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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03388203
Recruitment Status : Completed
First Posted : January 2, 2018
Last Update Posted : January 2, 2018
Information provided by (Responsible Party):
Silvia Giuliani, Azienda Ospedaliera di Bolzano

Tracking Information
First Submitted Date December 18, 2017
First Posted Date January 2, 2018
Last Update Posted Date January 2, 2018
Actual Study Start Date January 2015
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 29, 2017)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title 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
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition 25(OH)D Measurement and 25(OH)D Deficiency
Intervention 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.
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 29, 2017)
Original Actual Enrollment Same as current
Actual Study Completion Date June 2017
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • >18 years, outpatients;

Exclusion Criteria:

  • <18 years, inpatients;
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
Administrative Information
NCT Number NCT03388203
Other Study ID Numbers 0055719-BZ
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Silvia Giuliani, Azienda Ospedaliera di Bolzano
Study Sponsor Azienda Ospedaliera di Bolzano
Collaborators Not Provided
Principal Investigator: MARKUS HERRMANN, Medicine Clinical Institute for Medical and Chemical Laboratory Diagnostics, Medical University of Graz, Austria
PRS Account Azienda Ospedaliera di Bolzano
Verification Date December 2017