Lipid Metabolism DisordersNCT04467138
High Dose Intravenous Fish Oil Reduces Inflammation
An observational study of Lipid Metabolism Disorders, run by Stanley Dudrick's Memorial Hospital at 1 site in Poland.
Trial summary
Retrospective analysis of 51 patients (27 female, 24 male, mean age 51.5±12.6 years) who received all-in-one PN including amino acids, glucose and lipids supplemented with pure fish oil LE was performed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lipid Metabolism Disorders
- What is being tested?
- Omegaven
- How many people
- 51 participants
- Where
- 1 sitePoland
- Study dates
- 31 Jan 2020to 30 Jun 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with either inflammatory bowel disease or chronic intestinal failure. Both in and out patients
Who may be able to join
- ≥ 18 years of age,
- metabolic stability (the absence of pathological laboratory resulting in the change of PN regime for at least one month)
- ability to tolerate up to 1.0 g lipids/kg body weight per day as a part of PN.
Who cannot join
- patients with a history of cancer and anti-cancer treatment within the last 5 years, severe hyperlipidemia, severe coagulopathy, severe renal insufficiency, acute thromboembolic events, positive test for HIV, Hepatitis B or C (from medical history), known or suspected drug or alcohol abuse, participation in another interventional clinical trial in parallel or within three months prior to the start of this clinical trial, for women with childbearing potential (i.e. females who are not chemically or surgically sterile or females who are not postmenopausal) or women of childbearing potential tested positive on standard pregnancy test (urine dipstick) or/and lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Dose Intravenous Fish Oil Reduces Inflammation and Improves Liver Function
Retrospective analysis of 51 patients (27 female, 24 male, mean age 51.5±12.6 years) who received all-in-one PN including amino acids, glucose and lipids supplemented with pure fish oil LE was performed.
Read the detailed description
All patients depended on parenteral nutrition (PN) are prone to inflammation. This condition may aggravate already existing proinflammatory status and can become a critical factor for developing liver dysfunction (LD). Intravenous fish oil may attenuate the inflammatory status, , however, data on its use in adults is scarce. The aim of the study was to investigate the impact of the addition of pure fish oil intravenous lipid emulsion (ILE) as part of short- and long term PN in patients either at risk or with already existing inflammation.
Retrospective analysis of 51 patients (27 female, 24 male, mean age 51.5±12.6 years) who received all-in-one PN including amino acids, glucose and lipids supplemented with pure fish oil LE was performed. Pure fish oil emulsion (Omegaven®, Fresenius Kabi) was used as the additional product along with the standard lipid emulsion to reach a fish oil dose of approx. 0.5 g fish oil/kg/d. Diagnoses were chronic intestinal failure (CIF, n=20), Crohn's disease (CD, n=22), and Ulcerative colitis (UC, n=19). The observation period was 12 months for CIF and 21days for UC and CD.
- Conditions
- Lipid Metabolism Disorders
- Being tested
- Omegaven
- Medical subject headings
- Lipid Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmegavenDrug
Also called Fish oil
Pure fish oil emulsion (Omegaven®, Fresenius Kabi) was used as the additional product along with the standard lipid emulsion to reach a fish oil dose of approx. 0.5 g fish oil/kg/d.
| Study group | Role | What they receive |
|---|---|---|
| Inflammatory bowel disease | Patients with either Crohn's disease (CD, n=22), and Ulcerative colitis (UC, n=19). Receives: Drug: Omegaven | |
| Chronic intestinal failure | Patients with intestinal failure (CIF, n=20) Receives: Drug: Omegaven |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hsCRP concentration
Serum concentration of hsCRP (pg/mL)
Measured: 4 weeks
Change in Il-6 concentration
Serum concentration of Il-6 (pg/mL)
Measured: 4 weeks
Change in interleukin-10 concentration
Serum concentration of IL-10 (pg/mL)
Measured: 4 weeks
Change in procalcytonin concentration
Serum concentration of procalcytonin (ng/mL)
Measured: 4 weeks
Change in bilirubin concentration
Serum concentration of bilirubin (umol/L)
Measured: 4 weeks
Change in SGPT concentration
Serum concentration of SGPT(U/l)
Measured: 4 weeks
Change in SGOT concentration
Serum concentration of SGOT (U/l)
Measured: 4 weeks
Change in alkaline phosphatase concentration
Serum concentration of alkaline phosphatase (U/l)
Measured: 4 weeks
Change in C-reactive protein concentration
Serum concentration of CRP (mg/l)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start31 Jan 2020
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lipid Metabolism DisordersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanley Dudrick's Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stanislaw Klek, Stanley Dudrick's Memorial Hospital
- Investigators
- Stanislaw Klek, PhD, Principal investigator, 1972
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467138
- Sponsor's protocol ID
- Omegaven
- Status last verified
- Jul 2020
- First submitted
- 5 Jul 2020
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Klek S, Szczepanek K, Scislo L, Walewska E, Pietka M, Pisarska M, Pedziwiatr M. Intravenous lipid emulsions and liver function in adult chronic intestinal failure patients: results from a randomized clinical trial. Nutrition. 2018 Nov;55-56:45-50. doi: 10.1016/j.nut.2018.03.008. Epub 2018 Mar 22.
