Immune Modulation by Parenteral Lipids
Primary Purpose
Infections, Total Parenteral Nutrition
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Parenteral lipid emulsion (Omegaven)
Parenteral lipid emulsion (Intralipid)
Parental lipid emulsion (Saline 0.9%)
Sponsored by
About this trial
This is an interventional treatment trial for Infections focused on measuring total parenteral nutrition, infections, Infectious complications related to parenteral nutrition
Eligibility Criteria
Inclusion Criteria:
- Adult (>18 yrs of age)
- Healthy
- Willingness to give written informed consent
Exclusion Criteria:
- Smoking > 5 cigarettes/day
- Diet with > 2 portions of fatty fish per day
- Use of oral fish oil or vitamin substrates
- History of metabolic disorder (especially diabetes or lipid disorders)
- History of allergic, inflammatory of immunological disease
- History of pulmonary, cardiovascular, renal or hematological disease
- Medication use
Sites / Locations
- Radboud University Nijmegen Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
1
2
3
Arm Description
Omegaven 10%
Intralipid 10%
Placebo
Outcomes
Primary Outcome Measures
leukocyte counts
leukocyte functions
(anti-)oxidant status
Secondary Outcome Measures
plasma and leukocyte cell membrane (phospho)lipid composition.
Full Information
NCT ID
NCT00734916
First Posted
August 13, 2008
Last Updated
February 3, 2010
Sponsor
Radboud University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00734916
Brief Title
Immune Modulation by Parenteral Lipids
Official Title
Immune Modulation by Omega-3 Versus Omega-6 Based Parenteral Lipids in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Radboud University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Immune modulating properties of parenteral lipid emulsions seem to contribute to the increased risk for infections which remains associated with the use of total parenteral nutrition. Emulsions based on soy bean oil (SO) are the oldest and still most widely used lipid source in TPN formulations but their high content of omega-6 polyunsaturated fatty acids (PUFAs) may be a drawback. Fish oil-based lipid emulsions (FO), rich in omega-3 PUFAs, has been approved for parenteral nutrition in many countries. Mainly retrospective studies on clinical outcomes in septic and postoperative patients have suggested clinical benefits with the inclusion of FO in parenteral nutrition regimens. The exact mechanisms behind the beneficial immunological effects of parenteral FO have, however, not yet been elucidated.
Objective:
To evaluate the effects of intravenous infusion of a FO-based lipid emulsion and a SO-based emulsion on immune function as evidenced by effects on peripheral blood leukocyte counts and functions and on the susceptibility to oxidative stress.
Study design:
Randomized placebo controlled cross-over pilot study with healthy volunteers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Total Parenteral Nutrition
Keywords
total parenteral nutrition, infections, Infectious complications related to parenteral nutrition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Omegaven 10%
Arm Title
2
Arm Type
Active Comparator
Arm Description
Intralipid 10%
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Parenteral lipid emulsion (Omegaven)
Other Intervention Name(s)
Omegaven 10%, Fresenius Kabi, Bad Homburg Germany
Intervention Description
Omegaven 10%, 0.2g/kg/hr i.v.during 1 hour on 3 consecutive days
Intervention Type
Dietary Supplement
Intervention Name(s)
Parenteral lipid emulsion (Intralipid)
Other Intervention Name(s)
Intralipid 10%, Fresenius Kabi, Bad Homburg Germany
Intervention Description
Intralipid 10%, 0.2g/kg/hr i.v. during 1 hour on 3 consecutive days
Intervention Type
Dietary Supplement
Intervention Name(s)
Parental lipid emulsion (Saline 0.9%)
Other Intervention Name(s)
lipid free control
Intervention Description
Placebo (Saline 0.9%), same volume/hr as lipid emulsions
Primary Outcome Measure Information:
Title
leukocyte counts
Time Frame
T=0, T=4 days, T=11 days
Title
leukocyte functions
Time Frame
T=0, T=4 days and T=11 days
Title
(anti-)oxidant status
Time Frame
T=0, T=4 days, T=11 days
Secondary Outcome Measure Information:
Title
plasma and leukocyte cell membrane (phospho)lipid composition.
Time Frame
T=0, t=4 and T=11 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult (>18 yrs of age)
Healthy
Willingness to give written informed consent
Exclusion Criteria:
Smoking > 5 cigarettes/day
Diet with > 2 portions of fatty fish per day
Use of oral fish oil or vitamin substrates
History of metabolic disorder (especially diabetes or lipid disorders)
History of allergic, inflammatory of immunological disease
History of pulmonary, cardiovascular, renal or hematological disease
Medication use
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geert JA Wanten, MD, MSc, PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Radboud University Nijmegen Medical Centre
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500 HB
Country
Netherlands
12. IPD Sharing Statement
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Immune Modulation by Parenteral Lipids
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