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

February 22, 2013 updated by: Krishna Athota, University of Cincinnati
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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infectious complications
Time Frame: Up to 28 days
Incidence of infectious disease complications using established diagnostic criteria
Up to 28 days
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
Up to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cincinnati

Investigators

  • Principal Investigator: Krishna Athota, MD, University of Cincinnati
  • Study Director: Richard Branson, MSc, University of Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (ACTUAL)

November 1, 2012

Study Completion (ACTUAL)

November 1, 2012

Study Registration Dates

First Submitted

November 18, 2011

First Submitted That Met QC Criteria

November 18, 2011

First Posted (ESTIMATE)

November 22, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 25, 2013

Last Update Submitted That Met QC Criteria

February 22, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Athota-2010-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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