NCT06260891

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
20mo left

Started Feb 2026

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Feb 2026Dec 2027

First Submitted

Initial submission to the registry

February 7, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 15, 2024

Completed
2 years until next milestone

Study Start

First participant enrolled

February 14, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

February 7, 2024

Last Update Submit

March 10, 2026

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (2)

  • Biomarker of Bone Formation (PINP)

    Bone formation will be assessed by the change in type I procollagen n-terminal propeptide (PINP) between the usual care period (0-4 weeks) and the intervention period (4-16 weeks). These assays are competitive enzyme immunoassays using microtiter plate formats. Serum will be aliquoted and frozen at -70 until analyzed in batches.

    Total 16 weeks divided into: Usual Care (0 to 4 weeks) vs. Intervention Period (4 to 16 weeks)

  • Biomarker of Bone Resorption (CTx)

    Bone resorption will be assessed by the change in serum cross-linked C-telopeptide of type I collagen (CTx) during usual care (0 to 4 weeks) and the intervention period (4-16 weeks). These assays are competitive enzyme immunoassays using microtiter plate formats. Serum will be aliquoted and frozen at -70 until analyzed in batches.

    Total 16 weeks divided into: Usual Care (0 to 4 weeks) vs. Intervention Period (4 to 16 weeks)

Secondary Outcomes (2)

  • Biomarker of Bone Formation (BSAP)

    Total 16 weeks divided into: Usual Care (0 to 4 weeks) vs. Intervention Period (4 to 16 weeks)

  • Biomarker of Bone Resorption (TRAP 5b)

    Total 16 weeks divided into: Usual Care (0 to 4 weeks) vs. Intervention Period (4 to 16 weeks)

Other Outcomes (2)

  • Tolerability of Zinc Supplement

    Total 16 weeks divided into: Usual Care (0 to 4 weeks) vs. Intervention Period (4 to 16 weeks)

  • Adherence to Zinc Supplementation

    Total 12 weeks during Intervention Period (4 to 16 weeks)

Study Arms (2)

Dose 1: Zinc 25 mg/day

EXPERIMENTAL

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

Drug: 25 mg/day zinc

Dose 2: Zinc 40 mg/day

EXPERIMENTAL

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

Drug: 40 mg/day zinc

Interventions

25 mg/day zincDRUG

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

Dose 1: Zinc 25 mg/day
40 mg/day zincDRUG

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

Dose 2: Zinc 40 mg/day

Eligibility Criteria

Age15 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Taking any supplement containing zinc and unable/willing to stop for 3 months prior to study start
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

UCSF Benioff Children's Hospital Oakland

Oakland, California, 94609, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

NOT YET RECRUITING

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

NOT YET RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

NOT YET RECRUITING

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

NOT YET RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

NOT YET RECRUITING

Related Publications (1)

  • Fung EB, Kwiatkowski JL, Huang JN, Gildengorin G, King JC, Vichinsky EP. Zinc supplementation improves bone density in patients with thalassemia: a double-blind, randomized, placebo-controlled trial. Am J Clin Nutr. 2013 Oct;98(4):960-71. doi: 10.3945/ajcn.112.049221. Epub 2013 Aug 14.

    PMID: 23945720BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Zinc

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Ellen Fung, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Beth Anne Martin

CONTACT

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

Ellen Fung, PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
n/a the 2 zinc capsule dosages (25 and 40 mg) will be compounded to look identical
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This is a delayed start parallel design where all subjects will have a usual care period, 2 baseline samples 4 weeks apart, followed by a 12 week zinc intervention, with samples at 8 and 12 weeks.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2024

First Posted

February 15, 2024

Study Start

February 14, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Data sharing available upon request after the completion of the trial

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
upon completion of the trial the information will be available for 1 year

Locations

US(6)