Zinc Supplementation in Sickle Cell Disease: A Precursor to the Think Zinc for Bones Trial (NCT06260891)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (7 items).
Location: UCSF Benioff Children's Hospital Oakland — Oakland, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Taking any supplement containing zinc and unable/willing to stop for 3 months prior to study start
- 25-Hydroxy Vitamin D \< 20 ng/mL
- On chronic transfusion therapy (defined as \>8 Transfusions/year) and iron overloaded (defined as liver iron concentration \> 7 mg/g OR average serum ferritin \>4000 ug/L)
- Unable swallow pills or take daily supplement as instructed
- Currently participating in another investigational drug trial
- Prior diagnosis of chronic kidney disease (eGFR \< 30 mL/min/1.73m2)
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (6 Sites)
- UCSF Benioff Children's Hospital Oakland — Oakland, California
- Duke University Medical Center — Durham, North Carolina
- Cincinnati Children's Hospital — Cincinnati, Ohio
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania
- Baylor College of Medicine — Houston, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.