Evaluation of Omega 3 Supplementation on Neurological Recovery , Lipid Profile and Antioxidant Enzymes and Hormones After Chronic Spinal Cord Injury.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Lipid Metabolism Disorders
- Sponsor
- Tehran University of Medical Sciences
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Neurological recovery,metabolic profile and Antioxidant profile evaluation
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief 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
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •no metabolic, malignant or kidney disorder, normal TSH, LH, FSH, prolactin, and testosterone in men and normal prolactin, estradiol, LH, FSH, and TSH in women
Exclusion Criteria
- •pregnancy, lactation, presence of bone disease,hypersensitivity to fish or fish oil, hypertension
Outcomes
Primary Outcomes
Neurological recovery,metabolic profile and Antioxidant profile evaluation
Time Frame: 4 months
Primary outcome measures are professionals evaluation of neurological function by using : * Osteocalcin * osteoprotegrin * Bone Specified ALP * CTX * RANKL
Neurological recovery,metabolic profile and Antioxidant profile evaluation in SCI patients
Time Frame: 14 months
ASIA scale for sensory and motor function FIM scale for Functional potential FAM SF36 for quality of life by using: FBS 2hpp Insulin LDL Total cHOL TG HDL Leptin Adiponectin -Calcium- 25OHD PTH,LH, FSH, Prolactin,Testosterone in males
Secondary Outcomes
- Neurological recovery,metabolic profile and Antioxidant profile evaluation in patients with SCI(14 months)