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
|
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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 |
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 |
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
|
- 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
- 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
- Neurological recovery,metabolic profile and Antioxidant profile evaluation in patients with SCI [ Time Frame: 14 months ]BMD : Femur and Lumbar

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
Iran, Islamic Republic of | |
Brain and Spinal Injury Repair Research Center | |
Tehran, Iran, Islamic Republic of |
Study Director: | Abbas Nouroozi, Ph.D | Brain and Spinal Cord Injury Repair Research Center |
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 |