Ignite Creation Date:
2025-12-24 @ 12:09 PM
Ignite Modification Date:
2026-02-24 @ 12:25 AM
Study NCT ID:
NCT06561061
Status:
RECRUITING
Last Update Posted:
2025-02-13
First Post:
2024-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Zinc for Infection Prevention in Sickle Cell Anemia-2 (ZIPS-2)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019287', 'term': 'Zinc Sulfate'}], 'ancestors': [{'id': 'D013431', 'term': 'Sulfates'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017967', 'term': 'Zinc Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Double-blinded placebo-controlled trial'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized double-blinded placebo-controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-12', 'studyFirstSubmitDate': '2024-08-16', 'studyFirstSubmitQcDate': '2024-08-16', 'lastUpdatePostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Transcranial Doppler (TCD) velocity from enrollment to 6-month study endpoint', 'timeFrame': '6 months', 'description': 'Change in TCD Velocity'}], 'primaryOutcomes': [{'measure': 'Incidence of all-cause infections in the zinc vs. placebo groups', 'timeFrame': '6 months', 'description': 'Will assess the difference in the incidence of all cause infection between the Placebo arm and the experimental arm'}], 'secondaryOutcomes': [{'measure': 'Incidence of infections requiring hospitalization', 'timeFrame': '6 months', 'description': 'Incidence of Advance events greater or equal to grade 3'}, {'measure': 'Incidence of adverse events requiring discontinuation of study drug', 'timeFrame': '6 months', 'description': 'Incidence of Zinc related Advance events'}, {'measure': 'Incidence of stroke or death', 'timeFrame': '6 months', 'description': 'Incidence of death and stroke'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Zinc', 'All-cause infections'], 'conditions': ['Sickle Cell Disease']}, 'descriptionModule': {'briefSummary': 'A randomized double-blinded placebo-controlled trial of zinc to reduce the incidence of severe or invasive infections in Ugandan children with sickle cell anemia (SCA)', 'detailedDescription': 'The study will be a randomized, placebo-controlled, double blind clinical trial in which 100 Ugandan children 1.00-4.99 years of age with SCA will receive zinc (20 mg oral dispersible tablet daily) or placebo (identical to zinc in appearance) for 6 months. The primary study outcome will be incidence of infection (all causes).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '59 Months', 'minimumAge': '12 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented sickle cell anemia (HbSS supported by hemoglobin electrophoresis)\n* Age range of 1.00-4.99 years, inclusive, at the time of enrollment\n* Weight at least 5.0 kg at the time of enrollment\n* Willingness to comply with all study-related treatments, evaluations, and follow-up\n* Children whose parents or guardians give full written informed consent\n\nExclusion Criteria:\n\n* Known other chronic medical condition (e.g., HIV, malignancy, active clinical tuberculosis)\n* Severe malnutrition determined by impaired growth parameters as defined by WHO (weight for length/height or height for age z-score \\<-3, using WHO growth standards)\n* Absolute neutropenia (absolute neutrophil count \\<500)'}, 'identificationModule': {'nctId': 'NCT06561061', 'acronym': 'ZIPS-2', 'briefTitle': 'Zinc for Infection Prevention in Sickle Cell Anemia-2 (ZIPS-2)', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Zinc for Infection Prevention in Sickle Cell Anemia-2', 'orgStudyIdInfo': {'id': '2023-841'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zinc', 'description': 'Dispersible zinc sulfate tablet (20 mg)', 'interventionNames': ['Drug: zinc sulfate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Dispersible identical placebo tablet', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'zinc sulfate', 'type': 'DRUG', 'description': 'Dispersible (20 mg) tablet', 'armGroupLabels': ['Zinc']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Dispersible tablet', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jinja', 'status': 'RECRUITING', 'country': 'Uganda', 'contacts': [{'name': 'Isaac Birungi', 'role': 'CONTACT', 'email': 'isaacbirun@gmail.com'}], 'facility': 'Jinja Hospital', 'geoPoint': {'lat': 0.43902, 'lon': 33.20317}}], 'centralContacts': [{'name': 'Isaac Birungi', 'role': 'CONTACT', 'email': 'isaacbirun@gmail.com', 'phone': '0704236193', 'phoneExt': '+256'}, {'name': 'Ruth Namazzi, MBChB', 'role': 'CONTACT', 'email': 'namazzi101@gmail.com', 'phone': '0772356331', 'phoneExt': '+256'}], 'overallOfficials': [{'name': 'Chandy C John, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Global Health Uganda LTD', 'class': 'OTHER'}, {'name': 'Makerere University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatrics', 'investigatorFullName': 'Chandy John', 'investigatorAffiliation': 'Indiana University'}}}}