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: Traumatic spinal cord injury (SCI) constitutes a devastating event that often results in complete loss of motor and sensory function. Steroid hormones offer promising therapeutic perspectives during the acute phase of spinal cord injury while Progesterone and vitamin D remain controversial. The aim of the present study was to determine the effects of progesterone and vitamin D on outcome of patients with acute traumatic spinal cord injury.

Methods: This was a prospective, randomized, double-blind, placebo controlled study being performed in Al-Zahra hand Kashani hospitals, both tertiary healthcare center affiliated with Isfahan University of Medical Sciences during a 1-year period from September 2012 to September 2013. We included those patients with acute traumatic spinal cord injury admitted to our center within 8 hours of injury. Those who had received methylprednisolone before admission, those on steroids, pregnant subjects, pure sensory loss and complete cord injury were excluded from the study. All the patients received methylprednisolone on admission according to standard protocol (30 mg/kg as bolus dose and 15 mg/kg each 3 hour up to 24 hours). Patients were then randomly assigned to receive intramuscular injection of 0.5 mg progesterone twice  a day and 5mg oral vitamin D3 twice a day up to 5 days (n=32) or placebo (n=32). Patients were visited 24-hours, 6 days and 3 months after injury and motor and sensory function was assessed using International Standards for Neurological Classification of Spinal Cord Injury (ISCOS) and was compared between groups.

Results: There was no significant difference between two study groups regarding age (41.8 ± 13.6 vs. 45.1 ± 13.7; p=0.341), gender (p=0.802) and therapeutic approach (p=0.793). T12 (17.2%) and L1 (15.6%) were the most common involved segments. We did not found any significant difference between two study groups regarding the motor and sensory function of the involved segments after 24 hours, 6 days and 3 months. However the motor powers as well as sensory function increased significantly after 3 months in both study groups.

Conclusion: The results of this study indicate that administration of progesterone and vitamin D in acute phase of spinal cord injury does not encompass neuroprotection effects. Further studies are required to shed light on this issue. 

 Iran Clinical Trial Registry Code: IRCT201310082445N2