Omega 3 in Intervention Spinal Cord Injured People

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Omega 3 Supplementation on Neurological Recovery , Lipid Profile and Antioxidant Enzymes and Hormones After Chronic Spinal Cord Injury.

Conditions
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Lipid Metabolism Disorders, Peroxidase; Defect

Intervention / Treatment
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* Dietary Supplement: w3 supplement in SCI
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: w3 supplement + capsule CA-D<br>Mor DHA :w3 supp will be given to this group + capsule Ca(500 mg)-D(200 micro gram) | Dietary Supplement: w3 supplement in SCI<br>* supplements(Mor DHA and Ca 500 mg -D200 micro g )( will be given in this group<br>|
| Placebo Comparator: placebo+ CA-D<br>placebo in the same color,shape,size | Other: placebo<br>* placebo+ capsule CA-D<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological recovery,metabolic profile and Antioxidant profile evaluation | Primary outcome measures are professionals evaluation of neurological function by using : Osteocalcin osteoprotegrin Bone Specified ALP CTX RANKL | 4 months | 
| Neurological recovery,metabolic profile and Antioxidant profile evaluation in SCI patients | 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 | 14 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological recovery,metabolic profile and Antioxidant profile evaluation in patients with SCI | BMD : Femur and Lumbar | 14 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal,, bone, cord injury, lipid,antioxidant