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

August 13, 2008
February 3, 2010
August 2008
August 2009   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00734916 on ClinicalTrials.gov Archive Site
plasma and leukocyte cell membrane (phospho)lipid composition. [ Time Frame: T=0, t=4 and T=11 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Immune Modulation by Parenteral Lipids
Immune Modulation by Omega-3 Versus Omega-6 Based Parenteral Lipids in Healthy Volunteers

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Infections
  • Total Parenteral Nutrition
  • 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
  • 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
  • Dietary Supplement: Parental lipid emulsion (Saline 0.9%)
    Placebo (Saline 0.9%), same volume/hr as lipid emulsions
    Other Name: lipid free control
  • Active Comparator: 1
    Omegaven 10%
    Intervention: Dietary Supplement: Parenteral lipid emulsion (Omegaven)
  • Active Comparator: 2
    Intralipid 10%
    Intervention: Dietary Supplement: Parenteral lipid emulsion (Intralipid)
  • Placebo Comparator: 3
    Placebo
    Intervention: Dietary Supplement: Parental lipid emulsion (Saline 0.9%)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
February 2010
August 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00734916
GW/MV/20307, CMO 2008/140
No
M.W.J. Versleijen, MD, MSc and G.J.A. Wanten, MD, MSc, PhD, Radboud University Nijmegen Medical Centre
Radboud University
Not Provided
Study Director: Geert JA Wanten, MD, MSc, PhD Radboud University
Radboud University
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP