Zinc Supplementation for Sickle Cell Disease

(ZnSCD Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Ellen Fung, PhD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of California, San Francisco

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of 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 15-35 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 7 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.

Research Team

Ellen Fung, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for people aged 15-35 with homozygous Sickle Cell Disease (SCD-SS). Participants will be chosen from certain research centers and must be able to attend multiple study visits over a 16-week period. Details on specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

I am between 15 and 35 years old.

I have Sickle Cell Disease-SS and haven't had a pain crisis in at least 10 days.

I am either male or female, aged between 15-35.

Exclusion Criteria

I receive more than 8 blood transfusions a year.

I take zinc supplements and cannot or will not stop them for 3 months before the study starts.

I cannot swallow pills or take daily supplements as instructed.

Treatment Details

Interventions

• Zinc (Mineral Supplement)

Trial Overview The study is testing the effects of two different daily doses of zinc, one group taking 25 mg and another taking 40 mg, to see which dose better influences biomarkers related to bone health in patients with SCD-SS.

Participant Groups

Group I: Dose 2: Zinc 40 mg/day Experimental Treatment 1 Intervention

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

Group II: Dose 1: Zinc 25 mg/day Experimental Treatment 1 Intervention

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

UCSF Benioff Children's Hospital Oakland Oakland, CA

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2636

Patients Recruited

19,080,000+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Patients Recruited

11,400,000+

Children's Hospital Medical Center, Cincinnati

Collaborator

Trials

844

Patients Recruited

6,566,000+

Baylor College of Medicine

Collaborator

Trials

1044

Patients Recruited

6,031,000+

Newark Beth Israel Medical Center

Collaborator

Trials

12

Patients Recruited

1,300+

American Society Hematology, Research Collaborative

Collaborator

Trials

1

Patients Recruited

30+

Johns Hopkins University

Collaborator

Trials

2366

Patients Recruited

15,160,000+

Children's National Research Institute

Collaborator

Trials

227

Patients Recruited

258,000+

University of Pennsylvania

Collaborator

Trials

2118

Patients Recruited

45,270,000+

Cincinnati Children's Hospital Medical Center (CCHMC)

Collaborator

Trials

3

Patients Recruited

3,600+