Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2026-01-10 @ 11:21 AM
Study NCT ID:
NCT03388203
Status:
COMPLETED
Last Update Posted:
2018-01-02
First Post:
2017-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LC-MS/MS 25(OH)D Status in a Large Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74235}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-29', 'studyFirstSubmitDate': '2017-12-18', 'studyFirstSubmitQcDate': '2017-12-29', 'lastUpdatePostDateStruct': {'date': '2018-01-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '25(OH)D measurement', 'timeFrame': '2015-2016', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['25(OH)D', 'PTH', 'mass spectrometry', 'data mining'], 'conditions': ['25(OH)D Measurement and 25(OH)D Deficiency']}, 'referencesModule': {'references': [{'pmid': '16595781', 'type': 'BACKGROUND', 'citation': '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': '21646368', 'type': 'BACKGROUND', 'citation': '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': '18689402', 'type': 'BACKGROUND', 'citation': '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': '24571762', 'type': 'BACKGROUND', 'citation': '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': '22230812', 'type': 'BACKGROUND', 'citation': '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': '23113977', 'type': 'BACKGROUND', 'citation': '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': '23930771', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The present study assessed serum 25(OH)D in a cohort of 74235 outpatients by liquid-chromatography-tandem-mass-spectrometry (LC-MS/MS).\n\nThe 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 years, outpatients;\n\nExclusion Criteria:\n\n* \\<18 years, inpatients;'}, 'identificationModule': {'nctId': 'NCT03388203', 'briefTitle': 'LC-MS/MS 25(OH)D Status in a Large Cohort', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliera di Bolzano'}, 'officialTitle': 'LC-MS/MS Based 25(OH)D Status in a Large Central European Outpatient Cohort- Gender and Age Specific Differences', 'orgStudyIdInfo': {'id': '0055719-BZ'}}, 'armsInterventionsModule': {'interventions': [{'name': '25(OH)D measurement, PTH measurement', 'type': 'DIAGNOSTIC_TEST', 'description': '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.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'MARKUS HERRMANN, Medicine', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Institute for Medical and Chemical Laboratory Diagnostics, Medical University of Graz, Austria'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliera di Bolzano', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Clinical Pathology', 'investigatorFullName': 'Silvia Giuliani', 'investigatorAffiliation': 'Azienda Ospedaliera di Bolzano'}}}}