Effects of Synchronic Administration of Vitamin D and Progesterone on Outcome of Patients with Acute Spinal Cord Injury; A Randomized, Double Blind, Placebo Controlled Study

The aim of the present study is to determine the effects of vitamin D and progesterone administration on outcome of patients with acute traumatic spinal cord injury between 18 and 65 years of age who are referred within 8 hours after injury. We will exclude those receiving maintenance steroids for other reasons; those who had received more than 100 mg of methylprednisolone or its equivalent before admission to the center; pure sensory loss; complete motor deficit; cauda equina only and gunshot wounds. All the patients will receive standard treatment with methylprednisolone (30 mg/kg intravenously as bolus dose and 15 mg/kg each 3 hours till 24 hours). Patients will be randomized using a computer-based random digit generator. Those assigned to treatment group will receive intramuscular injection of progesterone twice a day for 5 days in addition to oral vitamin D3 twice a day for 5 days on admission while those in placebo group will receive placebo injections and tablets in the same manner. Patients would not be aware of the medication they receive as treatment. The nurse prescribing the drug would also be blinded to ward the type of medication. Patients would be visited 24 hours, 6 days and 3 months later and would be assessed regarding International Standards for Neurological Classification of Spinal Cord Injury (ISCOS). The scores would be compared between groups. The physician recording the outcome would be blinded toward the study groups.

Isfahan University of Medical Sciences