Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-28 @ 12:13 AM
Study NCT ID:
NCT00921934
Status:
COMPLETED
Last Update Posted:
2017-12-21
First Post:
2009-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intravenous Vitamin C in the Treatment of Viral Infection, Especially in the Treatment of Shingles
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006562', 'term': 'Herpes Zoster'}, {'id': 'D006561', 'term': 'Herpes Simplex'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D000073618', 'term': 'Varicella Zoster Virus Infection'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D017193', 'term': 'Skin Diseases, Viral'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '+0049-2602-684-614', 'title': 'Dr. med. Martin Schencking', 'organization': 'Department for Complementary and Alternative Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1.5 years', 'eventGroups': [{'id': 'EG000', 'title': 'Vitamin C', 'description': 'Adult patients suffering from acute viral infection, especially herpes zoster, presenting themselves in Primary Care Centers or hospitals all over Germany, and who are treated with standard therapy and add-on vitamin C.', 'otherNumAtRisk': 68, 'otherNumAffected': 2, 'seriousNumAtRisk': 68, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Sensation of heat on the injection site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'numbness sensation up to the fingertips', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'burning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Urticarial drug inducted exanthema on truncus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Urticarial drug inducted exanthema on torso', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'protracted diarrhoe', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change of Pain Measured by VAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vitamin C', 'description': 'Adult patients suffering from acute viral infection, especially herpes zoster, presenting themselves in Primary Care Centers or hospitals all over Germany, and who are treated with standard therapy and add-on vitamin C.'}], 'classes': [{'title': 'V1 (Baseline)', 'categories': [{'measurements': [{'value': '5.8', 'spread': '2.4', 'groupId': 'OG000'}]}]}, {'title': 'V2 (week 2)', 'categories': [{'measurements': [{'value': '2.2', 'spread': '2.2', 'groupId': 'OG000'}]}]}, {'title': 'V3 (week 12)', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Last visit', 'categories': [{'measurements': [{'value': '1.2', 'spread': '2.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'visit 1 - 3', 'description': 'VAS (minimum = 0 = no pain, maximum = 10 = extrem pain, change of pain measured by VAS', 'unitOfMeasure': 'pain intensity', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Three patients had no pain at baseline (score value = 0) and were thus excluded from the statistical analysis. The descriptive results per visit are presented in the data below. V1 (Baseline) N=64, V2 (week 2)N=64, V3 (week 12)N= 47, Last vsit (N=64).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vitamin C', 'description': 'Adult patients suffering from acute viral infection, especially herpes zoster, presenting themselves in Primary Care Centers or hospitals all over Germany, and who are treated with standard therapy and add-on vitamin C.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The patients were recruited from general practioners between April 2009 and December 2010.', 'preAssignmentDetails': 'Between April 2009 and December 2010 16 general practitioners recorded data of 68 participants with symptomatic herpes zoster (one patient with viral infection) who received vitamin C intravenously (Pascorbin® 7.5 g/50 ml) for approximately 2 weeks in addition to standard treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Vitamin C', 'description': 'Adult patients suffering from acute viral infection, especially herpes zoster, presenting themselves in Primary Care Centers or hospitals all over Germany, and who are treated with standard therapy and add-on vitamin C.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Between 18 and 65 years', 'categories': [{'measurements': [{'value': '43.6', 'spread': '14.5', 'groupId': 'BG000'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '67.7', 'spread': '8.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': 'NA', 'comment': 'zero patients were analyzed in this age group', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body mass index', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '24.4', 'spread': '3.9', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '27.6', 'spread': '4.9', 'groupId': 'BG000'}]}]}, {'title': 'Total', 'categories': [{'measurements': [{'value': '25.8', 'spread': '4.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weihgt, kg', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '65.6', 'spread': '10.6', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '83.3', 'spread': '12.4', 'groupId': 'BG000'}]}]}, {'title': 'Total', 'categories': [{'measurements': [{'value': '73.1', 'spread': '14.