Study Stopped
Terminated due to slow enrollment and interim analysis showing no difference between treatment arms.
Effects of Omega-3 Fatty Acid Supplementation on Inflammatory Response in Multisystem Trauma Patients
1 other identifier
interventional
12
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 18, 2011
CompletedFirst Posted
Study publicly available on registry
November 22, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedFebruary 25, 2013
February 1, 2013
1.4 years
November 18, 2011
February 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Inflammatory markers
Plasma levels of pro-inflammatory cytokines IL-6 and IL-8, as well as C-reactive protein
Up to 28 days
Secondary Outcomes (2)
Infectious complications
Up to 28 days
Intensive Care Unit length of stay
Up to 28 days
Study Arms (2)
Omega-3
ACTIVE COMPARATOR50 mg/kg per day of omega-3 fatty acids (DHA Omega-3, Martek Biosciences, Columbia, MD)
Placebo
PLACEBO COMPARATOR50 mg/kg per day of vehicle
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital
Cincinnati, Ohio, 45219, United States
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Krishna Athota, MD
University of Cincinnati
- STUDY DIRECTOR
Richard Branson, MSc
University of Cincinnati
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Clinical Professor
Study Record Dates
First Submitted
November 18, 2011
First Posted
November 22, 2011
Study Start
June 1, 2011
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
February 25, 2013
Record last verified: 2013-02