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Terminated Phase 3 Interventional

Early Versus Delayed Enteral Feeding and Omega-3 Fatty Acid/Antioxidant Supplementation for Treating People With Acute Lung Injury or Acute Respiratory Distress Syndrome (The EDEN-Omega Study)

ClinicalTrials.gov ID: NCT00609180

Public ClinicalTrials.gov record NCT00609180. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 12:52 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Prospective, Randomized, Multi-Center Trial of Initial Trophic Enteral Feeding Followed by Advancement to Full-Calorie Enteral Feeding vs. Early Advancement to Full-Calorie Enteral Feeding in Patients With Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS) and Prospective, Randomized, Blinded, Placebo-Controlled, Multi-Center Trial of Omega-3 Fatty Acid, Gamma-Linolenic Acid, and Anti-Oxidant Supplementation in the Management of Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Acute respiratory distress syndrome (ARDS) and acute lung injury (ALI) are medical conditions that occur when there is severe inflammation and increased fluids in both lungs, making it difficult for the lungs to function properly. Hospital treatment for a person with ALI/ARDS often includes the use of a breathing machine, or ventilator, until the person is able to breathe without assistance. Initiating proper nutrition through a feeding tube early in a person's hospital stay may help to improve recovery, but the optimal timing, composition, and amount of feeding treatments are unknown. This study will evaluate whether early or delayed full-calorie feeding through a feeding tube is more effective in reducing recovery time and increasing survival rates in people with ALI/ARDS. The study will also determine whether supplementing the feedings with omega-3 fatty acids and antioxidants benefits people with ALI/ARDS.

Study identification

NCT ID
NCT00609180
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 3
Enrollment
272 participants

Conditions and interventions

Interventions

Behavioral · Dietary Supplement

Eligibility (public fields only)

Age range
13 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 2007 (Type not available)
Primary completion
Feb 2009 (Actual)
Completion
Apr 2009 (Actual)
Last update posted
Apr 13, 2016

2007 – 2009

United States locations

U.S. sites
41
U.S. states
14
U.S. cities
23
Facility City State ZIP Site status
University of San Francisco-Fresno Medical Center Fresno California — —
University of California, Davis Medical Center Sacramento California — —
UCSF-Moffitt Hospital San Francisco California — —
UCSF-San Francisco General Hospital San Francisco California — —
Centura St. Anthony Central Hospital Denver Colorado — —
Denver Health Medical Center Denver Colorado — —
Rose Medical Center Denver Colorado — —
University of Colorado Health Sciences Center Denver Colorado — —
Washington Hospital Center Washington D.C. District of Columbia — —
Baton Rouge General Hospital-Blue Bonnet Baton Rouge Louisiana — —
Baton Rouge General Hospital-Midcity Baton Rouge Louisiana — —
Earl K. Long Medical Center Baton Rouge Louisiana — —
Our Lady of the Lake Regional Medical Center Baton Rouge Louisiana — —
Medical Center of Louisiana New Orleans Louisiana — —
Ochsner Clinic Foundation New Orleans Louisiana — —
Tulane University Health Sciences Center New Orleans Louisiana — —
Baltimore VA Medical Center Baltimore Maryland — —
Johns Hopkins Bayview Medical Center Baltimore Maryland — —
Johns Hopkins Hospital Baltimore Maryland — —
University of Maryland Shock Trauma Center Baltimore Maryland — —
Baystate Medical Center Springfield Massachusetts — —
Rochester Methodist Hospital Rochester Minnesota — —
St. Mary's Hospital, Mayo Clinic Rochester Minnesota — —
University of North Carolina Chapel Hill North Carolina — —
Duke University Medical Center Durham North Carolina — —
Durham Regional Medical Center Durham North Carolina — —
Moses Cone Health System Greensboro North Carolina — —
Wesley Long Community Hospital Greensboro North Carolina — —
Wake Forest University Baptist Medical Center Winston-Salem North Carolina — —
Cleveland Clinic Foundation Cleveland Ohio — —
MetroHealth Medical Center Cleveland Ohio — —
University Hospitals of Cleveland Cleveland Ohio — —
Vanderbilt University Medical Center Nashville Tennessee — —
Baylor College of Medicine Houston Texas — —
Intermountain Medical Center Murray Utah — —
McKay-Dee Hospital Ogden Utah — —
Utah Valley Regional Medical Center Provo Utah — —
LDS Hospital Salt Lake City Utah — —
University of Virginia Medical Center Charlottesville Virginia — —
Harborview Medical Center Seattle Washington — —
University of Washington Seattle Washington — —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00609180, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 13, 2016 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00609180 live on ClinicalTrials.gov.

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