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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:
Information provided by (Responsible Party):
Krishna Athota, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01477697
First received: November 18, 2011
Last updated: February 22, 2013
Last verified: February 2013
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Injuries Wounds
U.S. FDA Resources

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • Inflammatory markers [ Time Frame: Up to 28 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Incidence of infectious disease complications using established diagnostic criteria

  • Intensive Care Unit length of stay [ Time Frame: Up to 28 days ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Krishna Athota, Assistant Clinical Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01477697     History of Changes
Other Study ID Numbers: Athota-2010-01
Study First Received: November 18, 2011
Last Updated: February 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
Trauma

Additional relevant MeSH terms:
Multiple Trauma
Wounds and Injuries

ClinicalTrials.gov processed this record on May 16, 2013