Parenteral NutritionPhase 4NCT03149653

Crossover Study on the Effect of Omegaven in Combination With Different Lipid Emulsions in Home Parenteral Nutrition

A Phase 4 study testing ClinOleic (baseline), ClinOleic + Omegaven and Lipoplus (baseline) in people with Parenteral Nutrition, run by General University Hospital, Prague at 1 site in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Parenteral Nutrition
What is being tested?: ClinOleic (baseline), ClinOleic + Omegaven and Lipoplus (baseline)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteCzechia
Study dates: 15 Jan 2012to 30 Jun 2016
Phase: Phase 4
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 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Home parenteral nutrition patients in need of parenteral nutrition administration > 4 days/week
Parenteral duration expectancy > 8 months
Stable clinical condition without any complications in the past 2 months
Written consent from the subject

Who cannot join

Known hypersensitivity to any of the active substances or excipients
Unstable conditions
Active cancer or its treatment
Established immunodeficiency
Advanced organ dysfunction from chronic disease

Trial locations and contacts

1 site in 1 country.

Czechia1 site

General University Hospital
Prague, 12808

Other trials in Czechia

About this study

Official title: A Prospective, Randomized, Controlled, Double-blind, Crossover-Design, Mono-center, Phase IV Study Comparing the Effect of Omegaven in Combination With Clinoleic or Lipoplus or SMOFlipid in Home Parenteral Nutrition Patients

The aim of this study was to evaluate the safety and tolerance of ClinOleic or Lipoplus or SMOFlipid lipid emulsions. After 6 weeks of each lipid emulsion, Omegaven (fish oil) was added for a further 4 weeks. The safety and tolerance was evaluated after each lipid emulsion cycle by biochemistry, hematology and coagulation variables, vital signs and adverse events. We also analysed fatty acid profiles in plasma or erythrocyte phospholipids, antioxidant enzyme activities, lipid peroxidation products, plasma lipids and pro-inflammatory cytokine production after in vitro stimulation of whole blood by lipopolysacharide in HPN patients. The non-interventional group of healthy controls was included for comparison.

Read the detailed description

Intravenous lipid emulsions (LEs) are an indispensable part of home parenteral nutrition (HPN). All commercially obtainable LEs are applicable for HPN in providing a source of energy and essential fatty acids. The originally used soyabean oil-based LE (Intralipid) have been suspected of being associated with a higher risk of pro-inflammatory lipid-mediator production due to their high content of n-6 polyunsaturated fatty acids. The more modern mixes of soyabean oil, and/or olive oil, and/or fish oil LEs with beneficial responses compared with Intralipid are available. Given that there are no clear clinical recommendations for LE application in HPN, we performed this cross-over design, phase 4 study comparing ClinOleic, Lipoplus or SMOFlipid in chronic intestinal failure patients with additional escalation of fish oil using Omegaven.

Conditions: Parenteral Nutrition
Being tested: ClinOleic (baseline), ClinOleic + Omegaven, Lipoplus (baseline), Lipoplus + Omegaven, SMOFlipid (baseline)
Keywords: lipid emulsion, olive oil, fish oil, intestinal failure, home parenteral nutrition
Medical subject headings: Hyperphagia, Intestinal Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ClinOleic (baseline)Drug
Also called ClinOleic 20% Baxter
Lipid emulsion in pharmacy compounded all-in-one admixture
ClinOleic + OmegavenDrug
Also called ClinOleic 20% Baxter + Omegaven 10% Fresenius Kabi
Lipid emulsion in pharmacy compounded all-in-one admixture
Lipoplus (baseline)Drug
Also called Lipoplus 20% BBraun Melsungen
Lipid emulsion in pharmacy compounded all-in-one admixture
Lipoplus + OmegavenDrug
Also called Lipoplus 20% BBraun Melsungen + Omegaven 10% Fresenius Kabi
Lipid emulsion in pharmacy compounded all-in-one admixture
SMOFlipid (baseline)Drug
Also called SMOFlipid 20% Fresenius Kabi
Lipid emulsion in pharmacy compounded all-in-one admixture
SMOFlipid + OmegavenDrug
Also called SMOFlipid 20% Fresenius Kabi + Omegaven 10% Fresenius Kabi
Lipid emulsion in pharmacy compounded all-in-one admixture

