Vitamin D DeficiencyVitDgenNCT01741233
The Genetics Behind Vitamin D Status (VitDgen)
A study testing VitDgen in people with Vitamin D Deficiency, run by Technical University of Denmark at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- VitDgen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 2 sitesDenmark
- Study dates
- Nov 2012to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Health participants over 18 years, that previously participated in VitmaD intervention study
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Bispebjerg Hospital
Bispebjerg, Copenhagen, 2400
DTU / National Food Institute
Mørkhøj, Søborg, 2860
About this study
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.
Read the 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.
- Conditions
- Vitamin D Deficiency
- Being tested
- VitDgen
- Keywords
- SNPs, vitamin D, Vitamin D status, UVB irradiation, genetics
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitDgenGenetic
| Study group | Role | What they receive |
|---|---|---|
| UV-B irraditation | Experimental | VitDgen Receives: Genetic: VitDgen |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum 25-hydroxyvitamin D
Measures the vitamin D status i serum at baseline and at the end of the project
Measured: 10 days
Secondary outcomes (1)
Skintest
Optimize scientific; measures pigmentation and redness of the skin. Are measured at baseline and at end of project
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Bispebjerg Hospital
- Responsible party
- Principal investigator, Lone Banke Rasmussen, Technical University of Denmark
- Investigators
- Lone Rasmussen, M.Sc., Ph.D., Principal investigator, DTU, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01741233
- Sponsor's protocol ID
- H-4-2012-071
- Acronym
- VitDgen
- Status last verified
- Dec 2012
- First submitted
- 30 Nov 2012
- Last updated
- 1 Aug 2013
- Results posted
- No
Publications
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.
PubMed 25527766
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Genetics Behind Vitamin D Status (VitDgen)
- ClinicalTrials.gov ID
- NCT01741233
- Acronym / sponsor ID
- VitDgen / H-4-2012-071
- Conditions
- Vitamin D Deficiency
- Keywords
- SNPs, vitamin D, Vitamin D status, UVB irradiation, genetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Technical University of DenmarkUniversity, hospital or other
- Collaborators
- Bispebjerg Hospital
- Study start
- Nov 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 4 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UV-B irraditation | Experimental | Genetic: VitDgenVitDgen |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Health participants over 18 years, that previously participated in VitmaD intervention study
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VitDgen | Genetic | UV-B irraditation |
Primary outcome
serum 25-hydroxyvitamin D
Time frame: 10 days
Measures the vitamin D status i serum at baseline and at the end of the project
1 secondary outcome
Skintest
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2013.
- Derived from this study: PubMed 25527766Nissen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lone Rasmussen, M.Sc., Ph.D. principal investigator
DTU, Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VitDgen in people with Vitamin D Deficiency, run by Technical University of Denmark at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum 25-hydroxyvitamin D (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01741233, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2013.