Effects of Omega-3 Fatty Acid Supplementation on Inflammatory Response in Multisystem Trauma Patients
NCT ID: NCT01477697
Last Updated: 2013-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
12 participants
INTERVENTIONAL
2011-06-30
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Omega-3
50 mg/kg per day of omega-3 fatty acids (DHA Omega-3, Martek Biosciences, Columbia, MD)
Omega-3
50 mg/kg per day of omega-3 fatty acids
Placebo
50 mg/kg per day of vehicle
Placebo
50 mg/kg per day of placebo equivalent
Interventions
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Omega-3
50 mg/kg per day of omega-3 fatty acids
Placebo
50 mg/kg per day of placebo equivalent
Eligibility Criteria
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Inclusion Criteria
* Ages 18 through 65 years, inclusive
* Admission to ICU
* Nasogastric or nasoenteric feeding tube in place
* Intention of primary medical team to feed the patient enterally
Exclusion Criteria
* Intracranial hemorrhage
* Pregnant or breast feeding
* Patient, surrogate, or physician not committed to full support
* Refractory shock
* Unable to obtain enteral access
* Presence of partial or complete mechanical bowel obstruction, or ischemia, or infarction
* Current total parenteral nutrition (TPN) use, or intent to use TPN within 7 days
* Current gastrointestinal bleeding
* Requirement for vasopressors
18 Years
65 Years
ALL
No
Sponsors
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University of Cincinnati
OTHER
Responsible Party
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Krishna Athota
Assistant Clinical Professor
Principal Investigators
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Krishna Athota, MD
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Richard Branson, MSc
Role: STUDY_DIRECTOR
University of Cincinnati
Locations
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University Hospital
Cincinnati, Ohio, United States
Countries
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Other Identifiers
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Athota-2010-01
Identifier Type: -
Identifier Source: org_study_id
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