Daily Vitamin D for Sickle-cell Respiratory Complications (NCT04170348) | Clinical Trial Compass
CompletedPhase 2
Daily Vitamin D for Sickle-cell Respiratory Complications
United States58 participantsStarted 2020-09-15
Plain-language summary
This study aims to answer the question whether daily oral vitamin D supplementation can reduce the risk of respiratory or lung complications in children and adolescents with sickle cell disease. Respiratory problems are the leading causes of sickness and of death in sickle cell disease. The investigators hypothesize that daily oral vitamin D3, compared to monthly oral vitamin D, will rapidly increase circulating vitamin D3, and reduce the rate of respiratory complications by 50% or more within the first year of supplementation in children and adolescents with sickle cell disease.
This study is funded by the FDA Office of Orphan Products Development (OOPD).
Who can participate
Age range3 Years β 20 Years
SexALL
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β. Patient unwilling or unable to provide written informed consent (and assent, if applicable)
β. Patient unable or unwilling to comply with requirements of the clinical trial
β. Participation in another clinical trial
β. Current diagnosis of rickets
β. History of hypercalcemia or diagnosis of any medical condition associated with hypercalcemia, including primary hyperparathyroidism, malignancy, sarcoidosis, tuberculosis, granulomatous disease, familial hypocalciuric hypercalcemia
β. Current use of corticosteroids, excluding inhaled steroids
β. Current use of anticonvulsants (phenytoin, phenobarbital, carbamazepine)