Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-02-25 @ 6:36 PM
Study NCT ID:
NCT03342651
Status:
COMPLETED
Last Update Posted:
2017-11-17
First Post:
2017-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Vitamin D Levels and Respiratory Complications of General Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}], 'ancestors': [{'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D000758', 'term': 'Anesthesia'}], 'ancestors': [{'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-13', 'studyFirstSubmitDate': '2017-10-08', 'studyFirstSubmitQcDate': '2017-11-13', 'lastUpdatePostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relationship between Vitamin D levels and respiratory complications', 'timeFrame': 'Perioperative period', 'description': 'Low vitamin D levels may be a potential risk in terms of respiratory complications related to general anesthesia'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vitamin D', 'general anesthesia', 'respiratory complications'], 'conditions': ['Vitamin D Deficiency']}, 'referencesModule': {'references': [{'pmid': '28856215', 'type': 'RESULT', 'citation': 'Hutchinson K, Healy M, Crowley V, Louw M, Rochev Y. Verification of Abbott 25-OH-vitamin D assay on the architect system. Pract Lab Med. 2017 Jan 17;7:27-35. doi: 10.1016/j.plabm.2017.01.001. eCollection 2017 Apr.'}, {'pmid': '25121616', 'type': 'RESULT', 'citation': 'Turan A, Hesler BD, You J, Saager L, Grady M, Komatsu R, Kurz A, Sessler DI. The association of serum vitamin D concentration with serious complications after noncardiac surgery. Anesth Analg. 2014 Sep;119(3):603-612. doi: 10.1213/ANE.0000000000000096.'}, {'pmid': '18400738', 'type': 'RESULT', 'citation': 'Holick MF, Chen TC. Vitamin D deficiency: a worldwide problem with health consequences. Am J Clin Nutr. 2008 Apr;87(4):1080S-6S. doi: 10.1093/ajcn/87.4.1080S.'}, {'pmid': '25374465', 'type': 'RESULT', 'citation': 'Bener A, Ehlayel MS, Bener HZ, Hamid Q. The impact of Vitamin D deficiency on asthma, allergic rhinitis and wheezing in children: An emerging public health problem. J Family Community Med. 2014 Sep;21(3):154-61. doi: 10.4103/2230-8229.142967.'}, {'pmid': '25221606', 'type': 'RESULT', 'citation': 'Columbo M, Panettieri RA Jr, Rohr AS. Asthma in the elderly: a study of the role of vitamin D. Allergy Asthma Clin Immunol. 2014 Sep 5;10(1):48. doi: 10.1186/1710-1492-10-48. eCollection 2014.'}, {'pmid': '22365730', 'type': 'RESULT', 'citation': 'Banerjee A, Panettieri R Jr. Vitamin D modulates airway smooth muscle function in COPD. Curr Opin Pharmacol. 2012 Jun;12(3):266-74. doi: 10.1016/j.coph.2012.01.014. Epub 2012 Feb 25.'}, {'pmid': '23075939', 'type': 'RESULT', 'citation': 'Quraishi SA, Camargo CA Jr. Vitamin D in acute stress and critical illness. Curr Opin Clin Nutr Metab Care. 2012 Nov;15(6):625-34. doi: 10.1097/MCO.0b013e328358fc2b.'}, {'pmid': '24698317', 'type': 'RESULT', 'citation': "Mulligan JK, Nagel W, O'Connell BP, Wentzel J, Atkinson C, Schlosser RJ. Cigarette smoke exposure is associated with vitamin D3 deficiencies in patients with chronic rhinosinusitis. J Allergy Clin Immunol. 2014 Aug;134(2):342-9. doi: 10.1016/j.jaci.2014.01.039. Epub 2014 Mar 31."}, {'pmid': '19063829', 'type': 'RESULT', 'citation': 'Ginde AA, Mansbach JM, Camargo CA Jr. Vitamin D, respiratory infections, and asthma. Curr Allergy Asthma Rep. 2009 Jan;9(1):81-7. doi: 10.1007/s11882-009-0012-7.'}, {'pmid': '20067648', 'type': 'RESULT', 'citation': 'Bartley J. Vitamin D, innate immunity and upper respiratory tract infection. J Laryngol Otol. 2010 May;124(5):465-9. doi: 10.1017/S0022215109992684. Epub 2010 Jan 13.'}]}, 'descriptionModule': {'briefSummary': 'Vitamin D deficiency is a commonly observed health problem in the world. With a role in many chronic diseases and especially lung diseases, the importance of vitamin D deficiency in anesthesia management is increased. This research aims to investigate whether there is a correlation between the respiratory complications occurring in patients under general anesthesia and preoperative vitamin D levels.', 'detailedDescription': 'This study included 95 adult cases aged from 18-65 years operated under general anesthesia. The cases had total 25-hydroxyvitamin D (25OHD) levels identified in blood samples before the operation. Patients given routine general anesthesia and postoperative monitoring procedures were assessed in terms of respiratory complications during anesthesia induction, extubation, anesthesia recovery and the first 24 hours postoperative.\n\nThis research observed that patients with low preoperative 25OHD vitamin levels encountered respiratory complications related to general anesthesia more often. Especially in the early postoperative period there is a very significant difference between complications and low 25OHD vitamin levels. Our study results show that low vitamin D levels may be a potential risk in terms of respiratory complications related to general anesthesia causing severe morbidity and mortality increase. The results lead to the consideration that optimizing vitamin D levels in the preoperative period for patients undergoing general anesthesia may aid in reducing complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- American Society of Anesthesiologists I - II risk classification, healthy adult surgery cases\n\nExclusion Criteria:\n\n* Thoracic surgery, those with severe respiratory, neuromuscular or endocrine system diseases, those with difficult intubation, morbid obesity, using vitamin D supplements and those who smoked'}, 'identificationModule': {'nctId': 'NCT03342651', 'acronym': 'VitaminD', 'briefTitle': 'Preoperative Vitamin D Levels and Respiratory Complications of General Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Ordu University'}, 'officialTitle': 'Evaluation of the Effect of Preoperative Vitamin D Levels and Respiratory Complications of General Anesthesia', 'orgStudyIdInfo': {'id': 'DVIT1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Observational research', 'description': 'Vitamin D levels and respiratory complications; observational research.', 'interventionNames': ['Other: Vitamin D']}], 'interventions': [{'name': 'Vitamin D', 'type': 'OTHER', 'otherNames': ['Anesthesia, respiratory complications'], 'description': 'Vitamin D, general anesthesia, respiratory complications', 'armGroupLabels': ['Observational research']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Nilay Taş, Assoc.Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ordu University, Turkey'}, {'name': 'Tevfik Noyan, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Ordu University, Turkey'}, {'name': 'Özgür Yağan, Assoc. Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Ordu University, Turkey'}, {'name': 'Volkan Hancı, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Ordu University, Turkey'}, {'name': 'Ebru Çanakçı, Ass. Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Ordu University, Turkey'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ordu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Nilay Tas', 'investigatorAffiliation': 'Ordu University'}}}}