The Vitamin D Dose-Response Relationship

Study Overview
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Brief Summary
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The purpose of the study is to determine the importance of the UV intensity and the UVB dose on the Vitamin D response after UVB.

Detailed Description
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The work is addressing vitamin D production after UVB exposure and explore the importance of UVB dose and UV intensity. Four different UVB doses and four different UV intensities are used to explore these relationships. Many assumptions have been made concerning the vitamin D production after UVB exposure but only few studies exist.

Official Title
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Vitamin D Production Depends on Ultraviolet-B Dose But Not on UV-intensity. A Randomized Controlled Trial

Conditions
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Vitamin D Status

Intervention / Treatment
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* Radiation: UVB
* Radiation: UVB
* Radiation: UVB
* Radiation: UVB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-65 years Healthy Exclusion Criteria: Sun bed use Holiday or business travel south of 45 degrees latitude during trial Illness Drug addiction Pregnancy Lactating

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: Group 1<br>UV intensity 10 MIN | Radiation: UVB<br>* 0.375 SED x 4 in a week<br>* Other names: UVB radiation;Radiation: UVB<br>* 0.75 SED x 4 in a week<br>* Other names: UVB radiation;Radiation: UVB<br>* 1.5 SED x 4 in a week<br>* Other names: UVB radiation;Radiation: UVB<br>* 3.0 SED x 4 in a week<br>* Other names: UVB radiation;|
| Active Comparator: Group 2<br>UV intensity 5 MIN | Radiation: UVB<br>* 0.375 SED x 4 in a week<br>* Other names: UVB radiation;Radiation: UVB<br>* 0.75 SED x 4 in a week<br>* Other names: UVB radiation;Radiation: UVB<br>* 1.5 SED x 4 in a week<br>* Other names: UVB radiation;Radiation: UVB<br>* 3.0 SED x 4 in a week<br>* Other names: UVB radiation;|
| Active Comparator: Group 3<br>UV intensity 1 MIN | Radiation: UVB<br>* 3.0 SED x 4 in a week<br>* Other names: UVB radiation;|
| Active Comparator: Group 4<br>UV intensity 20 MIN | Radiation: UVB<br>* 1.5 SED x 4 in a week<br>* Other names: UVB radiation;Radiation: UVB<br>* 3.0 SED x 4 in a week<br>* Other names: UVB radiation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D (nmol/l) | Vitamin D measured in a blood sample to define the dose-response relationship between UVB dose, UV intensity and Vitamin D production in the skin after UVB exposure. | 2 days after exposure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other parameters | To invesitage whether other parameters like sex, BMI, Diet etc. influences the vitamin D production after UVB exposure. | 2 days after radiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, UVB, Dose-Response, UV intensity, Skin cancer