NCT01042197

Brief Summary

The purpose of this study is to investigate the relation between vitamin D production after UVB and exposed body surface areas with different UVB doses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 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
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2010

Completed
Last Updated

January 12, 2010

Status Verified

December 1, 2007

Enrollment Period

1.2 years

First QC Date

January 4, 2010

Last Update Submit

January 11, 2010

Conditions

Vitamin D Status

Keywords

Vitamin DUVBDose-ResponseBody surface area

Outcome Measures

Primary Outcomes (1)

  • Vitamin D (nmol/l) measured in a blood sample to define just how much sun exposure is necessary to obtain a sufficient vitamin D production.

    Before and 2 days after the last UVB session.

Study Arms (9)

2

ACTIVE COMPARATOR

Body surface area: 12 %

Radiation: Broadband UVB

1

ACTIVE COMPARATOR

Body surface area: 6 %

Radiation: Broadband UVB

3

ACTIVE COMPARATOR

Body surface area: 24 %

Radiation: Broadband UVB

4

ACTIVE COMPARATOR

Body surface area: 6 %

Radiation: Broadband UVB

5

ACTIVE COMPARATOR

Body surface area: 12 %

Radiation: Broadband UVB

6

ACTIVE COMPARATOR

Body surface area: 24 %

Radiation: Broadband UVB

7

ACTIVE COMPARATOR

Body surface area: 6 %

Radiation: Broadband UVB

8

ACTIVE COMPARATOR

Body surface area: 12 %

Radiation: Broadband UVB

9

ACTIVE COMPARATOR

Body surface area: 24 %

Radiation: Broadband UVB

Interventions

Broadband UVBRADIATION

UVB dose: 0.75 SED. Four UVB sessions with 2 days in between.

1

Eligibility Criteria

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

You may qualify if:

  • Healthy individuals between 18 - 65 years of age.
  • Avoidance of sun bed exposure
  • Not Holidaying south of 45 degrees latitude 3 months before
  • Avoiding vitamin D supplementation during and two months before

You may not qualify if:

  • Illness as well as age above 65 years.
  • Skin diseases
  • Psychiatric diseases
  • Drug addiction
  • Intake of photosensitive medicine.
  • Intake of cholesterol-lowering medicine.
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital, Department of Dermatology D92, Bispebjerg Bakke 23,

Copenhagen Nv, Copenhagen, 2400, Denmark

Location

Study Officials

  • Hans Christian Wulf, Full Prof.

    Bispebjerg Hospital

    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

January 4, 2010

First Posted

January 5, 2010

Study Start

January 1, 2008

Primary Completion

April 1, 2009

Study Completion

December 1, 2009

Last Updated

January 12, 2010

Record last verified: 2007-12

Locations

DK(1)