Omega 3 in Intervention Spinal Cord Injured People

NCT01311375 | Completed Phase 2 DMC

• 1 other identifier: 87-03-85-7538
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Lipid Metabolism Disorders; Peroxidase; Defect

Keywords

spinal,, bone, cord injury, lipid,antioxidant

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (1)

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

  14 months

Study Arms (2)

w3 supplement + capsule CA-D

EXPERIMENTAL

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

Dietary Supplement: w3 supplement in SCI

placebo+ CA-D

PLACEBO COMPARATOR

placebo in the same color,shape,size

Other: placebo

Interventions

w3 supplement in SCI DIETARY_SUPPLEMENT

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

w3 supplement + capsule CA-D

placebo OTHER

placebo+ capsule CA-D

placebo+ CA-D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• pregnancy, lactation, presence of bone disease,hypersensitivity to fish or fish oil, hypertension

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Brain and Spinal Injury Repair Research Center

Tehran, Iran

Location

MeSH Terms

Conditions

Lipid Metabolism Disorders

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Abbas Nouroozi, Ph.D

  Brain and Spinal Cord Injury Repair Research Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2011
• First Posted: March 9, 2011
• Study Start: November 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: November 14, 2012

Record last verified: 2012-11

Locations

IR (1)