Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2026-01-04 @ 9:36 AM
Study NCT ID:
NCT04249050
Status:
UNKNOWN
Last Update Posted:
2020-04-28
First Post:
2020-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Immunonutrition in Patients With Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-24', 'studyFirstSubmitDate': '2020-01-28', 'studyFirstSubmitQcDate': '2020-01-29', 'lastUpdatePostDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Interleukin-6', 'timeFrame': 'daily measure from first day of inclusion until discharge (maximum 10 days)', 'description': 'Measure of the acute immune response'}], 'secondaryOutcomes': [{'measure': 'Length of stay', 'timeFrame': 'From admittance to discharge (maximum 10 days)', 'description': 'Measure of hospitalized days'}, {'measure': 'Hand grip strength', 'timeFrame': 'Daily from admittance to discharge (maximum 10 days)', 'description': 'Measure of the mobilization of strength'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pneumonia', 'Lung Infection', 'Muscle Loss', 'Malnutrition', 'Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '12464864', 'type': 'RESULT', 'citation': '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': '22549749', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The project is a randomized controlled trial taking place in the North Zealand hospital in the city Hilleroed, Denmark.\n\nThe 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.', 'detailedDescription': "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.\n\nThe 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Authorized individuals diagnosed with pneumonia who speak and write in danish\n\nExclusion Criteria:\n\n* individuals with Immunodeficiency\n* individuals with another primary diagnose\n* individuals with an allergy against product ingredients\n* individuals with dementia\n* individuals with dysphagia\n* individuals with cancer in treatment\n* individuals with Chronic Obstructive Pulmonary Disease on continuing steroid treatment or home administered oxygen treatment'}, 'identificationModule': {'nctId': 'NCT04249050', 'briefTitle': 'Effects of Immunonutrition in Patients With Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Effects of Immunonutrition on the Acute Immune Response in Hospitalized Patients With Pneumonia', 'orgStudyIdInfo': {'id': 'H-19088763'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'The intervention group is receiving a nutritional drink containing potential immune stimulating ingredients (fish oil, arginine, nucleotides)', 'interventionNames': ['Dietary Supplement: Oral Impact powder']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The Control group is receiving the hospital´s Standard Of Care.'}], 'interventions': [{'name': 'Oral Impact powder', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral nutritional supplement containing fish oil, arginine and RNA', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3400', 'city': 'Hillerød', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Birgitte L Madsen, PhD', 'role': 'CONTACT', 'email': 'birgitte.lindegaard.madsen@regionh.dk'}], 'facility': 'Department of Lung Medicine and Infectious Diseases', 'geoPoint': {'lat': 55.92791, 'lon': 12.30081}}], 'centralContacts': [{'name': 'Jens R Andersen, Assoc. Prof.', 'role': 'CONTACT', 'email': 'jra@nexs.ku.dk', 'phone': '004523346654'}, {'name': 'Anna G Eilersen, student', 'role': 'CONTACT', 'email': 'hbj467@alumni.ku.dk', 'phone': '004529246129'}], 'overallOfficials': [{'name': 'Birgitte L Madsen, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'North Zealand Hospital, Hilleroed, Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jens Rikardt Andersen', 'investigatorAffiliation': 'University of Copenhagen'}}}}