Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-02-20 @ 7:24 PM
Study NCT ID:
NCT00826657
Status:
COMPLETED
Last Update Posted:
2015-05-21
First Post:
2009-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin B12 Supplementation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014806', 'term': 'Vitamin B 12 Deficiency'}], 'ancestors': [{'id': 'D014804', 'term': 'Vitamin B Deficiency'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014805', 'term': 'Vitamin B 12'}, {'id': 'D000073893', 'term': 'Sugars'}], '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'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-19', 'studyFirstSubmitDate': '2009-01-16', 'studyFirstSubmitQcDate': '2009-01-20', 'lastUpdatePostDateStruct': {'date': '2015-05-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'response to B12 supplementation in serum B12, Methylmalonic acid, homocystein, and holotranscobalamin concentrations', 'timeFrame': '0 and 3 mos'}], 'secondaryOutcomes': [{'measure': 'DNA methylation change, and hematological response to B12 supplementation', 'timeFrame': '0 and 3 mos'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['B12 deficiency', 'methylmalonic acid', 'homocystein', 'vitamin B12 supplementation intervention'], 'conditions': ['Vitamin B12 Deficiency']}, 'referencesModule': {'references': [{'pmid': '22915298', 'type': 'DERIVED', 'citation': 'Shahab-Ferdows S, Anaya-Loyola MA, Vergara-Castaneda H, Rosado JL, Keyes WR, Newman JW, Miller JW, Allen LH. Vitamin B-12 supplementation of rural Mexican women changes biochemical vitamin B-12 status indicators but does not affect hematology or a bone turnover marker. J Nutr. 2012 Oct;142(10):1881-7. doi: 10.3945/jn.112.165712. Epub 2012 Aug 22.'}]}, 'descriptionModule': {'briefSummary': 'We hope to learn the clinical and functional signs of sub-clinical vitamin B12 deficiency and its response to supplementation in non-anemic, non-pregnant, and non-lactating women in Rural Mexico. Vitamin B12 is important in hematopoiesis, neuro-cognitive functions and genetic integrity. However vitamin B12 is only found in animal source foods therefore a large segment of the population in developing countries and those practicing vegetarianism are at risk of deficiency of the vitamin. This information will help decide weather supplementation with vitamin B12 is necessary in such populations for public health reasons.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women age 20-59, apparently healthy, no severe B12 deficiency\n\nExclusion Criteria:\n\n* pregnancy, lactation, anemia and disease states'}, 'identificationModule': {'nctId': 'NCT00826657', 'briefTitle': 'Vitamin B12 Supplementation Study', 'organization': {'class': 'FED', 'fullName': 'USDA, Western Human Nutrition Research Center'}, 'officialTitle': 'Assessment of Functional Vitamin B12 Deficiency in Mexican Women', 'orgStudyIdInfo': {'id': '200412519-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Receive placebo (sugar pill) during the intervention. Received a 1000 mg vitamin B12 injection at the end of the study.', 'interventionNames': ['Dietary Supplement: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vitamin B12', 'description': 'Received 500 micrograms vitamin B12 per day during the study Received a 1000 mg vitamin B12 injection at the start of the study', 'interventionNames': ['Dietary Supplement: Vitamin B12']}], 'interventions': [{'name': 'Vitamin B12', 'type': 'DIETARY_SUPPLEMENT', 'description': '500 microgram daily supplement of vitamin B12 1000 mg injection vitamin B12 given at the start of the study', 'armGroupLabels': ['Vitamin B12']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['sugar pill'], 'description': 'placebo given as a daily supplement 1000 mg injection of vitamin B12 given at the end of the study', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Querétaro', 'country': 'Mexico', 'facility': 'Universidad Autonoma de Queretaro', 'geoPoint': {'lat': 15.83752, 'lon': -92.75774}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'USDA, Western Human Nutrition Research Center', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}