NCT01074541

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2010

Completed
Last Updated

February 24, 2010

Status Verified

February 1, 2010

Enrollment Period

2 months

First QC Date

February 23, 2010

Last Update Submit

February 23, 2010

Conditions

Vitamin D Status

Keywords

Vitamin DUVBDose-ResponseUV intensitySkin cancer

Outcome Measures

Primary Outcomes (1)

  • Vitamin D (nmol/l)

    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 Outcomes (1)

  • Other parameters

    2 days after radiation

Study Arms (4)

Group 1

ACTIVE COMPARATOR

UV intensity 10 MIN

Radiation: UVB

Group 2

ACTIVE COMPARATOR

UV intensity 5 MIN

Radiation: UVB

Group 3

ACTIVE COMPARATOR

UV intensity 1 MIN

Radiation: UVB

Group 4

ACTIVE COMPARATOR

UV intensity 20 MIN

Radiation: UVB

Interventions

UVBRADIATION

0.375 SED x 4 in a week

Also known as: UVB radiation
Group 1Group 2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years
  • Healthy

You may not qualify if:

  • Sun bed use
  • Holiday or business travel south of 45 degrees latitude during trial
  • Illness
  • Drug addiction
  • Pregnancy
  • Lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital, Department of Dermatology

Copenhagen NV, NV, 2400, Denmark

Location

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Hans Christian Wulf, Professor

    Bispebjerg Hospital, Deparment of Dermatology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 23, 2010

First Posted

February 24, 2010

Study Start

January 1, 2008

Primary Completion

March 1, 2008

Study Completion

February 1, 2010

Last Updated

February 24, 2010

Record last verified: 2010-02

Locations

DK(1)