Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-01-03 @ 8:15 PM
Study NCT ID:
NCT00097669
Status:
COMPLETED
Last Update Posted:
2020-09-25
First Post:
2004-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
VITATOPS: A Study of VITAmins TO Prevent Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Federal Republic of Yugoslavia', 'Serbia and Montenegro']}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002546', 'term': 'Ischemic Attack, Transient'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D002545', 'term': 'Brain Ischemia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D014805', 'term': 'Vitamin B 12'}], 'ancestors': [{'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D045728', 'term': 'Corrinoids'}, {'id': 'D045725', 'term': 'Tetrapyrroles'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': "julia.o'dea@health.wa.gov.au", 'phone': '+61892247004', 'title': 'Clinical Trial Coordinator', 'organization': 'VITATOPS'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Active VITATOPS Tablet (Folic Acid 2mg, B6 25mg , B12 500ug)', 'description': 'Active Treatment Arm: VITATOPS study tablet (folate 2 mg, B6 25 mg, B12 500 ug). Taken daily for the duration of the study.\n\nActive VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug): multivitamin', 'otherNumAtRisk': 4089, 'otherNumAffected': 0, 'seriousNumAtRisk': 4089, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Tablet', 'description': 'Placebo Treatment Arm: The placebo tablet will have the same appearance, taste and texture as the vitamin preparation and contains excipients, coating and coating aids.', 'otherNumAtRisk': 4075, 'otherNumAffected': 0, 'seriousNumAtRisk': 4075, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Non-fatal Stroke, Non-fatal Myocardial Infarction or Death Due to Vascular Causes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4089', 'groupId': 'OG000'}, {'value': '4075', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active VITATOPS Tablet (Folic Acid 2mg, B6 25mg , B12 500ug)', 'description': 'Active Treatment Arm: VITATOPS study tablet (folate 2 mg, B6 25 mg, B12 500 ug). Taken daily for the duration of the study.\n\nActive VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug): multivitamin'}, {'id': 'OG001', 'title': 'Placebo Tablet', 'description': 'Placebo Treatment Arm: The placebo tablet will have the same appearance, taste and texture as the vitamin preparation and contains excipients, coating and coating aids.'}], 'classes': [{'categories': [{'measurements': [{'value': '616', 'groupId': 'OG000'}, {'value': '678', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.00', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'We used Kaplan-Meier methods to construct cumulative time-to-event curves for the two groups, with a comparison by use of the log-rank test.\n\nWe used a Cox proportional hazard model analysis to control for any potential imbalance in baseline characteristics and follow-up between the two groups.'}, {'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.00', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis before adjusting for any potential imbalance in the baseline characteristics and follow-up duration between the groups.'}, {'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.03', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis after adjusting for any potential imbalance in the baseline characteristics and follow-up duration between the groups.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'The primary outcome was measured over a median follow-up period of 3.4 years (interquartile range IQR 1.0-5.5 years).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat analysis population of all patients randomised (n=8164)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active VITATOPS Tablet (Folic Acid 2mg, B6 25mg , B12 500ug)', 'description': 'Active Treatment Arm: VITATOPS study tablet (folate 2 mg, B6 25 mg, B12 500 ug). Taken daily for the duration of the study.