Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-03-06 @ 3:09 AM
Study NCT ID:
NCT00953134
Status:
COMPLETED
Last Update Posted:
2021-04-19
First Post:
2009-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Periconceptional Iron Supplementation in Rural Bangladesh
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C031621', 'term': 'ferrous fumarate'}, {'id': 'D007501', 'term': 'Iron'}, {'id': 'D005492', 'term': 'Folic Acid'}], 'ancestors': [{'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}, {'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': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 273}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-14', 'studyFirstSubmitDate': '2009-08-04', 'studyFirstSubmitQcDate': '2009-08-05', 'lastUpdatePostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemoglobin', 'timeFrame': 'February 2007-February 2008'}], 'secondaryOutcomes': [{'measure': 'Plasma ferritin', 'timeFrame': 'February 2007-February 2008'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['periconceptional', 'iron', 'folic acid', 'supplementation'], 'conditions': ['Anemia']}, 'referencesModule': {'references': [{'pmid': '19793860', 'type': 'DERIVED', 'citation': "Khambalia AZ, O'Connor DL, Macarthur C, Dupuis A, Zlotkin SH. Periconceptional iron supplementation does not reduce anemia or improve iron status among pregnant women in rural Bangladesh. Am J Clin Nutr. 2009 Nov;90(5):1295-302. doi: 10.3945/ajcn.2009.28350. Epub 2009 Sep 30."}], 'seeAlsoLinks': [{'url': 'http://www.brac.net/index.php', 'label': 'brac'}]}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that periconceptional iron supplementation to married, nulliparous women in rural Bangladesh will significantly reduce anemia and improve hemoglobin concentrations before and during pregnancy.', 'detailedDescription': 'In 2007, the National Strategy for Anemia Prevention and Control in Bangladesh included adolescents and newly married women as target groups for future iron and folic acid (IFA) supplementation programs. This double-blinded RCT examined the effect of daily periconceptional IFA vs. folic acid (FA) on anemia and iron indictors before and during pregnancy among married, nulliparous women in rural Bangladesh. Biochemical indices were collected at baseline and either at 15 weeks gestation or after 9 months among non-pregnant women (NPW).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nWomen were eligible if they were:\n\n* Married\n* Nulliparous\n* \\< 40 years old\n* Living in the same household as their husband\n\nExclusion Criteria:\n\nWomen were excluded if they were:\n\n* Pregnant at enrollment\n* Planning to move out of the region\n* Using iron supplements within the previous 3 months\n* Using an implant form of birth control, or had surgery to prevent pregnancy\n* Women with a Hb concentration of \\< 70 g/L, defined as severely anemic according to WHO definition (5), were excluded from the study and appropriately treated'}, 'identificationModule': {'nctId': 'NCT00953134', 'briefTitle': 'Periconceptional Iron Supplementation in Rural Bangladesh', 'organization': {'class': 'OTHER', 'fullName': 'The Hospital for Sick Children'}, 'officialTitle': 'Periconceptional Iron Supplementation on Iron and Folate Indicators Among Pregnant and Non-pregnant Women in Rural Bangladesh.', 'orgStudyIdInfo': {'id': 'Periconceptional_Fe'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'IFA - Iron and Folic Acid (60 mg of ferrous fumarate and 400 mcg folic acid)', 'interventionNames': ['Dietary Supplement: Ferrous fumarate (iron)', 'Dietary Supplement: folic acid']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'FA - Folic Acid (400 mcg folic acid)', 'interventionNames': ['Dietary Supplement: folic acid']}], 'interventions': [{'name': 'Ferrous fumarate (iron)', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Powdered micronutrient supplement (Sprinkles®, Ped-Med Ltd)'], 'description': '60 mg of ferrous fumarate', 'armGroupLabels': ['1']}, {'name': 'folic acid', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Powdered micronutrient supplement (Sprinkles®, Ped-Med Ltd)'], 'description': '400 mcg folic acid', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1212', 'city': 'Dhaka', 'state': 'Dhaka Division', 'country': 'Bangladesh', 'facility': 'Brac', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}], 'overallOfficials': [{'name': 'Amina Khambalia, MSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The Hospital for Sick Children'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hospital for Sick Children', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Global Child Health', 'investigatorFullName': 'Stanley Zlotkin', 'investigatorAffiliation': 'The Hospital for Sick Children'}}}}