Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clearance of 25-hydroxyvitamin D in Cystic Fibrosis (CF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03104855
Recruitment Status : Completed
First Posted : April 7, 2017
Last Update Posted : May 18, 2020
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Ian deBoer, University of Washington

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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: d6-25-hydroxyvitamin D3 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clearance of 25-hydroxyvitamin D in Cystic Fibrosis
Actual Study Start Date : April 3, 2017
Actual Primary Completion Date : October 9, 2018
Actual Study Completion Date : October 9, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
Drug Information available for: Calcifediol

Arm Intervention/treatment
Experimental: Single pharmacokinetics arm Drug: d6-25-hydroxyvitamin D3
intravenous administration of stable isotope-labeled D6-25(OH)D3




Primary Outcome Measures :
  1. Metabolic clearance of D6-25(OH)D3 [ Time Frame: 8 weeks ]
    Metabolic clearance is calculated as the administered dose of 25(OH)D3 divided by the area under the plasma concentration-time curve (AUC). AUC is calculated using the linear trapezoidal method.


Secondary Outcome Measures :
  1. AUC of D6-25(OH)D3 [ Time Frame: 8 weeks ]
    AUC is calculated using the linear trapezoidal method.

  2. Terminal half-life of D6-25(OH)D3 [ Time Frame: 8 weeks ]
    Terminal half-life is equal to ln2/k, where k is the slope of the terminal regression line estimated using ≥3 plasma concentrations.

  3. Volume of distribution of D6-25(OH)D3 [ Time Frame: 8 weeks ]
    Volume of distribution in the central compartment is calculated as dose/C0, where dose is the administered dose of 25(OH)D3 and C0 is the initial (estimated) concentration of drug in plasma.


Other Outcome Measures:
  1. Metabolic formation clearance of D6-25(OH)D3 metabolites [ Time Frame: 8 weeks ]
    Metabolic formation clearance is calculated as the daughter metabolite plasma AUC divided by the AUC of D6-25(OH)D3 (metabolite/parent AUC ratio). AUC is calculated using the linear trapezoidal method.

  2. serum concentration of calcium [ Time Frame: 7 days ]
    Change in the serum concentration of calcium from baseline to 7 days after 25(OH)D3

  3. serum concentration of creatinine [ Time Frame: 7 days ]
    Change in the serum concentration of creatinine from baseline to 7 days after 25(OH)D3

  4. serum concentration of AST [ Time Frame: 7 days ]
    Change in the serum concentration of AST from baseline to 7 days after 25(OH)D3

  5. serum concentration of ALT [ Time Frame: 7 days ]
    Change in the serum concentration of ALT from baseline to 7 days after 25(OH)D3



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 <=3.5 g/dL, or PT >= 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 < 9 g/dL

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): NCT03104855


Locations
Layout table for location information
United States, Washington
University of Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Layout table for investigator information
Principal Investigator: Ian de Boer, MD, MS University of Washington
Layout table for additonal information
Responsible Party: Ian deBoer, Associate Professor, Medicine/Nephrology, University of Washington
ClinicalTrials.gov Identifier: NCT03104855    
Other Study ID Numbers: 50852
R01DK099199 ( U.S. NIH Grant/Contract )
P30DK089507 ( U.S. NIH Grant/Contract )
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ian deBoer, University of Washington:
cystic fibrosis
vitamin d catabolism
Additional relevant MeSH terms:
Layout table for MeSH terms
Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Hydroxycholecalciferols
Calcifediol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents