Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2026-02-01 @ 2:42 PM
Study NCT ID:
NCT01888861
Status:
UNKNOWN
Last Update Posted:
2013-06-28
First Post:
2013-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Alpha-lipoic Acid on Biochemical Markers and Important Outcomes in Patients Admitted to Intensive Care Units
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008063', 'term': 'Thioctic Acid'}], 'ancestors': [{'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-06-27', 'studyFirstSubmitDate': '2013-06-23', 'studyFirstSubmitQcDate': '2013-06-27', 'lastUpdatePostDateStruct': {'date': '2013-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'length of stay in ICU', 'timeFrame': 'day 28', 'description': 'number of days that patient stay in intensive care unit'}, {'measure': 'mortality', 'timeFrame': 'day 28', 'description': 'percent of mortality'}, {'measure': 'ventilator free days', 'timeFrame': '10 days', 'description': 'show by days'}], 'secondaryOutcomes': [{'measure': 'sequential organ failure assessment score', 'timeFrame': '10 days', 'description': 'determine by SOFA score form'}, {'measure': 'insulin resistance', 'timeFrame': '10 days', 'description': 'measure by HOMA calculation equation'}, {'measure': 'malondialdehyde', 'timeFrame': '10 days', 'description': 'measure by spectrophotometery'}, {'measure': 'total antioxidant capacity', 'timeFrame': '10 days', 'description': 'measure by eliza kit'}, {'measure': 'C reactive protein', 'timeFrame': '10 days', 'description': 'measure by nephelometry method'}, {'measure': 'interleukin-6', 'timeFrame': '10 days', 'description': 'measure by eliza kit'}, {'measure': 'Albumin', 'timeFrame': '10 days', 'description': 'record from routine lab data of patients in hospital'}, {'measure': 'preAlbumin', 'timeFrame': '10 days', 'description': 'by turbidimetric assay'}, {'measure': 'Total lymphocyte count', 'timeFrame': '10 days', 'description': 'record from routine lab data of patients in hospital'}, {'measure': 'Mid arm circumference', 'timeFrame': '10 days', 'description': 'measure by non flexible meter in mid arm'}, {'measure': 'total protein', 'timeFrame': '10 days', 'description': 'record from routine lab data of patients in hospital'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['length of stay in ICU', 'ventilator free days'], 'conditions': ['Oxidative Stress', 'Inflammation', 'Malnutrition']}, 'descriptionModule': {'briefSummary': "Increasing Reactive oxygen and nitrogen production occurred simultaneously with decreasing serum and intracellular level of antioxidants and enzymes in critical ill patients, which result in increasing ventilator dependency and length of stay in intensive care unit and it also accelerate organ failures in patients. In this double blind clinical trial, the investigators examine effect of alfa-lipoic acid on those patients who admitted to intensive care unit that the investigators expect to stay for more than 7 days in this ward and who have tube feeding and don't have severe liver and kidney failure, AIDS and hepatitis. After randomization of included patients by block randomization the investigators will give 900mg/day alfa-lipoic acid for ten days to treatment group and identical placebo to control group by naso-gastric tube. The purposes of this study are decreasing ventilator dependency period, length of stay in ICU, mortality and decelerate of organ failures."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥ 18;\n* expected length of stay more than 7 days;\n* using enteral feeding method during admitted to ICU\n\nExclusion Criteria:\n\n* having the history of autoimmune disease\n* severe renal or liver failure\n* AIDS,\n* hepatitis;\n* having severe malnutrition at the admission time;\n* having TPN at the admission time in ICU;\n* extreme intolerance to enteral feeding.'}, 'identificationModule': {'nctId': 'NCT01888861', 'briefTitle': 'Effect of Alpha-lipoic Acid on Biochemical Markers and Important Outcomes in Patients Admitted to Intensive Care Units', 'organization': {'class': 'OTHER', 'fullName': 'Shiraz University of Medical Sciences'}, 'officialTitle': 'Evaluating the Effect of Alpha Lipoic Acid on Biochemical Markers, Length of Stay and Other Important Outcomes in Patients Admitted to Intensive Care Units.', 'orgStudyIdInfo': {'id': '916423'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'alpha-lipoic acid', 'description': 'the patients in this arm were received 900mg alpha-lipoic acid for 10 days through nasogastric(NG) tube.', 'interventionNames': ['Dietary Supplement: alpha-lipoic acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'the patients in this arm were received 900mg placebo through NG tube.', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'alpha-lipoic acid', 'type': 'DIETARY_SUPPLEMENT', 'description': 'the patients in this arm receive 900mg alpha-lipoic acid through NG tube.', 'armGroupLabels': ['alpha-lipoic acid']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'the patients in this arm were received 900mg placebo through NG tube.', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7157617516', 'city': 'Shiraz', 'state': 'Fars', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Najmeh Hejazi, PhD', 'role': 'CONTACT', 'email': 'n20hejazi@yahoo.com'}, {'name': 'Najmeh Hejazi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shiraz University of Medical Sciences, Department of Nutrition', 'geoPoint': {'lat': 29.61031, 'lon': 52.53113}}], 'centralContacts': [{'name': 'Najmeh Hejazi, Ph.D', 'role': 'CONTACT', 'email': 'n20hejazi@yahoo.com'}], 'overallOfficials': [{'name': 'Najmeh Hejazi, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shiraz University of Medical Sciences,Nutrition department'}, {'name': 'Zohreh Mazloom, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shiraz University of Medical Sciences, Faculty of Nutrition'}, {'name': 'Farid Zand, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Shiraz University of Medical Sciences, anesthesiology and critical care research center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'najmeh hejazi', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shiraz University of Medical Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PhD of Nutrition,Shiraz University of Medical Sciences', 'investigatorFullName': 'najmeh hejazi', 'investigatorAffiliation': 'Shiraz University of Medical Sciences'}}}}