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

NCT ID: NCT03388203

Last Updated: 2018-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

74235 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-06-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* \>18 years, outpatients;

Exclusion Criteria

* \<18 years, inpatients;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliera di Bolzano

OTHER

Sponsor Role lead

Responsible Party

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Silvia Giuliani

Department of Clinical Pathology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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MARKUS HERRMANN, Medicine

Role: PRINCIPAL_INVESTIGATOR

Clinical Institute for Medical and Chemical Laboratory Diagnostics, Medical University of Graz, Austria

References

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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.

Reference Type BACKGROUND
PMID: 16595781 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21646368 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18689402 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24571762 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22230812 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23113977 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23930771 (View on PubMed)

Other Identifiers

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0055719-BZ

Identifier Type: -

Identifier Source: org_study_id

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