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Clinical Trial Summary

The objective of this study is to evaluate the effect of omega 3 fatty acid on neurological recovery, lipid profile and Antioxidant system in patients with spinal cord injury. One hundred spinal cord injured patients who come to clinic of spinal injury repair research center selected. Then the patients will receive two supplements capsules of omega 3 (600 mg) in the intervention group and placebo in the control group. Primary outcome measures are professionals evaluation of neurological function by using :

- ASIA scale for sensory and motor function

- FIM scale for Functional potential

- FAM

- SF_36 for quality of life

Lipid profile and Antioxidant profile evaluation by using:

- FBS

- 2hpp

- Insulin

- LDL

- Total cHOL

- TG

- HDL

- Leptin Adiponectin -Calcium-

- 25OHD

- PTH,LH, FSH, Prolactin,Testosterone in males Bone markers by serum levels of :Osteocalcin-Osteoprotegrin_Bone Specified ALP- CTX - RANKL

- BMD


Clinical Trial Description

All no neurological evaluation will be done by experiment researcher under considering of a neurologist.All Sub clinical evaluation will be done by specific, sensitive and valid laboratory methods. Intervention time will be 14 months.Comparison of these variables will be done before and after intervention. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


NCT number NCT01311375
Study type Interventional
Source Tehran University of Medical Sciences
Contact
Status Completed
Phase Phase 2/Phase 3
Start date November 2010
Completion date April 2012

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