Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-26 @ 12:52 AM
Study NCT ID:
NCT03528434
Status:
COMPLETED
Last Update Posted:
2021-02-09
First Post:
2018-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS)
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': 'D015032', 'term': 'Zinc'}], 'ancestors': [{'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-12-11', 'size': 231043, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-05-07T12:10', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized, placebo-controlled, double blind clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-08', 'studyFirstSubmitDate': '2018-05-07', 'studyFirstSubmitQcDate': '2018-05-16', 'lastUpdatePostDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of infection', 'timeFrame': '12 months', 'description': 'The investigators will assess reduction in incidence of severe or invasive infections, with or without culture or PCR confirmation.'}], 'secondaryOutcomes': [{'measure': 'Incidence of all clinical infections', 'timeFrame': '12 months', 'description': 'Incidence of all clinical infections'}, {'measure': 'Incidence of confirmed bacterial infections (by culture or PCR)', 'timeFrame': '12 months', 'description': 'Incidence of confirmed bacterial infections (by culture or PCR)'}, {'measure': 'Incidence of vaso-occlusive crisis (VOC)', 'timeFrame': '12 months', 'description': 'Incidence of vaso-occlusive crisis (VOC)'}, {'measure': 'Change in height-for-age z-score', 'timeFrame': 'Enrollment to 12 months', 'description': 'Change in height-for-age z-score'}, {'measure': 'Incidence of zinc-related adverse events', 'timeFrame': '12 months', 'description': 'Incidence of zinc-related adverse events'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Zinc'], 'conditions': ['Sickle Cell Disease']}, 'referencesModule': {'references': [{'pmid': '38775255', 'type': 'DERIVED', 'citation': 'Bolarinwa AB, Oduwole O, Okebe J, Ogbenna AA, Otokiti OE, Olatinwo AT. Antioxidant supplementation for sickle cell disease. Cochrane Database Syst Rev. 2024 May 22;5(5):CD013590. doi: 10.1002/14651858.CD013590.pub2.'}, {'pmid': '36735400', 'type': 'DERIVED', 'citation': 'Namazzi R, Opoka R, Conroy AL, Datta D, Tagoola A, Bond C, Goings MJ, Ryu MS, Cusick SE, Krebs NF, Jang JH, Tu W, Ware RE, John CC. Zinc for infection prevention in children with sickle cell anemia: a randomized double-blind placebo-controlled trial. Blood Adv. 2023 Jul 11;7(13):3023-3031. doi: 10.1182/bloodadvances.2022008539.'}, {'pmid': '31349866', 'type': 'DERIVED', 'citation': 'Datta D, Namazzi R, Conroy AL, Cusick SE, Hume HA, Tagoola A, Ware RE, Opoka RO, John CC. Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS): study protocol for a randomized placebo-controlled trial in Ugandan children with sickle cell anemia. Trials. 2019 Jul 26;20(1):460. doi: 10.1186/s13063-019-3569-z.'}]}, '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 250 Ugandan children 1.00-4.99 years of age with SCA will receive zinc (10 mg oral dispersible tablet daily) or placebo (identical to zinc in appearance) for 12 months. The primary study outcome will be incidence of severe or invasive infections. Secondary outcomes will include incidence of all clinical infections, confirmed bacterial infections (by culture or PCR), incidence of vaso-occlusive crisis (VOC), change in height-for-age z-score, and incidence of zinc-related adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Documented sickle cell anemia (HbSS supported by hemoglobin electrophoresis)\n2. Age range of 1.00-4.99 years, inclusive, at the time of enrollment\n3. Weight at least 5.0 kg at the time of enrollment\n4. Willingness to comply with all study-related treatments, evaluations, and follow-up\n\nExclusion Criteria:\n\n1. Known other chronic medical condition (e.g., HIV, malignancy, active clinical tuberculosis)\n2. Severe malnutrition determined by impaired growth parameters as defined by the World Health Organization (WHO) (weight for length/height or height for age z-score \\<-3, using WHO growth standards)'}, 'identificationModule': {'nctId': 'NCT03528434', 'acronym': 'ZIPS', 'briefTitle': 'Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS)', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'for Infection Prevention in Sickle Cell Anemia (ZIPS)', 'orgStudyIdInfo': {'id': '1712339562'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zinc', 'description': 'Dietary Supplement: Zinc 10mg dispersible zinc sulfate tablet', 'interventionNames': ['Dietary Supplement: Zinc']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Dispersible tablet with inert ingredients, identical to zinc in appearance', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Zinc', 'type': 'DIETARY_SUPPLEMENT', 'description': '10mg dispersible zinc sulfate tablet', 'armGroupLabels': ['Zinc']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Dispersible tablet with inert ingredients, identical to zinc in appearance', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jinja', 'country': 'Uganda', 'facility': 'Jinja Reginal Referral Hospital', 'geoPoint': {'lat': 0.43902, 'lon': 33.20317}}], 'overallOfficials': [{'name': 'Chandy C. John, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, {'name': 'Makerere University', 'class': 'OTHER'}, {'name': 'Jinja Regional Referral Hospital', 'class': 'UNKNOWN'}, {'name': 'Université de Montréal', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatrics', 'investigatorFullName': 'Chandy John', 'investigatorAffiliation': 'Indiana University'}}}}