Vitamin D for Sickle-cell Respiratory Complications
Status:
Completed
Trial end date:
2015-02-15
Target enrollment:
Participant gender:
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
Phase:
Phase 2
Details
Lead Sponsor:
Gary M Brittenham, MD
Treatments:
Cholecalciferol Ergocalciferols Vitamin D Vitamins