Recruiting
Phase 2

Zinc Supplementation

Sponsor:

UCLA

Code:

NCT06260891

Conditions

Sickle Cell Disease

Eligibility Criteria

Sex: All

Age: 15 - 40

Healthy Volunteers: Not accepted

Interventions

25 mg/day zinc

40 mg/day zinc

Study Details

Brief summary:

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.

Conditions

Sickle Cell Disease

Study ID

NCT06260891

Start date

Feb 14, 2026

Status verified date

Mar, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 40

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age: ≥ 15.0 to ≤ 40.0 years
  • Diagnosis: SCD-SS or SCD-S Beta zero Thalassemia, in steady state (defined as a minimum of 2 weeks days following pain crisis)
  • Male or Female

Exclusion Criteria:

  • Taking any supplement containing zinc and unable/willing to stop for 3 months prior to study start
  • 25-Hydroxy Vitamin D < 20 ng/mL
  • On chronic transfusion therapy (defined as >8 Transfusions/year) and iron overloaded (defined as liver iron concentration > 7 mg/g OR average serum ferritin >4000 ug/L)
  • Unable swallow pills or take daily supplement as instructed
  • Currently participating in another investigational drug trial
  • Prior diagnosis of chronic kidney disease (eGFR < 30 mL/min/1.73m2)

Study Design

Enrollment

34 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

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

Interventions

25 mg/day zinc

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

40 mg/day zinc

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

Central Contacts and Locations

Central contacts

Beth Anne Martin

480-793-2162beth.martin@ucsf.edu

Ellen Fung, PhD

510-428-3885ellen.fung@ucsf.edu

Locations

UCSF Benioff Children's Hospital Oakland

Recruiting

Oakland, California, United States, 94609

Contacts

Ellen Fung, PhD

510-428-3885ellen.fung@ucsf.edu

Beth Anne Martin

beth.martin@ucsf.edu

More Information

Sponsor

University of California, San Francisco

Last update posted

Mar 13, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-03-13.