Clinical trial NCT04467138: High Dose Intravenous Fish Oil Reduces Inflammation
Official title: High Dose Intravenous Fish Oil Reduces Inflammation and Improves Liver Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lipid Metabolism Disorders
Lead sponsor: Stanley Dudrick's Memorial Hospital
Sponsor class: OTHER
First posted: 2020-07-10
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with either inflammatory bowel disease or chronic intestinal failure. Both in and out patients

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in hsCRP concentration
timeFrame: 4 weeks
measure: Change in Il-6 concentration
timeFrame: 4 weeks
measure: Change in interleukin-10 concentration
timeFrame: 4 weeks
measure: Change in procalcytonin concentration
timeFrame: 4 weeks
measure: Change in bilirubin concentration
timeFrame: 4 weeks
measure: Change in SGPT concentration
timeFrame: 4 weeks
measure: Change in SGOT concentration
timeFrame: 4 weeks
measure: Change in alkaline phosphatase concentration
timeFrame: 4 weeks
measure: Change in C-reactive protein concentration
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Skawina
country: Poland
facility: Stanley Dudrick's Memorial Hospital
Study officials:
affiliation: 1972
name: Stanislaw Klek, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.