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

NCT ID: NCT01477697

Last Updated: 2013-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Trauma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Omega-3

50 mg/kg per day of omega-3 fatty acids (DHA Omega-3, Martek Biosciences, Columbia, MD)

Group Type ACTIVE_COMPARATOR

Omega-3

Intervention Type DIETARY_SUPPLEMENT

50 mg/kg per day of omega-3 fatty acids

Placebo

50 mg/kg per day of vehicle

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

50 mg/kg per day of placebo equivalent

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Omega-3

50 mg/kg per day of omega-3 fatty acids

Intervention Type DIETARY_SUPPLEMENT

Placebo

50 mg/kg per day of placebo equivalent

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Cincinnati

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Krishna Athota

Assistant Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Krishna Athota, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Richard Branson, MSc

Role: STUDY_DIRECTOR

University of Cincinnati

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital

Cincinnati, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Athota-2010-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.