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Immune Modulation by Parenteral Lipids

This study has been completed.
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00734916
First received: August 13, 2008
Last updated: February 3, 2010
Last verified: February 2010
History of Changes
  Purpose

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.


Condition Intervention
Infections
Total Parenteral Nutrition
 Dietary Supplement: Parenteral lipid emulsion (Omegaven)
Dietary Supplement: Parenteral lipid emulsion (Intralipid)
Dietary Supplement: Parental lipid emulsion (Saline 0.9%)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Immune Modulation by Omega-3 Versus Omega-6 Based Parenteral Lipids in Healthy Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • leukocyte counts [ Time Frame: T=0, T=4 days, T=11 days ] [ Designated as safety issue: Yes ]
  • leukocyte functions [ Time Frame: T=0, T=4 days and T=11 days ] [ Designated as safety issue: Yes ]
  • (anti-)oxidant status [ Time Frame: T=0, T=4 days, T=11 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • plasma and leukocyte cell membrane (phospho)lipid composition. [ Time Frame: T=0, t=4 and T=11 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 8
Study Start Date: August 2008
Study Completion Date: February 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Omegaven 10%
 Dietary Supplement: Parenteral lipid emulsion (Omegaven)
Omegaven 10%, 0.2g/kg/hr i.v.during 1 hour on 3 consecutive days
Other Name: Omegaven 10%, Fresenius Kabi, Bad Homburg Germany
Active Comparator: 2
Intralipid 10%
 Dietary Supplement: Parenteral lipid emulsion (Intralipid)
Intralipid 10%, 0.2g/kg/hr i.v. during 1 hour on 3 consecutive days
Other Name: Intralipid 10%, Fresenius Kabi, Bad Homburg Germany
Placebo Comparator: 3
Placebo
 Dietary Supplement: Parental lipid emulsion (Saline 0.9%)
Placebo (Saline 0.9%), same volume/hr as lipid emulsions
Other Name: lipid free control

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00734916

Locations
Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Investigators
Study Director: Geert JA Wanten, MD, MSc, PhD Radboud University
  More Information

No publications provided

Responsible Party: M.W.J. Versleijen, MD, MSc and G.J.A. Wanten, MD, MSc, PhD, Radboud University Nijmegen Medical Centre
ClinicalTrials.gov Identifier: NCT00734916     History of Changes
Other Study ID Numbers: GW/MV/20307, CMO 2008/140
Study First Received: August 13, 2008
Last Updated: February 3, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
total parenteral nutrition
infections
Infectious complications related to parenteral nutrition

ClinicalTrials.gov processed this record on May 16, 2013