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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00762918 |
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Date of registration:
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26/09/2008 |
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Primary sponsor: |
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Public title:
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Vitamin D3 for the Treatment of Low Vitamin D in Cystic Fibrosis
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Scientific title:
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Vitamin D and Its Non-Classic Roles in Cystic Fibrosis |
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Date of first enrolment:
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March 2008 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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http://clinicaltrials.gov/show/NCT00762918 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Andrea Kelly, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Hospital of Philadelphia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Subjects age 10-25 years
2. cystic fibrosis
3. 25-(OH)-D < 20 ng/mL
4. FEV1 > 40% -
Exclusion Criteria:
1. inability to perform pulmonary function or hand-grip tests
2. liver disease (including cirrhosis and portal hypertension) or baseline liver enzymes
21/2-fold greater than the upper limit of normal
3. acute use of glucocorticoids at time of testing
4. acute pulmonary exacerbation at time of testing
5. known non-adherence to enzyme replacement
6. hypercalcemia
7. engages in "suntanning
Age minimum:
10 Years
Age maximum:
25 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Vitamin D Deficiency
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Intervention(s)
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Dietary Supplement: cholecalciferol
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Primary Outcome(s)
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serum 25-hydroxy vitamin D levels
[Time Frame: 3 months]
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Secondary Outcome(s)
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body composition
[Time Frame: 3 months]
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inflammatory markers
[Time Frame: 3 months]
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muscles strength
[Time Frame: 3 months]
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Secondary ID(s)
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2007-12-5688
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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