Omega 3 in Intervention Spinal Cord Injured People

Tehran University of Medical Sciences

Status and phase: Completed; Phase 3; Phase 2

Conditions: Lipid Metabolism Disorders; Peroxidase; Defect

Treatments: Dietary Supplement: w3 supplement in SCI; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01311375

87-03-85-7538

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

w3 supplement + capsule CA-D

Experimental group

Description:

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

Treatment:

Dietary Supplement: w3 supplement in SCI

placebo+ CA-D

Placebo Comparator group

Description:

placebo in the same color,shape,size

Treatment:

Other: placebo