Crossover Study on the Effect of Omegaven in Combination With Different Lipid Emulsions in Home Parenteral Nutrition

May 9, 2017 updated by: Frantisek Novak, General University Hospital, Prague

A Prospective, Randomized, Controlled, Double-blind, Crossover-Design, Mono-center, Phase IV Study Comparing the Effect of Omegaven in Combination With Clinoleic or Lipoplus or SMOFlipid in Home Parenteral Nutrition Patients

The aim of this study was to evaluate the safety and tolerance of ClinOleic or Lipoplus or SMOFlipid lipid emulsions. After 6 weeks of each lipid emulsion, Omegaven (fish oil) was added for a further 4 weeks. The safety and tolerance was evaluated after each lipid emulsion cycle by biochemistry, hematology and coagulation variables, vital signs and adverse events. We also analysed fatty acid profiles in plasma or erythrocyte phospholipids, antioxidant enzyme activities, lipid peroxidation products, plasma lipids and pro-inflammatory cytokine production after in vitro stimulation of whole blood by lipopolysacharide in HPN patients. The non-interventional group of healthy controls was included for comparison.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Intravenous lipid emulsions (LEs) are an indispensable part of home parenteral nutrition (HPN). All commercially obtainable LEs are applicable for HPN in providing a source of energy and essential fatty acids. The originally used soyabean oil-based LE (Intralipid) have been suspected of being associated with a higher risk of pro-inflammatory lipid-mediator production due to their high content of n-6 polyunsaturated fatty acids. The more modern mixes of soyabean oil, and/or olive oil, and/or fish oil LEs with beneficial responses compared with Intralipid are available. Given that there are no clear clinical recommendations for LE application in HPN, we performed this cross-over design, phase 4 study comparing ClinOleic, Lipoplus or SMOFlipid in chronic intestinal failure patients with additional escalation of fish oil using Omegaven.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Prague, Czechia, 12808
        • General University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Home parenteral nutrition patients in need of parenteral nutrition administration > 4 days/week
  • Parenteral duration expectancy > 8 months
  • Stable clinical condition without any complications in the past 2 months
  • Written consent from the subject

Exclusion Criteria:

