NCT06260891RecruitingPhase 2
Zinc Supplementation in Sickle Cell Disease: A Precursor to the Think Zinc for Bones Trial
Source: ClinicalTrials.gov · Last updated 13 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 34 (estimated)
- First submitted
- 7 Feb 2024
- Start date
- 14 Feb 2026
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- University of California, San Francisco
- Diseases
- Sickle cell disease
- NCT number
- NCT06260891
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 34
- From 14 Feb 2026 to the primary completion date, 31 Jul 2027
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Taking any supplement containing zinc and unable/willing to stop for 3 months prior to study start
- Currently participating in another investigational drug trial
Lab values
- 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)
- Prior diagnosis of chronic kidney disease (eGFR \< 30 mL/min/1.73m2)
Other
- 25-Hydroxy Vitamin D \< 20 ng/mL
- Unable swallow pills or take daily supplement as instructed
Who the study is looking for
- 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
Age in the registry: 15 years to 40 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cincinnati Children's Hospital Coordinator of this site? Confirm its status | Cincinnati | United States | Not yet recruiting |
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Not yet recruiting |
| Baylor College of Medicine Coordinator of this site? Confirm its status | Houston | United States | Not yet recruiting |
| UCSF Benioff Children's Hospital Oakland Coordinator of this site? Confirm its status | Oakland | United States | Recruiting |
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Not yet recruiting |
| Thomas Jefferson University Hospital Coordinator of this site? Confirm its status | Philadelphia | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.