NCT00734916

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

February 4, 2010

Status Verified

February 1, 2010

Enrollment Period

1 year

First QC Date

August 13, 2008

Last Update Submit

February 3, 2010

Conditions

InfectionsTotal Parenteral Nutrition

Keywords

total parenteral nutritioninfectionsInfectious complications related to parenteral nutrition

Outcome Measures

Primary Outcomes (3)

  • leukocyte counts

    T=0, T=4 days, T=11 days

  • leukocyte functions

    T=0, T=4 days and T=11 days

  • (anti-)oxidant status

    T=0, T=4 days, T=11 days

Secondary Outcomes (1)

  • plasma and leukocyte cell membrane (phospho)lipid composition.

    T=0, t=4 and T=11 days

Study Arms (3)

1

ACTIVE COMPARATOR

Omegaven 10%

Dietary Supplement: Parenteral lipid emulsion (Omegaven)

2

ACTIVE COMPARATOR

Intralipid 10%

Dietary Supplement: Parenteral lipid emulsion (Intralipid)

3

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Parental lipid emulsion (Saline 0.9%)

Interventions

Parenteral lipid emulsion (Omegaven)DIETARY_SUPPLEMENT

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

Also known as: Omegaven 10%, Fresenius Kabi, Bad Homburg Germany
1
Parenteral lipid emulsion (Intralipid)DIETARY_SUPPLEMENT

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

Also known as: Intralipid 10%, Fresenius Kabi, Bad Homburg Germany
2
Parental lipid emulsion (Saline 0.9%)DIETARY_SUPPLEMENT

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

Also known as: lipid free control
3

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult (\>18 yrs of age)
  • Healthy
  • Willingness to give written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

MeSH Terms

Conditions

InfectionsHyperphagia

Interventions

fish oil triglyceridessoybean oil, phospholipid emulsionSodium Chloride

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Geert JA Wanten, MD, MSc, PhD

    Radboud University Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 13, 2008

First Posted

August 14, 2008

Study Start

August 1, 2008

Primary Completion

August 1, 2009

Study Completion

February 1, 2010

Last Updated

February 4, 2010

Record last verified: 2010-02

Locations

NL(1)