RECRUITINGPhase 2INTERVENTIONAL

Zinc Supplementation in Sickle Cell Disease: A Precursor to the Think Zinc for Bones Trial

About This 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 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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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)

Treatments Being Tested

DRUG

25 mg/day zinc

25 mg of zinc as zinc gluconate taken orally once a day

DRUG

40 mg/day zinc

40 mg of zinc as zinc gluconate taken orally once a day

Locations (6)

UCSF Benioff Children's Hospital Oakland

Oakland, California, United States

Duke University Medical Center

Durham, North Carolina, United States

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Baylor College of Medicine

Houston, Texas, United States