Clearance of 25-hydroxyvitamin D in Cystic Fibrosis
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/13/2018 |
| Start Date: | April 3, 2017 |
| End Date: | December 2019 |
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.
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.
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
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