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New treatment option for Sickle Cell Disease
Official title Zinc Supplementation in Sickle Cell Disease: A Precursor to the Think Zinc for Bones Trial
ClinicalTrials.gov ID: NCT06260891
What this study is testing
What is 25 mg/day zinc?
25 mg/day zinc is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for sickle cell disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 15 to 40
You may be able to join if
- 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
You likely can't join if
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Oakland, California, United States
- Durham, North Carolina, United States
- Cincinnati, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 15 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oakland, California, United States; Durham, North Carolina, United States; Cincinnati, Ohio, United States; Philadelphia, Pennsylvania, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.