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

University of Washington

Status and phase

Completed

Phase 1

Conditions

Cystic Fibrosis

Treatments

Drug: d6-25-hydroxyvitamin D3

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03104855

P30DK089507 (U.S. NIH Grant/Contract)

50852

R01DK099199 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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