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Immune Modulation by Parenteral Lipids

NCT00734916 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2010-02-04

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Parenteral lipid emulsion (Omegaven)

Omegaven 10%, 0.2g/kg/hr i.v.during 1 hour on 3 consecutive days

DIETARY_SUPPLEMENT

Parenteral lipid emulsion (Intralipid)

Intralipid 10%, 0.2g/kg/hr i.v. during 1 hour on 3 consecutive days

DIETARY_SUPPLEMENT

Parental lipid emulsion (Saline 0.9%)

Placebo (Saline 0.9%), same volume/hr as lipid emulsions

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Geert JA Wanten, MD, MSc, PhD · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2009-08-31
Completion
2010-02-28

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00734916 on ClinicalTrials.gov