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NCT06260891 · ClinicalTrials.gov registry record · Phase 2
Zinc Supplementation in Sickle Cell Disease: A Precursor to the Think Zinc for Bones Trial
A Phase 2 study of Sickle Cell Disease, sponsored by University of California, San Francisco.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
- 6
- Study locations
NCT06260891: Recruiting Phase 2 study of Sickle Cell Disease, sponsored by University of California, San Francisco.
NCT06260891 is a Phase 2 study of Sickle Cell Disease that is actively recruiting participants, run by University of California, San Francisco. The registered enrollment target is 34 participants, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (88% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06260891, a Phase 2 study of Sickle Cell Disease, is actively recruiting participants, sponsored by University of California, San Francisco.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
- 6
- Study locations
Study 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.
Primary Outcome
Bone formation will be assessed by the change in type I procollagen n-terminal propeptide (PINP) between the usual care period (0-4 weeks) and the intervention period (4-16 weeks). These assays are competitive enzyme immunoassays using microtiter plate formats. Serum will be aliquoted and frozen at -70 until analyzed in batches.
Conditions Studied
Interventions
- DRUG 25 mg/day zinc
- DRUG 40 mg/day zinc
Study Locations (6)
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
- Thomas Jefferson University Hospital - Philadelphia
California
- UCSF Benioff Children's Hospital Oakland - Oakland
North Carolina
- Duke University Medical Center - Durham
Ohio
- Cincinnati Children's Hospital - Cincinnati
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2026-02-14 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
What NCT06260891 shows while recruiting
NCT06260891 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Sickle Cell Disease appearing as the primary indexed condition, and to 2 interventions - of which 25 mg/day zinc is the first listed.
NCT06260891 lists 6 locations in 5 states (Pennsylvania, California, North Carolina).
Frequently Asked Questions
What is clinical trial NCT06260891 about?
NCT06260891 is a clinical study titled "Zinc Supplementation in Sickle Cell Disease: A Precursor to the Think Zinc for Bones Trial". 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 re...
What is the current status of trial NCT06260891?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2026-02-14. Estimated completion is 2027-12-31.
What conditions does trial NCT06260891 study?
This clinical trial studies the following conditions: Sickle Cell Disease.
What interventions are being tested in trial NCT06260891?
The interventions under investigation include: 25 mg/day zinc (DRUG), 40 mg/day zinc (DRUG).
Who is sponsoring clinical trial NCT06260891?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06260891 being conducted?
This trial has 6 study locations across California, North Carolina, Ohio, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06260891's enrollment target sits among peer trials
34 135th of 213 higher than 78 of 213 other Sickle Cell Disease trials
participants (enrollment target), bucketed by value
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