Status:
COMPLETED
Vitamin D for Sickle-cell Respiratory Complications
Lead Sponsor:
Gary M Brittenham, MD
Conditions:
Sickle Cell Disease
Vitamin D Deficiency
Eligibility:
All Genders
3-20 years
Phase:
PHASE2
Brief 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 c...
Detailed Description
This study will be a Phase 2 double-blind randomized clinical trial in 80 patients with sickle cell disease, ages 3 to 20 years-old, comparing a 2-year monthly oral dose of vitamin D3, 100,000 IU (equ...
Eligibility Criteria
Inclusion
- Diagnosis of sickle cell disease (HbSS, HbSC, HbS Beta-thalassemia)
- Age 3 to 20 years old
Exclusion
- 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
Key Trial Info
Start Date :
December 13 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2015
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01443728
Start Date
December 13 2011
End Date
February 15 2015
Last Update
August 9 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Columbia University Irving Medical Center
New York, New York, United States, 10032