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Zinc Supplementation in Sickle Cell Disease: A Precursor to the Think Zinc for Bones Trial
Sponsor: University of California, San Francisco
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 15-40 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 6 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.
Key Details
Gender
All
Age Range
15 Years - 40 Years
Study Type
INTERVENTIONAL
Enrollment
34
Start Date
2026-02-14
Completion Date
2027-12-31
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
25 mg/day zinc
25 mg of zinc as zinc gluconate taken orally once a day
40 mg/day zinc
40 mg of zinc as zinc gluconate taken orally once a day
Locations (6)
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States
Duke University Medical Center
Durham, North Carolina, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States