\n\nActive VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug): multivitamin'}, {'id': 'FG001', 'title': 'Placebo Tablet', 'description': 'Placebo Treatment Arm: The placebo tablet will have the same appearance, taste and texture as the vitamin preparation and contains excipients, coating and coating aids.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4089'}, {'groupId': 'FG001', 'numSubjects': '4075'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4089'}, {'groupId': 'FG001', 'numSubjects': '4075'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4089', 'groupId': 'BG000'}, {'value': '4075', 'groupId': 'BG001'}, {'value': '8164', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active VITATOPS Tablet (Folic Acid 2mg, B6 25mg , B12 500ug)', 'description': 'Active Treatment Arm: VITATOPS study tablet (folate 2 mg, B6 25 mg, B12 500 ug). Taken daily for the duration of the study.\n\nActive VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug): multivitamin'}, {'id': 'BG001', 'title': 'Placebo Tablet', 'description': 'Placebo Treatment Arm: The placebo tablet will have the same appearance, taste and texture as the vitamin preparation and contains excipients, coating and coating aids.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.5', 'spread': '12.6', 'groupId': 'BG000'}, {'value': '62.6', 'spread': '12.4', 'groupId': 'BG001'}, {'value': '62.6', 'spread': '12.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1475', 'groupId': 'BG000'}, {'value': '1471', 'groupId': 'BG001'}, {'value': '2946', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2614', 'groupId': 'BG000'}, {'value': '2604', 'groupId': 'BG001'}, {'value': '5218', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Functional severity of qualifying stroke', 'classes': [{'title': 'Independent (Oxford handicap score 0-3)', 'categories': [{'measurements': [{'value': '3035', 'groupId': 'BG000'}, {'value': '3024', 'groupId': 'BG001'}, {'value': '6059', 'groupId': 'BG002'}]}]}, {'title': 'Dependent (Oxford handicap score 3,4 or 5)', 'categories': [{'measurements': [{'value': '951', 'groupId': 'BG000'}, {'value': '943', 'groupId': 'BG001'}, {'value': '1894', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Oxford Handicap Score (\\<3 = functionally independent; 3-5= functional dependent on help)', 'unitOfMeasure': 'participants'}, {'title': 'past history of stroke, prior to qualifying stroke or transient ischemic attack (TIA)', 'classes': [{'categories': [{'measurements': [{'value': '624', 'groupId': 'BG000'}, {'value': '658', 'groupId': 'BG001'}, {'value': '1282', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'This measure refers to the number of randomised patients who had a history of a previous stroke, prior to the stroke or transient ischemic attack (TIA) that qualified them for entry into the trial.', 'unitOfMeasure': 'participants'}, {'title': 'laboratory results for fasting homocysteine', 'classes': [{'categories': [{'measurements': [{'value': '14.4', 'spread': '9.2', 'groupId': 'BG000'}, {'value': '14.2', 'spread': '7.7', 'groupId': 'BG001'}, {'value': '14.3', 'spread': '8.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Fasting blood homocysteine concentrations were measured and expressed in micromoles per litre', 'unitOfMeasure': 'micromoles per liter', 'dispersionType': 'STANDARD_DEVIATION'}]}}, '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': 8164}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-07', 'studyFirstSubmitDate': '2004-11-24', 'resultsFirstSubmitDate': '2014-01-20', 'studyFirstSubmitQcDate': '2004-11-24', 'lastUpdatePostDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-07', 'studyFirstPostDateStruct': {'date': '2004-11-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Non-fatal Stroke, Non-fatal Myocardial Infarction or Death Due to Vascular Causes', 'timeFrame': 'The primary outcome was measured over a median follow-up period of 3.4 years (interquartile range IQR 1.0-5.5 years).