protocolSection identificationModule nctId: NCT06260891, orgStudyIdInfo id: ZnSCD, briefTitle: Zinc Supplementation in Sickle Cell Disease, acronym: ZnSCD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-04-01, primaryCompletionDateStruct date: 2026-09-30, completionDateStruct date: 2026-09-30, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: University of California, San Francisco, class: OTHER, collaborators name: American Society Hematology, Research Collaborative, collaborators name: Children's Hospital of Philadelphia, collaborators name: Johns Hopkins University, collaborators name: Baylor College of Medicine, collaborators name: Children's National Research Institute, collaborators name: Children's Hospital Medical Center, Cincinnati, collaborators name: Newark Beth Israel Medical Center, collaborators name: University of Pennsylvania, descriptionModule briefSummary: The goal of this short term prospective Phase II study is to compare the effects of two alternate daily doses of zinc (25 and 40 mg/day) in 34 randomly assigned homozygous Sickle Cell Disease (SCD-SS) patients aged 15-35 years old. The main question it aims to answer is: Which biomarkers are most responsive to zinc supplementation, and what is the maximum tolerated zinc dose that induces the desired changes in biomarkers of bone turnover? Participants will be recruited from 7 American Society Hematology Research Collaborative SCD Centers. Eligible SCD subjects will be invited to participate in the 16-week study, involving 2 baseline blood draws 4 weeks apart, followed by a 12-week zinc intervention. The findings from this study will be used to determine the dosage of zinc to be used in a larger, future study on the long term impact of zinc supplementation on bone health in SCD-SS., conditionsModule conditions: Sickle Cell Disease, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a delayed start parallel design where all subjects will have a usual care period, 2 baseline samples 4 weeks apart, followed by a 12 week zinc intervention, with samples at 8 and 12 weeks., primaryPurpose: OTHER, maskingInfo masking: QUADRUPLE, maskingDescription: n/a the 2 zinc capsule dosages (25 and 40 mg) will be compounded to look identical, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 34, type: ESTIMATED, armsInterventionsModule interventions name: 25 mg/day zinc, interventions name: 40 mg/day zinc, outcomesModule primaryOutcomes measure: Biomarker of Bone Formation (PINP), primaryOutcomes measure: Biomarker of Bone Resorption (CTx), secondaryOutcomes measure: Biomarker of Bone Formation (BSAP), secondaryOutcomes measure: Biomarker of Bone Resorption (TRAP 5b), eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 35 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: UCSF Benioff Children's Hospital Oakland, city: Oakland, state: California, zip: 94609, country: United States, contacts name: Ellen Fung, PhD, role: CONTACT, phone: 510-428-3885, phoneExt: 4939, email: ellen.fung@ucsf.edu, contacts name: Beth Anne Martin, role: CONTACT, email: beth.martin@ucsf.edu, geoPoint lat: 37.80437, lon: -122.2708, hasResults: False