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Concomitant immunosuppressive disease', 'classes': [{'title': 'yes', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': 'no', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Immunosuppressive conditions = malignant neoformation of the mammae, diabetes mellitus, bronchial asthma, neurodermatitis, malignant neoformation, chemotherapy, breast ablation, hyperthyreosis, B-cell lymphoma, laryngeal cancer, pernicious anaemia, hepatitis, non-Hodgkin lymphoma, immunoglobulin-G deficiency, pneumoconiosis.', 'unitOfMeasure': 'participants'}, {'title': 'Duration of Herpes Zoster-specific complaints (separated into groups)', 'classes': [{'title': '0 to 14 days', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}, {'title': '2 to 6 weeks', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}, {'title': '> 6 weeks', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Number of concomitant medications for the inclusion diagnosis', 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': '4', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Common symptoms at baseline gerneral fatigue', 'classes': [{'title': 'Not present', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}, {'title': 'Strong', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Common symptoms at baseline impaired concentration', 'classes': [{'title': 'Not present', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}, {'title': 'Strong', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-23', 'studyFirstSubmitDate': '2009-06-16', 'resultsFirstSubmitDate': '2012-08-01', 'studyFirstSubmitQcDate': '2009-06-16', 'lastUpdatePostDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-09-25', 'studyFirstPostDateStruct': {'date': '2009-06-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Pain Measured by VAS', 'timeFrame': 'visit 1 - 3', 'description': 'VAS (minimum = 0 = no pain, maximum = 10 = extrem pain, change of pain measured by VAS'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Herpes', 'Shingles', 'virus disease', 'vitamin C', 'ascorbic acid', 'antioxidant', 'oxidative stress'], 'conditions': ['Virus Diseases', 'Herpes Zoster']}, 'descriptionModule': {'briefSummary': 'Chronic viral infections induce oxidative stress that can cause a number of concomitant diseases, e.g. cardio-vascular diseases or metabolic disorders. Therefore, a sufficient treatment of oxidative stress may be of benefit for the patient to prevent further diseases.\n\nShingles (herpes zoster infection) have been successfully treated with antioxidative substances like high-dose vitamin C for ages. Not only the acute symptoms can be diminished by high-dose vitamin C. Even long-term sequelae, like painful post-herpetic neuropathy, may be mitigated or even fully avoided.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cohort of adult patients suffering from acute viral infections, especially herpes zoster, presenting themselves in Primary Care Centers or hospitals all over Germany.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Due to the design of an Observational Cohort Study, no inclusion or exclusion criteria are named. The included patient group is described under "Cohort / Group".\n\nObservational Criteria:\n\n* adult patients\n* acute viral infection (especially herpes zoster)\n* Primary Care patient\n* eligible for add-on therapy with vitamin C\n* willingness to provide pseudonymized data to the Sponsor'}, 'identificationModule': {'nctId': 'NCT00921934', 'acronym': '168', 'briefTitle': 'Intravenous Vitamin C in the Treatment of Viral Infection, Especially in the Treatment of Shingles', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pascoe Pharmazeutische Praeparate GmbH'}, 'officialTitle': 'PASCORBIN 7.5g in the Treatment of Viral Infection, Especially Varicella Zoster Infection: An Observational Cohort Study', 'orgStudyIdInfo': {'id': '168 A 08 VC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Vitamin C', 'description': 'Adult patients suffering from acute viral infection, especially herpes zoster, presenting themselves in Primary Care Centers or hospitals all over Germany, and who are treated with standard therapy and add-on vitamin C.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '56235', 'city': 'Ransbach-Baumbach', 'state': 'Rhineland-Palatinate', 'country': 'Germany', 'facility': 'Praxis Dr. Schencking, Rheinstr. 77a', 'geoPoint': {'lat': 50.46496, 'lon': 7.7283}}], 'overallOfficials': [{'name': 'Martin Schencking, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rheinstr. 77a, D-56235 Ransbach-Baumbach'}, {'name': 'Bianka Krick', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pascoe Pharmazeutische Praeparate GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pascoe Pharmazeutische Praeparate GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Dr. Loges & Co. GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}