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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01741233
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : August 1, 2013
Sponsor:
Collaborator:
Bispebjerg Hospital
Information provided by (Responsible Party):
Lone Banke Rasmussen, Technical University of Denmark

Tracking Information
First Submitted Date  ICMJE November 30, 2012
First Posted Date  ICMJE December 4, 2012
Last Update Posted Date August 1, 2013
Study Start Date  ICMJE November 2012
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2012)
serum 25-hydroxyvitamin D [ Time Frame: 10 days ]
Measures the vitamin D status i serum at baseline and at the end of the project
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2012)
Skintest [ Time Frame: 10 days ]
Optimize scientific; measures pigmentation and redness of the skin. Are measured at baseline and at end of project
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Genetics Behind Vitamin D Status (VitDgen)
Official Title  ICMJE The Genetics Behind Vitamin D Status (VitDgen)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Vitamin D Deficiency
Intervention  ICMJE Genetic: VitDgen
Study Arms  ICMJE Experimental: UV-B irraditation
VitDgen
Intervention: Genetic: VitDgen
Publications * Nissen J, Vogel U, Ravn-Haren G, Andersen EW, Madsen KH, Nexø 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 D₃-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 31, 2013)
102
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2012)
80
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01741233
Other Study ID Numbers  ICMJE H-4-2012-071
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lone Banke Rasmussen, Technical University of Denmark
Study Sponsor  ICMJE Technical University of Denmark
Collaborators  ICMJE Bispebjerg Hospital
Investigators  ICMJE
Principal Investigator: Lone Rasmussen, M.Sc., Ph.D. DTU, Denmark
PRS Account Technical University of Denmark
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP