Vitamin D and Progesterone for Acute Spinal Cord Injury
Phase 1
- Conditions
- Spinal cord injury.multiple fractures of spine, level unspecified
- Registration Number
- IRCT201310082445N2
- Lead Sponsor
- Isfahan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
Age between 18 and 65 years; giving informed written consents; traumatic acute spinal-cord injury; being randomized within 8 hours of the injury.
Exclusion criteria: Age less than 18 or more than 65 years; involvement of the nerve root; cauda equina only; gunshot wounds; life-threatening morbidity; those who were pregnant; addicted to narcotics; receiving maintenance steroids for other reasons; those who had received more than 100 mg of methylprednisolone or its equivalent, or 1 mg of naloxone before admission to the center; those in whom follow-up would be difficult; pure sensory loss; complete motor deficit; randomization >8 hours after injury.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Muscular force of the effected limbs. Timepoint: 24-hour, 6 days, 3 months. Method of measurement: International Standards for Neurological Classification of Spinal Cord Injury.
- Secondary Outcome Measures
Name Time Method Sensory level. Timepoint: 24-hour, 6 days, 3 months. Method of measurement: Pinprick and Light Touch.