PubMed 29960156
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Dose Intravenous Fish Oil Reduces Inflammation and Improves Liver Function
- ClinicalTrials.gov ID
- NCT04467138
- Acronym / sponsor ID
- Omegaven
- Conditions
- Lipid Metabolism Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Stanley Dudrick's Memorial HospitalUniversity, hospital or other
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 10 Jul 2020 (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.
Retrospective analysis of 51 patients (27 female, 24 male, mean age 51.5±12.6 years) who received all-in-one PN including amino acids, glucose and lipids supplemented with pure fish oil LE was performed.
Detailed description
All patients depended on parenteral nutrition (PN) are prone to inflammation. This condition may aggravate already existing proinflammatory status and can become a critical factor for developing liver dysfunction (LD). Intravenous fish oil may attenuate the inflammatory status, , however, data on its use in adults is scarce. The aim of the study was to investigate the impact of the addition of pure fish oil intravenous lipid emulsion (ILE) as part of short- and long term PN in patients either at risk or with already existing inflammation.
Retrospective analysis of 51 patients (27 female, 24 male, mean age 51.5±12.6 years) who received all-in-one PN including amino acids, glucose and lipids supplemented with pure fish oil LE was performed. Pure fish oil emulsion (Omegaven®, Fresenius Kabi) was used as the additional product along with the standard lipid emulsion to reach a fish oil dose of approx. 0.5 g fish oil/kg/d. Diagnoses were chronic intestinal failure (CIF, n=20), Crohn's disease (CD, n=22), and Ulcerative colitis (UC, n=19). The observation period was 12 months for CIF and 21days for UC and CD.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inflammatory bowel disease | – | Drug: OmegavenPatients with either Crohn's disease (CD, n=22), and Ulcerative colitis (UC, n=19). |
| Chronic intestinal failure | – | Drug: OmegavenPatients with intestinal failure (CIF, n=20) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with either inflammatory bowel disease or chronic intestinal failure. Both in and out patients
Key inclusion criteria (3 listed)
- ≥ 18 years of age,
- metabolic stability (the absence of pathological laboratory resulting in the change of PN regime for at least one month)
- ability to tolerate up to 1.0 g lipids/kg body weight per day as a part of PN.
Key exclusion criteria (1 listed)
- patients with a history of cancer and anti-cancer treatment within the last 5 years, severe hyperlipidemia, severe coagulopathy, severe renal insufficiency, acute thromboembolic events, positive test for HIV, Hepatitis B or C (from medical history), known or suspected drug or alcohol abuse, participation in another interventional clinical trial in parallel or within three months prior to the start of this clinical trial, for women with childbearing potential (i.e. females who are not chemically or surgically sterile or females who are not postmenopausal) or women of childbearing potential tested positive on standard pregnancy test (urine dipstick) or/and lactation.
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 |
|---|---|---|
| OmegavenAlso: Fish oilPure fish oil emulsion (Omegaven®, Fresenius Kabi) was used as the additional product along with the standard lipid emulsion to reach a fish oil dose of approx. 0.5 g fish oil/kg/d. | Drug | Chronic intestinal failure, Inflammatory bowel disease |
Primary outcome
Change in hsCRP concentration
Time frame: 4 weeks
Serum concentration of hsCRP (pg/mL)
Change in Il-6 concentration
Time frame: 4 weeks
Serum concentration of Il-6 (pg/mL)
Change in interleukin-10 concentration
Time frame: 4 weeks
Serum concentration of IL-10 (pg/mL)
Change in procalcytonin concentration
Time frame: 4 weeks
Serum concentration of procalcytonin (ng/mL)
Change in bilirubin concentration
Time frame: 4 weeks
Serum concentration of bilirubin (umol/L)
Change in SGPT concentration
Time frame: 4 weeks
Serum concentration of SGPT(U/l)
Change in SGOT concentration
Time frame: 4 weeks
Serum concentration of SGOT (U/l)
Change in alkaline phosphatase concentration
Time frame: 4 weeks
Serum concentration of alkaline phosphatase (U/l)
Change in C-reactive protein concentration
Time frame: 4 weeks
Serum concentration of CRP (mg/l)
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 22 Jul 2020.
- Results publication: PubMed 29960156Klek S, Szczepanek K, Scislo L, Walewska E, Pietka M, Pisarska M, Pedziwiatr M. Intravenous lipid emulsions and liver function in adult chronic intestinal failure patients: results from a randomized clinical trial. Nutrition. 2018 Nov;55-56:45-50. doi: 10.1016/j.nut.2018.03.008. Epub 2018 Mar 22.
- Individual participant dataSharing planned: No
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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.
Stanislaw Klek, PhD principal investigator
1972
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lipid Metabolism Disorders, run by Stanley Dudrick's Memorial Hospital at 1 site in Poland.
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 1 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 22 Jul 2020. 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 Poland. 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.
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 in hsCRP concentration (time frame: 4 weeks). The study lists 9 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 NCT04467138, which also lists 1 linked publication.
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 22 Jul 2020; AzTrials last refreshed its copy on 6 Nov 2026.