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LC-MS/MS 25(OH)D Status in a Large Cohort

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ClinicalTrials.gov Identifier: NCT03388203
Recruitment Status : Completed
First Posted : January 2, 2018
Last Update Posted : January 2, 2018
Sponsor:
Information provided by (Responsible Party):
Silvia Giuliani, Azienda Ospedaliera di Bolzano

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.


Condition or disease Intervention/treatment
25(OH)D Measurement and 25(OH)D Deficiency Diagnostic Test: 25(OH)D measurement, PTH measurement

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 Type : Observational
Actual Enrollment : 74235 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: LC-MS/MS Based 25(OH)D Status in a Large Central European Outpatient Cohort- Gender and Age Specific Differences
Actual Study Start Date : January 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : June 2017

Intervention Details:
    Diagnostic Test: 25(OH)D measurement, PTH measurement
    25(OH)D analyses by LC-MS/MS were performed as part of our routine clinical work with a commercial kit from Recipe (Munich, Germany) ; PTH was measured in lithium-heparin plasma using the PTH STAT assay from Roche Diagnostics (Mannheim, Germany) on a Cobas 8000 auto-analyzer.


Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • >18 years, outpatients;

Exclusion Criteria:

  • <18 years, inpatients;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03388203


Sponsors and Collaborators
Azienda Ospedaliera di Bolzano
Investigators
Principal Investigator: MARKUS HERRMANN, Medicine Clinical Institute for Medical and Chemical Laboratory Diagnostics, Medical University of Graz, Austria

Publications:

Responsible Party: Silvia Giuliani, Department of Clinical Pathology, Azienda Ospedaliera di Bolzano
ClinicalTrials.gov Identifier: NCT03388203     History of Changes
Other Study ID Numbers: 0055719-BZ
First Posted: January 2, 2018    Key Record Dates
Last Update Posted: January 2, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Silvia Giuliani, Azienda Ospedaliera di Bolzano:
25(OH)D
PTH
mass spectrometry
data mining