Vitamin D Status

Intervention ^ICMJE

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.

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2009

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT01042197

Other Study ID Numbers ^ICMJE

H-B-2007-100

Has Data Monitoring Committee

Yes

Responsible Party

Morten Bogh M.D., Bispebjerg Hospital, Department of Dermatology

Study Sponsor ^ICMJE

Bispebjerg Hospital

Collaborators ^ICMJE

Vejle Hospital

Investigators ^ICMJE

Study Chair:

Hans Christian Wulf, Full Prof.

Bispebjerg Hospital

Information Provided By

Bispebjerg Hospital

Verification Date

December 2007

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

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