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The Genetics Behind Vitamin D Status (VitDgen) (VitDgen)

Primary Purpose

Vitamin D Deficiency

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
VitDgen
Sponsored by
Technical University of Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Vitamin D Deficiency focused on measuring SNPs, vitamin D, Vitamin D status, UVB irradiation, genetics

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Bispebjerg Hospital
  • DTU / National Food Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

UV-B irraditation

Arm Description

VitDgen

Outcomes

Primary Outcome Measures

serum 25-hydroxyvitamin D
Measures the vitamin D status i serum at baseline and at the end of the project

Secondary Outcome Measures

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

Full Information

First Posted
November 30, 2012
Last Updated
July 31, 2013
Sponsor
Technical University of Denmark
Collaborators
Bispebjerg Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01741233
Brief Title
The Genetics Behind Vitamin D Status (VitDgen)
Acronym
VitDgen
Official Title
The Genetics Behind Vitamin D Status (VitDgen)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Technical University of Denmark
Collaborators
Bispebjerg Hospital

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
Keywords
SNPs, vitamin D, Vitamin D status, UVB irradiation, genetics

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UV-B irraditation
Arm Type
Experimental
Arm Description
VitDgen
Intervention Type
Genetic
Intervention Name(s)
VitDgen
Primary Outcome Measure Information:
Title
serum 25-hydroxyvitamin D
Description
Measures the vitamin D status i serum at baseline and at the end of the project
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Skintest
Description
Optimize scientific; measures pigmentation and redness of the skin. Are measured at baseline and at end of project
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lone Rasmussen, M.Sc., Ph.D.
Organizational Affiliation
DTU, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bispebjerg Hospital
City
Bispebjerg
State/Province
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Facility Name
DTU / National Food Institute
City
Morkhoj
State/Province
Søborg
ZIP/Postal Code
2860
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
25527766
Citation
Nissen J, Vogel U, Ravn-Haren G, Andersen EW, Madsen KH, Nexo BA, Andersen R, Mejborn H, Bjerrum PJ, Rasmussen LB, Wulf HC. Common variants in CYP2R1 and GC genes are both determinants of serum 25-hydroxyvitamin D concentrations after UVB irradiation and after consumption of vitamin D(3)-fortified bread and milk during winter in Denmark. Am J Clin Nutr. 2015 Jan;101(1):218-27. doi: 10.3945/ajcn.114.092148. Epub 2014 Nov 5.
Results Reference
derived

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The Genetics Behind Vitamin D Status (VitDgen)

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