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Omega 3 in Intervention Spinal Cord Injured People

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ClinicalTrials.gov Identifier: NCT01311375
Recruitment Status : Completed
First Posted : March 9, 2011
Last Update Posted : November 14, 2012
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences

Study Description
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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

Condition or disease Intervention/treatment Phase
Lipid Metabolism Disorders Peroxidase; Defect Dietary Supplement: w3 supplement in SCI Other: placebo Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Evaluation of Omega 3 Supplementation on Neurological Recovery , Lipid Profile and Antioxidant Enzymes and Hormones After Chronic Spinal Cord Injury.
Study Start Date : November 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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



Secondary Outcome Measures :
  1. Neurological recovery,metabolic profile and Antioxidant profile evaluation in patients with SCI [ Time Frame: 14 months ]
    BMD : Femur and Lumbar


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01311375


Locations
Iran, Islamic Republic of
Brain and Spinal Injury Repair Research Center
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Study Director: Abbas Nouroozi, Ph.D Brain and Spinal Cord Injury Repair Research Center
More Information
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Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01311375     History of Changes
Other Study ID Numbers: 87-03-85-7538
First Posted: March 9, 2011    Key Record Dates
Last Update Posted: November 14, 2012
Last Verified: November 2012

Keywords provided by Tehran University of Medical Sciences:
spinal,, bone, cord injury, lipid,antioxidant

Additional relevant MeSH terms:
Metabolic Diseases
Lipid Metabolism Disorders
Antioxidants
 Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs