Omega 3 in Intervention Spinal Cord Injured People - Full Text View

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:

MedlinePlus related topics: Antioxidants Dietary Supplements Lipid Metabolism Disorders Spinal Cord Injuries

U.S. FDA Resources

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 (Adult, Senior)
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


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 Lipid Metabolism Disorders Antioxidants	Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 27, 2016