NCT03388203

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74,235

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 2, 2018

Completed
Last Updated

January 2, 2018

Status Verified

December 1, 2017

Enrollment Period

1.9 years

First QC Date

December 18, 2017

Last Update Submit

December 29, 2017

Conditions

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

Keywords

25(OH)DPTHmass spectrometrydata mining

Outcome Measures

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.

    2015-2016

Interventions

25(OH)D measurement, PTH measurementDIAGNOSTIC_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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • \>18 years, outpatients;

You may not qualify if:

  • \<18 years, inpatients;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 16595781BACKGROUND

  • 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.

    PMID: 21646368BACKGROUND

  • 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.

    PMID: 18689402BACKGROUND

  • 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.

    PMID: 24571762BACKGROUND

  • 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.

    PMID: 22230812BACKGROUND

  • 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.

    PMID: 23113977BACKGROUND

  • 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.

    PMID: 23930771BACKGROUND

Study Officials

  • MARKUS HERRMANN, Medicine

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Clinical Pathology

Study Record Dates

First Submitted

December 18, 2017

First Posted

January 2, 2018

Study Start

January 1, 2015

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

January 2, 2018

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share