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['VITATOPS', 'stroke', 'prevention', 'multivitamins', 'homocysteine'], 'conditions': ['Stroke', 'Transient Ischemic Attack']}, 'referencesModule': {'references': [{'pmid': '24004645', 'type': 'DERIVED', 'citation': 'Gommans J, Yi Q, Eikelboom JW, Hankey GJ, Chen C, Rodgers H; VITATOPS trial study group. The effect of homocysteine-lowering with B-vitamins on osteoporotic fractures in patients with cerebrovascular disease: substudy of VITATOPS, a randomised placebo-controlled trial. BMC Geriatr. 2013 Sep 3;13:88. doi: 10.1186/1471-2318-13-88.'}, {'pmid': '23765945', 'type': 'DERIVED', 'citation': 'Hankey GJ, Ford AH, Yi Q, Eikelboom JW, Lees KR, Chen C, Xavier D, Navarro JC, Ranawaka UK, Uddin W, Ricci S, Gommans J, Schmidt R, Almeida OP, van Bockxmeer FM; VITATOPS Trial Study Group. Effect of B vitamins and lowering homocysteine on cognitive impairment in patients with previous stroke or transient ischemic attack: a prespecified secondary analysis of a randomized, placebo-controlled trial and meta-analysis. Stroke. 2013 Aug;44(8):2232-9. doi: 10.1161/STROKEAHA.113.001886. Epub 2013 Jun 13.'}, {'pmid': '23093615', 'type': 'DERIVED', 'citation': 'Cavalieri M, Schmidt R, Chen C, Mok V, de Freitas GR, Song S, Yi Q, Ropele S, Grazer A, Homayoon N, Enzinger C, Loh K, Wong KS, Wong A, Xiong Y, Chang HM, Wong MC, Fazekas F, Eikelboom JW, Hankey GJ; VITATOPS Trial Study Group. B vitamins and magnetic resonance imaging-detected ischemic brain lesions in patients with recent transient ischemic attack or stroke: the VITAmins TO Prevent Stroke (VITATOPS) MRI-substudy. Stroke. 2012 Dec;43(12):3266-70. doi: 10.1161/STROKEAHA.112.665703. Epub 2012 Oct 23.'}, {'pmid': '22554931', 'type': 'DERIVED', 'citation': 'Hankey GJ, Eikelboom JW, Yi Q, Lees KR, Chen C, Xavier D, Navarro JC, Ranawaka UK, Uddin W, Ricci S, Gommans J, Schmidt R; VITATOPS trial study group. Antiplatelet therapy and the effects of B vitamins in patients with previous stroke or transient ischaemic attack: a post-hoc subanalysis of VITATOPS, a randomised, placebo-controlled trial. Lancet Neurol. 2012 Jun;11(6):512-20. doi: 10.1016/S1474-4422(12)70091-1. Epub 2012 May 2.'}, {'pmid': '22474057', 'type': 'DERIVED', 'citation': 'Hankey GJ, Eikelboom JW, Yi Q, Lees KR, Chen C, Xavier D, Navarro JC, Ranawaka UK, Uddin W, Ricci S, Gommans J, Schmidt R; VITAmins TO Prevent Stroke (VITATOPS) Trial Study Group. Treatment with B vitamins and incidence of cancer in patients with previous stroke or transient ischemic attack: results of a randomized placebo-controlled trial. Stroke. 2012 Jun;43(6):1572-7. doi: 10.1161/STROKEAHA.111.641613. Epub 2012 Apr 3.'}, {'pmid': '20976769', 'type': 'DERIVED', 'citation': 'Almeida OP, Marsh K, Alfonso H, Flicker L, Davis TM, Hankey GJ. B-vitamins reduce the long-term risk of depression after stroke: The VITATOPS-DEP trial. Ann Neurol. 2010 Oct;68(4):503-10. doi: 10.1002/ana.22189.'}, {'pmid': '20688574', 'type': 'DERIVED', 'citation': 'VITATOPS Trial Study Group. B vitamins in patients with recent transient ischaemic attack or stroke in the VITAmins TO Prevent Stroke (VITATOPS) trial: a randomised, double-blind, parallel, placebo-controlled trial. Lancet Neurol. 2010 Sep;9(9):855-65. doi: 10.1016/S1474-4422(10)70187-3. Epub 2010 Aug 3.'}, {'pmid': '18705976', 'type': 'DERIVED', 'citation': 'VITATOPS Trial Study Group; Hankey GJ, Algra A, Chen C, Wong MC, Cheung R, Wong L, Divjak I, Ferro J, de Freitas G, Gommans J, Groppa S, Hill M, Spence D, Lees K, Lisheng L, Navarro J, Ranawaka U, Ricci S, Schmidt R, Slivka A, Tan K, Tsiskaridze A, Uddin W, Vanhooren G, Xavier D, Armitage J, Hobbs M, Le M, Sudlow C, Wheatley K, Yi Q, Bulder M, Eikelboom JW, Hankey GJ, Ho WK, Jamrozik K, Klijn K, Koedam E, Langton P, Nijboer E, Tuch P, Pizzi J, Tang M, Antenucci M, Chew Y, Chinnery D, Cockayne C, Loh K, McMullin L, Smith F, Schmidt R, Chen C, Wong MC, de Freitas G, Hankey GJ, Loh K, Song S. VITATOPS, the VITAmins TO prevent stroke trial: rationale and design of a randomised trial of B-vitamin therapy in patients with recent transient ischaemic attack or stroke (NCT00097669) (ISRCTN74743444). Int J Stroke. 