Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT00894920
Status:
COMPLETED
Last Update Posted:
2015-03-02
First Post:
2009-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biotin Status in Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C531633', 'term': 'Biotin deficiency'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001710', 'term': 'Biotin'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-26', 'studyFirstSubmitDate': '2009-05-06', 'studyFirstSubmitQcDate': '2009-05-06', 'lastUpdatePostDateStruct': {'date': '2015-03-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lymphocyte propionyl-CoA carboxylase (PCC) activities', 'timeFrame': '2-3 months'}], 'secondaryOutcomes': [{'measure': 'Urinary biotin excretion', 'timeFrame': '2-3 months'}, {'measure': 'Urinary 3-hydroxyisovaleric acid (3HIA) excretion', 'timeFrame': '2-3 months'}, {'measure': 'Other biotin-related indicators in urine and blood', 'timeFrame': '2-3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['biotin', 'deficiency', 'pregnancy', 'lymphocyte propionyl-CoA carboxylase'], 'conditions': ['Biotin Deficiency']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to estimate the number of pregnant women who, during pregnancy, have low levels of the vitamin biotin. The hypothesis of this study is that a large number of pregnant women will have low biotin levels. This information will be used to later determine if low biotin levels during pregnancy cause certain birth defects.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-40\n* in early pregnancy (less than 15 weeks gestation)\n* under care of physician\n* normal pregnancy\n* taking prenatal vitamin with less than 30 mcg biotin\n\nExclusion Criteria:\n\n* prenatal vitamin with greater than 30 mcg biotin\n* antibiotic use\n* known renal disease\n* drug, alcohol abuse\n* gastric bypass\n* daily diet high in biotin\n* use of certain meal replacement products high in biotin\n* previous history of children with birth defects'}, 'identificationModule': {'nctId': 'NCT00894920', 'briefTitle': 'Biotin Status in Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'University of Arkansas'}, 'officialTitle': 'Biotin Status in Pregnancy', 'orgStudyIdInfo': {'id': '3114301'}, 'secondaryIdInfos': [{'id': 'R01DK079892-01', 'link': 'https://reporter.nih.gov/quickSearch/R01DK079892-01', 'type': 'NIH'}, {'id': '107068'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Dietary Supplement: biotin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'biotin', 'interventionNames': ['Dietary Supplement: biotin']}], 'interventions': [{'name': 'biotin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'capsule approximately 30 mcg daily 21 days', 'armGroupLabels': ['placebo']}, {'name': 'biotin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'capsule 300 mcg daily 21 days', 'armGroupLabels': ['biotin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}], 'overallOfficials': [{'name': 'Donald M Mock, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arkansas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arkansas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}