Clearance of 25-hydroxyvitamin D in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

— CF  

Official title:

Clearance of 25-hydroxyvitamin D in Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03104855
• Other study ID #: 50852
• Secondary ID: R01DK099199P30DK
• Status: Completed
• Phase: Phase 1
• Start date: April 3, 2017
• Est. completion date: September 6, 2023

Study information

• Verified date: September 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 6, 2023
• Est. primary completion date: October 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• d6-25-hydroxyvitamin D3
intravenous administration of stable isotope-labeled D6-25(OH)D3

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Metabolic Formation Clearance of D6-25(OH)D3 Metabolites	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.	8 weeks
Other	Serum Concentration of Calcium	Change in the serum concentration of calcium from baseline to 7 days after 25(OH)D3	7 days
Other	Serum Concentration of Creatinine	Change in the serum concentration of creatinine from baseline to 7 days after 25(OH)D3	7 days
Other	Serum Concentration of AST	Change in the serum concentration of AST from baseline to 7 days after 25(OH)D3	7 days
Other	Serum Concentration of ALT	Change in the serum concentration of ALT from baseline to 7 days after 25(OH)D3	7 days
Primary	Metabolic Clearance of D6-25(OH)D3	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.	8 weeks
Secondary	AUC of D6-25(OH)D3	AUC is calculated using the linear trapezoidal method.	8 weeks
Secondary	Terminal Half-life of D6-25(OH)D3	Terminal half-life is equal to ln2/k, where k is the slope of the terminal regression line estimated using =3 plasma concentrations.	8 weeks
Secondary	Volume of Distribution of D6-25(OH)D3	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.	8 weeks