Omega 3 in Intervention Spinal Cord Injured People

Lipid Metabolism Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01311375
• Other study ID #: 87-03-85-7538
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 6, 2011
• Last updated: November 13, 2012
• Start date: November 2010
• Est. completion date: April 2012

Study information

• Verified date: November 2012
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of HealthIran: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Lipid Metabolism Disorders
• Metabolic Diseases
• Peroxidase; Defect

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Brain and Spinal Injury Repair Research Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 months	Yes
Primary	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	14 months	Yes
Secondary	Neurological recovery,metabolic profile and Antioxidant profile evaluation in patients with SCI	BMD : Femur and Lumbar	14 months	Yes