The Relation Between Vitamin D Production and UVB Exposed Body Surface Area

NCT ID: NCT01042197

Last Updated: 2010-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Vitamin D deficiency is very common. Rachitis, osteoporosis, cancer, sclerosis as well as cardiovascular diseases are related to vitamin D deficiency. Elderly people, immigrants as well as patients with malabsorption diseases often have vitamin D deficiency. 90-95 % of the total vitamin D requirements are obtained from the ultraviolet (UV) radiation of the skin.In spite of the risk of skin-cancer, treatment with sunlight radiation is often recommended against vitamin D deficiency. This fact has raised a scientific debate, where concern has been expressed with regard to the risk of skin-cancer. This dilemma should also be examined as no human studies are available on the vitamin D production in the skin after UV-radiation showing the frequency and dose necessary for sufficient production of vitamin D. The lowest exposure frequency, the smallest body surface area and the lowest UV dose should therefore be established to be exposed in order to minimize the risk of skin-cancer by unnecessary UV-radiation. The purpose of the project is therefore to clarify which factors there are of importance for the production of vitamin D in the skin after UVB radiation.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vitamin D Status

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

2

Body surface area: 12 %

Group Type ACTIVE_COMPARATOR

Broadband UVB

Intervention Type RADIATION

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

1

Body surface area: 6 %

Group Type ACTIVE_COMPARATOR

Broadband UVB

Intervention Type RADIATION

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

3

Body surface area: 24 %

Group Type ACTIVE_COMPARATOR

Broadband UVB

Intervention Type RADIATION

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

4

Body surface area: 6 %

Group Type ACTIVE_COMPARATOR

Broadband UVB

Intervention Type RADIATION

UVB dose: 1.5 SED. Four UVB sessions with 2 days in between.

5

Body surface area: 12 %

Group Type ACTIVE_COMPARATOR

Broadband UVB

Intervention Type RADIATION

UVB dose: 1.5 SED. Four UVB sessions with 2 days in between.

6

Body surface area: 24 %

Group Type ACTIVE_COMPARATOR

Broadband UVB

Intervention Type RADIATION

UVB dose: 1.5 SED. Four UVB sessions with 2 days in between.

7

Body surface area: 6 %

Group Type ACTIVE_COMPARATOR

Broadband UVB

Intervention Type RADIATION

UVB dose: 3.0 SED. Four UVB sessions with 2 days in between.

8

Body surface area: 12 %

Group Type ACTIVE_COMPARATOR

Broadband UVB

Intervention Type RADIATION

UVB dose: 3.0 SED. Four UVB sessions with 2 days in between.

9

Body surface area: 24 %

Group Type ACTIVE_COMPARATOR

Broadband UVB

Intervention Type RADIATION

UVB dose: 3.0 SED. Four UVB sessions with 2 days in between.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Broadband UVB

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

Intervention Type RADIATION

Broadband UVB

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

Intervention Type RADIATION

Broadband UVB

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

Intervention Type RADIATION

Broadband UVB

UVB dose: 1.5 SED. Four UVB sessions with 2 days in between.

Intervention Type RADIATION

Broadband UVB

UVB dose: 1.5 SED. Four UVB sessions with 2 days in between.

Intervention Type RADIATION

Broadband UVB

UVB dose: 1.5 SED. Four UVB sessions with 2 days in between.

Intervention Type RADIATION

Broadband UVB

UVB dose: 3.0 SED. Four UVB sessions with 2 days in between.

Intervention Type RADIATION

Broadband UVB

UVB dose: 3.0 SED. Four UVB sessions with 2 days in between.

Intervention Type RADIATION

Broadband UVB

UVB dose: 3.0 SED. Four UVB sessions with 2 days in between.

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Vejle Hospital

OTHER

Sponsor Role collaborator

Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Bispebjerg Hospital, Department of Dermatology

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hans Christian Wulf, Full Prof.

Role: STUDY_CHAIR

Bispebjerg Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Copenhagen Nv, Copenhagen, Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H-B-2007-100

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.