Ignite Creation Date:
2025-12-25 @ 1:30 AM
Ignite Modification Date:
2025-12-27 @ 11:24 PM
Study NCT ID:
NCT00901394
Status:
COMPLETED
Last Update Posted:
2020-09-16
First Post:
2009-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vitamin B12 and Folate Administration on Homocysteine Concentrations After Nitrous Oxide Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009609', 'term': 'Nitrous Oxide'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'C041364', 'term': 'nitrox'}, {'id': 'D000388', 'term': 'Air'}], 'ancestors': [{'id': 'D009589', 'term': 'Nitrogen Oxides'}, {'id': 'D005740', 'term': 'Gases'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D001272', 'term': 'Atmosphere'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D055669', 'term': 'Ecological and Environmental Phenomena'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D008685', 'term': 'Meteorological Concepts'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '7737022544', 'title': 'Principal Investigator', 'organization': 'University of Chicago'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'AEs were assessed only in the immediate study period (surgery to postoperative day 1)', 'eventGroups': [{'id': 'EG000', 'title': 'B-vitamins Plus Nitrous Oxide', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Nitrous Oxide Plus Placebo', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 2, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Nitrous Oxide-free Group Plus Placebo', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 1, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'PONV', 'notes': 'Postopertaive nausea and vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Postop. cardiac troponin elevation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Plasma Total Homocysteine Concentration (tHcy)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment 1', 'description': 'B12-Folic acid, nitrous oxide\n\nB12-Folic Acid, nitrous oxide: IV vitamin B12 (cyanocobalamin) 1 mg, single administration over 30 min.\n\nIV folic acid, 5 mg, single administration over 30 min.\n\nBoth diluted in 250 ml normal saline.\n\nNitrous oxide (NO) and placebo: 60% nitrous oxide anesthesia plus saline'}, {'id': 'OG001', 'title': 'Treatment 2', 'description': 'Nitrous oxide (NO) and placebo\n\nNitrous oxide (NO) and placebo: 60% nitrous oxide anesthesia plus saline\n\nPlacebo: Saline'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'oxygen nitrogen\n\nPlacebo: Saline\n\noxygen nitrogen: 60% air and oxygen mix.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '3.6'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '4.8'}, {'value': '0.5', 'groupId': 'OG002', 'lowerLimit': '-0.8', 'upperLimit': '1.9'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'For baseline comparisons among the three groups, one-way ANOVA was used for normally distributed variables and χ2 goodness-of-fit for categorical variables. To model the effects of B-vitamin treatment on nitrous-oxide-induced total homocysteine increase at the three different timepoints within individual patients and between the three groups, a linear mixed model with was used and we included a group × time interaction in the model.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Immediately postoperatively and on postoperative day 1', 'description': 'Difference between baseline (pre-operative) and peak postoperative (i.e., maximum of postoperative value obtained within 30 minutes after anesthesia end time and morning of post-operative day 1) tHcy concentration .\n\nOf note: there were no secondary outcomes.', 'unitOfMeasure': 'mcmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'B-vitamins Plus Nitrous Oxide', 'description': 'IV vitamin B12 (cyanocobalamin) 1 mg,\n\nIV folic acid, 5 mg,\n\n60% nitrous oxide'}, {'id': 'FG001', 'title': 'Nitrous Oxide Plus Placebo', 'description': '60% nitrous oxide\n\nPlacebo: normal saline (no vitamins)'}, {'id': 'FG002', 'title': 'Nitrous Oxide-free Group Plus Placebo', 'description': 'No nitrous oxide during anesthesia (oxygen/nitrogen)\n\nPlacebo: normal saline'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'recruitmentDetails': '63 patients were consented however only 59 were analyzed.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'B-vitamins Plus Nitrous Oxide'}, {'id': 'BG001', 'title': 'Nitrous Oxide Plus Placebo'}, {'id': 'BG002', 'title': 'Nitrous Oxide-free Group Plus Placebo'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40', 'spread': '13', 'groupId': 'BG000'}, {'value': '40', 'spread': '14', 'groupId': 'BG001'}, {'value': '42', 'spread': '15', 'groupId': 'BG002'}, {'value': '41', 'spread': '14', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-31', 'studyFirstSubmitDate': '2009-05-08', 'resultsFirstSubmitDate': '2018-04-23', 'studyFirstSubmitQcDate': '2009-05-12', 'lastUpdatePostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-31', 'studyFirstPostDateStruct': {'date': '2009-05-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Plasma Total Homocysteine Concentration (tHcy)', 'timeFrame': 'Immediately postoperatively and on postoperative day 1', 'description': 'Difference between baseline (pre-operative) and peak postoperative (i.e., maximum of postoperative value obtained within 30 minutes after anesthesia end time and morning of post-operative day 1) tHcy concentration .\n\nOf note: there were no secondary outcomes.