The Genetics Behind Vitamin D Status (VitDgen) | NCT01741233

Studies
The Genetics Behind Vitamin D Status (VitDgen)

NCT01741233

Sponsor

Technical University of Denmark

Status

Completed

Last Update Posted

Aug 1, 2013Estimated

Enrollment

102Actual

Phase

Not Applicable

Conditions

Vitamin D Deficiency

Interventions

VitDgen

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Mar 2013Actual

Completion Date

Mar 2013Actual

First Submitted Date

Nov 30, 2012

First Submission Date that Met QC Criteria

Nov 30, 2012

First Posted Date

Dec 4, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 31, 2013

Last Update Posted Date

Aug 1, 2013Estimated

Name	Class
Bispebjerg Hospital	OTHER

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

102Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
UV-B irraditation	Experimental	VitDgen	Genetic: VitDgen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VitDgen	Genetic		UV-B irraditation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lone Rasmussen, M.Sc., Ph.D.	DTU, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bispebjerg Hospital		Bispebjerg	Copenhagen	2400	Denmark
DTU / National Food Institute

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25527766	Derived	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.

ID	Term
D001361	Avitaminosis
D003677	Deficiency Diseases
D044342	Malnutrition
D009748	Nutrition Disorders