Study groups in NCT03149653
Study group	Role	What they receive
1 Home Parenteral Nutrition, Cross-over	Experimental	Random Cycle Sequence - Cycle 1: Clinoleic (baseline), 50g/per day, 42 days Clinoleic + Omegaven, 40g + 10g/per day, 28 days. Cycle 2: Lipoplus (baseline), 50g/per day, 42 days Lipoplus + Omegaven, 40g + 10g/per day, 28 days. Cycle 3: SMOFlipid (baseline), 50g/per day, 42 days SMOFlipid + Omegaven, 40g + 10g/per day, 28 days. Receives: Drug: ClinOleic (baseline); Drug: ClinOleic + Omegaven; Drug: Lipoplus (baseline); Drug: Lipoplus + Omegaven; Drug: SMOFlipid (baseline); Drug: SMOFlipid + Omegaven
2 Home Parenteral Nutrition, Cross-over	Active comparator	Random Cycle Sequence - Cycle 1: Clinoleic (baseline), 50g/per day, 42 days Clinoleic + Omegaven, 40g + 10g/per day, 28 days. Cycle 2: Lipoplus (baseline), 50g/per day, 42 days Lipoplus + Omegaven, 40g + 10g/per day, 28 days. Cycle 3: SMOFlipid (baseline), 50g/per day, 42 days SMOFlipid + Omegaven, 40g + 10g/per day, 28 days. Receives: Drug: ClinOleic (baseline); Drug: ClinOleic + Omegaven; Drug: Lipoplus (baseline); Drug: Lipoplus + Omegaven; Drug: SMOFlipid (baseline); Drug: SMOFlipid + Omegaven
Comparator3	No intervention	Healthy Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline lipid emulsion production of TNF-alpha after in vitro stimulation of whole blood by lipopolysacharide at 4 weeks of Omegaven lipid emulsion addition
The whole blood culture supernatant concentration of TNF-alpha (ng/L)
Measured: day 42, day 70
Change from baseline lipid emulsion production of IL-1-beta after in vitro stimulation of whole blood by lipopolysacharide at 4 weeks of Omegaven lipid emulsion addition
The whole blood culture supernatant concentration of IL-1-beta (ng/L)
Measured: day 42, day 70
Change from baseline lipid emulsion production of IL-6 after in vitro stimulation of whole blood by lipopolysacharide at 4 weeks of Omegaven lipid emulsion addition
The whole blood culture supernatant concentration of IL-6 (ng/L)
Measured: day 42, day 70
Change from baseline lipid emulsion production of IL-8 after in vitro stimulation of whole blood by lipopolysacharide at 4 weeks of Omegaven lipid emulsion addition
The whole blood culture supernatant concentration of IL-8 (ng/L)
Measured: day 42, day 70

Secondary outcomes (19)

