High Dose Intravenous Fish Oil Reduces Inflammation

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.

Study Overview

• Status: Completed
• Conditions: Lipid Metabolism Disorders
• Intervention / Treatment: Drug: Omegaven

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 Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• Poland
  • Skawina, Poland, 32-050
    • Stanley Dudrick's Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with either inflammatory bowel disease or chronic intestinal failure. Both in and out patients

Description

Inclusion Criteria:

• ≥ 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Inflammatory bowel disease; Patients with either Crohn's disease (CD, n=22), and Ulcerative colitis (UC, n=19).	Drug: Omegaven; 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.; Other Names: Fish oil
Chronic intestinal failure; Patients with intestinal failure (CIF, n=20)	Drug: Omegaven; 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.; Other Names: Fish oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hsCRP concentration	Serum concentration of hsCRP (pg/mL)	4 weeks
Change in Il-6 concentration	Serum concentration of Il-6 (pg/mL)	4 weeks
Change in interleukin-10 concentration	Serum concentration of IL-10 (pg/mL)	4 weeks
Change in procalcytonin concentration	Serum concentration of procalcytonin (ng/mL)	4 weeks
Change in bilirubin concentration	Serum concentration of bilirubin (umol/L)	4 weeks
Change in SGPT concentration	Serum concentration of SGPT(U/l)	4 weeks
Change in SGOT concentration	Serum concentration of SGOT (U/l)	4 weeks
Change in alkaline phosphatase concentration	Serum concentration of alkaline phosphatase (U/l)	4 weeks
Change in C-reactive protein concentration	Serum concentration of CRP (mg/l)	4 weeks

Collaborators and Investigators

• Sponsor: Stanley Dudrick's Memorial Hospital
• Investigators: Principal Investigator: Stanislaw Klek, PhD, 1972

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2020
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: July 5, 2020
• First Submitted That Met QC Criteria: July 9, 2020
• First Posted (Actual): July 10, 2020

Study Record Updates

• Last Update Posted (Actual): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 19, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Metabolic Diseases; Lipid Metabolism Disorders
• Other Study ID Numbers: OMEGAVEN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No