High Dose Intravenous Fish Oil Reduces Inflammation

Study Overview
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Brief Summary
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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
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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.

Official Title
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High Dose Intravenous Fish Oil Reduces Inflammation and Improves Liver Function

Conditions
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Lipid Metabolism Disorders

Intervention / Treatment
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* Drug: Omegaven


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Inflammatory bowel disease<br>Patients with either Crohn's disease (CD, n=22), and Ulcerative colitis (UC, n=19). | Drug: Omegaven<br>* 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.<br>* Other names: Fish oil;|
| Chronic intestinal failure<br>Patients with intestinal failure (CIF, n=20) | Drug: Omegaven<br>* 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.<br>* Other names: Fish oil;|

What is the study measuring?
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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 |