Omega 3 in Intervention Spinal Cord Injured People

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01311375
First received: March 6, 2011
Last updated: November 13, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Lipid Metabolism Disorders
Peroxidase; Defect
Dietary Supplement: w3 supplement in SCI
Other: placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Neurological recovery,metabolic profile and Antioxidant profile evaluation [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 14 months ] [ Designated as safety issue: Yes ]

    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:
  • Neurological recovery,metabolic profile and Antioxidant profile evaluation in patients with SCI [ Time Frame: 14 months ] [ Designated as safety issue: Yes ]
    BMD : Femur and Lumbar


Enrollment: 100
Study Start Date: November 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01311375     History of Changes
Other Study ID Numbers: 87-03-85-7538
Study First Received: March 6, 2011
Last Updated: November 13, 2012
Health Authority: Iran: Ministry of Health
Iran: Ethics Committee

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

Additional relevant MeSH terms:
Metabolic Diseases
Spinal Cord Injuries
Lipid Metabolism Disorders
Sphingolipidoses
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Lysosomal Storage Diseases, Nervous System
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Lipidoses
Lipid Metabolism, Inborn Errors
Lysosomal Storage Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014