Immune Modulation by Parenteral Lipids

NCT ID: NCT00734916

Last Updated: 2010-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2010-02-28

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.

Conditions

Infections; Total Parenteral Nutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

Omegaven 10%

Group Type: ACTIVE_COMPARATOR

Parenteral lipid emulsion (Omegaven)

Intervention Type: DIETARY_SUPPLEMENT

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

2

Intralipid 10%

Group Type: ACTIVE_COMPARATOR

Parenteral lipid emulsion (Intralipid)

Intervention Type: DIETARY_SUPPLEMENT

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

3

Placebo

Group Type: PLACEBO_COMPARATOR

Parental lipid emulsion (Saline 0.9%)

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Parenteral lipid emulsion (Omegaven)

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

Intervention Type: DIETARY_SUPPLEMENT

Parenteral lipid emulsion (Intralipid)

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

Intervention Type: DIETARY_SUPPLEMENT

Parental lipid emulsion (Saline 0.9%)

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Omegaven 10%, Fresenius Kabi, Bad Homburg Germany; Intralipid 10%, Fresenius Kabi, Bad Homburg Germany; lipid free control

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Radboud University Nijmegen Medical Centre

Principal Investigators

Geert JA Wanten, MD, MSc, PhD

Role: STUDY_DIRECTOR

Radboud University Medical Center

Locations

Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, Netherlands

Countries

Netherlands

Other Identifiers

CMO 2008/140

Identifier Type: -

Identifier Source: secondary_id

GW/MV/20307

Identifier Type: -

Identifier Source: org_study_id