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Study protocol
Abdolreza Norouzy
Mashhad University of Medical Sciences
Corresponding Author
ORCiD: https://orcid.org/0000-0002-1497-184X
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Trials.
Background Traumatic Brain Injury (TBI) is the most common trauma worldwide and is a leading cause of injury-related death and disability. Inflammation is a major problem among TBL patients which is in association with severity of illness and mortality in brain trauma patients, especially in subdural hemorrhage and epidural hemorrhage cases. A high percentage of adults admitted to the intensive care unit with critical conditions are diagnosed with vitamin D-deficiency, this deficiency may induce impaired immune responses and increase the risk of infections. Vitamin D intervention has been shown to modulate pro- and anti-inflammatory cytokines in non-critically ill patients, but to date, there is no substantial data on the effectiveness of vitamin D for the improvement of immune function in traumatic brain injury patients.Methods/design A randomized clinical trial (RCT) will be performed on 74 Iranian adults 18-65 years old with brain trauma, and will be treated daily by vitamin D supplements (100000 IU oral drop) or a similar placebo (1000 IU) for 5 days.Discussion If this randomized clinical trial elucidates reduction in inflammatory cytokines, it would provide the evidence for multi-central clinical trials to evaluate the efficacy of vitamin D supplementation in neuro -critically ill patients. Since vitamin D supplements are inexpensive and safe, this clinical trial could have the potential to improve clinical outcomes in traumatic brain injury patients through reduction of inflammation and infection associated morbidity and mortality rates.
Keywords
traumatic brain injury, vitamin D, inflammation, mortality
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CURRENT STATUS: Published
Published
On 29 Jul, 2020
No community comments so far
Review #2 received
Received 27 May, 2020
Editorial decision: Minor revision
On 27 May, 2020
Reviewer #2 agreed
On 20 Apr, 2020
Review #1 received
Received 01 Apr, 2020
Reviewers invited
Invitations sent on 31 Mar, 2020
Reviewer #1 agreed
On 31 Mar, 2020
Editor assigned
On 30 Mar, 2020
Submission checks complete
On 29 Mar, 2020
No comments provided
Review #1 received
Received 22 Mar, 2020
Editorial decision: Major revision
On 22 Mar, 2020
Reviewer #1 agreed
On 18 Mar, 2020
Reviewers invited
Invitations sent on 15 Mar, 2020
Editor assigned
On 13 Mar, 2020
Submission checks complete
On 12 Mar, 2020
Version 1
Posted 30 Oct, 2019
No comments provided
Review #2 received
Received 09 Mar, 2020
Editorial decision: Minor revision
On 09 Mar, 2020
Reviewer #2 agreed
On 17 Jan, 2020
Reviewer #1 agreed
On 08 Nov, 2019
Review #1 received
Received 08 Nov, 2019
Reviewers invited
Invitations sent on 07 Nov, 2019
Editor assigned
On 24 Oct, 2019
Submission checks complete
On 17 Oct, 2019
First submitted
On 30 Sep, 2019
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Abdolreza Norouzy
Mashhad University of Medical Sciences
Corresponding Author
ORCiD: https://orcid.org/0000-0002-1497-184X
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
Published
On 29 Jul, 2020
No community comments so far
Review #2 received
Received 27 May, 2020
Editorial decision: Minor revision
On 27 May, 2020
Reviewer #2 agreed
On 20 Apr, 2020
Review #1 received
Received 01 Apr, 2020
Reviewers invited
Invitations sent on 31 Mar, 2020
Reviewer #1 agreed
On 31 Mar, 2020
Editor assigned
On 30 Mar, 2020
Submission checks complete
On 29 Mar, 2020
No comments provided
Review #1 received
Received 22 Mar, 2020
Editorial decision: Major revision
On 22 Mar, 2020
Reviewer #1 agreed
On 18 Mar, 2020
Reviewers invited
Invitations sent on 15 Mar, 2020
Editor assigned
On 13 Mar, 2020
Submission checks complete
On 12 Mar, 2020
Version 1
Posted 30 Oct, 2019
No comments provided
Review #2 received
Received 09 Mar, 2020
Editorial decision: Minor revision
On 09 Mar, 2020
Reviewer #2 agreed
On 17 Jan, 2020
Reviewer #1 agreed
On 08 Nov, 2019
Review #1 received
Received 08 Nov, 2019
Reviewers invited
Invitations sent on 07 Nov, 2019
Editor assigned
On 24 Oct, 2019
Submission checks complete
On 17 Oct, 2019
First submitted
On 30 Sep, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Trials.
Background Traumatic Brain Injury (TBI) is the most common trauma worldwide and is a leading cause of injury-related death and disability. Inflammation is a major problem among TBL patients which is in association with severity of illness and mortality in brain trauma patients, especially in subdural hemorrhage and epidural hemorrhage cases. A high percentage of adults admitted to the intensive care unit with critical conditions are diagnosed with vitamin D-deficiency, this deficiency may induce impaired immune responses and increase the risk of infections. Vitamin D intervention has been shown to modulate pro- and anti-inflammatory cytokines in non-critically ill patients, but to date, there is no substantial data on the effectiveness of vitamin D for the improvement of immune function in traumatic brain injury patients.Methods/design A randomized clinical trial (RCT) will be performed on 74 Iranian adults 18-65 years old with brain trauma, and will be treated daily by vitamin D supplements (100000 IU oral drop) or a similar placebo (1000 IU) for 5 days.Discussion If this randomized clinical trial elucidates reduction in inflammatory cytokines, it would provide the evidence for multi-central clinical trials to evaluate the efficacy of vitamin D supplementation in neuro -critically ill patients. Since vitamin D supplements are inexpensive and safe, this clinical trial could have the potential to improve clinical outcomes in traumatic brain injury patients through reduction of inflammation and infection associated morbidity and mortality rates.
Figure 1
Figure 2
Figure 3
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