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The Vitamin D Dose-Response Relationship

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01074541
First Posted: February 24, 2010
Last Update Posted: February 24, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Danish Medical Research Council
Information provided by:
Bispebjerg Hospital
  Purpose
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 Intervention
Vitamin D Status Radiation: UVB

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • Vitamin D (nmol/l) [ Time Frame: 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:
  • Other parameters [ Time Frame: 2 days after radiation ]
    To invesitage whether other parameters like sex, BMI, Diet etc. influences the vitamin D production after UVB exposure.


Enrollment: 55
Study Start Date: January 2008
Study Completion Date: February 2010
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1
UV intensity 10 MIN
Radiation: UVB
0.375 SED x 4 in a week
Other Name: UVB radiation
Radiation: UVB
0.75 SED x 4 in a week
Other Name: UVB radiation
Radiation: UVB
1.5 SED x 4 in a week
Other Name: UVB radiation
Radiation: UVB
3.0 SED x 4 in a week
Other Name: UVB radiation
Active Comparator: Group 2
UV intensity 5 MIN
Radiation: UVB
0.375 SED x 4 in a week
Other Name: UVB radiation
Radiation: UVB
0.75 SED x 4 in a week
Other Name: UVB radiation
Radiation: UVB
1.5 SED x 4 in a week
Other Name: UVB radiation
Radiation: UVB
3.0 SED x 4 in a week
Other Name: UVB radiation
Active Comparator: Group 3
UV intensity 1 MIN
Radiation: UVB
3.0 SED x 4 in a week
Other Name: UVB radiation
Active Comparator: Group 4
UV intensity 20 MIN
Radiation: UVB
1.5 SED x 4 in a week
Other Name: UVB radiation
Radiation: UVB
3.0 SED x 4 in a week
Other Name: UVB radiation

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01074541


Locations
Denmark
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
  More Information

Responsible Party: Morten Bogh MD, Bispebjerg Hospital, Department of Dermatology
ClinicalTrials.gov Identifier: NCT01074541     History of Changes
Other Study ID Numbers: 271-08-0461
First Submitted: February 23, 2010
First Posted: February 24, 2010
Last Update Posted: February 24, 2010
Last Verified: February 2010

Keywords provided by Bispebjerg Hospital:
Vitamin D
UVB
Dose-Response
UV intensity
Skin cancer

Additional relevant MeSH terms:
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents