Ignite Creation Date:
2025-12-24 @ 4:06 PM
Ignite Modification Date:
2025-12-29 @ 9:00 PM
Study NCT ID:
NCT00136266
Status:
COMPLETED
Last Update Posted:
2016-02-03
First Post:
2005-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adherence With Iron Sprinkles Among High-Risk Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C007792', 'term': 'Fumigant 93'}, {'id': 'D014815', 'term': 'Vitamins'}, {'id': 'D008903', 'term': 'Minerals'}], 'ancestors': [{'id': 'D018977', 'term': 'Micronutrients'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000078622', 'term': 'Nutrients'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-09', 'completionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-02', 'studyFirstSubmitDate': '2005-08-25', 'studyFirstSubmitQcDate': '2005-08-25', 'lastUpdatePostDateStruct': {'date': '2016-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'full adherence, use of iron supplements 6-7 days/week for 3 months'}], 'secondaryOutcomes': [{'measure': 'iron deficiency at 9 months of age'}, {'measure': 'anemia at 9 months of age'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Adherence', 'Supplements', 'Iron', 'Iron deficiency', 'Anemia', 'Vitamins', 'Minerals'], 'conditions': ['Anemia', 'Iron Deficiency']}, 'referencesModule': {'references': [{'pmid': '19111318', 'type': 'RESULT', 'citation': 'Geltman PL, Hironaka LK, Mehta SD, Padilla P, Rodrigues P, Meyers AF, Bauchner H. Iron supplementation of low-income infants: a randomized clinical trial of adherence with ferrous fumarate sprinkles versus ferrous sulfate drops. J Pediatr. 2009 May;154(5):738-43. doi: 10.1016/j.jpeds.2008.11.003. Epub 2008 Dec 25.'}]}, 'descriptionModule': {'briefSummary': 'Compared with iron drops, iron sprinkles supplied for 3 months to high-risk children beginning at age 5-7 months will increase adherence and reduce the rates of anemia and iron deficiency.', 'detailedDescription': 'Iron deficiency is the most common known nutrient deficiency and cause of anemia in childhood. It is associated with numerous adverse health effects, particularly delayed mental and motor development, that may be irreversible. Despite advances of iron nutrition, the prevalence of iron deficiency remains high among low-income infants and toddlers. Previous studies suggest adherence with iron containing drops is low. Adherence to iron sprinkles among children as tested in studies in less developed countries appears high.\n\nComparison: Children randomized to ferrous sulfate drops will be compared with children randomized to ferrous fumarate sprinkles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Months', 'minimumAge': '5 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy infants\n* Age 5-7 months\n* Presenting for 6 months well-child care\n* Caregiver speaks English or Spanish\n\nExclusion Criteria:\n\n* Pre-existing medical conditions with potential relation to iron deficiency or anemia (e.g., hemoglobinopathies, gastrointestinal disorders resulting in malabsorption, chronic renal disease, gestational age at birth of less than 36 weeks, and HIV infection)\n* Inability to speak English or Spanish\n* Use of vitamin or iron supplements in the previous three months'}, 'identificationModule': {'nctId': 'NCT00136266', 'briefTitle': 'Adherence With Iron Sprinkles Among High-Risk Infants', 'organization': {'class': 'FED', 'fullName': 'Centers for Disease Control and Prevention'}, 'officialTitle': 'Adherence With Iron Sprinkles Among High-Risk Infants', 'orgStudyIdInfo': {'id': 'CDC-NCCDPHP-MM-0835-O5/05'}, 'secondaryIdInfos': [{'id': 'CDC-MM-0835-O5/05'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Ferrous sulphate drops with vitamins A, D, and C', 'type': 'DRUG'}, {'name': 'Ferrous fumarate sprinkles with vitamins and minerals', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02108', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Whittier Street Health Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center Pediatric Primary Care Clinic', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Paul L. Geltman, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}}}}