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NCT06260891Not yet recruiting

Zinc Supplementation in Sickle Cell Disease

Zinc Supplementation in Sickle Cell Disease: A Precursor to the 'Think Zinc for Bones' Trial
University of California, San FranciscoPhase 2ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Sickle Cell Disease
Drug/Device/Intervention
25 mg/day zinc
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
University of California, San Francisco
Location
Oakland, United States of America
Timeline & enrollment
Phase
Phase 2
Start date
Apr 01, 2025
End date
Sep 30, 2026
Enrollment
34 participants
Primary outcome

Biomarker of Bone Formation (PINP),Biomarker of Bone Resorption (CTx)

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 15-35 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.

ICD-10 classifications
Sickle-cell disordersOther sickle-cell disordersSickle-cell traitSickle-cell anaemia with crisisSickle-cell anaemia without crisis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06260891
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06260891 through Pure Global AI's free database. This Phase 2 trial is sponsored by University of California, San Francisco and is currently Not yet recruiting. The study focuses on Sickle Cell Disease. Target enrollment is 34 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.