Zinc supplements for bone health in sickle cell disease
Official title: Zinc Supplementation in Sickle Cell Disease: A Precursor to the Think Zinc for Bones Trial
Run by University of California, San Francisco · NCT06260891 · Data updated 2026-11-12
This 12-week test gives two different daily zinc doses (25 mg or 40 mg) to people aged 15 to 40 with homozygous sickle cell disease to see which dose most changes blood markers of bone turnover.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 15 Years to 40 Years |
| Sex | All |
| Enrollment | 34 (estimated) |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 6 sites (Oakland, California and 5 other locations) |
| Status | Recruiting |
| Started | February 14, 2026 |
| Main results expected | July 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | March 13, 2026 |
| Trial ID | NCT06260891 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are males or females aged 15 to 40 with SCD-SS or Sβ0 thalassemia in steady state who can stop zinc supplements and meet laboratory criteria.
✕Probably not a fit
Patients on chronic transfusion with iron overload, those with vitamin D deficiency (<20 ng/mL), significant kidney disease (eGFR <30 mL/min/1.73m2), or those unable or unwilling to stop zinc supplements are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, double-blind Phase II trial will enroll 34 participants with SCD-SS or Sβ0 thalassemia across multiple U.S. centers and randomly assign them to 25 mg or 40 mg of zinc daily. Participants will have two baseline blood draws four weeks apart followed by a 12-week zinc intervention with monitoring of bone formation and resorption biomarkers and tolerability. The primary goals are to identify which biochemical markers respond to zinc supplementation and to determine the maximum tolerated dose that produces desired biomarker changes. Findings will provide dosing data for a larger future trial on the long-term impact of zinc on bone health in sickle cell disease.
Why it matters
Potential benefit: If successful, the trial could identify a safe zinc dose that improves bone turnover markers and support future efforts to prevent early bone loss and fractures in young people with SCD.
How similar studies have gone: Although zinc deficiency and benefits for growth and red cell stability have been reported in SCD, the short-term effects of zinc on bone turnover biomarkers in SCD are novel and have not been previously described in the literature.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: ≥ 15.0 to ≤ 40.0 years * Diagnosis: SCD-SS or SCD-S Beta zero Thalassemia, in steady state (defined as a minimum of 2 weeks days following pain crisis) * Male or Female 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)
Where it's running
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UCSF Benioff Children's Hospital Oakland
Oakland, California, United States Recruiting -
Duke University Medical Center
Durham, North Carolina, United States Not yet recruiting -
Cincinnati Children's Hospital
Cincinnati, Ohio, United States Not yet recruiting -
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States Not yet recruiting -
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States Not yet recruiting -
Baylor College of Medicine
Houston, Texas, United States Not yet recruiting
Study contacts
- Principal investigator: Ellen Fung, PhD — University of California, San Francisco
- Study coordinator: Beth Anne Martin
- Email: beth.martin@ucsf.edu
- Phone: 480-793-2162
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.