NCT03342651

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2015

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

April 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

1 year

First QC Date

October 8, 2017

Last Update Submit

November 13, 2017

Conditions

Keywords

Vitamin Dgeneral anesthesiarespiratory complications

Outcome Measures

Primary Outcomes (1)

  • Relationship between Vitamin D levels and respiratory complications

    Low vitamin D levels may be a potential risk in terms of respiratory complications related to general anesthesia

    Perioperative period

Study Arms (1)

Observational research

OTHER

Vitamin D levels and respiratory complications; observational research.

Other: Vitamin D

Interventions

Vitamin D, general anesthesia, respiratory complications

Also known as: Anesthesia, respiratory complications
Observational research

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- American Society of Anesthesiologists I - II risk classification, healthy adult surgery cases

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Vitamin DAnesthesia

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsAnesthesia and Analgesia

Study Officials

  • Nilay Taş, Assoc.Prof.

    Ordu University, Turkey

    PRINCIPAL INVESTIGATOR
  • Tevfik Noyan, Prof.

    Ordu University, Turkey

    STUDY CHAIR
  • Özgür Yağan, Assoc. Prof.

    Ordu University, Turkey

    STUDY CHAIR
  • Volkan Hancı, Prof.

    Ordu University, Turkey

    STUDY CHAIR
  • Ebru Çanakçı, Ass. Prof.

    Ordu University, Turkey

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 8, 2017

First Posted

November 17, 2017

Study Start

April 1, 2015

Primary Completion

April 1, 2016

Study Completion

December 31, 2016

Last Updated

November 17, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share