Effects of Immunonutrition in Patients With Pneumonia

NCT ID: NCT04249050

Last Updated: 2020-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-30

Study Completion Date

2020-08-15

Brief Summary

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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

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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.

Conditions

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Pneumonia Lung Infection Muscle Loss Malnutrition Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention group

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

Group Type EXPERIMENTAL

Oral Impact powder

Intervention Type DIETARY_SUPPLEMENT

Oral nutritional supplement containing fish oil, arginine and RNA

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Oral Impact powder

Oral nutritional supplement containing fish oil, arginine and RNA

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Jens Rikardt Andersen

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Birgitte L Madsen, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

North Zealand Hospital, Hilleroed, Denmark

Locations

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Department of Lung Medicine and Infectious Diseases

Hillerød, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Jens R Andersen, Assoc. Prof.

Role: CONTACT

004523346654

Anna G Eilersen, student

Role: CONTACT

004529246129

Facility Contacts

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Birgitte L Madsen, PhD

Role: primary

References

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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.

Reference Type RESULT
PMID: 12464864 (View on PubMed)

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.

Reference Type RESULT
PMID: 22549749 (View on PubMed)

Other Identifiers

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H-19088763

Identifier Type: -

Identifier Source: org_study_id

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