Omega 3 in Intervention Spinal Cord Injured People

November 13, 2012 updated by: Tehran University of Medical Sciences

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 months
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
14 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Investigators

  • Study Director: Abbas Nouroozi, Ph.D, Brain and Spinal Cord Injury Repair Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

March 6, 2011

First Submitted That Met QC Criteria

March 8, 2011

First Posted (Estimate)

March 9, 2011

Study Record Updates

Last Update Posted (Estimate)

November 14, 2012

Last Update Submitted That Met QC Criteria

November 13, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 87-03-85-7538

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lipid Metabolism Disorders

Clinical Trials on w3 supplement in SCI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe