The Genetics Behind Vitamin D Status (VitDgen)

• Sponsor: Technical University of Denmark (Other)
• Overall Status: Completed
• CT.gov ID: NCT01741233
• Collaborator: Bispebjerg Hospital (Other)
• Enrollment: 102
• Locations: 2
• Arm: 1
• Duration (Months): 3.9
• Patients Per Site: 51
• Patients Per Site Per Month: 12.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Vitamin D Deficiency	Genetic: VitDgen	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 102 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: The Genetics Behind Vitamin D Status (VitDgen)
• Study Start Date: Nov 1, 2012
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: UV-B irraditation VitDgen	Genetic: VitDgen

Outcome Measures

Primary Outcome Measures

1. serum 25-hydroxyvitamin D [10 days]

   Measures the vitamin D status i serum at baseline and at the end of the project

Secondary Outcome Measures

1. Skintest [10 days]

   Optimize scientific; measures pigmentation and redness of the skin. Are measured at baseline and at end of project

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bispebjerg Hospital	Bispebjerg	Copenhagen	Denmark	2400
2	DTU / National Food Institute	Morkhoj	Søborg	Denmark	2860

Sponsors and Collaborators

• Technical University of Denmark
• Bispebjerg Hospital

Investigators

• Principal Investigator: Lone Rasmussen, M.Sc., Ph.D., DTU, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lone Banke Rasmussen, M.Sc., Ph.D., Technical University of Denmark
• ClinicalTrials.gov Identifier: NCT01741233
• Other Study ID Numbers: H-4-2012-071
• First Posted: Dec 4, 2012
• Last Update Posted: Aug 1, 2013
• Last Verified: Dec 1, 2012

• Keywords provided by Lone Banke Rasmussen, M.Sc., Ph.D., Technical University of Denmark: SNPs; vitamin D; Vitamin D status; UVB irradiation; genetics
• Additional relevant MeSH terms: Vitamin D Deficiency

Study Results

No Results Posted as of Aug 1, 2013