NCT03104855

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2017

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

April 3, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 7, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2018

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2023

Completed
1 month until next milestone

Results Posted

Study results publicly available

October 12, 2023

Completed
Last Updated

October 12, 2023

Status Verified

September 1, 2023

Enrollment Period

1.5 years

First QC Date

February 17, 2017

Results QC Date

September 18, 2023

Last Update Submit

September 18, 2023

Conditions

Cystic Fibrosis

Keywords

cystic fibrosisvitamin d catabolism

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • AUC of D6-25(OH)D3

    8 weeks

  • Terminal Half-life of D6-25(OH)D3

    8 weeks

  • Volume of Distribution of D6-25(OH)D3

    8 weeks

Other Outcomes (5)

  • Metabolic Formation Clearance of D6-25(OH)D3 Metabolites

    8 weeks

  • Serum Concentration of Calcium

    7 days

  • Serum Concentration of Creatinine

    7 days

  • +2 more other outcomes

Study Arms (1)

Single pharmacokinetics arm

EXPERIMENTAL
Drug: d6-25-hydroxyvitamin D3

Interventions

d6-25-hydroxyvitamin D3DRUG

intravenous administration of stable isotope-labeled D6-25(OH)D3

Single pharmacokinetics arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Results Point of Contact

Title
Dr. Ian de Boer
Organization
University of Washington
IDeBoer@Nephrology.washington.edu
206-616-5403

Study Officials

  • Ian de Boer, MD, MS

    University of Washington

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Medicine/Nephrology

Study Record Dates

First Submitted

February 17, 2017

First Posted

April 7, 2017

Study Start

April 3, 2017

Primary Completion

October 9, 2018

Study Completion

September 6, 2023

Last Updated

October 12, 2023

Results First Posted

October 12, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

Locations

US(1)