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CompletedNCT03388203Updated Jan 2, 2018

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

An observational study in 25(OH)D Measurement and 25(OH)D Deficiency, sponsored by Azienda Ospedaliera di Bolzano. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-02.

Sponsored by Azienda Ospedaliera di Bolzano · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
74,235
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • 25(OH)D Measurement and 25(OH)D Deficiency

Keywords

  • 25(OH)D
  • PTH
  • mass spectrometry
  • data mining
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In context

Lead sponsor

Azienda Ospedaliera di Bolzano is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • >18 years, outpatients;

Exclusion criteria

Exclusion Criteria:

  • \<18 years, inpatients;
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
74,235 participants (actual)
Patient registry
No

Interventions

  • Diagnostic test25(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.

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What researchers measure

Primary outcomes

  1. 25(OH)D measurement

    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.

    Time frame: 2015-2016

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Giovannucci E, Liu Y, Rimm EB, Hollis BW, Fuchs CS, Stampfer MJ, Willett WC. Prospective study of predictors of vitamin D status and cancer incidence and mortality in men. J Natl Cancer Inst. 2006 Apr 5;98(7):451-9. doi: 10.1093/jnci/djj101. PubMed 16595781 ↗
  • Holick MF, Binkley NC, Bischoff-Ferrari HA, Gordon CM, Hanley DA, Heaney RP, Murad MH, Weaver CM; Endocrine Society. Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011 Jul;96(7):1911-30. doi: 10.1210/jc.2011-0385. Epub 2011 Jun 6. Erratum In: J Clin Endocrinol Metab. 2011 Dec;96(12):3908. J Clin Endocrinol Metab. 2024 Sep 16;109(10):e1991. doi: 10.1210/clinem/dgae373. PubMed 21646368 ↗
  • Yetley EA. Assessing the vitamin D status of the US population. Am J Clin Nutr. 2008 Aug;88(2):558S-564S. doi: 10.1093/ajcn/88.2.558S. PubMed 18689402 ↗
  • Powe CE, Karumanchi SA, Thadhani R. Vitamin D-binding protein and vitamin D in blacks and whites. N Engl J Med. 2014 Feb 27;370(9):880-1. doi: 10.1056/NEJMc1315850. No abstract available. PubMed 24571762 ↗
  • Farrell CJ, Martin S, McWhinney B, Straub I, Williams P, Herrmann M. State-of-the-art vitamin D assays: a comparison of automated immunoassays with liquid chromatography-tandem mass spectrometry methods. Clin Chem. 2012 Mar;58(3):531-42. doi: 10.1373/clinchem.2011.172155. Epub 2012 Jan 9. PubMed 22230812 ↗
  • Farrell C, Soldo J, Williams P, Herrmann M. 25-Hydroxyvitamin D testing: challenging the performance of current automated immunoassays. Clin Chem Lab Med. 2012 Nov;50(11):1953-63. doi: 10.1515/cclm-2012-0522. PubMed 23113977 ↗
  • 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. PubMed 23930771 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 2, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03388203
Lead sponsor
Azienda Ospedaliera di Bolzano
Responsible party
Silvia Giuliani (Department of Clinical Pathology, Azienda Ospedaliera di Bolzano) — Principal investigator
First posted
Jan 2, 2018
Start date
Jan 2015
Primary completion
Dec 2016
Completion
Jun 2017
Last update
Jan 2, 2018

Study contacts

MARKUS HERRMANN, Medicine
principal investigator · Clinical Institute for Medical and Chemical Laboratory Diagnostics, Medical University of Graz, Austria

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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