Phase 1
N=10
Clearance of 25-hydroxyvitamin D in Cystic Fibrosis
Cystic Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT03104855 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Metabolic Clearance of D6-25(OH)D3 — 397; 342 mL/day
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- d6-25-hydroxyvitamin D3 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Metabolic Clearance of D6-25(OH)D3 |
397; 342 | — |
| SECONDARY AUC of D6-25(OH)D3 |
58.3; 67.2 | — |
| SECONDARY Terminal Half-life of D6-25(OH)D3 |
16.2; 15.8 | — |
| SECONDARY Volume of Distribution of D6-25(OH)D3 |
8.4; 7.2 | — |
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.
Eligibility 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 = 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
Data sourced from ClinicalTrials.gov (NCT03104855). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.