Vitamin D DeficiencyVitaminDNCT03342651
Preoperative Vitamin D Levels and Respiratory Complications of General Anesthesia
A study testing Vitamin D in people with Vitamin D Deficiency, run by Ordu University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2015to 31 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists I - II risk classification, healthy adult surgery cases
Who cannot join
- 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
About this study
Official title: Evaluation of the Effect of Preoperative Vitamin D Levels and Respiratory Complications of General Anesthesia
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.
- Conditions
- Vitamin D Deficiency
- Being tested
- Vitamin D
- Keywords
- Vitamin D, general anesthesia, respiratory complications
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DOther
Also called Anesthesia, respiratory complications
Vitamin D, general anesthesia, respiratory complications
| Study group | Role | What they receive |
|---|---|---|
| Observational research | Other | Vitamin D levels and respiratory complications; observational research. Receives: Other: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Apr 2015
- Primary completion1 Apr 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilay Tas, Ordu University
- Investigators
- Nilay Taş, Assoc.Prof., Principal investigator, Ordu University, TurkeyTevfik Noyan, Prof., Study chair, Ordu University, TurkeyÖzgür Yağan, Assoc. Prof., Study chair, Ordu University, TurkeyVolkan Hancı, Prof., Study chair, Ordu University, TurkeyEbru Çanakçı, Ass. Prof., Study chair, Ordu University, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03342651
- Sponsor's protocol ID
- DVIT1
- Acronym
- VitaminD
- Status last verified
- Nov 2017
- First submitted
- 8 Oct 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 28856215Turan 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 25121616Holick 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 18400738Bener 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 25374465Columbo 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 25221606Banerjee 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 22365730Quraishi 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 23075939Mulligan 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 24698317Ginde 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 19063829Bartley 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Preoperative Vitamin D Levels and Respiratory Complications of General Anesthesia
- ClinicalTrials.gov ID
- NCT03342651
- Acronym / sponsor ID
- VitaminD / DVIT1
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D, general anesthesia, respiratory complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 1 Apr 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational research | Other | Other: Vitamin DVitamin D levels and respiratory complications; observational research. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists I - II risk classification, healthy adult surgery cases
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DAlso: Anesthesia, respiratory complicationsVitamin D, general anesthesia, respiratory complications | Other | Observational research |
Primary outcome
Relationship between Vitamin D levels and respiratory complications
Time frame: Perioperative period
Low vitamin D levels may be a potential risk in terms of respiratory complications related to general anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Results publication: PubMed 28856215Hutchinson 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.
- Results publication: PubMed 25121616Turan 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.
- Results publication: PubMed 18400738Holick 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.
- Results publication: PubMed 25374465Bener 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.
- Results publication: PubMed 25221606Columbo 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.
- Results publication: PubMed 22365730Banerjee 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.
- Results publication: PubMed 23075939Quraishi 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.
- Results publication: PubMed 24698317Mulligan 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.
- Results publication: PubMed 19063829Ginde 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.
- Results publication: PubMed 20067648Bartley 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Vitamin D Deficiency, run by Ordu University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between Vitamin D levels and respiratory complications (time frame: Perioperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03342651, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.