Study Results
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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UNKNOWN
NA
40 participants
INTERVENTIONAL
2020-03-30
2020-08-15
Brief Summary
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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.
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
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)
Oral Impact powder
Oral nutritional supplement containing fish oil, arginine and RNA
Control group
The Control group is receiving the hospital´s Standard Of Care.
No interventions assigned to this group
Interventions
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Oral Impact powder
Oral nutritional supplement containing fish oil, arginine and RNA
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of Copenhagen
OTHER
Responsible Party
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Jens Rikardt Andersen
Associate Professor
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
Countries
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Central Contacts
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Facility Contacts
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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.
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.
Other Identifiers
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H-19088763
Identifier Type: -
Identifier Source: org_study_id
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