Summary

Eligibility
for people ages 15-35 (full criteria)
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Ellen Fung, PhD (ucsf)
Headshot of Ellen Fung
Ellen Fung

Description

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.

Details

Keywords

Sickle Cell Disease, Sickle Cell Anemia, Zinc, 25 mg/day zinc, 40 mg/day zinc

Eligibility

Location

  • UCSF Benioff Children's Hospital Oakland
    Oakland California 94609 United States

Lead Scientist at University of California Health

  • Ellen Fung, PhD (ucsf)
    Dr. Fung has advanced training in nutrition and a long-standing curiosity on the impact of nutrition and physical activity on bone health in children and young adults with chronic disease. She has a passion for hemoglobin disorders including thalassemia and sickle cell disease and has been conducting much of her research within these populations for the last 2 decades.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT06260891
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 34 study participants
Last Updated