Abstract
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.
Neuroprotective Role of Oral Vitamin D Supplementation on Consciousness and Inflammatory Biomarkers in Determining Severity Outcome in Acute Traumatic Brain Injury Patients: A Double-Blind Randomized Clinical Trial
