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Omega 3 in Intervention Spinal Cord Injured People

NCT01311375 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2012-11-14

No results posted yet for this study

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

Conditions

  • Lipid Metabolism Disorders
  • Peroxidase; Defect

Interventions

DIETARY_SUPPLEMENT

w3 supplement in SCI

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

OTHER

placebo

placebo+ capsule CA-D

Sponsors & Collaborators

  • Tehran University of Medical Sciences

    lead OTHER

Principal Investigators

  • Abbas Nouroozi, Ph.D · Brain and Spinal Cord Injury Repair Research Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • Iran

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01311375 on ClinicalTrials.gov