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Clearance of 25-hydroxyvitamin D in Cystic Fibrosis

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Disease Information

Descriptive Information
Brief Title † Clearance of 25-hydroxyvitamin D in Cystic Fibrosis
Official Title † Clearance of 25-hydroxyvitamin D in Cystic Fibrosis
Brief Summary The goal of this study is to define 25(OH)D3 catabolism in CF patients using gold standard pharmacokinetics studies. Specifically, the investigators will evaluate the metabolic clearance of 25(OH)D3 among participants with CF and matched control subjects. The goal of this work is to provide the first comprehensive characterization of vitamin D metabolism in CF patients and promote novel hypotheses for subsequent studies.
Detailed Description
Study Phase Phase 1
Study Type † Interventional
Study Design †
Primary Outcome Measure † Metabolic clearance of D6-25(OH)D3
Secondary Outcome Measure † AUC of D6-25(OH)D3
Condition † Cystic Fibrosis
Intervention † Drugd6-25-hydroxyvitamin D3
Study Arms / Comparison Groups Single pharmacokinetics arm
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 20
Start Date † April 3, 2017
Completion Date December 2019
Primary Completion Date December 2019
Eligibility Criteria † Inclusion Criteria: - Age ≥ 18 years - Serum total 25(OH)D 10-50 ng/mL - Diagnosis of cystic fibrosis in accordance with CF Foundation Guidelines; OR, normal CONTROL Exclusion Criteria: - Primary hyperparathyroidism - Gastric bypass - Tuberculosis or sarcoidosis - Current pregnancy - Child-Pugh Class B or C cirrhosis (i.e. cirrhosis with ascites, hepatic encephalopathy, bilirubin >=2 mg/dL, serum albumin = 4 seconds) - History of kidney transplantation or end stage renal disease treated with dialysis - Use of vitamin D3 or vitamin D2 supplements exceeding a mean daily dose of 400 IU, within 3 months (wash-out allowed) - Use of 1,25(OH)2D3 or an analogue, calcimimetics, or medications known to induce CYP24A1 within 4 weeks (wash-out allowed) - Serum calcium > 10.1 mg/dL - Hemoglobin
Gender All
Ages 18 Years - N/A
Accepts Healthy Volunteers Accepts Healthy Volunteers
Contacts †† Laura Curtin, 206 221-3938, lcurtin@uw.edu
Location Countries † United States
Administrative Information
NCT ID † NCT03104855
Organization ID 50852
Secondary IDs †† R01DK099199, P30DK089507
Responsible Party Principal Investigator
Study Sponsor † University of Washington
Collaborators †† National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators † Principal Investigator: Ian de Boer, MD, MS, University of Washington
Information Provided By
Verification Date May 2017
First Received Date † February 17, 2017
Last Updated Date May 17, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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