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Clinical Trial Summary

There are approximately 90,000 individuals in the United States with sickle cell disease (SCD). Studies have shown that up to 98 percent of patients with Sickle Cell Disease have a vitamin D deficiency, defined as a 25-hydroxyvitamin D level (25(OH)D) less than or equal to 20 ng/mL. As a result, of low bone density, patients may develop osteonecrosis, chronic inflammation and related pain. This study will be coordinated with patients' regularly scheduled visits for medical care and will require patients to submit blood sample at the start of the study and at 3, 6, 9, AND 12 month visits. Patients will also be scheduled for a bone density measurement (DXA scan) at the start of the study and after 12 months of supplementation to assess for any bone re-mineralization. Thus, the main purpose of this study is to find the amount of nutritional vitamin D that needs to be taken by patients with sickle cell disease in order to correct vitamin D deficiency. The study will also test whether vitamin D supplements improve bone health and reduce inflammation.


Clinical Trial Description

This is an observational cohort study to follow vitamin D levels over time in patients with sickle cell disease receiving doses of vitamin D as part of their clinical care for vitamin D deficiency. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03012555
Study type Observational
Source Icahn School of Medicine at Mount Sinai
Contact
Status Completed
Phase N/A
Start date October 2014
Completion date August 11, 2016

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