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Showing 1–24 of 40 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Fish oil emulsion Clear all
Recruiting Phase 4 Interventional

Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients

NCT06049680
View directory record Official record
Conditions
Malnutrition, Child, Malnutrition, Essential Fatty Acid Deficiency (EFAD), Parenteral Nutrition Associated Cholestasis
Interventions
SMOFlipid® (lipid injectable emulsion)
Drug
Lead sponsor
Fresenius Kabi
Industry
Eligibility
1 Month to 17 Years
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2026
U.S. locations
5
States / cities
Atlanta, Georgia • Chicago, Illinois • Indianapolis, Indiana + 2 more
Source: ClinicalTrials.gov public record
Updated Jul 16, 2026 · Synced Sep 7, 2026, 5:20 AM EDT
Terminated Phase 3 Interventional Results available

Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and Infants

NCT02579265
View directory record Official record
Conditions
Hospitalized Neonates and Infants, Expected to Require Parenteral Nutrition for 28 Days
Interventions
Smoflipid 20% (investigational lipid for parenteral nutrition), Intralipid® 20%
Drug
Lead sponsor
Fresenius Kabi
Industry
Eligibility
0 Weeks and older
Enrollment
204 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2020
U.S. locations
13
States / cities
Palo Alto, California • San Diego, California • New Haven, Connecticut + 8 more
Source: ClinicalTrials.gov public record
Updated Jan 4, 2022 · Synced Sep 7, 2026, 5:20 AM EDT
Not listed Not applicable Interventional

Omegaven® as Parenteral Nutrition

NCT02334293
View directory record Official record
Conditions
Cholestasis
Interventions
Omegaven
Drug
Lead sponsor
Carle Foundation Hospital
Other
Eligibility
14 Days to 4 Months
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2013
U.S. locations
1
States / cities
Urbana, Illinois
Source: ClinicalTrials.gov public record
Updated Jan 7, 2015 · Synced Sep 7, 2026, 5:20 AM EDT
Terminated Phase 2 Interventional Results available

Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Hepatic Injury

NCT01325584
View directory record Official record
Conditions
Cancer, Hepatic Injury
Interventions
Omegaven
Drug
Lead sponsor
Midwestern Regional Medical Center
Other
Eligibility
18 Years to 80 Years
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2017
U.S. locations
1
States / cities
Zion, Illinois
Source: ClinicalTrials.gov public record
Updated Aug 6, 2018 · Synced Sep 7, 2026, 5:20 AM EDT
Recruiting No phase listed Observational

Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment

NCT06274788
View directory record Official record
Conditions
Parenteral Nutrition Associated Liver Disease (PNALD), Essential Fatty Acid Deficiency, Malnutrition, Pediatric ALL
Interventions
Omegaven® (fish oil triglycerides) Injectable Emulsion
Drug
Lead sponsor
Fresenius Kabi
Industry
Eligibility
1 Day to 17 Years
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2028
U.S. locations
10
States / cities
Fountain Valley, California • Los Angeles, California • Chicago, Illinois + 7 more
Source: ClinicalTrials.gov public record
Updated Aug 13, 2026 · Synced Sep 7, 2026, 5:20 AM EDT
Completed Phase 3 Interventional

Use of Omegaven Fish Oil Emulsion for Parenteral Nutrition Associated Liver Disease in Infants and Children

NCT01194063
View directory record Official record
Conditions
Cholestasis
Interventions
Omega-3 fish oil lipid emulsion
Drug
Lead sponsor
Kapiolani Medical Center For Women & Children
Other
Eligibility
Up to 18 Years
Enrollment
36 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2019
U.S. locations
1
States / cities
Honolulu, Hawaii
Source: ClinicalTrials.gov public record
Updated Apr 2, 2026 · Synced Sep 7, 2026, 5:20 AM EDT
Completed Phase 2 Interventional Results available

Omega-3 Long Chain Polyunsaturated Fatty Acid (LCPUFA) Supplementation in Very Low Birth Weight Infants for The Prevention Retinopathy of Prematurity

NCT02486042
View directory record Official record
Conditions
Retinopathy of Prematurity
Interventions
Omegaven, Standard lipids (primarily omega-6 fatty acids)
Drug · Dietary Supplement
Lead sponsor
University of California, San Diego
Other
Eligibility
Up to 7 Days
Enrollment
48 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2019
U.S. locations
1
States / cities
La Jolla, California
Source: ClinicalTrials.gov public record
Updated Dec 28, 2022 · Synced Sep 7, 2026, 5:20 AM EDT
Completed Not applicable Interventional Results available

Compassionate Use of an Intravenous Fish Oil Emulsion in the Treatment of Liver Injury in Infants