Change from baseline lipid emulsion plasma concentration of TNF-alpha at 4 weeks of Omegaven lipid emulsion addition
The plasma concentration of TNF-alpha (ng/L)
Measured: day 42, day 70
Change from baseline lipid emulsion plasma concentration of IL-1-beta at 4 weeks of Omegaven lipid emulsion addition
The plasma concentration of IL-1-beta (ng/L)
Measured: day 42, day 70
Change from baseline lipid emulsion plasma concentration of IL-6 at 4 weeks of Omegaven lipid emulsion addition
The plasma concentration of IL-6 (ng/L)
Measured: day 42, day 70
Change from baseline lipid emulsion plasma concentration of IL-8 at 4 weeks of Omegaven lipid emulsion addition
The plasma concentration of IL-8 (ng/L)
Measured: day 42, day 70
Change from baseline lipid emulsion plasma concentration ratio of oxidized LDL/LDL cholesterol at 4 weeks of Omegaven lipid emulsion addition
The plasma concentration ratio of oxidized LDL/LDL cholesterol (ox-LDL/LDL-C)
Measured: day 42, day 70
Change from baseline lipid emulsion plasma concentration of triglycerides at 4 weeks of Omegaven lipid emulsion addition
The plasma concentration of triglycerides (mmol/L)
Measured: day 42, day 70
Change from baseline lipid emulsion plasma concentration of total cholesterol at 4 weeks of Omegaven lipid emulsion addition
The plasma concentration of total cholesterol (mmol/L)
Measured: day 42, day 70
Change from baseline lipid emulsion plasma concentration of HDL cholesterol at 4 weeks of Omegaven lipid emulsion addition
The plasma concentration of HDL cholesterol (mmol/L)
Measured: day 42, day 70
Change from baseline lipid emulsion plasma concentration of LDL cholesterol at 4 weeks of Omegaven lipid emulsion addition
The plasma concentration of LDL cholesterol (mmol/L)
Measured: day 42, day 70
Change from baseline lipid emulsion plasma phospholipid fatty acid profile at 4 weeks of Omegaven lipid emulsion addition
The plasma phospholipid fatty acid profile (mol%)
Measured: day 42, day 70
Change from baseline lipid emulsion erythrocyte phospholipid fatty acid profile at 4 weeks of Omegaven lipid emulsion addition
The erythrocyte phospholipid fatty acid profile (mol%)
Measured: day 42, day 70
Change from baseline lipid emulsion plasma concentration of fibrothelial growth factor 19 at 4 weeks of Omegaven lipid emulsion addition
The plasma concentration of fibrothelial growth factor 19 (ng/L)
Measured: day 42, day 70
Change from baseline lipid emulsion erythrocyte superoxide dismutase activity at 4 weeks of Omegaven lipid emulsion addition
The erythrocyte activity of SOD (U/g Hb)
Measured: day 42, day 70
Change from baseline lipid emulsion erythrocyte catalase activity at 4 weeks of Omegaven lipid emulsion addition
The erythrocyte activity of CAT (U/g Hb)
Measured: day 42, day 70
Change from baseline lipid emulsion erythrocyte glutathione peroxidase activity at 4 weeks of Omegaven lipid emulsion addition
The erythrocyte activity of GPX (U/g Hb)
Measured: day 42, day 70
Change from baseline lipid emulsion erythrocyte glutathione reductase activity at 4 weeks of Omegaven lipid emulsion addition
The erythrocyte activity of GR (U/g Hb)
Measured: day 42, day 70
Change from baseline lipid emulsion plasma paraoxonase 1 activity at 4 weeks of Omegaven lipid emulsion addition
The plasma activity of PON1 (U/L)
Measured: day 42, day 70
Alteration of liver function
Liver function tests
Measured: week 6, week 10, week 16, week 20, week 26, week 30
Septic complications
Catheter-related bloodstream infections
Measured: week 6, week 10, week 16, week 20, week 26, week 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jan 201230 Jun 2016

First posted11 May 2017
Study start15 Jan 2012
Primary completion7 Jan 2016
Study completion30 Jun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Parenteral NutritionStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03149653
Sponsor's protocol ID: NT13236-4/2012
Status last verified: May 2017
First submitted: 11 Apr 2017
Last updated: 11 May 2017
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruitingPhase 2
Effect of a Parenteral Emulsion With Omega3 on Neonates With PPHN and CDH
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RecruitingPhase 4
Initial Triple Therapy Including Parenteral Treprostinil vs Initial Double Oral Therapy in PAH Group I Patients
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RecruitingPhase 4
Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients
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Active, not recruitingPhase 3
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All Parenteral Nutrition trials

Study at a glance

From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Randomized, Controlled, Double-blind, Crossover-Design, Mono-center, Phase IV Study Comparing the Effect of Omegaven in Combination With Clinoleic or Lipoplus or SMOFlipid in Home Parenteral Nutrition Patients
ClinicalTrials.gov ID: NCT03149653
Acronym / sponsor ID: NT13236-4/2012
Conditions: Parenteral Nutrition
Keywords: lipid emulsion, olive oil, fish oil, intestinal failure, home parenteral nutrition
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: General University Hospital, PragueUniversity, hospital or other
Collaborators: Charles University, Czech Republic, Ministry of Health, Czech Republic
Study start: 15 Jan 2012 (actual)
Primary completion: 7 Jan 2016 (actual)
Study completion: 30 Jun 2016 (actual)
First posted: 11 May 2017 (actual)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
1 Home Parenteral Nutrition, Cross-over	Experimental	Drug: ClinOleic (baseline), Drug: ClinOleic + Omegaven, Drug: Lipoplus (baseline), Drug: Lipoplus + Omegaven, Drug: SMOFlipid (baseline), Drug: SMOFlipid + OmegavenRandom Cycle Sequence - Cycle 1: Clinoleic (baseline), 50g/per day, 42 days Clinoleic + Omegaven, 40g + 10g/per day, 28 days. Cycle 2: Lipoplus (baseline), 50g/per day, 42 days Lipoplus + Omegaven, 40g + 10g/per day, 28 days. Cycle 3: SMOFlipid (baseline), 50g/per day, 42 days SMOFlipid + Omegaven, 40g + 10g/per day, 28 days.
2 Home Parenteral Nutrition, Cross-over	Active comparator	Drug: ClinOleic (baseline), Drug: ClinOleic + Omegaven, Drug: Lipoplus (baseline), Drug: Lipoplus + Omegaven, Drug: SMOFlipid (baseline), Drug: SMOFlipid + OmegavenRandom Cycle Sequence - Cycle 1: Clinoleic (baseline), 50g/per day, 42 days Clinoleic + Omegaven, 40g + 10g/per day, 28 days. Cycle 2: Lipoplus (baseline), 50g/per day, 42 days Lipoplus + Omegaven, 40g + 10g/per day, 28 days. Cycle 3: SMOFlipid (baseline), 50g/per day, 42 days SMOFlipid + Omegaven, 40g + 10g/per day, 28 days.
Comparator3	No intervention	–Healthy Control

