Sickle Cell Disease study: 25 mg/day zinc vs 40 mg/day zinc
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, taken by mouth once daily, 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 study wants to see which blood markers change with zinc and what the highest safe zinc dose is for affecting bone‑related markers.
- Who it's for
- People with homozygous sickle cell disease who are 15 to 40 years old.
- What's involved
- Participants will have two blood draws four weeks apart, then take a zinc pill each day for 12 weeks at either 25 mg or 40 mg.
- Time commitment
- The trial lasts about 16 weeks, with visits for the two baseline blood draws and follow‑up during the 12‑week dosing period.
- 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 is enrolling
- Oakland, California, 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, but 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?
This study is enrolling now at Oakland, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.