Effects of Immunonutrition in Patients With Pneumonia

April 24, 2020 updated by: Jens Rikardt Andersen, University of Copenhagen

Effects of Immunonutrition on the Acute Immune Response in Hospitalized Patients With Pneumonia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jens R Andersen, Assoc. Prof.
  • Phone Number: 004523346654
  • Email: jra@nexs.ku.dk

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention group
The intervention group is receiving a nutritional drink containing potential immune stimulating ingredients (fish oil, arginine, nucleotides)
Dietary supplement: Oral Impact powder
Oral nutritional supplement containing fish oil, arginine and RNA
NO_INTERVENTION: Control group
The Control group is receiving the hospital´s Standard Of Care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interleukin-6
Time Frame: daily measure from first day of inclusion until discharge (maximum 10 days)
Measure of the acute immune response
daily measure from first day of inclusion until discharge (maximum 10 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay
Time Frame: From admittance to discharge (maximum 10 days)
Measure of hospitalized days
From admittance to discharge (maximum 10 days)
Hand grip strength
Time Frame: Daily from admittance to discharge (maximum 10 days)
Measure of the mobilization of strength
Daily from admittance to discharge (maximum 10 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Investigators

  • Principal Investigator: Birgitte L Madsen, M.D., Ph.D., North Zealand Hospital, Hilleroed, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 30, 2020

Primary Completion (ANTICIPATED)

August 1, 2020

Study Completion (ANTICIPATED)

August 15, 2020

Study Registration Dates

First Submitted

January 28, 2020

First Submitted That Met QC Criteria

January 29, 2020

First Posted (ACTUAL)

January 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 28, 2020

Last Update Submitted That Met QC Criteria

April 24, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-19088763

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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