Omega 3 in Intervention Spinal Cord Injured People

Tehran University of Medical Sciences100 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

100

Conditions

Lipid Metabolism Disorders Peroxidase; Defect

Interventions

w3 supplement in SCIDIETARY_SUPPLEMENT

supplements(Mor DHA and Ca "500 mg" -D200 micro g" )( will be given in this group

placeboOTHER

placebo+ capsule CA-D

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Brain and Spinal Injury Repair Research Center

Tehran, Iran

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 14 months

Secondary Outcomes

Neurological recovery,metabolic profile and Antioxidant profile evaluation in patients with SCI

BMD : Femur and Lumbar

Time frame: 14 months

Data from ClinicalTrials.gov

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