InfectionsNCT00734916
Immune Modulation by Parenteral Lipids
A study testing Parenteral lipid emulsion (Omegaven), Parenteral lipid emulsion (Intralipid) and Parental lipid emulsion (Saline 0.9%) in people with Infections and Total Parenteral Nutrition, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Infections, Total Parenteral Nutrition
- What is being tested?
- Parenteral lipid emulsion (Omegaven), Parenteral lipid emulsion (Intralipid) and Parental lipid emulsion (Saline 0.9%)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2008to Feb 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult (>18 yrs of age)
- Healthy
- Willingness to give written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, 6500 HB
About this study
Official title: 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:
Read more
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
- Being tested
- Parenteral lipid emulsion (Omegaven), Parenteral lipid emulsion (Intralipid), Parental lipid emulsion (Saline 0.9%)
- Keywords
- total parenteral nutrition, infections, Infectious complications related to parenteral nutrition
- Medical subject headings
- Infections, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenteral lipid emulsion (Omegaven)Dietary supplement
Also called Omegaven 10%, Fresenius Kabi, Bad Homburg Germany
Omegaven 10%, 0.2g/kg/hr i.v.during 1 hour on 3 consecutive days
Parenteral lipid emulsion (Intralipid)Dietary supplement
Also called Intralipid 10%, Fresenius Kabi, Bad Homburg Germany
Intralipid 10%, 0.2g/kg/hr i.v. during 1 hour on 3 consecutive days
Parental lipid emulsion (Saline 0.9%)Dietary supplement
Also called lipid free control
Placebo (Saline 0.9%), same volume/hr as lipid emulsions
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Omegaven 10% Receives: Dietary Supplement: Parenteral lipid emulsion (Omegaven) |
| 2 | Active comparator | Intralipid 10% Receives: Dietary Supplement: Parenteral lipid emulsion (Intralipid) |
| 3 | Placebo comparator | Placebo Receives: Dietary Supplement: Parental lipid emulsion (Saline 0.9%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
leukocyte counts
Measured: T=0, T=4 days, T=11 days
leukocyte functions
Measured: T=0, T=4 days and T=11 days
(anti-)oxidant status
Measured: T=0, T=4 days, T=11 days
Secondary outcomes (1)
plasma and leukocyte cell membrane (phospho)lipid composition.
Measured: T=0, t=4 and T=11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionAug 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Geert JA Wanten, MD, MSc, PhD, Study director, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00734916
- Sponsor's protocol ID
- GW/MV/20307
- Other IDs
- CMO 2008/140
- Status last verified
- Feb 2010
- First submitted
- 13 Aug 2008
- Last updated
- 4 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Modulation by Omega-3 Versus Omega-6 Based Parenteral Lipids in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00734916
- Acronym / sponsor ID
- GW/MV/20307
- Conditions
- Infections, Total Parenteral Nutrition
- Keywords
- total parenteral nutrition, infections, Infectious complications related to parenteral nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 14 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: Parenteral lipid emulsion (Omegaven)Omegaven 10% |
| 2 | Active comparator | Dietary Supplement: Parenteral lipid emulsion (Intralipid)Intralipid 10% |
| 3 | Placebo comparator | Dietary Supplement: Parental lipid emulsion (Saline 0.9%)Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (>18 yrs of age)
- Healthy
- Willingness to give written informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parenteral lipid emulsion (Omegaven)Also: Omegaven 10%, Fresenius Kabi, Bad Homburg GermanyOmegaven 10%, 0.2g/kg/hr i.v.during 1 hour on 3 consecutive days | Dietary supplement | 1 |
| Parenteral lipid emulsion (Intralipid)Also: Intralipid 10%, Fresenius Kabi, Bad Homburg GermanyIntralipid 10%, 0.2g/kg/hr i.v. during 1 hour on 3 consecutive days | Dietary supplement | 2 |
| Parental lipid emulsion (Saline 0.9%)Also: lipid free controlPlacebo (Saline 0.9%), same volume/hr as lipid emulsions | Dietary supplement | 3 |
Primary outcome
leukocyte counts
Time frame: T=0, T=4 days, T=11 days
leukocyte functions
Time frame: T=0, T=4 days and T=11 days
(anti-)oxidant status
Time frame: T=0, T=4 days, T=11 days
1 secondary outcome
plasma and leukocyte cell membrane (phospho)lipid composition.
Time frame: T=0, t=4 and T=11 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geert JA Wanten, MD, MSc, PhD study director
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parenteral lipid emulsion (Omegaven), Parenteral lipid emulsion (Intralipid) and Parental lipid emulsion (Saline 0.9%) in people with Infections and Total Parenteral Nutrition, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
leukocyte counts (time frame: T=0, T=4 days, T=11 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2010.