Actively Recruiting
Zinc Supplementation in Sickle Cell Disease: A Precursor to the Think Zinc for Bones Trial
Led by University of California, San Francisco · Updated on 2026-03-13
34
Participants Needed
6
Research Sites
97 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
C
Children's Hospital of Philadelphia
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Zinc Supplementation in Sickle Cell Disease: A Precursor to the Think Zinc for Bones Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 15 and 40 years
- Diagnosis of SCD-SS or SCD-S Beta zero Thalassemia in steady state (at least 2 weeks after pain crisis)
- Male or female
You will not qualify if you...
- Taking any zinc supplement and unable or unwilling to stop for 3 months before study start
- 25-Hydroxy Vitamin D level below 20 ng/mL
- On chronic transfusion therapy (>8 transfusions per year) and iron overloaded (liver iron concentration >7 mg/g or average serum ferritin >4000 ug/L)
- Unable to swallow pills or take daily supplement as instructed
- Currently participating in another investigational drug trial
- Prior diagnosis of chronic kidney disease with eGFR less than 30 mL/min/1.73m2
AI-Screening
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Trial Site Locations
Total: 6 locations
1
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States, 94609
Actively Recruiting
2
Duke University Medical Center
Durham, North Carolina, United States, 27710
Not Yet Recruiting
3
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229
Not Yet Recruiting
4
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
5
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Not Yet Recruiting
6
Baylor College of Medicine
Houston, Texas, United States, 77030
Not Yet Recruiting
Research Team
B
Beth Anne Martin
CONTACT
E
Ellen Fung, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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