Vitamin D for Sickle-cell Respiratory Complications

• Status: Completed
• Trial end date: 2015-02-15
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gary M Brittenham, MD
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• Diagnosis of sickle cell disease (HbSS, HbSC, HbS Beta-thalassemia)

• Age 3 to 20 years old

Exclusion Criteria:

• Patient (or parent or guardian) unwilling or unable to provide written informed consent (and assent, if applicable)

• Patient unable or unwilling to comply with requirements of the clinical trial

• Participation in other therapeutic clinical trial

• Current diagnosis of rickets

• History of hypercalcemia or diagnosis of any medical condition associated with hypercalcemia, including primary hyperparathyroidism, malignancy, sarcoidosis, tuberculosis, granulomatous disease, familial hypocalciuric hypercalcemia

• Current use of corticosteroids, excluding inhaled steroids

• Current use of anticonvulsants (phenytoin, phenobarbital, carbamazepine)

• Therapy with thiazide diuretics or lithium carbonate

• Known liver or renal disease

• Patients taking medications for pulmonary complications of sickle cell disease not on a stable dose of medications, as defined by a change in medications or doses within the three months prior to study entry

• Patients on chronic red blood cell transfusion therapy

• Absence of baseline record of respiratory events (respiratory infections, asthma exacerbations, episodes of acute chest syndrome) for the preceding year

• Pregnancy