Effects of progesterone and vitamin D on outcome of patients with acute traumatic spinal cord injury; a randomized, double-blind, placebo controlled study

Abstract

Background: Steroid hormones offer promising therapeutic perspectives during the acute phase of spinal cord injury (SCI) while the role of progesterone and vitamin D remain controversial. The aim of the current study was to investigate the effects of progesterone and vitamin D on functional outcome of patients with acute traumatic SCI. Methods: This was a randomized clinical trial including 64 adult patients with acute traumatic SCI admitted within 8 hours of injury. All the patients received methylprednisolone on admission according to standard protocol (30 mg/kg as bolus dose and 15 mg/kg each 3 hours up to 24 hours). Patients were randomly assigned to receive intramuscular injection of 0.5 mg/kg progesterone twice daily and 5 mu g/kg oral vitamin D3 twice daily up to 5 days (n = 32) or placebo (n = 32). Patients were visited 6 days, 3 and 6 months after injury and motor and sensory function was assessed according to American Spinal Injury Association (ASIA) score. Results: There was no significant difference between two study groups regarding age (P = 0.341), sex (P = 0.802) and therapy lag (P = 0.609). The motor powers and sensory function increased significantly after 6 months in both study groups. Those who received progesterone and vitamin D had significantly higher motor powers and sensory function after 6 months of therapy. Those who received the therapy within 4 hours of injury, had significantly higher motor powers and sensory function 6 months after treatment in progesterone and vitamin D group. Therapy lag was negatively associated with 6-month motor powers and sensory function in progesterone and vitamin D group. Conclusions: Administration of progesterone and vitamin D in acute phase of traumatic SCI is associated with better functional recovery and outcome.