The Vitamin D Dose-Response Relationship

February 23, 2010 updated by: Bispebjerg Hospital

Vitamin D Production Depends on Ultraviolet-B Dose But Not on UV-intensity. A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • NV
      • Copenhagen NV, NV, Denmark, 2400
        • Bispebjerg Hospital, Department of Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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
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 4
UV intensity 20 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 days after exposure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 days after radiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Collaborators

The Danish Medical Research Council

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

February 23, 2010

First Submitted That Met QC Criteria

February 23, 2010

First Posted (Estimate)

February 24, 2010

Study Record Updates

Last Update Posted (Estimate)

February 24, 2010

Last Update Submitted That Met QC Criteria

February 23, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 271-08-0461

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vitamin D Status

Clinical Trials on UVB

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe