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Maintenance of Vitamin D Level by UVB Radiation

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ClinicalTrials.gov Identifier: NCT01101243
Recruitment Status : Completed
First Posted : April 9, 2010
Last Update Posted : April 9, 2010
Sponsor:
Collaborator:
The Danish Medical Research Council
Information provided by:
Bispebjerg Hospital

Brief Summary:
The purpose of the study is to determine the frequency of UVB radiations necessary to maintain the Vitamin D level during winter time.

Condition or disease Intervention/treatment Phase
Vitamin D Status Radiation: Broadband UVB Other: Control group Not Applicable

Detailed Description:
The work is addressing vitamin D production after UVB exposure and explore how much UVB radiation which is necessary to maintain a sufficient vitamin D level during the winter period in Denmark. 4 different UVB exposure times and 2 different UVB doses to 2 different body surface areas.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: How Much UVB Radiation is Necessary to Maintain Summer Vitamin D Level During Winter?
Study Start Date : October 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Group 1
Body surface area: 88 %
Radiation: Broadband UVB
UVB dose: 1 SED every week
Active Comparator: Group 2
Body surface area: 22 %
Radiation: Broadband UVB
UVB dose: 4 SED every second week
Active Comparator: Group 3
Body surface area: 88 %
Radiation: Broadband UVB
UVB dose: 1 SED every second week
Active Comparator: Group 4
Body surface area: 88 %
Radiation: Broadband UVB
UVB dose: 1 SED every month
No Intervention: Group 5
Body surface area: 0 %
Other: Control group
No intervention



Primary Outcome Measures :
  1. Vitamin D (nmol/l) [ Time Frame: Monthly during 4 months ]
    Vitamin D measured in a blood sample to define the relationship between frequency of UVB radiations and the Vitamin D level.


Secondary Outcome Measures :
  1. Parathyroideahormone (pmol/l) [ Time Frame: 4 months ]
    To investigate whether parathyroideahormone is influenced by the UVB radiations.



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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

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): NCT01101243


Locations
Denmark
Bispebjerg Hospital
Copenhagen, NV, Denmark, 2400
Sponsors and Collaborators
Bispebjerg Hospital
The Danish Medical Research Council
Investigators
Study Chair: Hans Christian Wulf, Professor Bispebjerg Hospital, Department of Dermatology

Responsible Party: Morten Bogh MD, Bispebjerg Hospital, Department of Dermatology
ClinicalTrials.gov Identifier: NCT01101243     History of Changes
Other Study ID Numbers: H-C-2008-072
First Posted: April 9, 2010    Key Record Dates
Last Update Posted: April 9, 2010
Last Verified: April 2010

Keywords provided by Bispebjerg Hospital:
Vitamin D
UVB
Frequency
Body surface area
Dose-Response

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