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Effects of Immunonutrition in Patients With Pneumonia

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University of Copenhagen

Status

Unknown

Conditions

Lung Infection
Malnutrition
Pulmonary Disease
Pneumonia
Muscle Loss

Treatments

Dietary Supplement: Oral Impact powder

Study type

Interventional

Funder types

Other

Identifiers

NCT04249050
H-19088763

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Intervention group
Experimental group
Description:
The intervention group is receiving a nutritional drink containing potential immune stimulating ingredients (fish oil, arginine, nucleotides)
Treatment:
Dietary Supplement: Oral Impact powder
Control group
No Intervention group
Description:
The Control group is receiving the hospital´s Standard Of Care.

Trial contacts and locations

1

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Central trial contact

Anna G Eilersen, student; Jens R Andersen, Assoc. Prof.

Data sourced from clinicaltrials.gov

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