2007 May;2(2):144-50. doi: 10.1111/j.1747-4949.2007.00111.x.'}], 'seeAlsoLinks': [{'url': 'http://www.heartfoundation.com.au/', 'label': 'National Heart Foundation'}, {'url': 'http://www.strokesociety.com.au/', 'label': 'Stroke Society of Australasia Inc.'}]}, 'descriptionModule': {'briefSummary': 'The VITATOPS study is a multi-center, randomized, double blind, placebo-controlled secondary stroke prevention trial to determine whether the addition of vitamin supplements (B12 500 ug, B6 25 mg, Folate 2 mg) to best medical/surgical management (including modification of risk factors) will reduce the combined incidence of recurrent vascular events (stroke, myocardial infarction) and vascular death in patients with recent stroke or transient ischemic attack (TIA). All patients presenting to one of the participating neurologists or general physicians within seven months of stroke (ischemic or hemorrhagic) or TIA (eye or brain) are eligible for this trial. Eligible patients will be randomized in a double-blind fashion to receive multi-vitamins or placebo, 1 tablet daily. The primary outcome event is the composite event "stroke, myocardial infarction, or death from any vascular cause", whichever occurs first. Our target is to recruit a total of 8,000 patients over the next two years with a median follow-up of 2.5 years. Recruitment to the trial began in November 1998 and is planned to continue until December 2005. We aim to complete final follow-up by the end of 2006. However, the Steering Committee will be flexible in dictating the need for ongoing recruitment and continuing follow-up, depending on the overall rate of the primary outcome event in the entire cohort at each interim analysis.', 'detailedDescription': 'Background: Epidemiological studies suggest that raised plasma concentrations of total homocysteine (tHcy) may be a common, causal and treatable risk factor for atherothromboembolic ischemic stroke, dementia and depression. Although tHcy can be lowered effectively with small doses of folic acid, vitamin B12 and vitamin B6, it is not known whether lowering tHcy, by means of multivitamin therapy, can prevent stroke and other major atherothromboembolic vascular events, dementia and depression.\n\nPurpose: To determine whether vitamin supplements (folic acid 2 mg, B6 25 mg, B12 500 ug) reduce the risk of stroke, other serious vascular events, dementia and depression in patients with recent stroke or transient ischemic attacks of the brain or eye (TIA).\n\nMethods: An international, multi-center, randomized, double-blind, placebo-controlled clinical trial.\n\nSubjects: Patients with stroke or TIA in the previous 7 months.\n\nPrimary outcome measure: Non-fatal stroke, non-fatal myocardial infarction, or death due to vascular causes.\n\nSecondary outcome measures: TIA, Revascularisation procedures, Dementia, Depression.\n\nSample size calculation: To reliably identify a 15% reduction in relative risk of the primary outcome event from 8% to 6.8% per year with an alpha of 0.05 and power of 80%, 8,000 patients need to be randomized and followed-up for an average of two years.\n\nCurrent progress: As of November, 2004, more than 4,400 patients have been randomized in 73 centers in 19 countries in five continents: Australia, Austria, Belgium, Brazil, Hong Kong, Italy, Malaysia, Moldova, Netherlands, New Zealand, Pakistan, Philippines, Portugal, Republic of Georgia, Serbia \\& Monte Negro, Singapore, Sri Lanka, United Kingdom, and United States.