Status:
WITHDRAWN
Vitamin D3 for the Treatment of Low Vitamin D in Cystic Fibrosis
Lead Sponsor:
Children's Hospital of Philadelphia
Conditions:
Cystic Fibrosis
Vitamin D Deficiency
Eligibility:
All Genders
10-25 years
Phase:
PHASE3
Brief Summary
Vitamin D deficiency is common in cystic fibrosis. Vitamin D deficiency frequently persists despite aggressive treatment with ergocalciferol, a vitamin D preparation also known as vitamin D2. Cholecal...
Detailed Description
Vitamin D deficiency is common in cystic fibrosis (CF) and persists despite relatively high doses of ergocalciferol, vitamin D2. Replacement has traditionally been focused upon maintenance of calcium ...
Eligibility Criteria
Inclusion
- Subjects age 10-25 years
- cystic fibrosis
- 25-(OH)-D \< 20 ng/mL
- FEV1 \> 40% -
Exclusion
- inability to perform pulmonary function or hand-grip tests
- liver disease (including cirrhosis and portal hypertension) or baseline liver enzymes 21/2-fold greater than the upper limit of normal
- acute use of glucocorticoids at time of testing
- acute pulmonary exacerbation at time of testing
- known non-adherence to enzyme replacement
- hypercalcemia
- engages in "suntanning
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00762918
Start Date
March 1 2008
End Date
September 1 2008
Last Update
February 22 2010
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