The Genetics Behind Vitamin D Status (VitDgen)

This study has been completed.
Sponsor:
Collaborator:
Bispebjerg Hospital
Information provided by (Responsible Party):
Lone Banke Rasmussen, Technical University of Denmark
ClinicalTrials.gov Identifier:
NCT01741233
First received: November 30, 2012
Last updated: July 31, 2013
Last verified: December 2012
  Purpose

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 Intervention
Vitamin D Deficiency
Genetic: VitDgen

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: The Genetics Behind Vitamin D Status (VitDgen)

Resource links provided by NLM:


Further study details as provided by Technical University of Denmark:

Primary Outcome Measures:
  • serum 25-hydroxyvitamin D [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Measures the vitamin D status i serum at baseline and at the end of the project


Secondary Outcome Measures:
  • Skintest [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Optimize scientific; measures pigmentation and redness of the skin. Are measured at baseline and at end of project


Enrollment: 102
Study Start Date: November 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: UV-B irraditation
VitDgen
Genetic: VitDgen

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01741233

Locations
Denmark
Bispebjerg Hospital
Bispebjerg, Copenhagen, Denmark, 2400
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
  More Information

No publications provided

Responsible Party: Lone Banke Rasmussen, M.Sc., Ph.D., Technical University of Denmark
ClinicalTrials.gov Identifier: NCT01741233     History of Changes
Other Study ID Numbers: H-4-2012-071
Study First Received: November 30, 2012
Last Updated: July 31, 2013
Health Authority: Denmark: Ethics Committee

Keywords provided by Technical University of Denmark:
SNPs
vitamin D
Vitamin D status
UVB irradiation
genetics

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 16, 2014