Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2026-01-09 @ 1:46 AM
Study NCT ID:
NCT00479102
Status:
UNKNOWN
Last Update Posted:
2007-05-25
First Post:
2007-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Iron Deficiency in 2nd Year of Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'lastUpdateSubmitDate': '2007-05-24', 'studyFirstSubmitDate': '2007-05-24', 'studyFirstSubmitQcDate': '2007-05-24', 'lastUpdatePostDateStruct': {'date': '2007-05-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-25', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Iron supplementation', 'Babies', 'Prevention'], 'conditions': ['Iron Deficiency', 'Anemia']}, 'descriptionModule': {'briefSummary': 'Healthy babies(age 8-18 months) following a routine blood count, with no anemia or iron deficiency, will be randomly placed in two groups. Group 1 will receive a 3 months preventive dose of an iron preparation (Ferripel 3 iron polysaccharide complex). Group 2 will be followed up as a control group. Following a nutritional questionnair, parents of all babies will receive instruction regarding appropriate nutrition in the 2nd year of life. A follow-up blood count will be taken from all participating babies 3 months after recruitment. The study aims to evaluate effectiveness of iron supplementation in the 2nd year of life. The hypothesis is that babies who receive iron supplementation in the 2nd year of life are less likely to develop iron deficiency or anemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '18 Months', 'minimumAge': '8 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy babies without iron deficiency\n\nExclusion Criteria:\n\n* Babies with iron deficiency or chronic diseases, premature babies and babies with hereditary hematological disease'}, 'identificationModule': {'nctId': 'NCT00479102', 'briefTitle': 'Prevention of Iron Deficiency in 2nd Year of Life', 'organization': {'class': 'OTHER', 'fullName': 'Soroka University Medical Center'}, 'officialTitle': 'Effectiveness of Iron Supplementation in the Second Year of Life for Prevention of Iron Deficiency', 'orgStudyIdInfo': {'id': 'sor448707ctil'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ferripel-3 - iron polysaccharide complex for prevention', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rahat', 'country': 'Israel', 'contacts': [{'name': 'Hanna Shalev, MD', 'role': 'CONTACT', 'email': 'hannash@clalit.org.il', 'phone': '972-52-8504058'}], 'facility': 'Clalit Health Services Child Health Center', 'geoPoint': {'lat': 31.39547, 'lon': 34.75699}}], 'centralContacts': [{'name': 'Hanna Shalev, MD', 'role': 'CONTACT', 'email': 'hannash@clalit.org.il', 'phone': '972-52-8504058'}], 'overallOfficials': [{'name': 'Hanna Shalev, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clalit Health Services'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soroka University Medical Center', 'class': 'OTHER'}}}}