Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2025-12-25 @ 7:21 PM
Study NCT ID:
NCT00207532
Status:
COMPLETED
Last Update Posted:
2005-09-21
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dosage Effects of Folic Acid on Blood Folates of Honduran Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C536410', 'term': 'Neural tube defects X-linked'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005492', 'term': 'Folic Acid'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'completionDateStruct': {'date': '2005-06'}, 'lastUpdateSubmitDate': '2005-09-13', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Spina Bifida and Anencephaly']}, 'descriptionModule': {'briefSummary': 'CDC staff at the National Center on Birth Defects and Developmental Disabilities have been working closely with a Honduras-based organization, Project Healthy Children (PNS) and the Ministry of Health, on a folic acid supplementation study among female maquila workers. Participants are divided into two groups. One group receives a 1.0 milligram pill daily while the other group receives a 5.0 milligram pill weekly. The aim of this study is to assess serum blood folate levels measured at baseline, midpoint, and endpoint of the study. Hypothesis: Folic acid (5mg)given once weekly is as effective as folic acid (1mg)given daily in raising blood folate levels.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nminimum employment in factory 6 mths\n\n\\-\n\nExclusion Criteria:\n\n* pregnant\n* currently consuming folic acid\n* prior birth-defect affected pregnancy\n* chronic disease\n* currently taking folic acid antagonist'}, 'identificationModule': {'nctId': 'NCT00207532', 'briefTitle': 'Dosage Effects of Folic Acid on Blood Folates of Honduran Women', 'organization': {'class': 'FED', 'fullName': 'Centers for Disease Control and Prevention'}, 'officialTitle': 'Dosage Effects of Folic Acid on Blood Folates of Honduran Women', 'orgStudyIdInfo': {'id': 'CDC-NCBDDD-4501'}}, 'armsInterventionsModule': {'interventions': [{'name': 'folic acid', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'San Pedro Sula', 'country': 'Honduras', 'facility': 'PROTEXSA', 'geoPoint': {'lat': 15.50585, 'lon': -88.02588}}], 'overallOfficials': [{'name': 'Gayle Milla', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Project Healthy Children (Honduras)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}, 'collaborators': [{'name': 'Ministry of Health, Honduras', 'class': 'OTHER_GOV'}, {'name': 'Project Healthy Children', 'class': 'UNKNOWN'}]}}}