Omega 3 in Intervention Spinal Cord Injured People

Phase 2

Completed

• Conditions: Lipid Metabolism Disorders; Peroxidase; Defect
• Interventions: Other: placebo; Dietary Supplement: w3 supplement in SCI

• Registration Number: NCT01311375
• Lead Sponsor: Tehran University of Medical Sciences

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.

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-03-06
• Study First Submitted QC: 2011-03-08
• Study First Posted: 2011-03-09
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-13
• Last Update Posted: 2012-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo+ CA-D	placebo	placebo in the same color,shape,size
w3 supplement + capsule CA-D	w3 supplement in SCI	Mor DHA :w3 supp will be given to this group + capsule Ca(500 mg)-D(200 micro gram)

Primary Outcome Measures

Name	Time	Method
Neurological recovery,metabolic profile and Antioxidant profile evaluation	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	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 Outcome Measures

Name	Time	Method
Neurological recovery,metabolic profile and Antioxidant profile evaluation in patients with SCI	14 months	BMD : Femur and Lumbar

Trial Locations

Locations (1)

Brain and Spinal Injury Repair Research Center; 🇮🇷 Tehran, Iran, Islamic Republic of