NCT04467138

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 10, 2020

Completed
Last Updated

July 22, 2020

Status Verified

July 1, 2020

Enrollment Period

5 months

First QC Date

July 5, 2020

Last Update Submit

July 19, 2020

Conditions

Lipid Metabolism Disorders

Outcome Measures

Primary Outcomes (9)

  • 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

Study Arms (2)

Inflammatory bowel disease

Patients with either Crohn's disease (CD, n=22), and Ulcerative colitis (UC, n=19).

Drug: Omegaven

Chronic intestinal failure

Patients with intestinal failure (CIF, n=20)

Drug: Omegaven

Interventions

OmegavenDRUG

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.

Also known as: Fish oil
Chronic intestinal failureInflammatory bowel disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • ≥ 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanley Dudrick's Memorial Hospital

Skawina, 32-050, Poland

Location

Related 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: 10.1016/j.nut.2018.03.008. Epub 2018 Mar 22.

    PMID: 29960156RESULT

MeSH Terms

Conditions

Lipid Metabolism Disorders

Interventions

fish oil triglyceridesFish Oils

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

OilsLipids

Study Officials

  • Stanislaw Klek, PhD

    1972

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Unit

Study Record Dates

First Submitted

July 5, 2020

First Posted

July 10, 2020

Study Start

January 31, 2020

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

July 22, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)