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NCT01101243 Clinical Trial

Maintenance of Vitamin D Level by UVB Radiation

Vitamin D Status Clinical Trial

Official title:
How Much UVB Radiation is Necessary to Maintain Summer Vitamin D Level During Winter?

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01101243
Other study ID # H-C-2008-072
Secondary ID
Status Completed
Phase N/A
First received April 8, 2010
Last updated April 8, 2010
Start date October 2008
Est. completion date April 2010

Study information
Verified date April 2010
Source Bispebjerg Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: The Danish National Committee on Biomedical Research Ethics
Study type Interventional

Clinical Trial Summary

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

Description:

The work is addressing vitamin D production after UVB exposure and explore how much UVB radiation which is necessary to maintain a sufficient vitamin D level during the winter period in Denmark. 4 different UVB exposure times and 2 different UVB doses to 2 different body surface areas.

Recruitment information / eligibility
Status Completed
Enrollment 75
Est. completion date April 2010
Est. primary completion date March 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- 18-65 years

- Healthy

Exclusion Criteria:

- Sun bed use

- Holiday or business travel south of 45 degrees latitude during trial

- Illness

- Drug addiction

- Pregnancy

- Lactating

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Radiation:
• Broadband UVB
UVB dose: 1 SED every week
• Broadband UVB
UVB dose: 4 SED every second week
• Broadband UVB
UVB dose: 1 SED every second week
• Broadband UVB
UVB dose: 1 SED every month
Other:
• Control group
No intervention

Locations
Country Name City State
Denmark Bispebjerg Hospital Copenhagen NV

Sponsors (2)
Lead Sponsor Collaborator
Bispebjerg Hospital The Danish Medical Research Council

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Parathyroideahormone (pmol/l) To investigate whether parathyroideahormone is influenced by the UVB radiations. 4 months No
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