The Vitamin D Dose-Response Relationship

Vitamin D Status Clinical Trial

Official title:

Vitamin D Production Depends on Ultraviolet-B Dose But Not on UV-intensity. A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01074541
• Other study ID #: 271-08-0461
• Status: Completed
• Phase: N/A
• First received: February 23, 2010
• Last updated: February 23, 2010
• Start date: January 2008
• Est. completion date: February 2010

Study information

• Verified date: February 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 importance of the UV intensity and the UVB dose on the Vitamin D response after UVB.

Description:

The work is addressing vitamin D production after UVB exposure and explore the importance of UVB dose and UV intensity. Four different UVB doses and four different UV intensities are used to explore these relationships.

Many assumptions have been made concerning the vitamin D production after UVB exposure but only few studies exist.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: February 2010
• Est. primary completion date: March 2008
• 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

• Vitamin D Status

Intervention

Radiation:
• UVB
0.375 SED x 4 in a week
• UVB
0.75 SED x 4 in a week
• UVB
1.5 SED x 4 in a week
• UVB
3.0 SED x 4 in a week

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital, Department of Dermatology	Copenhagen NV	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 dose-response relationship between UVB dose, UV intensity and Vitamin D production in the skin after UVB exposure.	2 days after exposure	Yes
Secondary	Other parameters	To invesitage whether other parameters like sex, BMI, Diet etc. influences the vitamin D production after UVB exposure.	2 days after radiation	Yes