  • Known hypersensitivity to any of the active substances or excipients
  • Unstable conditions
  • Active cancer or its treatment
  • Established immunodeficiency
  • Advanced organ dysfunction from chronic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1 Home Parenteral Nutrition, Cross-over
Random Cycle Sequence - Cycle 1: Clinoleic (baseline), 50g/per day, 42 days Clinoleic + Omegaven, 40g + 10g/per day, 28 days. Cycle 2: Lipoplus (baseline), 50g/per day, 42 days Lipoplus + Omegaven, 40g + 10g/per day, 28 days. Cycle 3: SMOFlipid (baseline), 50g/per day, 42 days SMOFlipid + Omegaven, 40g + 10g/per day, 28 days.
Drug: ClinOleic (baseline)
Lipid emulsion in pharmacy compounded all-in-one admixture
Other Names:
  • ClinOleic 20% Baxter
Drug: ClinOleic + Omegaven
Lipid emulsion in pharmacy compounded all-in-one admixture
Other Names:
  • ClinOleic 20% Baxter + Omegaven 10% Fresenius Kabi
Drug: Lipoplus (baseline)
Lipid emulsion in pharmacy compounded all-in-one admixture
Other Names:
  • Lipoplus 20% BBraun Melsungen
Drug: Lipoplus + Omegaven
Lipid emulsion in pharmacy compounded all-in-one admixture
Other Names:
  • Lipoplus 20% BBraun Melsungen + Omegaven 10% Fresenius Kabi
Drug: SMOFlipid (baseline)
Lipid emulsion in pharmacy compounded all-in-one admixture
Other Names:
  • SMOFlipid 20% Fresenius Kabi
Drug: SMOFlipid + Omegaven
Lipid emulsion in pharmacy compounded all-in-one admixture
Other Names:
  • SMOFlipid 20% Fresenius Kabi + Omegaven 10% Fresenius Kabi
Active Comparator: 2 Home Parenteral Nutrition, Cross-over
Random Cycle Sequence - Cycle 1: Clinoleic (baseline), 50g/per day, 42 days Clinoleic + Omegaven, 40g + 10g/per day, 28 days. Cycle 2: Lipoplus (baseline), 50g/per day, 42 days Lipoplus + Omegaven, 40g + 10g/per day, 28 days. Cycle 3: SMOFlipid (baseline), 50g/per day, 42 days SMOFlipid + Omegaven, 40g + 10g/per day, 28 days.
Drug: ClinOleic (baseline)
Lipid emulsion in pharmacy compounded all-in-one admixture
Other Names:
  • ClinOleic 20% Baxter
Drug: ClinOleic + Omegaven
Lipid emulsion in pharmacy compounded all-in-one admixture
Other Names:
  • ClinOleic 20% Baxter + Omegaven 10% Fresenius Kabi
Drug: Lipoplus (baseline)
Lipid emulsion in pharmacy compounded all-in-one admixture
Other Names:
  • Lipoplus 20% BBraun Melsungen
Drug: Lipoplus + Omegaven
Lipid emulsion in pharmacy compounded all-in-one admixture
Other Names:
  • Lipoplus 20% BBraun Melsungen + Omegaven 10% Fresenius Kabi
Drug: SMOFlipid (baseline)
Lipid emulsion in pharmacy compounded all-in-one admixture
Other Names:
  • SMOFlipid 20% Fresenius Kabi
Drug: SMOFlipid + Omegaven
Lipid emulsion in pharmacy compounded all-in-one admixture
Other Names:
  • SMOFlipid 20% Fresenius Kabi + Omegaven 10% Fresenius Kabi
No Intervention: Comparator3
Healthy Control

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline lipid emulsion production of TNF-alpha after in vitro stimulation of whole blood by lipopolysacharide at 4 weeks of Omegaven lipid emulsion addition
Time Frame: day 42, day 70
The whole blood culture supernatant concentration of TNF-alpha (ng/L)
day 42, day 70
Change from baseline lipid emulsion production of IL-1-beta after in vitro stimulation of whole blood by lipopolysacharide at 4 weeks of Omegaven lipid emulsion addition
Time Frame: day 42, day 70
The whole blood culture supernatant concentration of IL-1-beta (ng/L)
day 42, day 70
Change from baseline lipid emulsion production of IL-6 after in vitro stimulation of whole blood by lipopolysacharide at 4 weeks of Omegaven lipid emulsion addition
Time Frame: day 42, day 70
The whole blood culture supernatant concentration of IL-6 (ng/L)
day 42, day 70
Change from baseline lipid emulsion production of IL-8 after in vitro stimulation of whole blood by lipopolysacharide at 4 weeks of Omegaven lipid emulsion addition
Time Frame: day 42, day 70
The whole blood culture supernatant concentration of IL-8 (ng/L)
day 42, day 70

