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Completed

NCT Number: NCT01311375

Omega 3 in Intervention Spinal Cord Injured People

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

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Key information

Conditions

Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Peroxidase; Defect

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Brain and Spinal Injury Repair Research Center

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

w3 supplement in SCI

Dietary Supplement

supplements(Mor DHA and Ca "500 mg" -D200 micro g" )( will be given in this group

Placebo

Other

placebo+ capsule CA-D

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Neurological recovery,metabolic profile and Antioxidant profile evaluation in patients with SCI

    Time frame: 14 months

    BMD : Femur and Lumbar

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study title

Evaluation of Omega 3 Supplementation on Neurological Recovery , Lipid Profile and Antioxidant Enzymes and Hormones After Chronic Spinal Cord Injury.

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 9, 2011
Registry last updated
Nov 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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