Maintenance of Vitamin D Level by UVB Radiation

This study has been completed.
Sponsor:
Collaborator:
The Danish Medical Research Council
Information provided by:
Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT01101243
First received: April 8, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
  Purpose

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


Condition Intervention
Vitamin D Status
Radiation: Broadband UVB
Other: Control group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: How Much UVB Radiation is Necessary to Maintain Summer Vitamin D Level During Winter?

Resource links provided by NLM:


Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • Vitamin D (nmol/l) [ Time Frame: Monthly during 4 months ] [ Designated as safety issue: No ]
    Vitamin D measured in a blood sample to define the relationship between frequency of UVB radiations and the Vitamin D level.


Secondary Outcome Measures:
  • Parathyroideahormone (pmol/l) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    To investigate whether parathyroideahormone is influenced by the UVB radiations.


Enrollment: 75
Study Start Date: October 2008
Study Completion Date: April 2010
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: April 8, 2010
Last Updated: April 8, 2010
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

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

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

ClinicalTrials.gov processed this record on August 28, 2014