High Dose Intravenous Fish Oil Reduces Inflammation

Lipid Metabolism Disorders Clinical Trial

Official title:

High Dose Intravenous Fish Oil Reduces Inflammation and Improves Liver Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04467138
• Other study ID #: Omegaven
• Status: Completed
• Start date: January 31, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2020
• Source: Stanley Dudrick's Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Inflammation
• Lipid Metabolism Disorders
• Metabolic Diseases

Intervention

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.

Locations

Country	Name	City	State
Poland	Stanley Dudrick's Memorial Hospital	Skawina

Sponsors (1)

Lead Sponsor	Collaborator
Stanley Dudrick's Memorial Hospital

Country where clinical trial is conducted

Poland, 

References & Publications (1)

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 — View Citation

Outcome

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