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

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01477697

Enrollment

Registered

2011-11-22

Start date

2011-06-30

Completion date

2012-11-30

Last updated

2013-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Trauma

Keywords

Trauma

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

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.

Interventions

DIETARY_SUPPLEMENTOmega-3

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

DIETARY_SUPPLEMENTPlacebo

50 mg/kg per day of placebo equivalent

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Inflammatory markers	Up to 28 days	Plasma levels of pro-inflammatory cytokines IL-6 and IL-8, as well as C-reactive protein

Secondary

Measure	Time frame	Description
Infectious complications	Up to 28 days	Incidence of infectious disease complications using established diagnostic criteria
Intensive Care Unit length of stay	Up to 28 days	A count of the number of days during which patients are resident in the Surgical Intensive Care Unit

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026