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The Vitamin D Dose-Response Relationship

Sponsor
Bispebjerg Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01074541
Collaborator
The Danish Medical Research Council (Other)
55
Enrollment
1
Location
4
Arms
25
Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: UVB
  • Radiation: UVB
  • Radiation: UVB
  • Radiation: UVB
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
55 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
Vitamin D Production Depends on Ultraviolet-B Dose But Not on UV-intensity. A Randomized Controlled Trial
Study Start Date :
Jan 1, 2008
Actual Primary Completion Date :
Mar 1, 2008
Actual Study Completion Date :
Feb 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group 1

UV intensity 10 MIN

Radiation: UVB
0.375 SED x 4 in a week
Other Names:
  • UVB radiation

    • Radiation: UVB
    0.75 SED x 4 in a week
    Other Names:
  • UVB radiation

    • Radiation: UVB
    1.5 SED x 4 in a week
    Other Names:
  • UVB radiation

    • Radiation: UVB
    3.0 SED x 4 in a week
    Other Names:
  • UVB radiation

    		•
    Active Comparator: Group 2

    UV intensity 5 MIN

    Radiation: UVB
    0.375 SED x 4 in a week
    Other Names:
  • UVB radiation

    • Radiation: UVB
    0.75 SED x 4 in a week
    Other Names:
  • UVB radiation

    • Radiation: UVB
    1.5 SED x 4 in a week
    Other Names:
  • UVB radiation

    • Radiation: UVB
    3.0 SED x 4 in a week
    Other Names:
  • UVB radiation

    		•
    Active Comparator: Group 3

    UV intensity 1 MIN

    Radiation: UVB
    3.0 SED x 4 in a week
    Other Names:
  • UVB radiation

    		•
    Active Comparator: Group 4

    UV intensity 20 MIN

    Radiation: UVB
    1.5 SED x 4 in a week
    Other Names:
  • UVB radiation

    • Radiation: UVB
    3.0 SED x 4 in a week
    Other Names:
  • UVB radiation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Vitamin D (nmol/l) [2 days after exposure]

      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.

    Secondary Outcome Measures

    1. Other parameters [2 days after radiation]

      To invesitage whether other parameters like sex, BMI, Diet etc. influences the vitamin D production after UVB exposure.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bispebjerg Hospital, Department of Dermatology Copenhagen NV NV Denmark 2400

    Sponsors and Collaborators

    • Bispebjerg Hospital
    • The Danish Medical Research Council

    Investigators

    • Study Chair: Hans Christian Wulf, Professor, Bispebjerg Hospital, Deparment of Dermatology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01074541
    Other Study ID Numbers:
    • 271-08-0461
    First Posted:
    Feb 24, 2010
    Last Update Posted:
    Feb 24, 2010
    Last Verified:
    Feb 1, 2010
    Keywords provided by , ,
    Vitamin D
    UVB
    Dose-Response
    UV intensity
    Skin cancer

    Study Results

    No Results Posted as of Feb 24, 2010