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nitrous oxide', 'cobalamin', 'homocysteine', 'vitamin B12', 'folate', 'No specific diseases targeted'], 'conditions': ['Cardiovascular Abnormalities']}, 'referencesModule': {'references': [{'pmid': '18580170', 'type': 'BACKGROUND', 'citation': 'Nagele P, Zeugswetter B, Wiener C, Burger H, Hupfl M, Mittlbock M, Fodinger M. Influence of methylenetetrahydrofolate reductase gene polymorphisms on homocysteine concentrations after nitrous oxide anesthesia. Anesthesiology. 2008 Jul;109(1):36-43. doi: 10.1097/ALN.0b013e318178820b.'}, {'pmid': '19339913', 'type': 'BACKGROUND', 'citation': 'Nagele P, Zeugswetter B, Eberle C, Hupfl M, Mittlbock M, Fodinger M. A common gene variant in methionine synthase reductase is not associated with peak homocysteine concentrations after nitrous oxide anesthesia. Pharmacogenet Genomics. 2009 May;19(5):325-9. doi: 10.1097/FPC.0b013e328328d54c.'}, {'pmid': '18813045', 'type': 'BACKGROUND', 'citation': 'Myles PS, Chan MT, Kaye DM, McIlroy DR, Lau CW, Symons JA, Chen S. Effect of nitrous oxide anesthesia on plasma homocysteine and endothelial function. Anesthesiology. 2008 Oct;109(4):657-63. doi: 10.1097/ALN.0b013e31818629db.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to find out if giving intravenous B-vitamins before general anesthesia with nitrous oxide prevents the increase in homocysteine, a metabolite that has been linked to cardiovascular complications.', 'detailedDescription': 'Patients will be randomized into the following arms:\n\n* Arm A: patients will receive N2O (60% N2O/40% O2) in an open-label fashion during surgery and vitamin supplementation (vitamin B12, 1 mg, and folate, 5 mg) before surgery.\n* Arm B: patients will receive N2O 60% N2O/40% O2) in an open-label fashion during surgery and placebo before and after surgery.\n* Arm C: patients will not receive N2O, vitamin supplementation, or placebo during/before surgery. Patients in this arm will not be randomized.\n\nPatients will have blood drawn (total of 1-2 teaspoons over 3 days). We will take these samples before their surgery, when their surgery is completed, and in the morning of post-operative day 1. We will be checking their troponin I and troponin T, homocysteine, Vitamin B12, and folate levels. We will also perform a 12-lead EKG. Before and after surgery for patients in Arm A or B, will receive either vitamin B12 (1 mg) and folic acid (5 mg) (or placebo) added to their IV infusion. We also plan to use a non-invasive test known as a nerve conduction study to measure the function of their nerve system. Briefly, 2 small electrodes are attached to their skin over a nerve and, like an EKG, faint electrical pulses are generated and recorded. A typical nerve conduction measurement lasts about 10 minutes.\n\nAfter the patients surgery we will do genetic testing of MTHFR genotype.\n\nAll study samples have been collected.\n\nOf note: there were no secondary outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult patients scheduled for elective surgery with expected duration \\> 2 hours\n* Healthy patients undergoing moderate surgery where the use of N2O is unproblematic\n\nExclusion Criteria:\n\n* Contraindication against N2O (pneumothorax, mechanical bowel obstruction, middle ear occlusion, laparoscopic surgery, raised intracranial pressure)\n* Patients requiring supplemental oxygen\n* Urgent or emergent surgery\n* Patients with vitamin B12 or folate deficiency or megaloblastic anemia\n* Patients with seizure disorder (epilepsy)\n* Allergy or hypersensitivity against IV cobalamin or folate\n* Patients with Leber's disease (hereditary optic nerve atrophy)\n* Patients taking supplemental vitamin B12 or folate"}, 'identificationModule': {'nctId': 'NCT00901394', 'acronym': 'Mini-VINO', 'briefTitle': 'Vitamin B12 and Folate Administration on Homocysteine Concentrations After Nitrous Oxide Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Influence of Preoperative Vitamin B12 and Folate Administration on Homocysteine Concentrations After Nitrous Oxide Anesthesia', 'orgStudyIdInfo': {'id': '09-0074'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment 1', 'description': 'B12-Folic acid, nitrous oxide', 'interventionNames': ['Drug: B12-Folic Acid, nitrous oxide', 'Drug: Nitrous oxide (NO) and placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment 2', 'description': 'Nitrous oxide (NO) and placebo', 'interventionNames': ['Drug: Nitrous oxide (NO) and placebo', 'Other: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'oxygen nitrogen', 'interventionNames': ['Other: Placebo', 'Other: oxygen nitrogen']}], 'interventions': [{'name': 'B12-Folic Acid, nitrous oxide', 'type': 'DRUG', 'otherNames': ['b supplements'], 'description': 'IV vitamin B12 (cyanocobalamin) 1 mg, single administration over 30 min.\n\nIV folic acid, 5 mg, single administration over 30 min.\n\nBoth diluted in 250 ml normal saline.', 'armGroupLabels': ['Treatment 1']}, {'name': 'Nitrous oxide (NO) and placebo', 'type': 'DRUG', 'otherNames': ['nitrous oxide'], 'description': '60% nitrous oxide anesthesia plus saline', 'armGroupLabels': ['Treatment 1', 'Treatment 2']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['saline'], 'description': 'Saline', 'armGroupLabels': ['Control group', 'Treatment 2']}, {'name': 'oxygen nitrogen', 'type': 'OTHER', 'otherNames': ['air'], 'description': '60% air and oxygen mix.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Barnes Jewish Hospital', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Peter Nagele, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Foundation for Anesthesia Education and Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}