Zinc Supplementation in Sickle Cell Disease - Trial NCT06260891
Access comprehensive clinical trial information for NCT06260891 through Pure Global AI's free database. This Phase 2 trial is sponsored by University of California, San Francisco and is currently Not yet recruiting. The study focuses on Sickle Cell Disease. Target enrollment is 34 participants.
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Study Focus
Sponsor & Location
University of California, San Francisco
Timeline & Enrollment
Phase 2
Apr 01, 2025
Sep 30, 2026
Primary Outcome
Biomarker of Bone Formation (PINP),Biomarker of Bone Resorption (CTx)
Summary
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06260891
Non-Device Trial