Trial · NCT00351533

A Phase II Randomized Trial of Fish Oil in Patients With Acute Lung Injury (ALI)

NCT00351533, Phase 2, Completed, University of Washington; results first posted 2011-10-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Phase II Randomized Trial of Fish Oil in Patients With Acute Lung Injury (ALI). Trials, record NCT00351533. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00351533

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Phase II Randomized Trial of Fish Oil in Patients With Acute Lung Injury (ALI)
NCT number: NCT00351533
Status: Completed
Phases: Phase 2
Enrollment: 90 participants, actual
Lead sponsor: University of Washington
Conditions: Respiratory Distress Syndrome, Adult, Acute Lung Injury, Acute Respiratory Distress Syndrome
Interventions: Fish oil (eicosapentaenoic acid and docosahexanoic acid)
First posted: 2006-07-13
Last updated: 2011-10-03
Results first posted: 2011-10-03

Source ClinicalTrials.gov

Registered outcomes28

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Bronchoalveolar Lavage Fluid (BALF) Interleukin (IL)-8	Days 1 and 5	30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.
Secondary	Change in BALF Leukotriene B4	Days 1 and 5	30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.
Secondary	Change in BALF Interleukin-6	Days 1 and 5	30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.
Secondary	Change in BALF Monocyte Chemotactic Protein-1	Days 1 and 5	30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.
Secondary	Change in BALF Neutrophil Count	Days 1 and 5	30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.
Secondary	Static Lung Compliance	Day 5	30 patients in the fish oil group and 36 patients in the enteral saline group remained intubated on day 5 and had this outcome available.
Secondary	Oxygenation	Day 5	PaO2/FiO2 is the ratio of partial pressure of arterial oxygen to the fraction of inspired oxygen. 30 patients in the fish oil group and 36 patients in the enteral saline group remained intubated on day 5 and had this outcome available.
Secondary	Change in Plasma Interleukin-8	Days 1 and 5	30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.
Secondary	Change in Plasma Leukotriene B4	Days 1 and 5	30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.
Secondary	Change in Plasma Interleukin-6	Days 1 and 5	30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.

1 to 10 of 28Source ClinicalTrials.gov

See all 28 registered outcomes

Outcomes28

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Bronchoalveolar Lavage Fluid (BALF) Interleukin (IL)-8	Days 1 and 5	The primary outcome was \>=50% reduction in BALF IL-8, measured as the change from baseline to day 5. With α=0.05 and β=0.2, we calculated that 26 patients per group were needed if participants underwent two BALs. Analysis was intention to treat (ITT).	pg/mL	MEDIAN
SECONDARY	Change in BALF Leukotriene B4	Days 1 and 5		pg/mL	MEDIAN
SECONDARY	Change in BALF Interleukin-6	Days 1 and 5		pg/mL	MEDIAN
SECONDARY	Change in BALF Monocyte Chemotactic Protein-1	Days 1 and 5		pg/mL	MEDIAN
SECONDARY	Change in BALF Neutrophil Count	Days 1 and 5		# of cells/mm^3	MEDIAN
SECONDARY	Static Lung Compliance	Day 5		L/cm H20	MEAN
SECONDARY	Oxygenation	Day 5		PaO2/FiO2	MEAN
SECONDARY	Change in Plasma Interleukin-8	Days 1 and 5		pg/mL	MEDIAN
SECONDARY	Change in Plasma Leukotriene B4	Days 1 and 5		pg/mL	MEDIAN
SECONDARY	Change in Plasma Interleukin-6	Days 1 and 5		pg/mL	MEDIAN

1 to 10 of 28Source ClinicalTrials.gov

See all 28 outcomes

Results by group56

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Bronchoalveolar Lavage Fluid (BALF) Interleukin (IL)-8	Enteral Fish Oil	43	Inter-Quartile Range -656 to 604	pg/mL
Change in Bronchoalveolar Lavage Fluid (BALF) Interleukin (IL)-8	Enteral Saline	-241	Inter-Quartile Range -807 to 349	pg/mL
Change in BALF Leukotriene B4	Enteral Fish Oil	6	Inter-Quartile Range -1 to 14	pg/mL
Change in BALF Leukotriene B4	Enteral Saline	-2	Inter-Quartile Range -26 to 9	pg/mL
Change in BALF Interleukin-6	Enteral Fish Oil	-24	Inter-Quartile Range -340 to 51	pg/mL
Change in BALF Interleukin-6	Enteral Saline	-200	Inter-Quartile Range -692 to 0	pg/mL
Change in BALF Monocyte Chemotactic Protein-1	Enteral Fish Oil	-150	Inter-Quartile Range -1812 to 93	pg/mL
Change in BALF Monocyte Chemotactic Protein-1	Enteral Saline	-226	Inter-Quartile Range -752 to -38	pg/mL
Change in BALF Neutrophil Count	Enteral Fish Oil	-3	Inter-Quartile Range -19 to 12	# of cells/mm^3
Change in BALF Neutrophil Count	Enteral Saline	-10	Inter-Quartile Range -21 to 7	# of cells/mm^3

1 to 10 of 56Source ClinicalTrials.gov

See all 56 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Enteral Fish Oil	41
Overall Study	STARTED	Enteral Saline	49
Overall Study	COMPLETED	Enteral Fish Oil	39
Overall Study	COMPLETED	Enteral Saline	44
Overall Study	NOT COMPLETED	Enteral Fish Oil	2
Overall Study	NOT COMPLETED	Enteral Saline	5

Source ClinicalTrials.gov

Adverse events36

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Total Infections	Infections and infestations	Enteral Fish Oil	24	41	51
other	Total Infections	Infections and infestations	Enteral Saline	27	49	50
serious	Atrial fibrillation with rapid ventricular response	Cardiac disorders	Enteral Fish Oil	2	41	2
serious	Atrial fibrillation with rapid ventricular response	Cardiac disorders	Enteral Saline	1	49	1
serious	Renal failure requiring renal replacement therapy	Renal and urinary disorders	Enteral Fish Oil	2	41	2
serious	Renal failure requiring renal replacement therapy	Renal and urinary disorders	Enteral Saline	2	49	2
serious	Pleural and pericardial effusions	Respiratory, thoracic and mediastinal disorders	Enteral Fish Oil	1	41	1
serious	Pleural and pericardial effusions	Respiratory, thoracic and mediastinal disorders	Enteral Saline	0	49	0
serious	Critical hypoxemia	Respiratory, thoracic and mediastinal disorders	Enteral Fish Oil	1	41	1
serious	Critical hypoxemia	Respiratory, thoracic and mediastinal disorders	Enteral Saline	2	49	2

1 to 10 of 36Source ClinicalTrials.gov

See all 36 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Enteral Fish Oil
Total, all-cause mortality	Enteral Saline
Total, other adverse events	Enteral Fish Oil	24	41
Total, other adverse events	Enteral Saline	27	49
Total, serious adverse events	Enteral Fish Oil	12	41
Total, serious adverse events	Enteral Saline	10	49

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Enteral Fish Oil vs Enteral Saline: 60-day Mortality	Trial comparisons
Enteral Fish Oil vs Enteral Saline: Hospital Mortality	Trial comparisons
Enteral Fish Oil vs Enteral Saline: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00351533

GET https://conductscience.org/api/trials/v1/NCT00351533/registered?page=2

API reference For AI assistants