Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2025-12-27 @ 10:46 PM
Study NCT ID:
NCT00213161
Status:
COMPLETED
Last Update Posted:
2021-04-19
First Post:
2005-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Iron Supplementation to Decrease Iron Deficiency Anemia in Infants and Young Children in India
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007505', 'term': 'Iron-Dextran Complex'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003911', 'term': 'Dextrans'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 425}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2005-06'}, 'lastUpdateSubmitDate': '2021-04-14', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemoglobin at 4 weeks, 8 weeks, 8 months after first dosing'}], 'secondaryOutcomes': [{'measure': 'Ferritin at 8 weeks'}, {'measure': 'Serum Transferrin Receptor (sTfR) at 8 weeks'}, {'measure': 'side effects every 2 weeks'}, {'measure': 'compliance with iron supplement assessed every 2 weeks'}]}, 'conditionsModule': {'keywords': ['anemia', 'iron deficiency', 'iron drops', 'iron supplement', 'malnutrition', 'pediatrics'], 'conditions': ['Anemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the smallest dose of Sprinkles, a single-serving package of iron and other micronutrients, to treat infants with iron deficiency anemia in India. Results have implications for programs using Sprinkles worldwide because lower doses of iron may have fewer side effects.', 'detailedDescription': "Iron deficiency anemia affects two thirds of children in most developing nations, and even mild anemia can have serious implications for child development. In India, government programs within India have been ineffective in controlling this public health problem due to the lack of effective iron supplements reaching children.\n\nOur research group developed 'Sprinkles', an inexpensive micronutrient supplement which is a single-serve sachet of tasteless powder that contain encapsulated iron and other micronutrients. Parents can be easily instructed to mix the contents of one sachet into a bowl of any complementary food.\n\nThis study is part of a partnership and capacity development between interdisciplinary research groups at The Hospital for Sick Children, University of Toronto, Canada and the King Edward Memorial Hospital in India, aimed at developing a long-term program of research that will address iron deficiency anemia among infants and young children in India. For Sprinkles to be implemented into national programs in India, a comprehensive strategy is needed which includes a single, safe and effective iron dose for the Indian population.\n\nThis specific study is to conduct a community-based, randomized clinical trial in India to determine the appropriate dose of supplementation required for the target age group."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '18 Months', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 6-18 months of age\n* anemic (Hb 70-100g/L)\n* ingesting weaning food in addition to breast milk\n* free from major illness (including symptomatic for malaria) and afebrile\n* living within study area for the next two months\n* parental consent obtained\n* only one child per household in the study\n\nExclusion Criteria:\n\n* Hb \\< 70 or ≥ 100 g/L\n* Not receiving any complementary foods\n* Receiving an iron supplement within two weeks of the date of enrolment\n* chronic illness\n* severely malnourished: weight for age z-score \\< -3.0\n* another child in the household is a subject in this study'}, 'identificationModule': {'nctId': 'NCT00213161', 'briefTitle': 'Using Iron Supplementation to Decrease Iron Deficiency Anemia in Infants and Young Children in India', 'organization': {'class': 'OTHER', 'fullName': 'The Hospital for Sick Children'}, 'officialTitle': 'Establishing an Iron Supplementation Strategy to Reduce the Prevalence of Iron Deficiency Anemia Among Infants and Young Children in India.', 'orgStudyIdInfo': {'id': '1000001031'}, 'secondaryIdInfos': [{'id': 'CIHR: GLH-63082'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'iron supplement, iron drops', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pune', 'state': 'Maharashtra', 'country': 'India', 'facility': 'King Edward Memorial Hospital (KEM)', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}], 'overallOfficials': [{'name': 'Stanley Zlotkin, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', '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'}}}}