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

July 31, 2013 updated by: Lone Banke Rasmussen, Technical University of Denmark

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Copenhagen
      • Bispebjerg, Copenhagen, Denmark, 2400
        • Bispebjerg Hospital
    • Søborg
      • Morkhoj, Søborg, Denmark, 2860
        • DTU / National Food Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum 25-hydroxyvitamin D
Time Frame: 10 days
Measures the vitamin D status i serum at baseline and at the end of the project
10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skintest
Time Frame: 10 days
Optimize scientific; measures pigmentation and redness of the skin. Are measured at baseline and at end of project
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Denmark

Collaborators

Bispebjerg Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

November 30, 2012

First Submitted That Met QC Criteria

November 30, 2012

First Posted (Estimate)

December 4, 2012

Study Record Updates

Last Update Posted (Estimate)

August 1, 2013

Last Update Submitted That Met QC Criteria

July 31, 2013

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-4-2012-071

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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