Effects of Immunonutrition in Patients With Pneumonia

Sponsor
University of Copenhagen (Other)
Overall Status
Unknown status
CT.gov ID
NCT04249050
Collaborator
(none)
40
1
2
4.5
8.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Oral Impact powder
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Effects of Immunonutrition on the Acute Immune Response in Hospitalized Patients With Pneumonia
Actual Study Start Date :
Mar 30, 2020
Anticipated Primary Completion Date :
Aug 1, 2020
Anticipated Study Completion Date :
Aug 15, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Interleukin-6 [daily measure from first day of inclusion until discharge (maximum 10 days)]

    Measure of the acute immune response

Secondary Outcome Measures

  1. Length of stay [From admittance to discharge (maximum 10 days)]

    Measure of hospitalized days

  2. Hand grip strength [Daily from admittance to discharge (maximum 10 days)]

    Measure of the mobilization of strength

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Lung Medicine and Infectious Diseases Hillerød Denmark 3400

Sponsors and Collaborators

  • University of Copenhagen

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jens Rikardt Andersen, Associate Professor, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT04249050
Other Study ID Numbers:
  • H-19088763
First Posted:
Jan 30, 2020
Last Update Posted:
Apr 28, 2020
Last Verified:
Apr 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:

Study Results

No Results Posted as of Apr 28, 2020