Lipid Metabolism DisordersPhase 2/3NCT01311375
Omega 3 in Intervention Spinal Cord Injured People
A Phase 2/3 study testing w3 supplement in SCI in people with Lipid Metabolism Disorders and Peroxidase; Defect, run by Tehran University of Medical Sciences at 1 site in Iran.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lipid Metabolism Disorders, Peroxidase; Defect
- What is being tested?
- w3 supplement in SCI
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIran
- Study dates
- Nov 2010to Apr 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- pregnancy, lactation, presence of bone disease,hypersensitivity to fish or fish oil, hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Omega 3 Supplementation on Neurological Recovery , Lipid Profile and Antioxidant Enzymes and Hormones After Chronic Spinal Cord Injury.
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
Read more
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
Read the 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.
- Conditions
- Lipid Metabolism Disorders, Peroxidase; Defect
- Being tested
- w3 supplement in SCI, placebo
- Keywords
- spinal,, bone, cord injury, lipid,antioxidant
- Medical subject headings
- Lipid Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
w3 supplement in SCIDietary supplement
supplements(Mor DHA and Ca "500 mg" -D200 micro g" )( will be given in this group
placeboOther
placebo+ capsule CA-D
| Study group | Role | What they receive |
|---|---|---|
| w3 supplement + capsule CA-D | Experimental | Mor DHA :w3 supp will be given to this group + capsule Ca(500 mg)-D(200 micro gram) Receives: Dietary Supplement: w3 supplement in SCI |
| placebo+ CA-D | Placebo comparator | placebo in the same color,shape,size Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 14 months
Secondary outcomes (1)
Neurological recovery,metabolic profile and Antioxidant profile evaluation in patients with SCI
BMD : Femur and Lumbar
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2011 (estimated)
- Study startNov 2010
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lipid Metabolism DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abbas Nouroozi, Ph.D, Study director, Brain and Spinal Cord Injury Repair Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01311375
- Sponsor's protocol ID
- 87-03-85-7538
- Status last verified
- Nov 2012
- First submitted
- 6 Mar 2011
- Last updated
- 14 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Omega 3 Supplementation on Neurological Recovery , Lipid Profile and Antioxidant Enzymes and Hormones After Chronic Spinal Cord Injury.
- ClinicalTrials.gov ID
- NCT01311375
- Acronym / sponsor ID
- 87-03-85-7538
- Conditions
- Lipid Metabolism Disorders, Peroxidase; Defect
- Keywords
- spinal,, bone, cord injury, lipid,antioxidant
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 9 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| w3 supplement + capsule CA-D | Experimental | Dietary Supplement: w3 supplement in SCIMor DHA :w3 supp will be given to this group + capsule Ca(500 mg)-D(200 micro gram) |
| placebo+ CA-D | Placebo comparator | Other: placeboplacebo in the same color,shape,size |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- pregnancy, lactation, presence of bone disease,hypersensitivity to fish or fish oil, hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| w3 supplement in SCIsupplements(Mor DHA and Ca "500 mg" -D200 micro g" )( will be given in this group | Dietary supplement | w3 supplement + capsule CA-D |
| placeboplacebo+ capsule CA-D | Other | placebo+ CA-D |
Primary outcome
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
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
1 secondary outcome
Neurological recovery,metabolic profile and Antioxidant profile evaluation in patients with SCI
Time frame: 14 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abbas Nouroozi, Ph.D study director
Brain and Spinal Cord Injury Repair Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing w3 supplement in SCI in people with Lipid Metabolism Disorders and Peroxidase; Defect, run by Tehran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurological recovery,metabolic profile and Antioxidant profile evaluation (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2012.