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Clinical Trials/NCT03388203
NCT03388203CompletedNot Applicable

LC-MS/MS Based 25(OH)D Status in a Large Central European Outpatient Cohort- Gender and Age Specific Differences

Azienda Ospedaliera di Bolzano0 sites74,235 target enrollmentStarted: January 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
74,235
Primary Endpoint
25(OH)D measurement

Study Overview

Brief Summary

The present study assessed serum 25(OH)D in a cohort of 74235 outpatients by liquid-chromatography-tandem-mass-spectrometry (LC-MS/MS).

The investigators studied the distribution of serum 25(OH)D concentrations in males and females of different age groups, the prevalence of measurable amounts of 25(OH)D2 and seasonal variability.

Detailed Description

Measurements were performed under routine circumstances. Samples were collected in serum tubes with clot-activator. As per routine procedure, samples were centrifuged upon arrival in the lab and stored at 4° C until measurement. 25(OH)D3 and 25(OH)D2 were quantitated separately. Results from subjects <18 years were excluded from the analysis. The study was approved by the local Ethics Committee.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • >18 years, outpatients;

Exclusion Criteria

  • <18 years, inpatients;

Outcomes

Primary Outcomes

25(OH)D measurement

Time Frame: 2015-2016

Describe the 25(OH)D status in South-Tyrol,a region in central Europe, by a rigorously controlled, NIST 972a aligned LC-MS/MS method.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Azienda Ospedaliera di Bolzano
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Silvia Giuliani

Department of Clinical Pathology

Azienda Ospedaliera di Bolzano

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