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FDA Awards $2M to Phase 2 Trial of Vitamin D for Reducing Risk of SCD Respiratory Complications
The U.S. Food and Drug Administration (FDA) has awarded $2 million to support a Phase 2 clinical trial testing whether daily supplementation of vitamin D reduces the risk of respiratory complications in children and adolescents with sickle cell disease (SCD).
Gary M. Brittenham, MD, a pediatrician and professor at Columbia University Irving Medical Center in New York, was the recipient of the four-year grant.
The ViDAS-2 study will compare the effectiveness of a daily dose of oral vitamin D3 (3,333 IU/day) with a monthly dose (100,000 IU/month) over two years. It is intended to determine if daily supplementation can reduce more rapidly the rate of respiratory events — including respiratory infections, asthma exacerbations, or acute chest syndrome events — and lead to improvements in pulmonary and immune function.
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This platform is made possible through a partnership with the Sickle Cell Disease Association of America, Inc. (SCDAA) and its member organizations. SCDAA's mission is to advocate for people affected by sickle cell conditions and empower community-based organizations to maximize quality of life and raise public consciousness while advancing the search for a universal cure.