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Home parenteral nutrition patients in need of parenteral nutrition administration > 4 days/week
Parenteral duration expectancy > 8 months
Stable clinical condition without any complications in the past 2 months
Written consent from the subject

Key exclusion criteria (5 listed)

Known hypersensitivity to any of the active substances or excipients
Unstable conditions
Active cancer or its treatment
Established immunodeficiency
Advanced organ dysfunction from chronic 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
ClinOleic (baseline)Also: ClinOleic 20% BaxterLipid emulsion in pharmacy compounded all-in-one admixture	Drug	1 Home Parenteral Nutrition, Cross-over, 2 Home Parenteral Nutrition, Cross-over
ClinOleic + OmegavenAlso: ClinOleic 20% Baxter + Omegaven 10% Fresenius KabiLipid emulsion in pharmacy compounded all-in-one admixture	Drug	1 Home Parenteral Nutrition, Cross-over, 2 Home Parenteral Nutrition, Cross-over
Lipoplus (baseline)Also: Lipoplus 20% BBraun MelsungenLipid emulsion in pharmacy compounded all-in-one admixture	Drug	1 Home Parenteral Nutrition, Cross-over, 2 Home Parenteral Nutrition, Cross-over
Lipoplus + OmegavenAlso: Lipoplus 20% BBraun Melsungen + Omegaven 10% Fresenius KabiLipid emulsion in pharmacy compounded all-in-one admixture	Drug	1 Home Parenteral Nutrition, Cross-over, 2 Home Parenteral Nutrition, Cross-over
SMOFlipid (baseline)Also: SMOFlipid 20% Fresenius KabiLipid emulsion in pharmacy compounded all-in-one admixture	Drug	1 Home Parenteral Nutrition, Cross-over, 2 Home Parenteral Nutrition, Cross-over
SMOFlipid + OmegavenAlso: SMOFlipid 20% Fresenius Kabi + Omegaven 10% Fresenius KabiLipid emulsion in pharmacy compounded all-in-one admixture	Drug	1 Home Parenteral Nutrition, Cross-over, 2 Home Parenteral Nutrition, Cross-over

Primary outcome

Change from baseline lipid emulsion production of TNF-alpha after in vitro stimulation of whole blood by lipopolysacharide at 4 weeks of Omegaven lipid emulsion addition
Time frame: day 42, day 70
The whole blood culture supernatant concentration of TNF-alpha (ng/L)
Change from baseline lipid emulsion production of IL-1-beta after in vitro stimulation of whole blood by lipopolysacharide at 4 weeks of Omegaven lipid emulsion addition
Time frame: day 42, day 70
The whole blood culture supernatant concentration of IL-1-beta (ng/L)
Change from baseline lipid emulsion production of IL-6 after in vitro stimulation of whole blood by lipopolysacharide at 4 weeks of Omegaven lipid emulsion addition
Time frame: day 42, day 70
The whole blood culture supernatant concentration of IL-6 (ng/L)
Change from baseline lipid emulsion production of IL-8 after in vitro stimulation of whole blood by lipopolysacharide at 4 weeks of Omegaven lipid emulsion addition
Time frame: day 42, day 70
The whole blood culture supernatant concentration of IL-8 (ng/L)

