Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2026-01-05 @ 5:41 PM
Study NCT ID:
NCT02398968
Status:
COMPLETED
Last Update Posted:
2020-05-28
First Post:
2015-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iron Supplementation Outcome on Recurrent Upper Respiratory Tract Infections in 6-15 Years Old Egyptian School Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000747', 'term': 'Anemia, Hypochromic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-27', 'studyFirstSubmitDate': '2015-02-19', 'studyFirstSubmitQcDate': '2015-03-22', 'lastUpdatePostDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'effect of iron supplementation on recurrent upper respiratory tract infections measured by Canadian Acute Respiratory Illness and Flu Scale {CARIFS}', 'timeFrame': '15 months', 'description': 'Assessment of the upper respiratory tract infection incidence and severity throughout the study period will be done by a questionnaire including: Number of upper respiratory tract infection episodes per month with or without absenteeism from school, Total number of days sick with an upper respiratory tract infection ,and Canadian Acute Respiratory Illness and Flu Scale {CARIFS}'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Iron', 'RURTIs', 'CARIFS', 'children'], 'conditions': ['Recurrent Upper Respiratory Tract Infections', 'Iron Deficiency Anemia']}, 'descriptionModule': {'briefSummary': 'Recurrent upper respiratory infections ( RURTIs) are common in school aged children. An adequate iron status might reduce their prevalence. The aim of the study is to assess the percentage and type of RURTIs in Egyptian school children, assessing the percentage of iron deficiency anemia (IDA) and the effect of iron supplementation on the recurrence and severity of upper respiratory tract infections .', 'detailedDescription': 'This is a prospective interventional study in which 1000 Children (6-15 years) are recruited from two schools in urban Cairo; three months enrollment was done in early autumn ; students defined to have RURTIs were screened by Hemocue; if anemic (Hb \\< 11.5gm/dL),Complete blood picture and iron profile were done, they were enrolled into 2 groups: (A)children with IDA on oral iron fumerate therapy (6mg/kg/d) for 3 months, then maintained on oral iron (1mg/kg/d) for 12 months, and (B) Non anemic group; were randomly assigned in 1:1 ratio into: group (B1)children Received maintenance iron therapy for 12 months and group (B2) received placebo. Recurrence and severity of URTIs using (CARIFS score) throughout the study are recorded'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both genders were eligible, and we did not seek to balance the number of boys and girls.\n* Children completed the compulsory vaccination schedule of Egypt.\n\nExclusion Criteria:\n\n* Children with coexisting chronic disease such as renal, hepatic failure , IDDM, endocrine diseases, bronchial asthma and chronic diarrhea .\n* Patients with suspected immunodeficiency by presence of some of the warning symptoms or signs .'}, 'identificationModule': {'nctId': 'NCT02398968', 'briefTitle': 'Iron Supplementation Outcome on Recurrent Upper Respiratory Tract Infections in 6-15 Years Old Egyptian School Children', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Effect of Iron Supplementation on Recurrent Upper Respiratory Tract Infections in Egyptian School Children: A One Year Prospective Study', 'orgStudyIdInfo': {'id': '1-elalfy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'RURTI+IDA+iron therapy', 'description': 'children with iron deficiency anemia on therapeutic iron fumerate therapy (6mg/kg/d) for 3 months, then maintained on iron fumerate supplementation(1mg/kg/d) for 12 months', 'interventionNames': ['Dietary Supplement: iron fumerate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B1:RURTI+no anemia+iron maintenance', 'description': 'children with recurrent upper respiratory tract infection and no anemia receiving oral iron fumerate (1mg/kg/d) for 12 months', 'interventionNames': ['Dietary Supplement: iron fumerate']}, {'type': 'NO_INTERVENTION', 'label': 'B2:RURTI+no anemia', 'description': 'children with recurrent upper respiratory tract infection and no anemia followed up for 12 months'}], 'interventions': [{'name': 'iron fumerate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'iron fumerate supplementation (6mg/kg/d) for arm 1 iron fumerate supplementation (1mg/kg/d) for arm 2', 'armGroupLabels': ['B1:RURTI+no anemia+iron maintenance', 'RURTI+IDA+iron therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Pediatrics hospital Ain shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Mohsen S Elalfy, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ain Shams University'}, {'name': 'Ehab K Emam, professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Ain Shams University'}, {'name': 'Khaled M Abd-al aziz, professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Ain Shams University'}, {'name': 'Yasmin G El gendy, lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University'}, {'name': 'Mohamed T Hamza, lecturer', 'role': 'STUDY_CHAIR', 'affiliation': 'Ain Shams University'}, {'name': 'marian g rizk, ass lect', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of pediatrics', 'investigatorFullName': 'yasmin gamal el gendy', 'investigatorAffiliation': 'Ain Shams University'}}}}