At a glance
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Vitamin D for Sickle-cell Respiratory Complications
In Brief
A Phase 2 clinical trial evaluating Experimental: Vitamin D3 100,000 IU and Active Comparator: Vitamin D3 12,000 IU for Sickle Cell Disease and 4 related conditions. Completed, enrolled 70 participants across 1 site.
Detailed Summary
This study aims to answer the question whether oral vitamin D supplementation can decrease lung complications in children and adolescents with sickle cell disease. Lung complications are the leading causes of morbidity and of death in sickle cell disease. Infections and increased inflammation play important roles in the development of the lung problems in sickle cell disease. Emerging evidence shows that vitamin D helps the immune system to fight infection and to control inflammation and could potentially help prevent respiratory complications in patients with sickle cell disease. The investigators hypothesize that oral vitamin D3, 100,000 IU (2.5 mg), given once a month to a group of children and adolescents with sickle cell disease, will reduce the rate of respiratory events (infection, asthma exacerbation and acute chest syndrome) compared to the rate in a group given standard dose oral vitamin D3, 12,000 IU (0.3 mg) given once a month. Funding Source - U.S. Food \& Drug Administration, Office of Orphan Products Development
Study Details
Timeline
Interventions
Oral vitamin D3, 100,000 IU \[2.5 mg\] given once a month
Standard dose oral vitamin D3 12,000 IU \[0.3 mg\] given once a month