NCT00738101
View directory record Official record
Conditions
Cholestasis, Cholestasis of Parenteral Nutrition
Interventions
Omegaven
Drug
Lead sponsor
Baylor College of Medicine
Other
Eligibility
14 Days to 5 Years
Enrollment
293 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2020
U.S. locations
2
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated May 27, 2021 · Synced Sep 7, 2026, 5:20 AM EDT
Completed Phase 2Phase 3 Interventional Results available

Use of Omegaven for Treatment With Parenteral Nutrition Associated Liver Disease

NCT04697888
View directory record Official record
Conditions
Parenteral Nutrition-related Hepatitis
Interventions
Omegaven
Drug
Lead sponsor
Children's Mercy Hospital Kansas City
Other
Eligibility
Up to 17 Years
Enrollment
2 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2018
U.S. locations
1
States / cities
Kansas City, Missouri
Source: ClinicalTrials.gov public record
Updated Jun 10, 2021 · Synced Sep 7, 2026, 5:20 AM EDT
Completed Phase 1 Interventional

Safety and Tolerability of Intravenous Fish Oil Lipid Emulsion in Children Undergoing Hematopoietic Cell Transplantation

NCT02512718
View directory record Official record
Conditions
Hematopoietic Stem Cell Transplantation
Interventions
Omegaven, Soybean oil lipid emulsion
Drug
Lead sponsor
Alexandra N. Carey
Other
Eligibility
2 Years to 18 Years
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2023
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Sep 21, 2025 · Synced Sep 7, 2026, 5:20 AM EDT
Completed Early Phase 1 Interventional

Omega-3 Fatty Acids That Affect the Immune System in Kidney Transplant Patients

NCT00047983
View directory record Official record
Conditions
Kidney Diseases
Interventions
Canola oil, Arginine, Fish oil emulsion
Dietary Supplement
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
4 Years and older
Enrollment
75 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Ends 2004
U.S. locations
4
States / cities
Washington D.C., District of Columbia • Baltimore, Maryland • Durham, North Carolina + 1 more
Source: ClinicalTrials.gov public record
Updated Jan 10, 2017 · Synced Sep 7, 2026, 5:20 AM EDT
Withdrawn Not applicable Interventional

Compassionate Use of Omegaven IV Fat Emulsion

NCT01323907
View directory record Official record
Conditions
Total Parenteral Nutrition-induced Cholestasis
Interventions
Omegaven IV lipid emulsion
Drug
Lead sponsor
Sivan Kinberg
Other
Eligibility
2 Months to 18 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2019
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Feb 5, 2020 · Synced Sep 7, 2026, 5:20 AM EDT
Completed Phase 2 Interventional Results available

Omegaven® in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury

NCT01845116
View directory record Official record
Conditions
Total Parenteral Nutrition-induced Cholestasis
Interventions
Omegaven®
Drug
Lead sponsor
Wake Forest University Health Sciences
Other
Eligibility
4 Weeks to 18 Years
Enrollment
11 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2020
U.S. locations
1
States / cities
Charlotte, North Carolina
Source: ClinicalTrials.gov public record
Updated Nov 22, 2022 · Synced Sep 7, 2026, 5:20 AM EDT
Terminated Phase 4 Interventional Results available

Safety and Efficacy Study to Compare Smoflipid and Intralipid 20% in Pediatric Patients of 3 Months to 16 Years of Age

NCT03563222
View directory record Official record
Conditions
Malnutrition, Child
Interventions
Smoflipid, Intralipid, 20%
Drug
Lead sponsor
Fresenius Kabi
Industry
Eligibility
3 Months to 16 Years
Enrollment
1 participant
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2022
U.S. locations
1
States / cities
Pittsburgh, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Dec 11, 2022 · Synced Sep 7, 2026, 5:20 AM EDT
Approved For Marketing No phase listed Expanded access

Intravenous Fat Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Infants

NCT02534077
View directory record Official record
Conditions
Total Parenteral Nutrition-induced Cholestasis
Interventions
Omegaven, Omegaven
Dietary Supplement · Drug
Lead sponsor
Pediatrix
Other
Eligibility
14 Days to 2 Years
Healthy volunteers
Healthy volunteers not accepted
U.S. locations
1
States / cities
San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated Jul 25, 2024 · Synced Sep 7, 2026, 5:20 AM EDT
Completed Phase 1Phase 2 Interventional Results available

Compassionate Use of an Intravenous Fish Oil Emulsion in Infants With Cholestasis

NCT01601652
View directory record Official record
Conditions
Parenteral Nutrition Associated Cholestasis
Interventions
Omegaven
Drug
Lead sponsor
Arthur J De Lorimier
Other
Eligibility
Up to 1 Year
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2018
U.S. locations
1
States / cities
Sacramento, California
Source: ClinicalTrials.gov public record
Updated Jan 26, 2021 · Synced Sep 7, 2026, 5:20 AM EDT
Completed Not applicable Interventional

