Purpose of this Study
This study lasts about 16 weeks. If you join, you will go to four visits in person and have one visit on Zoom. You will fill out weekly online surveys and answer questionnaires. The study team will also collect some information from your medical record. You will have fasting blood tests before you start taking zinc and again while you are taking zinc. You will also give urine samples at several visits. There are two groups in the study, and you will be placed into one by chance. One group takes 25 milligrams of zinc and the other group takes 40 milligrams of zinc. You should stay on your regular medicines during the study and avoid starting new long term treatments. You cannot take any extra zinc outside of the study.
Who Can Participate?
Eligibility
A person may be able to join this study if they are between 15 and 40 years old and have sickle cell disease type SS or beta zero thalassemia. They must have been stable for at least two weeks, with no recent sickle cell pain crisis, hospital stay, or new health problem needing medical care. They cannot be taking zinc supplements, or they must be able to stop them for three months before the study begins. They must be able to swallow pills, take a zinc pill every day, and follow the study visits and surveys.
Some people cannot join the study. These include people who have very low vitamin D, severe kidney disease, are in another research drug study, have certain transfusion or iron overload problems, or have just started or changed some sickle cell medicines like hydroxyurea, L glutamine, or crizanlizumab.
Age Range
15-40
Sex/Genders
Male (cisgender)
Female (cisgender)
Looking for Healthy Participants
No
What is Involved?
Description
This study is being done to find out if zinc can help improve bone health in people with sickle cell disease. Many people with sickle cell disease have bone problems, but doctors do not fully understand why. What researchers learn from this study may help with future research and improve care for people with sickle cell disease.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
Zinc Supplementation in SCD: A Precursor to the Think Zinc for Bones Trial
Principal Investigator
John
Strouse
Protocol Number
PRO00119368
NCT ID
NCT06260891
Phase
I/II
Enrollment Status
Pending Open to Enrollment