Zinc SCD - Clinical Trial
What is the 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.
This study looks at how sickle cell disease affects bone health. People can join if they have sickle cell disease type SS or sickle cell beta zero thalassemia, which are two forms of sickle cell disease.
Who Can Participate in the Study?
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.
What is Involved?
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.
Study Details
