PneumoniaNCT04249050
Effects of Immunonutrition in Patients With Pneumonia
A study testing Oral Impact powder in people with Pneumonia and Lung Infection, run by University of Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Lung Infection, Muscle Loss
- What is being tested?
- Oral Impact powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Mar 2020to 15 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Authorized individuals diagnosed with pneumonia who speak and write in danish
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Lung Medicine and Infectious Diseases
Hillerød, 3400
Birgitte L Madsen, PhD, birgitte.lindegaard.madsen@regionh.dk
About this study
Official title: Effects of Immunonutrition on the Acute Immune Response in Hospitalized Patients With Pneumonia
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.
Read the 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.
- Conditions
- Pneumonia, Lung Infection, Muscle Loss, Malnutrition, Pulmonary Disease
- Being tested
- Oral Impact powder
- Medical subject headings
- Pneumonia, Muscular Atrophy, Malnutrition, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Impact powderDietary supplement
Oral nutritional supplement containing fish oil, arginine and RNA
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group is receiving a nutritional drink containing potential immune stimulating ingredients (fish oil, arginine, nucleotides) Receives: Dietary Supplement: Oral Impact powder |
| Control group | No intervention | The Control group is receiving the hospital´s Standard Of Care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin-6
Measure of the acute immune response
Measured: daily measure from first day of inclusion until discharge (maximum 10 days)
Secondary outcomes (2)
Length of stay
Measure of hospitalized days
Measured: From admittance to discharge (maximum 10 days)
Hand grip strength
Measure of the mobilization of strength
Measured: Daily from admittance to discharge (maximum 10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start30 Mar 2020
- Primary completion1 Aug 2020 (estimated)
- Study completion15 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jens Rikardt Andersen, University of Copenhagen
- Investigators
- Birgitte L Madsen, M.D., Ph.D., Principal investigator, North Zealand Hospital, Hilleroed, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249050
- Sponsor's protocol ID
- H-19088763
- Status last verified
- Apr 2020
- First submitted
- 28 Jan 2020
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12464864Marimuthu 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.
PubMed 22549749
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Immunonutrition on the Acute Immune Response in Hospitalized Patients With Pneumonia
- ClinicalTrials.gov ID
- NCT04249050
- Acronym / sponsor ID
- H-19088763
- Conditions
- Pneumonia, Lung Infection, Muscle Loss, Malnutrition, Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 15 Aug 2020 (estimated)
- First posted
- 30 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: Oral Impact powderThe intervention group is receiving a nutritional drink containing potential immune stimulating ingredients (fish oil, arginine, nucleotides) |
| Control group | No intervention | –The Control group is receiving the hospital´s Standard Of Care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Authorized individuals diagnosed with pneumonia who speak and write in danish
Key exclusion criteria (7 listed)
- individuals with Immunodeficiency
- individuals with another primary diagnose
- individuals with an allergy against product ingredients
- individuals with dementia
- individuals with dysphagia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Impact powderOral nutritional supplement containing fish oil, arginine and RNA | Dietary supplement | Intervention group |
Primary outcome
Interleukin-6
Time frame: daily measure from first day of inclusion until discharge (maximum 10 days)
Measure of the acute immune response
2 secondary outcomes
Length of stay
Time frame: From admittance to discharge (maximum 10 days)
Hand grip strength
Time frame: Daily from admittance to discharge (maximum 10 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Results publication: PubMed 12464864Braga 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.
- Results publication: PubMed 22549749Marimuthu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Birgitte L Madsen, M.D., Ph.D. principal investigator
North Zealand Hospital, Hilleroed, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Impact powder in people with Pneumonia and Lung Infection, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jens R Andersen, Assoc. Prof. (004523346654, jra@nexs.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interleukin-6 (time frame: daily measure from first day of inclusion until discharge (maximum 10 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04249050, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.