Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-26 @ 1:31 AM
Study NCT ID:
NCT00763633
Status:
UNKNOWN
Last Update Posted:
2008-12-31
First Post:
2008-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
B6 Treatment for Nausea and Vomiting in Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2010-03-05', 'releaseDate': '2010-02-16'}], 'estimatedResultsFirstSubmitDate': '2010-02-16'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009325', 'term': 'Nausea'}, {'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D025101', 'term': 'Vitamin B 6'}], 'ancestors': [{'id': 'D010847', 'term': 'Picolines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2008-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-12-30', 'studyFirstSubmitDate': '2008-09-29', 'studyFirstSubmitQcDate': '2008-09-29', 'lastUpdatePostDateStruct': {'date': '2008-12-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nausea and vomiting score', 'timeFrame': '2 weeks'}], 'secondaryOutcomes': [{'measure': 'Vitamin B6 concentration in nausea and vomiting of pregnancy', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['nausea', 'vomiting', 'pregnancy', 'B6'], 'conditions': ['Nausea and Vomiting Complain in Early Pregnancy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ui.ac.id/en', 'label': 'Univ. Indonesia web-link'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine vitamin B6 concentration and whether vitamin B6 is effective in nausea and vomiting of pregnancy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Nausea and vomiting of pregnancy\n\nExclusion Criteria:\n\n* Other medical condition causing nausea and vomiting of pregnancy'}, 'identificationModule': {'nctId': 'NCT00763633', 'briefTitle': 'B6 Treatment for Nausea and Vomiting in Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Showa University'}, 'officialTitle': 'Vitamin B6 Concentration and Treatment in Nausea and Vomiting of Pregnancy', 'orgStudyIdInfo': {'id': 'B601'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'highB6', 'description': 'high vitamin B6', 'interventionNames': ['Drug: vitamin B6']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'lowB6', 'description': 'low vitamin B6', 'interventionNames': ['Drug: vitamin B6']}], 'interventions': [{'name': 'vitamin B6', 'type': 'DRUG', 'description': 'high dose of vitamin B6', 'armGroupLabels': ['highB6']}, {'name': 'vitamin B6', 'type': 'DRUG', 'description': 'low vitamin B6', 'armGroupLabels': ['lowB6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13210', 'city': 'Jakarta', 'state': 'Jakarta Special Capital Region', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Noroyono Wibowo, MD, PhD', 'role': 'CONTACT', 'email': 'wibowonoroyono@yahoo.com', 'phone': '+6221 3915041'}, {'name': 'Noroyono Wibowo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yuditiya Purwosunu, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Dept. Obstetric Gynecology Univ. Indonesia', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}], 'centralContacts': [{'name': 'Noroyono Wibowo, MD, PhD', 'role': 'CONTACT', 'email': 'wibowonoroyono@yahoo.com', 'phone': '+6221 3915041'}, {'name': 'Yuditiya Purwosunu, MD', 'role': 'CONTACT', 'email': 'yudi@med.showa-u.ac.jp', 'phone': '+6221 3915041'}], 'overallOfficials': [{'name': 'Noroyono Wibowo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept. Obstetric Gynecology Univ. Indonesia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Showa University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Bologna', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dept. Obstetrics Gynecology Fac. Medicine Univ. Indonesia', 'oldOrganization': 'Univ. Indonesia'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2010-02-16', 'type': 'RELEASE'}, {'date': '2010-03-05', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Univ. Indonesia (Dept. Obstetrics Gynecology Fac. Medicine Univ. Indonesia)'}}}}