Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 12:45 AM
Study NCT ID:
NCT01413360
Status:
COMPLETED
Last Update Posted:
2016-07-15
First Post:
2011-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Effect of High Dose Vitamin C on the Liver Function in Chronic Hepatitis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D019698', 'term': 'Hepatitis C, Chronic'}, {'id': 'D006519', 'term': 'Hepatitis, Alcoholic'}], 'ancestors': [{'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008108', 'term': 'Liver Diseases, Alcoholic'}, {'id': 'D020751', 'term': 'Alcohol-Induced Disorders'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001205', 'term': 'Ascorbic Acid'}], 'ancestors': [{'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'yoonjh@snu.ac.kr', 'phone': '+82-2-2072-2228', 'title': 'Jung-Hwan Yoon', 'organization': 'Seoul National University Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'HD Vitamin C', 'description': 'High dose vitamin C\n\nHigh dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL', 'otherNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Change in Serum Alanine Aminotransferase Level From Baseline to 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HD Vitamin C', 'description': 'High dose vitamin C\n\nHigh dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL'}], 'classes': [{'title': 'ALT baseline', 'categories': [{'measurements': [{'value': '77.5', 'groupId': 'OG000', 'lowerLimit': '41', 'upperLimit': '142'}]}]}, {'title': 'ALT 12 weeks', 'categories': [{'measurements': [{'value': '105.5', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '170'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Serum alanine aminotransferase (ALT) level after 12 weeks of high dose vitamin C administration and Baseline serum ALT level', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Change in Serum Interleukin 22 Level From Baseline to 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HD Vitamin C', 'description': 'High dose vitamin C\n\nHigh dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL'}], 'classes': [{'title': 'IL-22 baseline', 'categories': [{'measurements': [{'value': '3.66', 'groupId': 'OG000', 'lowerLimit': '1.32', 'upperLimit': '11.84'}]}]}, {'title': 'IL-22 after 12 weeks', 'categories': [{'measurements': [{'value': '4.04', 'groupId': 'OG000', 'lowerLimit': '0.32', 'upperLimit': '5.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Serum interleukin 22(IL-22)level after 12 weeks of high vitamin C administration and Baseline IL-22 level', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HD Vitamin C', 'description': 'High dose vitamin C\n\nHigh dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'HD Vitamin C', 'description': 'High dose vitamin C\n\nHigh dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000', 'lowerLimit': '39', 'upperLimit': '70'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Etiology', 'classes': [{'title': 'HCV', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'Alcohol', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'ALT', 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000', 'lowerLimit': '41', 'upperLimit': '142'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'IU/L', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-06', 'studyFirstSubmitDate': '2011-08-09', 'resultsFirstSubmitDate': '2015-05-20', 'studyFirstSubmitQcDate': '2011-08-09', 'lastUpdatePostDateStruct': {'date': '2016-07-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-06-06', 'studyFirstPostDateStruct': {'date': '2011-08-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Change in Serum Alanine Aminotransferase Level From Baseline to 12 Weeks', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Serum alanine aminotransferase (ALT) level after 12 weeks of high dose vitamin C administration and Baseline serum ALT level'}], 'secondaryOutcomes': [{'measure': 'The Change in Serum Interleukin 22 Level From Baseline to 12 Weeks', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Serum interleukin 22(IL-22)level after 12 weeks of high vitamin C administration and Baseline IL-22 level'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Hepatitis', 'Chronic Hepatitis C', 'Chronic Alcoholic Hepatitis']}, 'descriptionModule': {'briefSummary': 'The investigators will evaluate the efficacy of high dose vitamin C in chronic hepatitis patients whose serum liver enzymes are elevated more than upper limit.', 'detailedDescription': 'The changes of laboratory findings including serum transaminase levels, serum albumin levels, Child-Pugh score, MELD score, and APRI score will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Chronic hepatitis C patients\n\n * positive anti-HCV antibody more than 6 months\n * serum alanine aminotransferase 40 - 80 IU/L for more than 6 months\n * not indicated for antiviral therapy with interferon and ribavirin\n2. Chronic alcoholic hepatitis\n\n * significant alcohol drinking history and no other cause of chronic hepatitis\n * serum alanine aminotransferase 40 - 80 IU/L for more than 6 months\n\nExclusion Criteria:\n\n* Chronic hepatitis B, autoimmune hepatitis, primary biliary cirrhosis, Wilson's disease, hemochromatosis, other chronic hepatitis except chronic hepatitis C or alcoholic hepatitis\n* decompensated liver cirrhosis\n* platelet \\< 50,000/uL or white blood cell \\< 1,500/uL\n* need and willing for antiviral therapy\n* significant renal dysfunction (GFR \\< 30 mL/min/kg) or history of renal stone\n* hepatotonic drug (i.e. silymarin, garlic oil, aronamin gold) usage within 2 weeks\n* pregnancy, lactating woman"}, 'identificationModule': {'nctId': 'NCT01413360', 'briefTitle': 'The Effect of High Dose Vitamin C on the Liver Function in Chronic Hepatitis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Phase 4 Study of High Dose Vitamin C in Chronic Hepatitis Patients', 'orgStudyIdInfo': {'id': 'VitC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HD Vitamin C', 'description': 'High dose vitamin C', 'interventionNames': ['Drug: High dose vitamin C']}], 'interventions': [{'name': 'High dose vitamin C', 'type': 'DRUG', 'otherNames': ['Koreaeundan Vitamin C 1000'], 'description': 'Vitamin C, 3g per day (tid), with meal, per oral with water 100mL', 'armGroupLabels': ['HD Vitamin C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-171', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jung-Hwan Yoon, M.D, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jung-Hwan Yoon', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}