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High Dose Intravenous Fish Oil Reduces Inflammation

Sponsor
Stanley Dudrick's Memorial Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04467138
Collaborator
(none)
51
Enrollment
1
Location
5
Actual Duration (Months)
10.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

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

Study Type:
Observational
Actual Enrollment :
51 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
High Dose Intravenous Fish Oil Reduces Inflammation and Improves Liver Function
Actual Study Start Date :
Jan 31, 2020
Actual Primary Completion Date :
Jun 30, 2020
Actual Study Completion Date :
Jun 30, 2020

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in hsCRP concentration [4 weeks]

      Serum concentration of hsCRP (pg/mL)

    2. Change in Il-6 concentration [4 weeks]

      Serum concentration of Il-6 (pg/mL)

    3. Change in interleukin-10 concentration [4 weeks]

      Serum concentration of IL-10 (pg/mL)

    4. Change in procalcytonin concentration [4 weeks]

      Serum concentration of procalcytonin (ng/mL)

    5. Change in bilirubin concentration [4 weeks]

      Serum concentration of bilirubin (umol/L)

    6. Change in SGPT concentration [4 weeks]

      Serum concentration of SGPT(U/l)

    7. Change in SGOT concentration [4 weeks]

      Serum concentration of SGOT (U/l)

    8. Change in alkaline phosphatase concentration [4 weeks]

      Serum concentration of alkaline phosphatase (U/l)

    9. Change in C-reactive protein concentration [4 weeks]

      Serum concentration of CRP (mg/l)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanley Dudrick's Memorial Hospital Skawina Poland 32-050

    Sponsors and Collaborators

    • Stanley Dudrick's Memorial Hospital

    Investigators

    • Principal Investigator: Stanislaw Klek, PhD, 1972

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stanislaw Klek, Head of the Unit, Stanley Dudrick's Memorial Hospital
    ClinicalTrials.gov Identifier:
    NCT04467138
    Other Study ID Numbers:
    • Omegaven
    First Posted:
    Jul 10, 2020
    Last Update Posted:
    Jul 22, 2020
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Metabolic Diseases
    Lipid Metabolism Disorders
    Inflammation

    Study Results

    No Results Posted as of Jul 22, 2020