Zinc Supplementation in Sickle Cell Disease: A Precursor to the Think Zinc for Bones Trial
University of California, San Francisco
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.
Description
The investigators propose a two-arm, double-blinded, Phase II study comparing the effects of two different daily doses of zinc (25 and 40 mg/day) in 34 patients with SCD-SS aged 15-40 years old, randomly assigned to either group. The aim of the study is to determine the maximum tolerated zinc dose that induces desired changes in rates of bone formation and resorption. The findings from this study will function as preliminary data for a future randomized clinical trial and provide a novel characterization of bone marker response to short term zinc supplementation in SCD that has not previously…
Eligibility
- Age range
- 15–40 years
- Sex
- All
- Healthy volunteers
- No
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 * Current…
Interventions
- Drug25 mg/day zinc
25 mg of zinc as zinc gluconate taken orally once a day
- Drug40 mg/day zinc
40 mg of zinc as zinc gluconate taken orally once a day
Locations (6)
- UCSF Benioff Children's Hospital OaklandOakland, California
- Duke University Medical CenterDurham, North Carolina
- Cincinnati Children's HospitalCincinnati, Ohio
- Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania
- Thomas Jefferson University HospitalPhiladelphia, Pennsylvania
- Baylor College of MedicineHouston, Texas