NCT01395303

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9,700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

April 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2011

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

November 11, 2016

Status Verified

November 1, 2016

Enrollment Period

5.3 years

First QC Date

July 14, 2011

Last Update Submit

November 10, 2016

Conditions

Keywords

infarctionstrokediabetesfractureaortic stenosiscancerdeathvitamin Dandrogensthyroid hormones

Study Arms (8)

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

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • lacking DNA sample

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tromsø

Tromsø, Tromsø, 9037, Norway

Location

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

DNA from blood clots

MeSH Terms

Conditions

InfarctionStrokeDiabetes MellitusFractures, BoneAortic Valve StenosisNeoplasmsDeath

Condition Hierarchy (Ancestors)

IschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesWounds and InjuriesAortic Valve DiseaseHeart Valve DiseasesHeart DiseasesVentricular Outflow Obstruction

Study Officials

  • Rolf Jorde, Professor

    University of Tromso

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 14, 2011

First Posted

July 15, 2011

Study Start

April 1, 2011

Primary Completion

July 1, 2016

Study Completion

August 1, 2016

Last Updated

November 11, 2016

Record last verified: 2016-11

Locations