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
Traumatic Brain Injury (TBI) is the most common trauma worldwide and is a leading cause of injuryrelated 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
... y 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. recruitment began on August 11, 2019, and completed on December 21, 2019. The trial procedures are expected to be completed by the end of January 2020. Abbreviations VITdAL-ICU: The correction vitamin D deficiency in critically ill patients ICU: Intensive care unit TBI: Traumatic brain injury EDH: Epidural hemorrhage SDH: subdural hemorrhage EN: Enteral TPN: Total parenteral nutrition BMI: Body mass index NPO: Nothing by mouth RCT: Randomized controlled trial GCS: Glasgow Coma Scale APACHE II: Acute physiology and chronic health evaluation SOFA: Sequential organ failure assessment IL-6: Interleukin 6 MCP-1: Monocyte chemoattractant protein-1 CRP: C-reactive protein PTH: Parathyroid hormone Ca: Calcium LOS: length of stay Declarations ASM, NA, SA and EM all contributed to the design of the present study protocol. SM, RH and RR collaborated to perform of the clinical trial and TH and RG promoted the statistical plan, which was approved by all the authors, and drafted the manuscript. All authors read and approved the final manuscript.