\n\nVITATOPS aims to recruit and follow up 8,000 patients between 2000 and 2006, and provide a reliable estimate of the safety and effectiveness of dietary supplementation with folic acid, vitamin B12, and vitamin B6 in reducing recurrent serious vascular events, dementia and depression among a wide range of patients with stroke and TIA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients presenting within seven months of stroke (ischemic or hemorrhagic) or TIA\n* Agree to take study medication\n* Be geographically accessible for follow-up\n* Provide written informed consent\n\nExclusion Criteria:\n\n* Taking folic acid or B6 on medical advice\n* Use of vitamin supplements containing folate, B6 or B12 (unless patient agrees to take study medication instead of the vitamin supplements which they usually take)\n* Taking Methotrexate for any reason\n* Pregnancy or women of child-bearing potential who are at risk of pregnancy\n* Limited life expectancy'}, 'identificationModule': {'nctId': 'NCT00097669', 'briefTitle': 'VITATOPS: A Study of VITAmins TO Prevent Stroke', 'organization': {'class': 'OTHER_GOV', 'fullName': 'VITATOPS'}, 'officialTitle': 'VITATOPS - A Study of VITAmins TO Prevent Stroke', 'orgStudyIdInfo': {'id': 'ec550'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug)', 'description': 'Active Treatment Arm: VITATOPS study tablet (folate 2 mg, B6 25 mg, B12 500 ug). Taken daily for the duration of the study.', 'interventionNames': ['Drug: Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug) or placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Tablet', 'description': 'Placebo Treatment Arm: The placebo tablet will have the same appearance, taste and texture as the vitamin preparation and contains excipients, coating and coating aids.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug) or placebo', 'type': 'DRUG', 'otherNames': ['VITATOPS study tablet'], 'description': 'multivitamin', 'armGroupLabels': ['Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug)']}, {'name': 'Placebo', 'type': 'OTHER', 'armGroupLabels': ['Placebo Tablet']}]}, 'contactsLocationsModule': {'locations': [{'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'JFK Hospital / Seton Hall University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Abington', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abington Memorial Hospital', 'geoPoint': {'lat': 40.12067, 'lon': -75.11795}}, {'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'South Carolina VA Hospital', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'University of South Carolina', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'city': 'Gosford', 'country': 'Australia', 'facility': 'Central Coast Neuroscience Research', 'geoPoint': {'lat': -33.4244, 'lon': 151.34399}}, {'city': 'New South Wales', 'country': 'Australia', 'facility': 'Bankstown Hospital'}, {'city': 'New South Wales', 'country': 'Australia', 'facility': 'John Hunter Hospital'}, {'city': 'New South Wales', 'country': 'Australia', 'facility': 'Liverpool Hospital'}, {'city': 'Perth', 'country': 'Australia', 'facility': 'Royal Perth Hospital', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'city': 'Queensland', 'country': 'Australia', 'facility': 'Greenslopes Hospital'}, {'city': 'Queensland', 'country': 'Australia', 'facility': 'Nambour Hospital'}, {'city': 'South Australia', 'country': 'Australia', 'facility': 'Flinders & Griffiths'}, {'city': 'Tasmania', 'country': 'Australia', 'facility': 'Royal Hobart Hospital'}, {'city': 'Victoria', 'country': 'Australia', 'facility': 'Alfred Hospital'}, {'city': 'Victoria', 'country': 'Australia', 'facility': 'Beleura & Frankston Hospital'}, {'city': 'Victoria', 'country': 'Australia', 'facility': 'Box Hill Hospital'}, {'city': 'Victoria', 'country': 'Australia', 'facility': 'National Stroke Research Institute - 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