19 secondary outcomes

Change from baseline lipid emulsion plasma concentration of TNF-alpha at 4 weeks of Omegaven lipid emulsion addition
Time frame: day 42, day 70
Change from baseline lipid emulsion plasma concentration of IL-1-beta at 4 weeks of Omegaven lipid emulsion addition
Time frame: day 42, day 70
Change from baseline lipid emulsion plasma concentration of IL-6 at 4 weeks of Omegaven lipid emulsion addition
Time frame: day 42, day 70
Change from baseline lipid emulsion plasma concentration of IL-8 at 4 weeks of Omegaven lipid emulsion addition
Time frame: day 42, day 70
Change from baseline lipid emulsion plasma concentration ratio of oxidized LDL/LDL cholesterol at 4 weeks of Omegaven lipid emulsion addition
Time frame: day 42, day 70
Change from baseline lipid emulsion plasma concentration of triglycerides at 4 weeks of Omegaven lipid emulsion addition
Time frame: day 42, day 70
Change from baseline lipid emulsion plasma concentration of total cholesterol at 4 weeks of Omegaven lipid emulsion addition
Time frame: day 42, day 70
Change from baseline lipid emulsion plasma concentration of HDL cholesterol at 4 weeks of Omegaven lipid emulsion addition
Time frame: day 42, day 70
Change from baseline lipid emulsion plasma concentration of LDL cholesterol at 4 weeks of Omegaven lipid emulsion addition
Time frame: day 42, day 70
Change from baseline lipid emulsion plasma phospholipid fatty acid profile at 4 weeks of Omegaven lipid emulsion addition
Time frame: day 42, day 70
Change from baseline lipid emulsion erythrocyte phospholipid fatty acid profile at 4 weeks of Omegaven lipid emulsion addition
Time frame: day 42, day 70
Change from baseline lipid emulsion plasma concentration of fibrothelial growth factor 19 at 4 weeks of Omegaven lipid emulsion addition
Time frame: day 42, day 70
Change from baseline lipid emulsion erythrocyte superoxide dismutase activity at 4 weeks of Omegaven lipid emulsion addition
Time frame: day 42, day 70
Change from baseline lipid emulsion erythrocyte catalase activity at 4 weeks of Omegaven lipid emulsion addition
Time frame: day 42, day 70
Change from baseline lipid emulsion erythrocyte glutathione peroxidase activity at 4 weeks of Omegaven lipid emulsion addition
Time frame: day 42, day 70
Change from baseline lipid emulsion erythrocyte glutathione reductase activity at 4 weeks of Omegaven lipid emulsion addition
Time frame: day 42, day 70
Change from baseline lipid emulsion plasma paraoxonase 1 activity at 4 weeks of Omegaven lipid emulsion addition
Time frame: day 42, day 70
Alteration of liver function
Time frame: week 6, week 10, week 16, week 20, week 26, week 30
Septic complications
Time frame: week 6, week 10, week 16, week 20, week 26, week 30

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 11 May 2017.
Individual participant dataSharing planned: No

Related trials for Parenteral Nutrition

Active, not recruiting
Compassionate-Use of 4% T-EDTA Lock Solution for Central Venous Lines of Pediatric PN Patients
Central Line Complication, Central Line-associated Bloodstream Infection (CLABSI)
Active, not recruitingPhase 2
Effect of a Parenteral Emulsion With Omega3 on Neonates With PPHN and CDH
Pulmonary Hypertension of Newborn, Diaphragm Defect
RecruitingPhase 4
Initial Triple Therapy Including Parenteral Treprostinil vs Initial Double Oral Therapy in PAH Group I Patients
Pulmonary Arterial Hypertension
RecruitingPhase 4
Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients
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Active, not recruitingPhase 3
Efficacy and Safety of PJ009 in Patients With Short Bowel Syndrome Requiring Parenteral Nutrition
Short Bowel Syndrome

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.

Frantisek Novak, MD, PhD principal investigator

General University Hospital, Prague

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ClinOleic (baseline), ClinOleic + Omegaven and Lipoplus (baseline) in people with Parenteral Nutrition, run by General University Hospital, Prague at 1 site in Czechia.

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 4 inclusion and 5 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 11 May 2017. 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 Czechia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Change from baseline lipid emulsion production of TNF-alpha after in vitro stimulation of whole blood by lipopolysacharide at 4 weeks of Omegaven lipid emulsion addition (time frame: day 42, day 70). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03149653.

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 11 May 2017.