Clinical trial NCT03388203: LC-MS/MS 25(OH)D Status in a Large Cohort
Official title: LC-MS/MS Based 25(OH)D Status in a Large Central European Outpatient Cohort- Gender and Age Specific Differences
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 25(OH)D Measurement and 25(OH)D Deficiency
Keywords: 25(OH)D
PTH
mass spectrometry
data mining
Lead sponsor: Azienda Ospedaliera di Bolzano
Sponsor class: OTHER
First posted: 2018-01-02
Enrollment: 74235
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The investigators analyzed retrospectively all serum 25(OH)D results from outpatients ( \>18 years ) that were generated between January 1, 2015 and December 31, 2016 at the Central Laboratory of Clinical Pathology at the Bolzano Hospital (Italy). Out of 74,235 samples 3,801 cases were identified where PTH was requested at the same occasion.

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.

Eligibility criteria: Inclusion Criteria:

* \>18 years, outpatients;

Exclusion Criteria:

* \<18 years, inpatients;

Primary outcomes:
measure: 25(OH)D measurement
timeFrame: 2015-2016
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Clinical Institute for Medical and Chemical Laboratory Diagnostics, Medical University of Graz, Austria
name: MARKUS HERRMANN, Medicine
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Hilger J, Friedel A, Herr R, Rausch T, Roos F, Wahl DA, Pierroz DD, Weber P, Hoffmann K. A systematic review of vitamin D status in populations worldwide. Br J Nutr. 2014 Jan 14;111(1):23-45. doi: 10.1017/S0007114513001840. Epub 2013 Aug 9.