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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

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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Cystic Fibrosis Dietary Supplement: Vitamin D3 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study Evaluating Single, High-dose Pharmacokinetics/Pharmacodynamics of Vitamin D3 in CF
Actual Study Start Date : June 17, 2019
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : December 1, 2019


Arm Intervention/treatment
Experimental: Adults with Cystic Fibrosis
CF adults with vitamin D insufficiency or deficiency will receive 300,000-600,000 IU vitamin D3 (cholecalciferol)
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

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)
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




Primary Outcome Measures :
  1. Peak plasma concentrations (Cmax) [ Time Frame: 10 weeks ]
  2. Time taken to reach the maximum concentration (Tmax) [ Time Frame: 10 weeks ]
  3. Area under the plasma concentration versus time curve (AUC) [ Time Frame: 10 weeks ]

Secondary Outcome Measures :
  1. Levels of serum inflammatory biomarkers [ Time Frame: 10 weeks ]
    Changes in IL-6, IL-8, TNF-α, IL-1β, C-reactive protein



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03734744


Contacts
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Contact: Paul M Beringer, Pharm.D. 323-442-1402 beringer@usc.edu

Locations
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United States, California
Keck Hospital of University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Lynn Fukushima, RN    323-442-5869    lynn.fukushima@med.usc.edu   
Sponsors and Collaborators
University of Southern California
Investigators
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Principal Investigator: Paul M Beringer, Pharm.D. University of Southern California
  Study Documents (Full-Text)

Documents provided by Paul Beringer, University of Southern California:
Publications:
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Responsible Party: Paul Beringer, Professor of Clinical Pharmacy, University of Southern California
ClinicalTrials.gov Identifier: NCT03734744    
Other Study ID Numbers: HS-18-00737
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paul Beringer, University of Southern California:
Pharmacokinetics
Pharmacodynamics
Additional relevant MeSH terms:
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Cystic Fibrosis
Vitamin D Deficiency
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents