Phase 1
N=19
Clearance of 25-hydroxyvitamin D3 During Vitamin D3 Supplementation
Chronic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT03576716 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Change in Metabolic Clearance of D6-25(OH)D3 — 21; 5 ml/d
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
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Metabolic Clearance of D6-25(OH)D3 |
21; 5 | — |
| SECONDARY Change in AUC of D6-25(OH)D3 |
0.07; -2.58 | — |
| SECONDARY Change in Terminal Half-life of D6-25(OH)D3 |
-1.3; 1.2 | — |
| SECONDARY Change in Volume of Distribution of D6-25(OH)D3 |
0.28; 0.55 | — |
Summary
The goal of this study is to determine how 25(OH)D3 clearance is affected by vitamin D3 supplementation using a gold standard pharmacokinetic approach.
Eligibility Criteria
Inclusion Criteria
- Successful prior completion of related protocol CLEAR (NCT02937350) or CLEAR-CF (NCT03104855)
- Age ≥ 18 years
- Self-reported race Caucasian, African American, or African
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 (unless failed transplant now treated with hemodialysis)
- 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 < 10 g/dL
Data sourced from ClinicalTrials.gov (NCT03576716). 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.