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Omega 3 in Intervention Spinal Cord Injured People

NCT ID: NCT01311375

Last Updated: 2012-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-04-30

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.

Conditions

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Lipid Metabolism Disorders Peroxidase; Defect

Keywords

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spinal,, bone, cord injury, lipid,antioxidant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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w3 supplement + capsule CA-D

Mor DHA :w3 supp will be given to this group + capsule Ca(500 mg)-D(200 micro gram)

Group Type EXPERIMENTAL

w3 supplement in SCI

Intervention Type DIETARY_SUPPLEMENT

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

placebo+ CA-D

placebo in the same color,shape,size

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

placebo+ capsule CA-D

Interventions

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w3 supplement in SCI

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

Intervention Type DIETARY_SUPPLEMENT

placebo

placebo+ capsule CA-D

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

* pregnancy, lactation, presence of bone disease,hypersensitivity to fish or fish oil, hypertension
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Abbas Nouroozi, Ph.D

Role: STUDY_DIRECTOR

Brain and Spinal Cord Injury Repair Research Center

Locations

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Brain and Spinal Injury Repair Research Center

Tehran, , Iran

Site Status

Countries

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Iran

Other Identifiers

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87-03-85-7538

Identifier Type: -

Identifier Source: org_study_id