Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-03-01 @ 6:03 AM
Study NCT ID:
NCT00116493
Status:
COMPLETED
Last Update Posted:
2012-04-09
First Post:
2005-06-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Severe Anemia Treatment Trials, Pakistan
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': 'D008463', 'term': 'Mebendazole'}, {'id': 'C067316', 'term': 'Geritol'}], 'ancestors': [{'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1009}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-06', 'studyFirstSubmitDate': '2005-06-29', 'studyFirstSubmitQcDate': '2005-06-29', 'lastUpdatePostDateStruct': {'date': '2012-04-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severe Anemia'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['severe anemia', 'anthelminthic', 'multivitamins', 'pregnancy', 'children', 'Pakistan'], 'conditions': ['Anemia']}, 'referencesModule': {'references': [{'pmid': '19535425', 'type': 'RESULT', 'citation': 'Bhutta Z, Klemm R, Shahid F, Rizvi A, Rah JH, Christian P. Treatment response to iron and folic acid alone is the same as with multivitamins and/or anthelminthics in severely anemic 6- to 24-month-old children. J Nutr. 2009 Aug;139(8):1568-74. doi: 10.3945/jn.108.103507. Epub 2009 Jun 17.'}, {'pmid': '19176737', 'type': 'RESULT', 'citation': 'Christian P, Shahid F, Rizvi A, Klemm RD, Bhutta ZA. Treatment response to standard of care for severe anemia in pregnant women and effect of multivitamins and enhanced anthelminthics. Am J Clin Nutr. 2009 Mar;89(3):853-61. doi: 10.3945/ajcn.2008.26826. Epub 2009 Jan 28.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the efficacy of two enhanced regimens (deworming and multivitamins) in the treatment of severe anemia in pregnant women and children 6-24 months of age in Karachi, Pakistan.', 'detailedDescription': 'Anemia continues to be a public health problem of global proportions. Severe anemia (hemoglobin, Hb\\< 70 g/L) is of special concern as it poses a significant health and mortality risk. Pregnant women and young children (6-24 months of age) are the two groups at highest risk. Severe anemia in pregnant women is associated with an elevated risk of maternal and perinatal mortality as well as case fatality. Pakistan, the country in which this study is ongoing, may harbor the highest prevalence of severe anemia in South Asia, with as high as 15% being reported among pregnant women. Comparable rates (11-12%) are also seen among 6-24 month old children. Iron deficiency is one of the major causes of anemia in young children and pregnant women in South Asia. In addition to iron, deficiency of vitamins such as folic acid, vitamin A, vitamin C, riboflavin and vitamin E can also inhibit erythropoiesis. Apart from these nutritional causes, two other infectious causes of severe anemia are malaria and geohelminths. The current international recommendation for treatment of anemia includes iron and folic acid but not other vitamins.\n\nComparisons: Severely anemic pregnant women and children 6-24 months are randomized to receive enhanced treatment of deworming and multivitamins over and above the standard of care of iron-folic acid using a 2x2 factorial design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women with severe anemia (Hb\\<70g/L)\n* Children 6-24 months with severe anemia (Hb\\<70 g/L)\n\nExclusion Criteria:\n\n* Gestational age \\>=36 weeks\n* Edema\n* Breathlessness'}, 'identificationModule': {'nctId': 'NCT00116493', 'briefTitle': 'Severe Anemia Treatment Trials, Pakistan', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins Bloomberg School of Public Health'}, 'officialTitle': 'Evaluation of Anthelminthics and Multivitamins for Treatment of Severe Anemia in Pregnant Women and Children 6-24 Months of Age in Pakistan', 'orgStudyIdInfo': {'id': 'H.22.03.04.22.A2'}, 'secondaryIdInfos': [{'id': 'Thrasher Research Fund 02817-9'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'Standard of care (Iron-folic acid + Deworming)', 'interventionNames': ['Dietary Supplement: Iron-folic acid and mebendazole']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: Mebendazole']}, {'type': 'EXPERIMENTAL', 'label': '3', 'interventionNames': ['Dietary Supplement: Multivitamins']}, {'type': 'EXPERIMENTAL', 'label': '4', 'interventionNames': ['Drug: Mebendazole + Multivitamin']}], 'interventions': [{'name': 'Iron-folic acid and mebendazole', 'type': 'DIETARY_SUPPLEMENT', 'description': '100 mg iron for pregnant women, 25 mg iron for children\n\n1 mg of folic acid for pregnant women, 100 ug folic acid for children 500 mg of mebendazole for both pregnant women and children', 'armGroupLabels': ['1']}, {'name': 'Mebendazole', 'type': 'DRUG', 'description': '100 mg twice a day for 3 days; Iron-folic acid also given', 'armGroupLabels': ['2']}, {'name': 'Multivitamins', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Iron-folic acid also given; Includes vitamins A, C, B12, E, and B2', 'armGroupLabels': ['3']}, {'name': 'Mebendazole + Multivitamin', 'type': 'DRUG', 'description': 'Multivitamins + Mebendazole at 100 mg twice a day for 3 days; Iron-folic acid also given', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Aga Khan University', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'Parul Christian, DrPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins Bloomberg School of Public Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins Bloomberg School of Public Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aga Khan University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Parul Christian', 'investigatorAffiliation': 'Johns Hopkins Bloomberg School of Public Health'}}}}