Effects of Immunonutrition in Patients With Pneumonia | NCT04249050

Studies
Effects of Immunonutrition in Patients With Pneumonia

NCT04249050

Sponsor

University of Copenhagen

Status

Unknown status

Last Update Posted

Apr 28, 2020Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Pneumonia
Lung Infection
Muscle Loss
Malnutrition
Pulmonary Disease

Interventions

Oral Impact powder

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 30, 2020Actual

Primary Completion Date

Aug 1, 2020Estimated

Completion Date

Aug 15, 2020Estimated

First Submitted Date

Jan 28, 2020

First Submission Date that Met QC Criteria

Jan 29, 2020

First Posted Date

Jan 30, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2020

Last Update Posted Date

Apr 28, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jens Rikardt Andersen, Associate Professor, University of CopenhagenPrincipal Investigator

Lead Sponsor

University of CopenhagenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oral Impact powder	Dietary Supplement	Oral nutritional supplement containing fish oil, arginine and RNA	Intervention group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jens R Andersen, Assoc. Prof.	Contact	004523346654		jra@nexs.ku.dk
Anna G Eilersen, student	Contact	004529246129		hbj467@alumni.ku.dk

Overall Officials

Name	Affiliation	Role
Birgitte L Madsen, M.D., Ph.D.	North Zealand Hospital, Hilleroed, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Lung Medicine and Infectious Diseases	Recruiting	Hillerød		3400	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12464864	Result	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.
22549749	Result	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.

ID	Term
D011014	Pneumonia
D009133	Muscular Atrophy
D044342	Malnutrition
D008171	Lung Diseases

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D012140	Respiratory Tract Diseases
D020879	Neuromuscular Manifestations