The Vitamin D Dose-Response Relationship

This study has been completed.
Sponsor:
Collaborator:
The Danish Medical Research Council
Information provided by:
Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT01074541
First received: February 23, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Morten Bogh MD, Bispebjerg Hospital, Department of Dermatology
ClinicalTrials.gov Identifier: NCT01074541     History of Changes
Other Study ID Numbers: 271-08-0461
Study First Received: February 23, 2010
Last Updated: February 23, 2010
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

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

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

ClinicalTrials.gov processed this record on October 30, 2014