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

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01311375

Enrollment

100

Registered

2011-03-09

Start date

2010-11-30

Completion date

2012-04-30

Last updated

2012-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lipid Metabolism Disorders, Peroxidase; Defect

Keywords

spinal,, bone, cord injury, lipid,antioxidant

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.

Interventions

DIETARY_SUPPLEMENTw3 supplement in SCI

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

OTHERplacebo

placebo+ capsule CA-D

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Neurological recovery,metabolic profile and Antioxidant profile evaluation	4 months	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	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

Measure	Time frame	Description
Neurological recovery,metabolic profile and Antioxidant profile evaluation in patients with SCI	14 months	BMD : Femur and Lumbar

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026