Efficacy of high-dose versus low-dose vitamin D supplementation on serum levels of inflammatory factors and mortality rate in severe traumatic brain injury patients: study protocol for a randomized placebo-controlled trial.

Autor: Arabi SM; Student Research Committee, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran., Sedaghat A; Cardiac Anesthesia Research Center, Mashhad University of Medical Sciences, Mashhad, Iran., Ehsaei MR; Department of Neurosurgery, Shahid Kamiab Hospital, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran., Safarian M; Metabolic Syndrome Research Center, Mashhad University of Medical Sciences, Mashhad, Iran., Ranjbar G; Metabolic Syndrome Research Center, Mashhad University of Medical Sciences, Mashhad, Iran., Rezaee H; Department of Neurosurgery, Shahid Kamiab Hospital, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran., Rezvani R; Metabolic Syndrome Research Center, Mashhad University of Medical Sciences, Mashhad, Iran., Tabesh H; Department of Medical Informatics, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran., Norouzy A; Metabolic Syndrome Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. Norouzya97@gmail.com.
Jazyk: angličtina
Zdroj: Trials [Trials] 2020 Jul 29; Vol. 21 (1), pp. 685. Date of Electronic Publication: 2020 Jul 29.
DOI: 10.1186/s13063-020-04622-6
Abstrakt: Background: Traumatic brain injury (TBI) is the most common trauma worldwide and is a leading cause of injury-related death and disability. Inflammation is initiated as a result of the TBI, 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 TBI 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 with vitamin D supplements (100,000 IU oral drop) or a similar placebo (1000 IU) for 5 days.
Discussion: If this randomized clinical trial demonstrates reductions in inflammatory cytokines, it would provide evidence for a multicenter clinical trial to evaluate the efficacy of vitamin D supplementation in neurocritically 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.
Trial Registration: Iranian Registry of Clinical Trials, IRCT20180619040151N3 . Registered on 10 August 2019.
Databáze: MEDLINE
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