Omega 3 in Intervention Spinal Cord Injured People

Sponsor

Tehran University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT01311375

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Nov 1, 2010

Actual Primary Completion Date :

Apr 1, 2012

Actual Study Completion Date :

Apr 1, 2012

Arms and Interventions

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

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

Primary Outcome Measures

Neurological recovery,metabolic profile and Antioxidant profile evaluation [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 [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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tehran University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT01311375

Other Study ID Numbers:

87-03-85-7538

First Posted:

Mar 9, 2011

Last Update Posted:

Nov 14, 2012

Last Verified:

Nov 1, 2012

Keywords provided by Tehran University of Medical Sciences

spinal,, bone, cord injury, lipid,antioxidant

Additional relevant MeSH terms:

Metabolic Diseases

Lipid Metabolism Disorders

Study Results

No Results Posted as of Nov 14, 2012