Omega 3 in Intervention Spinal Cord Injured People

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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