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PK/PD of Vitamin D3 in Adults With CF

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ClinicalTrials.gov Identifier: NCT03734744
Recruitment Status : Recruiting
First Posted : November 8, 2018
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Paul Beringer, University of Southern California

Tracking Information
First Submitted Date  ICMJE November 6, 2018
First Posted Date  ICMJE November 8, 2018
Last Update Posted Date July 23, 2019
Actual Study Start Date  ICMJE June 17, 2019
Estimated Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2018)
  • Peak plasma concentrations (Cmax) [ Time Frame: 10 weeks ]
  • Time taken to reach the maximum concentration (Tmax) [ Time Frame: 10 weeks ]
  • Area under the plasma concentration versus time curve (AUC) [ Time Frame: 10 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2018)
Levels of serum inflammatory biomarkers [ Time Frame: 10 weeks ]
Changes in IL-6, IL-8, TNF-α, IL-1β, C-reactive protein
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PK/PD of Vitamin D3 in Adults With CF
Official Title  ICMJE A Pilot Study Evaluating Single, High-dose Pharmacokinetics/Pharmacodynamics of Vitamin D3 in CF
Brief Summary Despite the extensive literature on adverse clinical outcomes associated with vitamin D deficiency, there are currently no proven treatment strategy that effectively achieves and maintains optimal serum vitamin D status in cystic fibrosis (CF) patients. For the treatment of vitamin D deficiency, CF Foundation currently recommends 2,000 IU daily. However, because achieving adequate serum 25(OH)D levels is a challenge in CF, higher doses of vitamin D may be necessary to reach and maintain vitamin D sufficiency. Poor oral bioavailability of ergocalciferol has been demonstrated in CF patients, which may potentially also be an issue with cholecalciferol. In order to optimize the treatment of vitamin D deficiency in CF, the kinetic disposition must be well understood. However, there are very few data currently available describing the kinetics of both vitamin D and 25-hydroxyvitamin D, and to the investigator's knowledge, no studies have yet characterized the pharmacokinetic disposition of vitamin D and its metabolites in cystic fibrosis. Addressing this issue is crucial in effectively and safely correcting vitamin D deficiency in CF.
Detailed Description Clinically stable CF patients with a history of pancreatic insufficiency (n=6) and matching non-CF subjects (n=6) will be recruited in this study. All subjects will be pre-screened for 25(OH)D status to include those with 25(OH)D levels below 30 ng/mL. The subjects will receive a single oral dose (300,000 - 600,000 IU) of vitamin D3, and the dose will be based on study participant's baseline 25-hydroxyvitamin D3 level. For CF patients, the dose will be administered with food and pancreatic enzyme supplement. This dose was chosen as previous studies in pediatric CF patients demonstrated that a large single dose of up to 600,000 IU vitamin D3 raised and maintained sufficient 25(OH)D concentrations without any signs of adverse events.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Vitamin D Deficiency
  • Cystic Fibrosis
Intervention  ICMJE Dietary Supplement: Vitamin D3
Vitamin D is a fat-soluble vitamin that plays an important role in immune modulation in addition to its classical roles in regulation of calcium homeostasis and bone health
Other Name: Cholecalciferol
Study Arms  ICMJE
  • Experimental: Adults with Cystic Fibrosis
    CF adults with vitamin D insufficiency or deficiency will receive 300,000-600,000 IU vitamin D3 (cholecalciferol)
    Intervention: Dietary Supplement: Vitamin D3
  • Experimental: Non-CF Controls with Low vitamin D
    Non-CF controls with vitamin D insufficiency or deficiency will receive 300,000-600,000 IU vitamin D3 (cholecalciferol)
    Intervention: Dietary Supplement: Vitamin D3
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 6, 2018)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2019
Estimated Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Paul M Beringer, Pharm.D. 323-442-1402 beringer@usc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03734744
Other Study ID Numbers  ICMJE HS-18-00737
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Paul Beringer, University of Southern California
Study Sponsor  ICMJE University of Southern California
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paul M Beringer, Pharm.D. University of Southern California
PRS Account University of Southern California
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP