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Effects of Immunonutrition in Patients With Pneumonia

Primary Purpose

Pneumonia, Lung Infection, Muscle Loss

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Oral Impact powder
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Authorized individuals diagnosed with pneumonia who speak and write in danish

Exclusion Criteria:

  • individuals with Immunodeficiency
  • individuals with another primary diagnose
  • individuals with an allergy against product ingredients
  • individuals with dementia
  • individuals with dysphagia
  • individuals with cancer in treatment
  • individuals with Chronic Obstructive Pulmonary Disease on continuing steroid treatment or home administered oxygen treatment

Sites / Locations

  • Department of Lung Medicine and Infectious DiseasesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

The intervention group is receiving a nutritional drink containing potential immune stimulating ingredients (fish oil, arginine, nucleotides)

The Control group is receiving the hospital´s Standard Of Care.

Outcomes

Primary Outcome Measures

Interleukin-6
Measure of the acute immune response

Secondary Outcome Measures

Length of stay
Measure of hospitalized days
Hand grip strength
Measure of the mobilization of strength

Full Information

First Posted
January 28, 2020
Last Updated
April 24, 2020
Sponsor
University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT04249050
Brief Title
Effects of Immunonutrition in Patients With Pneumonia
Official Title
Effects of Immunonutrition on the Acute Immune Response in Hospitalized Patients With Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 30, 2020 (Actual)
Primary Completion Date
August 1, 2020 (Anticipated)
Study Completion Date
August 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The project is a randomized controlled trial taking place in the North Zealand hospital in the city Hilleroed, Denmark. The aim is to investigate the potential beneficial effects of immunonutrition containing fish oil, arginine and RNA, on the acute immune response in patients with pneumonia.
Detailed Description
Immunonutrition has a well-documented beneficial effect on surgical patients by strengthening the immune system and reducing the following: inflammation, the number of infections as well as hospitalization time. A study in operated patients demonstrated the benefit of immunonutrition by reducing unwanted inflammation, measured by the pro-inflammatory signalling protein, interleukin-6. The same study saw a smaller decrease in immune function (measured as the level of phagocytosis) in the group receiving immunonutrition than in the control group. This project will investigate whether similar effects can be detected in patients with pneumonia. The project is being carried out in a collaboration between the University of Copenhagen, The main hospital of Copenhagen (Rigshospitalet) and North Zealand Hospital. The project is a randomized clinical intervention study, which spans 10 days. Participants are allocated to the intervention group or the control group. The project is being carried out at the North Zealand hospital, at the Department of Pulmonary- and Infectious Diseases. The intervention group receives the department's standard treatment (Standard Of Care) + immunonutrition, while the control group receives the hospital department's standard treatment (Standard Of Care). On a daily basis, the patient's clinical condition and the activity of the immune system is measured for the purpose of determine whether there is an effect of immunonutrition.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Lung Infection, Muscle Loss, Malnutrition, Pulmonary Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The intervention group is receiving a nutritional drink containing potential immune stimulating ingredients (fish oil, arginine, nucleotides)
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The Control group is receiving the hospital´s Standard Of Care.
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral Impact powder
Intervention Description
Oral nutritional supplement containing fish oil, arginine and RNA
Primary Outcome Measure Information:
Title
Interleukin-6
Description
Measure of the acute immune response
Time Frame
daily measure from first day of inclusion until discharge (maximum 10 days)
Secondary Outcome Measure Information:
Title
Length of stay
Description
Measure of hospitalized days
Time Frame
From admittance to discharge (maximum 10 days)
Title
Hand grip strength
Description
Measure of the mobilization of strength
Time Frame
Daily from admittance to discharge (maximum 10 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Authorized individuals diagnosed with pneumonia who speak and write in danish Exclusion Criteria: individuals with Immunodeficiency individuals with another primary diagnose individuals with an allergy against product ingredients individuals with dementia individuals with dysphagia individuals with cancer in treatment individuals with Chronic Obstructive Pulmonary Disease on continuing steroid treatment or home administered oxygen treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jens R Andersen, Assoc. Prof.
Phone
004523346654
Email
jra@nexs.ku.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Anna G Eilersen, student
Phone
004529246129
Email
hbj467@alumni.ku.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birgitte L Madsen, M.D., Ph.D.
Organizational Affiliation
North Zealand Hospital, Hilleroed, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Lung Medicine and Infectious Diseases
City
Hillerød
ZIP/Postal Code
3400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Birgitte L Madsen, PhD
Email
birgitte.lindegaard.madsen@regionh.dk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12464864
Citation
Braga M, Gianotti L, Vignali A, Carlo VD. Preoperative oral arginine and n-3 fatty acid supplementation improves the immunometabolic host response and outcome after colorectal resection for cancer. Surgery. 2002 Nov;132(5):805-14. doi: 10.1067/msy.2002.128350.
Results Reference
result
PubMed Identifier
22549749
Citation
Marimuthu K, Varadhan KK, Ljungqvist O, Lobo DN. A meta-analysis of the effect of combinations of immune modulating nutrients on outcome in patients undergoing major open gastrointestinal surgery. Ann Surg. 2012 Jun;255(6):1060-8. doi: 10.1097/SLA.0b013e318252edf8.
Results Reference
result

Learn more about this trial

Effects of Immunonutrition in Patients With Pneumonia

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