Trials / Completed
CompletedNCT01311375
Omega 3 in Intervention Spinal Cord Injured People
Evaluation of Omega 3 Supplementation on Neurological Recovery , Lipid Profile and Antioxidant Enzymes and Hormones After Chronic Spinal Cord Injury.
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- Tehran University of Medical Sciences · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | w3 supplement in SCI | supplements(Mor DHA and Ca "500 mg" -D200 micro g" )( will be given in this group |
| OTHER | placebo | placebo+ capsule CA-D |
Timeline
- Start date
- 2010-11-01
- Primary completion
- 2012-04-01
- Completion
- 2012-04-01
- First posted
- 2011-03-09
- Last updated
- 2012-11-14
Locations
1 site across 1 country: Iran
Source: ClinicalTrials.gov record NCT01311375. Inclusion in this directory is not an endorsement.