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline lipid emulsion plasma concentration of TNF-alpha at 4 weeks of Omegaven lipid emulsion addition
Time Frame: day 42, day 70
The plasma concentration of TNF-alpha (ng/L)
day 42, day 70
Change from baseline lipid emulsion plasma concentration of IL-1-beta at 4 weeks of Omegaven lipid emulsion addition
Time Frame: day 42, day 70
The plasma concentration of IL-1-beta (ng/L)
day 42, day 70
Change from baseline lipid emulsion plasma concentration of IL-6 at 4 weeks of Omegaven lipid emulsion addition
Time Frame: day 42, day 70
The plasma concentration of IL-6 (ng/L)
day 42, day 70
Change from baseline lipid emulsion plasma concentration of IL-8 at 4 weeks of Omegaven lipid emulsion addition
Time Frame: day 42, day 70
The plasma concentration of IL-8 (ng/L)
day 42, day 70
Change from baseline lipid emulsion plasma concentration ratio of oxidized LDL/LDL cholesterol at 4 weeks of Omegaven lipid emulsion addition
Time Frame: day 42, day 70
The plasma concentration ratio of oxidized LDL/LDL cholesterol (ox-LDL/LDL-C)
day 42, day 70
Change from baseline lipid emulsion plasma concentration of triglycerides at 4 weeks of Omegaven lipid emulsion addition
Time Frame: day 42, day 70
The plasma concentration of triglycerides (mmol/L)
day 42, day 70
Change from baseline lipid emulsion plasma concentration of total cholesterol at 4 weeks of Omegaven lipid emulsion addition
Time Frame: day 42, day 70
The plasma concentration of total cholesterol (mmol/L)
day 42, day 70
Change from baseline lipid emulsion plasma concentration of HDL cholesterol at 4 weeks of Omegaven lipid emulsion addition
Time Frame: day 42, day 70
The plasma concentration of HDL cholesterol (mmol/L)
day 42, day 70
Change from baseline lipid emulsion plasma concentration of LDL cholesterol at 4 weeks of Omegaven lipid emulsion addition
Time Frame: day 42, day 70
The plasma concentration of LDL cholesterol (mmol/L)
day 42, day 70
Change from baseline lipid emulsion plasma phospholipid fatty acid profile at 4 weeks of Omegaven lipid emulsion addition
Time Frame: day 42, day 70
The plasma phospholipid fatty acid profile (mol%)
day 42, day 70
Change from baseline lipid emulsion erythrocyte phospholipid fatty acid profile at 4 weeks of Omegaven lipid emulsion addition
Time Frame: day 42, day 70
The erythrocyte phospholipid fatty acid profile (mol%)
day 42, day 70
Change from baseline lipid emulsion plasma concentration of fibrothelial growth factor 19 at 4 weeks of Omegaven lipid emulsion addition
Time Frame: day 42, day 70
The plasma concentration of fibrothelial growth factor 19 (ng/L)
day 42, day 70
Change from baseline lipid emulsion erythrocyte superoxide dismutase activity at 4 weeks of Omegaven lipid emulsion addition
Time Frame: day 42, day 70
The erythrocyte activity of SOD (U/g Hb)
day 42, day 70
Change from baseline lipid emulsion erythrocyte catalase activity at 4 weeks of Omegaven lipid emulsion addition
Time Frame: day 42, day 70
The erythrocyte activity of CAT (U/g Hb)
day 42, day 70
Change from baseline lipid emulsion erythrocyte glutathione peroxidase activity at 4 weeks of Omegaven lipid emulsion addition
Time Frame: day 42, day 70
The erythrocyte activity of GPX (U/g Hb)
day 42, day 70
Change from baseline lipid emulsion erythrocyte glutathione reductase activity at 4 weeks of Omegaven lipid emulsion addition
Time Frame: day 42, day 70
The erythrocyte activity of GR (U/g Hb)
day 42, day 70
Change from baseline lipid emulsion plasma paraoxonase 1 activity at 4 weeks of Omegaven lipid emulsion addition
Time Frame: day 42, day 70
The plasma activity of PON1 (U/L)
day 42, day 70
Alteration of liver function
Time Frame: week 6, week 10, week 16, week 20, week 26, week 30
Liver function tests
week 6, week 10, week 16, week 20, week 26, week 30
Septic complications
Time Frame: week 6, week 10, week 16, week 20, week 26, week 30
Catheter-related bloodstream infections
week 6, week 10, week 16, week 20, week 26, week 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
General University Hospital, Prague

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Charles University, Czech Republic
Ministry of Health, Czech Republic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Frantisek Novak, MD, PhD, General University Hospital, Prague

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 7, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NT13236-4/2012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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