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

Trial Summary

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.

What data supports the effectiveness of the treatment zinc for sickle cell disease?

Research shows that zinc supplementation can improve growth and reduce infections in people with sickle cell disease. It also decreases the number of hospitalizations and painful episodes, making it a promising treatment for managing the condition. ^{1 2 3 4 5}

Is zinc supplementation safe for people with sickle cell disease?

Zinc supplementation is generally considered safe for people with sickle cell disease, as studies have shown no significant difference in serious adverse events between those taking zinc and those taking a placebo. It has been associated with improved growth and reduced infection rates, making it a promising intervention for managing sickle cell disease. ^{1 2 6 7 8}

How does zinc supplementation differ from other treatments for sickle cell disease?

Zinc supplementation is unique for sickle cell disease as it addresses zinc deficiency, which is common in these patients, and has been shown to improve growth, body weight, and some biochemical markers. Unlike other treatments, zinc specifically targets nutritional deficiencies that can exacerbate symptoms and complications of the disease. ^{5 6 8 9 10}

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.

Timeline

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

Treatment Details

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.

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

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Micronutrients and sickle cell disease, effects on growth, infection and vaso-occlusive crisis: a systematic review. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Plasma zinc status, growth, and maturation in children with sickle cell disease. [2019]

3. Uganda pubmed.ncbi.nlm.nih.gov

Serum levels of copper, zinc and disease severity scores in sickle cell disease patients in Benin City, Nigeria. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of zinc supplementation on incidence of infections and hospital admissions in sickle cell disease (SCD). [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Nutrition and sickle cell disease. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Zinc for infection prevention in children with sickle cell anemia: a randomized double-blind placebo-controlled trial. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Zinc in sickle cell disease: A narrative review. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Zinc deficiency in sickle cell disease. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

Zinc in sickle cell disease. [2013]

10. United States pubmed.ncbi.nlm.nih.gov

Zinc deficiency and effects of zinc supplementation on sickle cell anemia subjects. [2013]