Zinc Supplementation for Sickle Cell Disease (ZnSCD Trial)

Phase 2

Waitlist Available

Led By Ellen Fung, PhD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age: ≥ 15.0 to ≤ 35.0 years

Be younger than 65 years old

Must not have

On chronic transfusion therapy (defined as >8 Transfusions/year)

Unable swallow pills or take daily supplement as instructed

Timeline

Screening 3 weeks

Treatment Varies

Follow Up total 16 weeks divided into: usual care (0 to 4 weeks) vs. intervention period (4 to 16 weeks)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to investigate the effects of two different doses of zinc (25 and 40 mg/day) on Sickle Cell Disease patients aged 15-35 years old. The study will focus on

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not detailed in the information provided. However, common side effects of zinc supplementation may include nausea, vomiting, diarrhea, metallic taste, kidney and stomach damage if taken in high doses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 15 and 35 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I receive more than 8 blood transfusions a year.

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I cannot swallow pills or take daily supplements as instructed.

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My kidney function is impaired.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ total 16 weeks divided into: usual care (0 to 4 weeks) vs. intervention period (4 to 16 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~total 16 weeks divided into: usual care (0 to 4 weeks) vs. intervention period (4 to 16 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and total 16 weeks divided into: usual care (0 to 4 weeks) vs. intervention period (4 to 16 weeks) for reporting.