Effects of Omega-3 Fatty Acid Supplementation on Inflamma... | NCT01477697

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

NCT01477697

Sponsor

University of Cincinnati

Status

Terminated

Last Update Posted

Feb 25, 2013Estimated

Enrollment

12Actual

Phase

Phase 1Phase 2

Conditions

Multiple Trauma

Interventions

Omega-3
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Terminated due to slow enrollment and interim analysis showing no difference between treatment arms.

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Nov 2012Actual

Completion Date

Nov 2012Actual

First Submitted Date

Nov 18, 2011

First Submission Date that Met QC Criteria

Nov 18, 2011

First Posted Date

Nov 22, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2013

Last Update Posted Date

Feb 25, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Omega-3	Active Comparator	50 mg/kg per day of omega-3 fatty acids (DHA Omega-3, Martek Biosciences, Columbia, MD)	Dietary Supplement: Omega-3
Placebo	Placebo Comparator	50 mg/kg per day of vehicle	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Omega-3	Dietary Supplement	50 mg/kg per day of omega-3 fatty acids	Omega-3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Krishna Athota, MD	University of Cincinnati	Principal Investigator
Richard Branson, MSc	University of Cincinnati	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital		Cincinnati	Ohio	45219	United States

Condition Browse Module

MeSH Terms

ID	Term
D009104	Multiple Trauma
D014947	Wounds and Injuries

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004281	Docosahexaenoic Acids

Ancestor Terms

ID	Term
D015525	Fatty Acids, Omega-3
D004042	Dietary Fats, Unsaturated
D004041	Dietary Fats
D005223	Fats

Browse Leaves

Not provided

Browse Branches

Not provided