NCT01741233

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

August 1, 2013

Status Verified

December 1, 2012

Enrollment Period

4 months

First QC Date

November 30, 2012

Last Update Submit

July 31, 2013

Conditions

Vitamin D Deficiency

Keywords

SNPsvitamin DVitamin D statusUVB irradiationgenetics

Outcome Measures

Primary Outcomes (1)

  • serum 25-hydroxyvitamin D

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

    10 days

Secondary Outcomes (1)

  • Skintest

    10 days

Study Arms (1)

UV-B irraditation

EXPERIMENTAL

VitDgen

Genetic: VitDgen

Interventions

VitDgenGENETIC
UV-B irraditation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Health participants over 18 years, that previously participated in VitmaD intervention study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bispebjerg Hospital

Bispebjerg, Copenhagen, 2400, Denmark

Location

DTU / National Food Institute

Mørkhøj, Søborg, 2860, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 25527766DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Lone Rasmussen, M.Sc., Ph.D.

    DTU, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.Sc., Ph.D.

Study Record Dates

First Submitted

November 30, 2012

First Posted

December 4, 2012

Study Start

November 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

August 1, 2013

Record last verified: 2012-12

Locations

DK(2)