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OpenTrials
Completed

NCT Number: NCT03388203

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >18 years, outpatients;

Exclusion criteria

  • <18 years, inpatients;

Treatment and study plan

25(OH)D measurement, PTH measurement

Diagnostic Test

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera di Bolzano

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jan 2, 2018
Registry last updated
Jan 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.