The Genetics Behind Vitamin D Status (VitDgen)

Vitamin D Deficiency Clinical Trial

— VitDgen  

Official title:

The Genetics Behind Vitamin D Status (VitDgen)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01741233
• Other study ID #: H-4-2012-071
• Status: Completed
• Phase: N/A
• First received: November 30, 2012
• Last updated: July 31, 2013
• Start date: November 2012
• Est. completion date: March 2013

Study information

• Verified date: December 2012
• Source: Technical University of Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The overall purpose of the study is to investigate whether there is a relationship between 26 different single nucleotide polymorphisms (SNPs) in the vitamin D pathway, ultraviolet B (UV-B) irradiation of the skin and vitamin D status.

The hypothesis is that vitamin D status are influated by different genetic genotypes in the vitamin D pathway.

Description:

In this study approximately 80 participants (over 18 years) are included. All the participants has previously participated in the VitmaD intervention study (NCT01184716) .

Participants will in total receive 4 times UV-B irradiation (3 SED) with two day apart each time, to stimulate vitamin D production in the skin. The participants skintype will be measured. The study starts in January 2013 and runs to the end of Marts 2013. During this winter period, it is in Denmark not possible to produce vitamin D in the skin through sunlight exposure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Health participants over 18 years, that previously participated in VitmaD intervention study

Exclusion Criteria:

• skindiseases

• intake of medicin that causes photosensitive skin

• pregnant or nursing

• sun vacation 3 month before the intervention

• intake of vitamin D supplement 3 month before the intervention

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Genetic:
• VitDgen

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Bispebjerg	Copenhagen
Denmark	DTU / National Food Institute	Morkhoj	Søborg

Sponsors (2)

Lead Sponsor	Collaborator
Technical University of Denmark	Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum 25-hydroxyvitamin D	Measures the vitamin D status i serum at baseline and at the end of the project	10 days	No
Secondary	Skintest	Optimize scientific; measures pigmentation and redness of the skin. Are measured at baseline and at end of project	10 days	No