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

Part of paid clinical trials in Oakland, California.

Sponsor
University of California, San Francisco
Study ID
NCT06260891
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
15 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • 25 mg/day zinc — DRUG
    25 mg of zinc as zinc gluconate taken orally once a day
  • 40 mg/day zinc — DRUG
    40 mg of zinc as zinc gluconate taken orally once a day

Study Details

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.

Key Dates

Start date
Feb 14, 2026
Status verified
Mar 2026
Primary completion
Jul 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
34 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • 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

Primary Outcome Measure

Biomarker of Bone Formation (PINP) [ Time Frame: Total 16 weeks divided into: Usual Care (0 to 4 weeks) vs. Intervention Period (4 to 16 weeks) ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
UCSF Benioff Children's Hospital OaklandOaklandCalifornia94609
Ellen Fung, PhD
[email protected]
510-428-3885
Beth Anne Martin
[email protected]
Duke University Medical CenterDurhamNorth Carolina27710
Rania Mohamed
[email protected]
JJ Strouse, MD (PRINCIPAL_INVESTIGATOR)
Cincinnati Children's HospitalCincinnatiOhio45229
Charles Quinn, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Jemimah Frempong
[email protected]
Alexis Thompson, MD, PhD (PRINCIPAL_INVESTIGATOR)
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107
Prasanna Vardhan
[email protected]
Sophie Lanzkron, MD (PRINCIPAL_INVESTIGATOR)
Baylor College of MedicineHoustonTexas77030
Venee Tubman, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Oakland, CA

By condition
Sickle cell disease
By research site
UCSF Benioff Children's Hospital Oakland· Oakland, CADuke University Medical Center· Durham, NCCincinnati Children's Hospital· Cincinnati, OHChildren's Hospital of Philadelphia· Philadelphia, PAThomas Jefferson University Hospital· Philadelphia, PABaylor College of Medicine· Houston, TX

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