Main
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Note: This record shows only 22 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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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30 May 2022 |
Main ID: |
NCT03734744 |
Date of registration:
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06/11/2018 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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PK/PD of Vitamin D3 in Adults With CF
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Scientific title:
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A Pilot Study Evaluating Single, High-dose Pharmacokinetics/Pharmacodynamics of Vitamin D3 in CF |
Date of first enrolment:
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June 17, 2019 |
Target sample size:
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6 |
Recruitment status: |
Terminated |
URL:
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https://clinicaltrials.gov/show/NCT03734744 |
Study type:
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Interventional |
Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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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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Paul M Beringer, Pharm.D. |
Address:
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Telephone:
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Email:
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Affiliation:
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University of Southern California |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- For CF, diagnosis of CF based on positive sweat chloride or known CF mutation
- For CF, Patients with pancreatic insufficiency
- Age = 18 years
- Serum 25(OH)D concentrations below 30 ng/mL (75 nmol/L)
Exclusion Criteria:
- Pregnancy
- History of lung transplant,
- Severe anemia (hemoglobin concentration < 7 g/dL),
- Liver disease (AST/ALT > 3x ULN), kidney disease (GFR = 40 mL/min), or granulomatous
conditions
- Patients taking steroids, cholesterol-lowering drug (cholestyramine), weight-loss
drugs (orlistat) , statins, anti-tuberculosis drugs (rifampin and isoniazid),
phenobarbital, phenytoin, carbamazepine, immunosuppressants (cyclosporine, tacrolimus)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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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: Vitamin D3
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Primary Outcome(s)
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Area under the plasma concentration versus time curve (AUC)
[Time Frame: 10 weeks]
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Time taken to reach the maximum concentration (Tmax)
[Time Frame: 10 weeks]
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Peak plasma concentrations (Cmax)
[Time Frame: 10 weeks]
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Secondary Outcome(s)
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Levels of serum inflammatory biomarkers
[Time Frame: 10 weeks]
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Secondary ID(s)
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HS-18-00737
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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