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CompletedNCT01395303Updated Nov 11, 2016

Polymorphisms in the Vitamin D System and Health

An observational study in Infarction, Stroke and Diabetes, sponsored by University of Tromso. Completed at 1 site in Norway. Open to participants aged 30 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-11.

Sponsored by University of Tromso · Observational

Study type
Observational
Time perspective
Retrospective
Enrollment
9,700
Ages
30 Years to 90 Years
Sex
All
01

Study summary

Polymorphisms in the vitamin D system appear to affect the serum 25(OH)D levels. If so one would expect these polymorphisms to be associated with vitamin D related conditions and diseases, which will be tested in the present study including DNA analyses in 9700 subjects

Read the detailed description

Vitamin D, which is essential in calcium metabolism, is produced in the skin after sun exposure or obtained from food, mainly fatty fish or vitamin D supplements. For activation vitamin D must be hydroxylated in the liver to 25(OH)D and thereafter in the kidney to 1,25(OH)2D. In the circulation 25(OH)D and 1,25(OH)2D are bound to a carrier protein (DBP), and for 1,25(OH)2D to exert its effect it has to bind to the vitamin D receptor (VDR).

The serum level of 25(OH)D, which is the metabolite used to evaluate a person's vitamin D status, is in part genetically determined and several polymorphisms with effects on serum 25(OH)D have been identified. These polymorphisms, where the minor allele frequencies vary between 16 and 40 %, appear as important for the serum 25(OH)D level as the effect of season, physical activity or vitamin D supplementation.

Vitamin D is not only vital for the skeleton, but appears to be related to a number of health outcomes, including mortality as previously demonstrated in the Tromsø study. However, as the serum level of 25(OH)D is strongly influenced by life-style factors that are also related to health outcomes, it is difficult to decide whether the relation between vitamin D and health is causal or not.

On the other hand, the polymorphisms are not influenced by life-style, and the effect of the polymorphisms will be life-long. Accordingly, they may be a better marker of vitamin D status than a single serum 25(OH)D measurement. Furthermore, there are a number of polymorphisms regarding the vitamin D receptor (VDR) that may be associated with health.

In the present study we will therefore relate the polymorphisms affecting the serum 25(OH)D level and the function of the VDR, with anthropometric and biochemical measures, mortality, diseases and risk factors for disease. DNA will be obtained from the 4th Tromsø study.

If we find the expected associations between the polymorphisms and diseases, this will further strengthen the role of vitamin D in human health, and may be important for recommendations regarding vitamin D supplementation. Considering the high prevalence of vitamin D deficiency world wide, this may potentially have huge consequences for public health.

The main purpose of the present study is the vitamin D system, but in the Tromsø study we have previously also found a number of associations between thyroid and androgen function and health. Obtaining DNA for analysis will be the major cost in the project, whereas analyses of individual polymorphisms are relatively cheap. We will therefore also include polymorphisms regarding thyroid and androgen function.

02

Conditions studied

  • Infarction
  • Stroke
  • Diabetes
  • Fracture
  • Aortic Stenosis
  • Cancer
  • Death

Keywords

  • infarction
  • stroke
  • diabetes
  • fracture
  • aortic stenosis
  • cancer
  • death
  • vitamin D
  • androgens
  • thyroid hormones
03

In context

Aortic Valve Stenosis

985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.

This study's enrollment of 9,700 is above the median of 200 across 424 observational studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Lead sponsor

University of Tromso is the lead sponsor of 61 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Subjects from the fourth Tromsø study performed in 1994-1995 who had blood samples taken for later DNA analyses

Inclusion criteria

  • participated in the fourth Tromsø study, later registered in our end point registry or selected as a control subject

Exclusion criteria

Exclusion Criteria:

  • lacking DNA sample
05

Study design

Time perspective
Retrospective
Enrollment
9,700 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • myocardial infarction

    subjects with myocardial infarction in the Tromsø study end point registry

  • type 2 diabetes

    subjects with type 2 diabetes in the Tromsø study end point registry

  • stroke

    subjects with stroke in the Tromsø study end point registry

  • fracture

    subjects with fracture in the Tromsø study end point registry

  • cancer

    subjects with cancer in the Tromsø study end point registry

  • death

    subjects registered as dead in the Tromsø study end point registry

  • aortic stenosis

    subjects with aortic stenosis in the Tromsø study end point registry

  • control group

    randomly selected controls from the Tromsø study

06

Study locations

1 site
  • University of Tromsø
    Tromsø, 9037, Norway
07

References and documents

Publications

  • Jorde R, Schirmer H, Wilsgaard T, Joakimsen RM, Mathiesen EB, Njolstad I, Lochen ML, Figenschau Y, Berg JP, Svartberg J, Grimnes G. Polymorphisms related to the serum 25-hydroxyvitamin D level and risk of myocardial infarction, diabetes, cancer and mortality. The Tromso Study. PLoS One. 2012;7(5):e37295. doi: 10.1371/journal.pone.0037295. Epub 2012 May 23. PubMed 22649517 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01395303
Lead sponsor
University of Tromso
Responsible party
Rolf Jorde (Professor, University of Tromso) — Principal investigator
First posted
Jul 15, 2011
Start date
Apr 2011
Primary completion
Jul 2016
Completion
Aug 2016
Last update
Nov 11, 2016

Study contacts

Rolf Jorde, Professor
principal investigator · University of Tromso

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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