Phase 1
Completed N=88
Clearance of 25-hydroxyvitamin D in Chronic Kidney Disease
Source: ClinicalTrials.gov NCT02937350 ↗Enrolled (actual)
88
Serious AEs
1.2%
Results posted
Sep 2021
Primary outcomePrimary: Metabolic Clearance of D6-25(OH)D3 — 360; 313; 263 milliliter per day (ml/d)
Summary
The goal of this study is to better understand vitamin D catabolism and how it is affected by CKD and race.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Metabolic Clearance of D6-25(OH)D3 |
360; 313; 263 | — |
| SECONDARY AUC of D6-25(OH)D3 |
59.8; 68.7; 76.6 | — |
| SECONDARY Terminal Half-life of D6-25(OH)D3 |
21.9; 25.5; 35.6 | — |
| SECONDARY Volume of Distribution of D6-25(OH)D3 |
11.0; 11.1; 12.5 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years
- Self-reported race Caucasian, African American, or African
- Serum total 25(OH)D 10-50 ng/mL
- Estimated GFR:
- 60 mL/min/1.73m2 (N=40) 15-45 mL/min/1.73m2 (N=40) =2 mg/dL, serum albumin = 4 seconds)
- 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 < 10 g/dL
Data sourced from ClinicalTrials.gov (NCT02937350). 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. Informational only — not medical advice.