Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-01-02 @ 2:23 AM
Study NCT ID:
NCT00730093
Status:
COMPLETED
Last Update Posted:
2009-08-06
First Post:
2008-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Absorption of Vitamin B12 Among Healthy Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014805', 'term': 'Vitamin B 12'}], 'ancestors': [{'id': 'D045728', 'term': 'Corrinoids'}, {'id': 'D045725', 'term': 'Tetrapyrroles'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-05', 'studyFirstSubmitDate': '2008-07-11', 'studyFirstSubmitQcDate': '2008-08-07', 'lastUpdatePostDateStruct': {'date': '2009-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in vitamin B12 absorption during pregnancy, measured with CobaSorb.', 'timeFrame': '9 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vitamin B12 absorption', 'Pregnancy'], 'conditions': ['Pregnancy']}, 'descriptionModule': {'briefSummary': 'During pregnancy the woman uses more vitamin B12, but we do not know, whether it is through increased absorption or it eats into the womans vitamin B12 deposit . Sufficient B-vitamin is crucial for the normal development af foetus during pregnancy.\n\nIn Denmark the National Board of Health recommend an intake of Folic Acid, from the day the woman wishes to be pregnant and to the 12. week of gestation, but there is no recommendation for vitamin B12. We will measure the vitamin B12 absorption with a new non-radioactive test, CobaSorb.\n\n.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* the 13 week of gestation +/- 1 week (only fore pregnant women)\n* Between 20- 40 years\n* Northern European\n* abel to read and understand danish\n\nExclusion Criteria:\n\n* treatment with vitamin B12 within the last 5 years\n* daily intake of vitamins that contain more than 1µg vitamin B12\n* infectious disease\n* systemic disease\n* daily use of medicine that interferes with vitamin B12'}, 'identificationModule': {'nctId': 'NCT00730093', 'briefTitle': 'The Absorption of Vitamin B12 Among Healthy Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'The Absorption of Vitamin B12 Among Healthy Pregnant Women', 'orgStudyIdInfo': {'id': 'BH12008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'A', 'interventionNames': ['Dietary Supplement: B12 vitamin (Cyanocobalamin)']}], 'interventions': [{'name': 'B12 vitamin (Cyanocobalamin)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Arm A: B12 vitamin (Cyanocobalamin)', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Skejby', 'state': 'Jylland', 'country': 'Denmark', 'facility': 'Aarhus Universitetshospital, Skejby', 'geoPoint': {'lat': 56.19966, 'lon': 10.17587}}], 'overallOfficials': [{'name': 'Ebba Nexø, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Aarhus Universitetshospital, Aarhus Sygehus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Professor, md, Ebba Nexø', 'oldOrganization': 'Klinisk Biokemisk Afd., Århus Universitetshospital, Århus Sygehus,'}}}}