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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Vitamin D Status

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2<br>Body surface area: 12 % | Radiation: Broadband UVB<br>* UVB dose: 0.75 SED. Four UVB sessions with 2 days in between.<br>|
| Active Comparator: 1<br>Body surface area: 6 % | Radiation: Broadband UVB<br>* UVB dose: 0.75 SED. Four UVB sessions with 2 days in between.<br>|
| Active Comparator: 3<br>Body surface area: 24 % | Radiation: Broadband UVB<br>* UVB dose: 0.75 SED. Four UVB sessions with 2 days in between.<br>|
| Active Comparator: 4<br>Body surface area: 6 % | Radiation: Broadband UVB<br>* UVB dose: 1.5 SED. Four UVB sessions with 2 days in between.<br>|
| Active Comparator: 5<br>Body surface area: 12 % | Radiation: Broadband UVB<br>* UVB dose: 1.5 SED. Four UVB sessions with 2 days in between.<br>|
| Active Comparator: 6<br>Body surface area: 24 % | Radiation: Broadband UVB<br>* UVB dose: 1.5 SED. Four UVB sessions with 2 days in between.<br>|
| Active Comparator: 7<br>Body surface area: 6 % | Radiation: Broadband UVB<br>* UVB dose: 3.0 SED. Four UVB sessions with 2 days in between.<br>|
| Active Comparator: 8<br>Body surface area: 12 % | Radiation: Broadband UVB<br>* UVB dose: 3.0 SED. Four UVB sessions with 2 days in between.<br>|
| Active Comparator: 9<br>Body surface area: 24 % | Radiation: Broadband UVB<br>* UVB dose: 3.0 SED. Four UVB sessions with 2 days in between.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | Before and 2 days after the last UVB session. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, UVB, Dose-Response, Body surface area