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Effects of Omega-3 Fatty Acid Supplementation on Inflammatory Response in Multisystem Trauma Patients

This study has been terminated.
(Terminated due to slow enrollment and interim analysis showing no difference between treatment arms.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01477697
First Posted: November 22, 2011
Last Update Posted: February 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Krishna Athota, University of Cincinnati
  Purpose
This study will evaluate the effects of omega-3 fatty acid supplementation on inflammation in trauma patients. The main hypothesis is that such supplementation will reduce the presence of biomarkers of systemic inflammation, as compared to placebo

Condition Intervention Phase
Multiple Trauma Dietary Supplement: Omega-3 Dietary Supplement: Placebo Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Omega-3 Fatty Acid Supplementation on Inflammatory Response in Multisystem Trauma Patients

Resource links provided by NLM:


Further study details as provided by Krishna Athota, University of Cincinnati:

Primary Outcome Measures:
  • Inflammatory markers [ Time Frame: Up to 28 days ]
    Plasma levels of pro-inflammatory cytokines IL-6 and IL-8, as well as C-reactive protein


Secondary Outcome Measures:
  • Infectious complications [ Time Frame: Up to 28 days ]
    Incidence of infectious disease complications using established diagnostic criteria

  • Intensive Care Unit length of stay [ Time Frame: Up to 28 days ]
    A count of the number of days during which patients are resident in the Surgical Intensive Care Unit


Enrollment: 12
Study Start Date: June 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Omega-3
50 mg/kg per day of omega-3 fatty acids (DHA Omega-3, Martek Biosciences, Columbia, MD)
Dietary Supplement: Omega-3
50 mg/kg per day of omega-3 fatty acids
Placebo Comparator: Placebo
50 mg/kg per day of vehicle
Dietary Supplement: Placebo
50 mg/kg per day of placebo equivalent

Detailed Description:
This prospective, randomized study will evaluate the effects of omega-3 fatty acid supplementation on inflammatory response in multi-injured trauma patients. Its primary objective is to compare the intensity of inflammation between an active omega-3 group and a placebo group.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Multi-system blunt trauma patients
  • 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:

  • Expected mortality within 48 hours
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01477697


Locations
United States, Ohio
University Hospital
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: Krishna Athota, MD University of Cincinnati
Study Director: Richard Branson, MSc University of Cincinnati
  More Information

Responsible Party: Krishna Athota, Assistant Clinical Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01477697     History of Changes
Other Study ID Numbers: Athota-2010-01
First Submitted: November 18, 2011
First Posted: November 22, 2011
Last Update Posted: February 25, 2013
Last Verified: February 2013

Keywords provided by Krishna Athota, University of Cincinnati:
Trauma

Additional relevant MeSH terms:
Wounds and Injuries
Multiple Trauma