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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 15
Maximum Age: 40
Healthy Volunteers: f
View:

• Age: ≥ 15.0 to ≤ 40.0 years

• Diagnosis: SCD-SS or SCD-SBeta zero Thalassemia, in steady state (defined as a minimum of 2 weeks days following pain crisis)

• Male or Female

Locations
United States
California
UCSF Benioff Children's Hospital Oakland
RECRUITING
Oakland
Contact Information
Primary
Beth Anne Martin
beth.martin@ucsf.edu
480-793-2162
Backup
Ellen Fung, PhD
ellen.fung@ucsf.edu
510-428-3885
Time Frame
Start Date: 2025-11-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 34
Treatments
Experimental: Dose 1: Zinc 25 mg/day
25 mg of zinc as zinc gluconate taken orally once a day
Experimental: Dose 2: Zinc 40 mg/day
40 mg of zinc as zinc gluconate taken orally once a day
Sponsors
Leads: University of California, San Francisco
Collaborators: Thomas Jefferson University, Texas Children's Medical Center, Children's Hospital Medical Center, Cincinnati, Children's Hospital of Philadelphia, Duke University, American Society of Hematology, University of Pennsylvania

This content was sourced from clinicaltrials.gov

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