Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-01-01 @ 12:59 PM
Study NCT ID:
NCT03166956
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2017-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Glutamine and Vitamin C on Interleukin-6 and Clinical Outcomes in Surgical Intensive Care Unit Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005973', 'term': 'Glutamine'}], 'ancestors': [{'id': 'D024361', 'term': 'Amino Acids, Basic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000599', 'term': 'Amino Acids, Diamino'}, {'id': 'D021542', 'term': 'Amino Acids, Neutral'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'This is a prospective double-blind randomized study for surgical ICU patients whom can sustain enteral feeding. The test group was provided with glutamine and vitamin C (the GA group); the control (C) group was provided with maltodextrin of equivalent calories as that provided in the GA group.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2014-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-25', 'studyFirstSubmitDate': '2017-05-11', 'studyFirstSubmitQcDate': '2017-05-23', 'lastUpdatePostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Interleukin-6', 'timeFrame': 'Blood samples were collected for biochemical analyses on the starting day of enteral feeding (day of enrollment), and every 7 days until day of discharge from ICU, or on the day of discharge from ICU, which ever is shorter, assessed up to 14 days.', 'description': 'Blood samples were collected for biochemical on the starting day of enteral feeding, and every 7 days or on the day of discharge from ICU.'}, {'measure': 'Interleukin-10', 'timeFrame': 'Blood samples were collected for biochemical analyses on the starting day of enteral feeding (day of enrollment), and every 7 days until day of discharge from ICU, or on the day of discharge from ICU, which ever is shorter, assessed up to 14 days.', 'description': 'Blood samples were collected for biochemical on the starting day of enteral feeding, and every 7 days or on the day of discharge from ICU.'}, {'measure': 'Body mass index (BMI)', 'timeFrame': 'At enrollment.', 'description': 'body height and weight were taken and body mass index (BMI) calculated at baseline.'}, {'measure': 'Acute Physiology and Chronic Health Evaluation II (APACHE II) score', 'timeFrame': 'At enrollment.', 'description': 'APACHE II score was calculated to classify the disease severity.'}, {'measure': 'Plasma glutamine', 'timeFrame': 'Blood samples were collected for biochemical analyses on the starting day of enteral feeding, and every 7 days or on the day of discharge from ICU, assessed up to 14 days.', 'description': 'Blood was collected for analyses of plasma glutamine levels'}, {'measure': 'Red blood cells', 'timeFrame': 'On the starting day of enteral feeding (enrollment), and every 7 days or on the day of discharge from ICU, assessed up to 14 days.', 'description': 'Blood was collected for hematological analyses'}, {'measure': 'Hemoglobin', 'timeFrame': 'On the starting day of enteral feeding (enrollment), and every 7 days or on the day of discharge from ICU, assessed up to 14 days.', 'description': 'Blood was collected for hematological analyses'}, {'measure': 'White blood cells', 'timeFrame': 'On the starting day of enteral feeding (enrollment), and every 7 days or on the day of discharge from ICU, assessed up to 14 days.', 'description': 'Hematological analyses'}, {'measure': 'C reactive protein', 'timeFrame': 'On the starting day of enteral feeding (enrollment), and every 7 days or on the day of discharge from ICU, assessed up to 14 days.', 'description': 'Hematological analyses'}], 'secondaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': 'Up to one year', 'description': 'Clinical outcome'}, {'measure': 'Length of ICU stay', 'timeFrame': 'Up to one year', 'description': 'Clinical outcome'}, {'measure': 'Duration of ventilator use', 'timeFrame': 'Up to one year', 'description': 'Clinical outcome'}, {'measure': 'ICU infectious complications', 'timeFrame': 'Up to one year', 'description': 'Clinical outcome'}, {'measure': 'Mortality in ICU stay', 'timeFrame': 'Up to one year', 'description': 'Clinical outcome'}, {'measure': 'Mortality in hospital stay', 'timeFrame': 'Up to one year', 'description': 'Clinical outcome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vitamin C', 'Glutamine', 'Interleukin-6', 'Clinical outcomes'], 'conditions': ['Critical Care']}, 'descriptionModule': {'briefSummary': 'Background \\& Aims. Glutamine is a conditional essential amino acid that was found in reduced plasma amount in Intensive Care Unit (ICU) patients. The supplementations of glutamine and vitamin C potentially have beneficial effects on wound healing and a reduction in infection rate. In this investigation, enteral glutamine and vitamin C were provided for ICU patient, and the associated changes in proinflammatory cytokines and clinical outcomes were investigated.', 'detailedDescription': 'Background \\& Aims. Glutamine is a conditional essential amino acid that was found in reduced plasma amount in Intensive Care Unit (ICU) patients. The supplementation of glutamine in ICU patients has been under much debate. Another nutritional supplement, vitamin C, had a beneficial effect on wound healing and a reduction in infection rate. In this investigation, enteral glutamine and vitamin C were provided for ICU patient, and the associated changes in proinflammatory cytokines and clinical outcomes were investigated.\n\nMethods. This is a prospective double-blind randomized study for surgical ICU patients whom can sustain enteral feeding. The test group was provided with glutamine and vitamin C (the GA group); the control (C) group was provided with maltodextrin of equivalent calories as that provided in the GA group. Plasma glutamine, interleukin-6 (IL-6), and clinical data were collected and analyzed with biostatistical methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between the ages 20 and 85 years\n* Not enrolled in other clinical trials in the previous 1 month and during the study period\n* Surgical ICU patients cared by the 9 participating surgeons\n\nExclusion Criteria:\n\n* Older than age 85 years\n* Pregnant women\n* With an abnormal liver function (receiving drugs or clinical therapies)\n* Abnormal renal function (under hemodialysis)\n* Multiple organ failure (more than 2 organs)\n* Expected ICU stay of less than 72 hours'}, 'identificationModule': {'nctId': 'NCT03166956', 'briefTitle': 'Effect of Glutamine and Vitamin C on Interleukin-6 and Clinical Outcomes in Surgical Intensive Care Unit Patients', 'organization': {'class': 'OTHER', 'fullName': 'Chung Shan Medical University'}, 'officialTitle': 'The Effect of Enteral Glutamine and Vitamin C Supplementation on Interleukin-6 and Clinical Outcomes in Surgical Intensive Care Unit Patients: A Prospective, Double-Blind, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CS#12181'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GA (glutamine and vitamin C) group', 'description': 'Interventions of glutamine and vitamin C enteral supplementations were given to surgical intensive care unit (ICU) patients.\n\nSubjects in the GA group received enteral supplement of 10 g L-glutamine and 90 mg vitamin C per serving provided by Nutritec-Enjoy Nutrition Inc. (Taipei, Taiwan).', 'interventionNames': ['Dietary Supplement: Glutamine and vitamin C enteral supplement']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control (C) group', 'description': 'Placebo:\n\nSubjects in the C group received isocaloric maltodextrin as placebo.', 'interventionNames': ['Dietary Supplement: Glutamine and vitamin C enteral supplement']}], 'interventions': [{'name': 'Glutamine and vitamin C enteral supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Subjects in the GA group received enteral supplement of 10 g L-glutamine and 90 mg vitamin C per serving provided by Nutritec-Enjoy Nutrition Inc. (Taipei, Taiwan). Subjects in the C group received isocaloric maltodextrin as placebo.', 'armGroupLabels': ['Control (C) group', 'GA (glutamine and vitamin C) group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chung Shan Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department Chairman', 'investigatorFullName': 'Frank Lin, MD, PhD', 'investigatorAffiliation': 'Chung Shan Medical University'}}}}