Zinc Supplementation for Sickle Cell Disease

(ZnSCD Trial)

Overseen By Ellen Fung, PhD

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: University of California, San Francisco

Must not be taking: Zinc supplements

Disqualifiers: Chronic transfusions, Kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

34 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests zinc supplements to determine their effects on individuals with sickle cell disease (SCD-SS). Researchers aim to identify whether a daily dose of 25 mg or 40 mg of zinc better alters specific biological markers related to bone health. The goal is to establish the optimal zinc dosage for a future study on long-term bone health benefits. Individuals with SCD-SS who have not experienced a pain crisis for at least two weeks may qualify for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant findings.

Will I have to stop taking my current medications?

The trial requires that you stop taking any supplements containing zinc for 3 months before starting the study. Other medications are not mentioned, so it's unclear if you need to stop them.

Is there any evidence suggesting that zinc supplementation is likely to be safe for humans?

Research shows that zinc is generally safe for people with sickle cell disease. Studies have found that zinc can help children with sickle cell disease grow and may reduce their risk of infections. The body typically handles zinc well at the amounts used in research.

However, excessive zinc intake over time can lead to copper deficiency. Zinc and copper compete for absorption, and high zinc levels can reduce copper levels, potentially causing problems. At the doses tested in this study (25 mg and 40 mg per day), these issues are less likely.

Overall, evidence suggests that zinc is well-tolerated at the levels studied, but monitoring for side effects, especially with long-term use, remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about zinc supplementation for sickle cell disease because it offers a potential new approach to managing the condition. Unlike the standard treatments, such as hydroxyurea and blood transfusions, zinc is a dietary supplement that might help improve overall health and reduce sickle cell complications. Zinc is thought to strengthen the immune system and reduce inflammation, which are key issues in sickle cell disease. Additionally, it's taken orally, making it an easy and accessible option for patients. This simplicity and potential for fewer side effects make zinc an intriguing candidate for improving the quality of life for those affected by this challenging condition.

What evidence suggests that zinc supplementation might be an effective treatment for sickle cell disease?

This trial will compare two different dosages of zinc supplementation for people with sickle cell disease (SCD). Research has shown that zinc supplements can benefit individuals with SCD. Studies have found that zinc may lower the risk of infections, which pose a significant problem for those with SCD. Zinc might also aid growth and reduce the frequency and severity of painful episodes known as sickle cell crises. People with SCD often have lower zinc levels, so zinc supplements could address this deficiency. Overall, early evidence suggests that zinc could be a valuable part of treatment plans for people with SCD. ^{2 6 7 8 9}

Who Is on the Research Team?

Ellen Fung, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

2 visits (in-person)

Baseline

Participants undergo baseline blood draws to establish usual care measures

4 weeks

2 visits (in-person)

Treatment

Participants receive zinc supplementation (25 or 40 mg/day) for 12 weeks

12 weeks

Regular monitoring through Think Zinc app and pill counts

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Zinc

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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

Children's Hospital Medical Center, Cincinnati

Collaborator

Trials

844

Recruited

6,566,000+

Baylor College of Medicine

Collaborator

Trials

1,044

Recruited

6,031,000+

Newark Beth Israel Medical Center

Collaborator

Trials

12

Recruited

1,300+

American Society Hematology, Research Collaborative

Collaborator

Trials

1

Recruited

30+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Children's National Research Institute

Collaborator

Trials

227

Recruited

258,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Cincinnati Children's Hospital Medical Center (CCHMC)

Collaborator

Trials

3

Recruited

3,600+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12283855/

Zinc level and its impact on the phenotype of sickle cell ... Similarly, previous studies in adolescents and adults with SCD found that zinc supplementation reduced infection rates [27, 53]. These findings ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06260891

Zinc Supplementation in Sickle Cell Disease: A Precursor ... 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 ...

3. clinicaltrial.be clinicaltrial.be/nl/details/425590?only_active=0&only_eligible=0&only_recruiting=0&per_page=20

Zinc Supplementation in Sickle Cell Disease: A Precursor... Although emerging studies have reported that zinc supplementation might improve growth and has the potential for reducing the number and severity of sickle- ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2161831322011024

Discovery of Human Zinc Deficiency: Its Impact on ... Major clinical problems resulting from zinc deficiency in humans include growth retardation; cell-mediated immune dysfunction, and cognitive impairment.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9272455/

Zinc, Magnesium, and Copper Levels in Patients with Sickle ... This review showed that SCD patients may potentially prompt to have lower zinc and magnesium levels and higher copper levels compared with those without the ...

6. clinicaltrial.be clinicaltrial.be/en/details/425590?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Zinc Supplementation in Sickle Cell Disease: A Precursor... Although emerging studies have reported that zinc supplementation might improve growth and has the potential for reducing the number and severity of sickle- ...

7. ods.od.nih.gov ods.od.nih.gov/factsheets/Zinc-HealthProfessional/

Zinc - Health Professional Fact Sheet Children with sickle cell disease​​ Supplemental zinc might enhance growth in children with SCD and decrease the risk of bacterial infections, ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0022316622070675

Zinc Supplementation in Children Is Not Associated with ... These results suggest that zinc supplementation at doses typically used in randomized trials is a safe intervention with regards to hemoglobin concentrations.

9. mayoclinicproceedings.org mayoclinicproceedings.org/article/S0025-6196(11)62239-8/fulltext

Toxic Effects Associated With Consumption of Zinc Copper deficiency secondary to excessive zinc intake has been well described in patients taking large doses of supplemental zinc for treatment of sickle cell ...