Ignite Creation Date:
2025-12-17 @ 1:45 PM
Ignite Modification Date:
2025-12-23 @ 10:48 PM
Study NCT ID:
NCT00839761
Status:
COMPLETED
Last Update Posted:
2009-02-10
First Post:
2009-02-09
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Use of Ultra Rice Compared to Iron Drops Consumed by Anemic Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000747', 'term': 'Anemia, Hypochromic'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 175}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-09', 'studyFirstSubmitDate': '2009-02-09', 'studyFirstSubmitQcDate': '2009-02-09', 'lastUpdatePostDateStruct': {'date': '2009-02-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Before, the prevalence of ID and anemia in sample were 73.1% and 100%, respectively. At 5-mo, increases occurred in serum ferritin (SF) and hemoglobin (Hb). SF and Hb were observed in both groups. Increases in both measures were seen in the URG group.', 'timeFrame': 'Before and after 5 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Anemia', 'Iron Deficiency Anemia']}, 'referencesModule': {'references': [{'pmid': '17023709', 'type': 'BACKGROUND', 'citation': 'Moretti D, Zimmermann MB, Muthayya S, Thankachan P, Lee TC, Kurpad AV, Hurrell RF. Extruded rice fortified with micronized ground ferric pyrophosphate reduces iron deficiency in Indian schoolchildren: a double-blind randomized controlled trial. Am J Clin Nutr. 2006 Oct;84(4):822-9. doi: 10.1093/ajcn/84.4.822.'}]}, 'descriptionModule': {'briefSummary': 'Background: How best to improve iron status among infants in low-income settings is of continued concern in many countries, including Brazil\n\nObjective:\n\nDesign: In a double blind, 5-mo, home-based trial in Brazil, mildly anemic 6 - 24 month-old children (n=175) were randomly assigned to receive either Ultra Rice (URG) fortified with 23,4, mg Fe as micronized ferric pyrophosphate (MFP) and a placebo solution of iron drops, or identical non-fortified rice (CG) and a solution of iron drops. Parents were instructed on the correct dosage of iron drops and to feed their children (including whether and how much rice) as they normally would. Iron status and hemoglobin (Hb) were measured at baseline and at 5 mo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* anemia\n\nExclusion Criteria:\n\n* non anemic'}, 'identificationModule': {'nctId': 'NCT00839761', 'briefTitle': 'The Use of Ultra Rice Compared to Iron Drops Consumed by Anemic Children', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Minas Gerais'}, 'officialTitle': 'Efficacy of Iron Fortified Ultra Rice Compared to Supplemental Iron Drops in Infants and Young Children', 'orgStudyIdInfo': {'id': 'FDAAA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'iron fortified rice group', 'interventionNames': ['Dietary Supplement: iron fortified rice']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'iron drop group', 'interventionNames': ['Dietary Supplement: iron drops']}], 'interventions': [{'name': 'iron fortified rice', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['iron fortified rice group']}, {'name': 'iron drops', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['iron drop group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30130-100', 'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Federal University of Minas Gerais - UFMg', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Minas Gerais', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do estado de Minas Gerais', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Mark Anthony Beinner', 'oldOrganization': 'Escola de Enfermagem - UFMG'}}}}