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Omega 3 in Intervention Spinal Cord Injured People

Primary Purpose

Lipid Metabolism Disorders, Peroxidase; Defect

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
w3 supplement in SCI
placebo
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lipid Metabolism Disorders focused on measuring spinal,, bone, cord injury, lipid,antioxidant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Brain and Spinal Injury Repair Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

w3 supplement + capsule CA-D

placebo+ CA-D

Arm Description

Mor DHA :w3 supp will be given to this group + capsule Ca(500 mg)-D(200 micro gram)

placebo in the same color,shape,size

Outcomes

Primary Outcome Measures

Neurological recovery,metabolic profile and Antioxidant profile evaluation
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
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
BMD : Femur and Lumbar

Full Information

First Posted
March 6, 2011
Last Updated
November 13, 2012
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01311375
Brief Title
Omega 3 in Intervention Spinal Cord Injured People
Official Title
Evaluation of Omega 3 Supplementation on Neurological Recovery , Lipid Profile and Antioxidant Enzymes and Hormones After Chronic Spinal Cord Injury.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipid Metabolism Disorders, Peroxidase; Defect
Keywords
spinal,, bone, cord injury, lipid,antioxidant

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
w3 supplement + capsule CA-D
Arm Type
Experimental
Arm Description
Mor DHA :w3 supp will be given to this group + capsule Ca(500 mg)-D(200 micro gram)
Arm Title
placebo+ CA-D
Arm Type
Placebo Comparator
Arm Description
placebo in the same color,shape,size
Intervention Type
Dietary Supplement
Intervention Name(s)
w3 supplement in SCI
Intervention Description
supplements(Mor DHA and Ca "500 mg" -D200 micro g" )( will be given in this group
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
placebo+ capsule CA-D
Primary Outcome Measure Information:
Title
Neurological recovery,metabolic profile and Antioxidant profile evaluation
Description
Primary outcome measures are professionals evaluation of neurological function by using : Osteocalcin osteoprotegrin Bone Specified ALP CTX RANKL
Time Frame
4 months
Title
Neurological recovery,metabolic profile and Antioxidant profile evaluation in SCI patients
Description
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
Time Frame
14 months
Secondary Outcome Measure Information:
Title
Neurological recovery,metabolic profile and Antioxidant profile evaluation in patients with SCI
Description
BMD : Femur and Lumbar
Time Frame
14 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abbas Nouroozi, Ph.D
Organizational Affiliation
Brain and Spinal Cord Injury Repair Research Center
Official's Role
Study Director
Facility Information:
Facility Name
Brain and Spinal Injury Repair Research Center
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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Omega 3 in Intervention Spinal Cord Injured People

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