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CompletedNCT03342651VitaminDUpdated Nov 17, 2017

Preoperative Vitamin D Levels and Respiratory Complications of General Anesthesia

An interventional study of Vitamin D in Vitamin D Deficiency, sponsored by Ordu University. Completed. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-17.

Sponsored by Ordu University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 2 years 6 months after the study started (first participant enrolled Apr 2015, registered Oct 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
95
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

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.

This 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.

02

Conditions studied

  • Vitamin D Deficiency

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Keywords

  • Vitamin D
  • general anesthesia
  • respiratory complications
03

In context

Vitamin D Deficiency

784 studies on the registry are indexed under Vitamin D Deficiency; 61 are open to participants now.

This study's enrollment of 95 is above the median of 77 across 574 interventional studies indexed under Vitamin D Deficiency.

Browse Vitamin D Deficiency studies →

Lead sponsor

Ordu University is the lead sponsor of 32 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
95 participants (actual)

Study arms

  • Other
    Observational research

    Vitamin D levels and respiratory complications; observational research.

    Other: Vitamin D

Interventions

  • OtherVitamin D

    Vitamin D, general anesthesia, respiratory complications

    Also known as: Anesthesia, respiratory complications

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What researchers measure

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

    Time frame: Perioperative period

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 28856215 ↗
  • 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. PubMed 25121616 ↗
  • 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. PubMed 18400738 ↗
  • 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. PubMed 25374465 ↗
  • 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. PubMed 25221606 ↗
  • 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. PubMed 22365730 ↗
  • 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. PubMed 23075939 ↗
  • 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. PubMed 24698317 ↗
  • 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. PubMed 19063829 ↗
  • 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. PubMed 20067648 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2015 to primary completion in Apr 2016, 12 months.

Of 167 non-industry interventional studies with no phase under Vitamin D Deficiency, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 29. This study's 12 months is close to that.

Counting every sponsor, half of 169 studies reached it within 11 months; a quarter within 4 and three quarters within 29.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 8, 2017
First posted
Nov 17, 2017
StartActual
Apr 1, 2015
Primary completionActual
Apr 1, 2016
CompletionActual
Dec 31, 2016
Last update
Nov 17, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03342651
Lead sponsor
Ordu University
Responsible party
Nilay Tas (Associate Professor, Ordu University) — Principal investigator
First posted
Nov 17, 2017
Start date
Apr 1, 2015
Primary completion
Apr 1, 2016
Completion
Dec 31, 2016
Last update
Nov 17, 2017

Study contacts

Nilay Taş, Assoc.Prof.
principal investigator · Ordu University, Turkey
Tevfik Noyan, Prof.
study chair · Ordu University, Turkey
Özgür Yağan, Assoc. Prof.
study chair · Ordu University, Turkey
Volkan Hancı, Prof.
study chair · Ordu University, Turkey
Ebru Çanakçı, Ass. Prof.
study chair · Ordu University, Turkey

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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