NCT01101243

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2008

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

October 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 9, 2010

Completed
Last Updated

April 9, 2010

Status Verified

April 1, 2010

Enrollment Period

5 months

First QC Date

April 8, 2010

Last Update Submit

April 8, 2010

Conditions

Vitamin D Status

Keywords

Vitamin DUVBFrequencyBody surface areaDose-Response

Outcome Measures

Primary Outcomes (1)

  • Vitamin D (nmol/l)

    Vitamin D measured in a blood sample to define the relationship between frequency of UVB radiations and the Vitamin D level.

    Monthly during 4 months

Secondary Outcomes (1)

  • Parathyroideahormone (pmol/l)

    4 months

Study Arms (5)

Group 1

ACTIVE COMPARATOR

Body surface area: 88 %

Radiation: Broadband UVB

Group 2

ACTIVE COMPARATOR

Body surface area: 22 %

Radiation: Broadband UVB

Group 3

ACTIVE COMPARATOR

Body surface area: 88 %

Radiation: Broadband UVB

Group 4

ACTIVE COMPARATOR

Body surface area: 88 %

Radiation: Broadband UVB

Group 5

NO INTERVENTION

Body surface area: 0 %

Other: Control group

Interventions

Broadband UVBRADIATION

UVB dose: 1 SED every week

Group 1
Control groupOTHER

No intervention

Group 5

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

Copenhagen, NV, 2400, Denmark

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Hans Christian Wulf, Professor

    Bispebjerg Hospital, Department 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

April 8, 2010

First Posted

April 9, 2010

Study Start

October 1, 2008

Primary Completion

March 1, 2009

Study Completion

April 1, 2010

Last Updated

April 9, 2010

Record last verified: 2010-04

Locations

DK(1)