NCT01261039

Brief Summary

Background: Some patients do not readily absorb vitamin D from intestine. These patients may be helped by ultraviolet rays, which can come from sunlight or solar beds. When the skin is exposed to ultraviolet B rays (UVB) vitamin D is produced. This usually happens when the skin is exposed to sunlight. Vitamin D can also be ingested trough some foods, mainly fatty fish or supplements. Vitamin D is important for bone, and long-term vitamin D deficiency can lead to osteoporosis. Vitamin D may also be important for the immune system-including autoimmune diseases-and the cardiovascular system. Purpose: The main purpose of the study is to learn more about the production of vitamin D3 in the skin, by ultraviolet radiation. Study Course: Day 0: Randomization. Subjects are randomized to two groups. Subjects in both groups will be exposed to light in a solar bed for approximately 10 minutes on the first day, but only one of the solar beds wields ultraviolet rays. The other has a filter, which filters out the ultraviolet rays. Blood samples are drawn on the first day at following times: Before solar bed, after at 15 minutes, 1, 2, 4 and 6 hours. Day 1,2,3 and 7 after solar bed exposure: Blood samples are drawn and adverse events are registered.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2010

Shorter than P25 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

April 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 16, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

March 16, 2012

Status Verified

March 1, 2012

Enrollment Period

10 months

First QC Date

December 15, 2010

Last Update Submit

March 15, 2012

Conditions

Production of Vitamin D in Skin When Exposed to UV-B by Solar Bed.

Outcome Measures

Primary Outcomes (1)

  • Vitamin D 25-OHD

    8 days

Secondary Outcomes (1)

  • Changes in other calcium metabolic factors

    8 days

Study Arms (2)

Solar bed UV-radiation

ACTIVE COMPARATOR

Solar bed UV-radiation

Radiation: UV radiation

Solar bed with UV filter

SHAM COMPARATOR

Solar bed with UV filter

Radiation: UV radiation

Interventions

UV radiationRADIATION

Subjects in both groups will be exposed to light in a solar bed for approximately 10 minutes (depending on Fitzpatrick skin type test) on the first day, but only one of the solar beds wields ultraviolet rays. The other has a filter, which filters out the ultraviolet rays.

Solar bed UV-radiationSolar bed with UV filter

Eligibility Criteria

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

You may qualify if:

  • Healthy adults

You may not qualify if:

  • Abnormal ALT or Creatinine Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

Related Publications (1)

  • Langdahl JH, Schierbeck LL, Bang UC, Jensen JE. Changes in serum 25-hydroxyvitamin D and cholecalciferol after one whole-body exposure in a commercial tanning bed: a randomized study. Endocrine. 2012 Oct;42(2):430-5. doi: 10.1007/s12020-012-9641-z. Epub 2012 Mar 6.

    PMID: 22391940DERIVED

MeSH Terms

Interventions

Ultraviolet Rays

Intervention Hierarchy (Ancestors)

LightElectromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaOptical PhenomenaRadiationRadiation, IonizingRadiation, NonionizingSunlightWeatherAtmosphereEnvironmentEcological and Environmental PhenomenaBiological PhenomenaMeteorological ConceptsEnvironment and Public Health

Study Officials

  • Jens-Erik B Jensen, MD, PhD

    Hvidovre University Hospital

    STUDY CHAIR

  • Louise L Schierbeck, MD

    Dept. of Endocrinology

    STUDY CHAIR

  • Ulrich Bang, MD

    Hvidovre University Hospital

    STUDY CHAIR

  • Jakob H Langdahl

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, research fellow

Study Record Dates

First Submitted

December 15, 2010

First Posted

December 16, 2010

Study Start

April 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

March 16, 2012

Record last verified: 2012-03

Locations

DK(1)