Compassionate Use of Omegaven in the Treatment of Parenteral Nutrition Induced Hepatic Injury

NCT02010034
View directory record Official record
Conditions
Liver Disease, Impaired Liver Function, Parenteral Nutrition Associated Liver Disease
Interventions
Omegaven
Drug
Lead sponsor
Children's Medical Center Dallas
Other
Eligibility
2 Months to 10 Years
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2019
U.S. locations
1
States / cities
Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Feb 5, 2019 · Synced Sep 7, 2026, 5:20 AM EDT
Approved For Marketing No phase listed Expanded access

Expanded Access of Omegaven IV Fat Emulsion to Infants and Children With PNALD

NCT02929303
View directory record Official record
Conditions
Total Parenteral Nutrition-induced Cholestasis
Interventions
Omegaven IV lipid emulsion
Drug
Lead sponsor
Wake Forest University Health Sciences
Other
Eligibility
Up to 17 Years
U.S. locations
1
States / cities
Park Ridge, Illinois
Source: ClinicalTrials.gov public record
Updated Sep 30, 2025 · Synced Sep 7, 2026, 5:20 AM EDT
Completed Not applicable Interventional

Intralipid Versus SMOFlipid in HPN Patients

NCT03773237
View directory record Official record
Conditions
Short Bowel Syndrome, Intestinal Fistula, Crohn Disease, Intestinal Obstruction
Interventions
SMOFLipid, Intralipid
Dietary Supplement
Lead sponsor
Mayo Clinic
Other
Eligibility
18 Years to 75 Years
Enrollment
22 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2024
U.S. locations
1
States / cities
Rochester, Minnesota
Source: ClinicalTrials.gov public record
Updated May 15, 2025 · Synced Sep 7, 2026, 5:20 AM EDT
Completed Phase 3 Interventional Results available

Comparison of Smoflipid to Soy-based Lipid Reduction for Cholestasis Prevention in Surgical Neonates

NCT03387579
View directory record Official record
Conditions
Cholestasis of Parenteral Nutrition
Interventions
Smoflipid 20% Lipid Emulsion for Injection, Intralipid, 20% Intravenous Emulsion
Drug
Lead sponsor
Indiana University
Other
Eligibility
Not listed
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2024
U.S. locations
1
States / cities
Indianapolis, Indiana
Source: ClinicalTrials.gov public record
Updated Jul 29, 2025 · Synced Sep 7, 2026, 5:20 AM EDT
Completed Phase 4 Interventional Results available

Use of Omega-3 Fat Emulsion (Omegaven) in Infants With Parenteral Nutrition Associated Liver Disease

NCT00862446
View directory record Official record
Conditions
Parenteral Nutrition Associated Liver Disease
Interventions
Omegaven
Drug
Lead sponsor
Vanderbilt University Medical Center
Other
Eligibility
Up to 24 Months
Enrollment
48 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2019
U.S. locations
1
States / cities
Nashville, Tennessee
Source: ClinicalTrials.gov public record
Updated Jan 4, 2021 · Synced Sep 7, 2026, 5:20 AM EDT
No Longer Available No phase listed Expanded access

Expanded Access Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Liver Injury in Children

NCT02925520
View directory record Official record
Conditions
Parenteral Nutrition-Associated Liver Disease
Interventions
Omegaven
Drug
Lead sponsor
Cook Children's Health Care System
Other
Eligibility
4 Weeks to 5 Years
U.S. locations
1
States / cities
Fort Worth, Texas
Source: ClinicalTrials.gov public record
Updated Jan 9, 2019 · Synced Sep 7, 2026, 5:20 AM EDT
Withdrawn Phase 4 Interventional

SMOFLipid in Patients Who Are Intralipid Intolerant

NCT03054948
View directory record Official record
Conditions
Home Parenteral Nutrition, Short Bowel Syndrome
Interventions
SMOFLipid, Standard therapy
Drug
Lead sponsor
Mayo Clinic
Other
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2018
U.S. locations
1
States / cities
Rochester, Minnesota
Source: ClinicalTrials.gov public record
Updated Mar 21, 2018 · Synced Sep 7, 2026, 5:20 AM EDT
Approved For Marketing No phase listed Expanded access

Intravenous Fish Oils in the Treatment of Parenteral Nutrition Liver Injury

NCT02780193
View directory record Official record
Conditions
Cholestasis, Total Parenteral Nutrition-induced Cholestasis
Interventions
Omegaven
Drug
Lead sponsor
Rush University Medical Center
Other
Eligibility
Up to 18 Years
U.S. locations
1
States / cities
Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Apr 7, 2019 · Synced Sep 7, 2026, 5:20 AM EDT