NCT04249050

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

March 30, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2020

Completed
Last Updated

April 28, 2020

Status Verified

April 1, 2020

Enrollment Period

4 months

First QC Date

January 28, 2020

Last Update Submit

April 24, 2020

Conditions

PneumoniaLung InfectionMuscle LossMalnutritionPulmonary Disease

Outcome Measures

Primary Outcomes (1)

  • Interleukin-6

    Measure of the acute immune response

    daily measure from first day of inclusion until discharge (maximum 10 days)

Secondary Outcomes (2)

  • Length of stay

    From admittance to discharge (maximum 10 days)

  • Hand grip strength

    Daily from admittance to discharge (maximum 10 days)

Study Arms (2)

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

Oral Impact powderDIETARY_SUPPLEMENT

Oral nutritional supplement containing fish oil, arginine and RNA

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Authorized individuals diagnosed with pneumonia who speak and write in danish

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Lung Medicine and Infectious Diseases

Hillerød, 3400, Denmark

RECRUITING

Related Publications (2)

  • 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.

    PMID: 12464864RESULT

  • 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.

    PMID: 22549749RESULT

MeSH Terms

Conditions

PneumoniaMuscular AtrophyMalnutritionLung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsRespiratory Tract DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Birgitte L Madsen, M.D., Ph.D.

    North Zealand Hospital, Hilleroed, Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jens R Andersen, Assoc. Prof.

CONTACT

004523346654jra@nexs.ku.dk

Anna G Eilersen, student

CONTACT

004529246129hbj467@alumni.ku.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 28, 2020

First Posted

January 30, 2020

Study Start

March 30, 2020

Primary Completion

August 1, 2020

Study Completion

August 15, 2020

Last Updated

April 28, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)