A Phase 1 interventional study of D6-25-hydroxyvitamin D3 in Chronic Kidney Disease, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-01.
Sponsored by University of Washington · Phase 1, Interventional, and Diagnostic
The goal of this study is to better understand vitamin D catabolism and how it is affected by CKD and race.
Specifically, the study team will evaluate the metabolic clearance of 25-hydroxyvitamin D3 in individuals with varying degrees of CKD and among participants who self-report race as Caucasian, African American or African. The long-term goal of this work is to enhance the clinical evaluation and treatment of impaired vitamin D metabolism.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 88 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
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Estimated GFR:
Exclusion Criteria:
D6-25-hydroxyvitamin D3
Drug: D6-25-hydroxyvitamin D3
Intravenous administration of a deuterium-labeled 25(OH)D3 to evaluate the metabolic clearance of 25(OH)D3
Also known as: stable isotope deuterium-labeled 25(OH)D3
Metabolic Clearance of D6-25(OH)D3
Metabolic clearance is calculated as the administered dose of 25(OH)D3 divided by the area under the plasma concentration-time curve (AUC). AUC is calculated using the linear trapezoidal method. Concentration was measured at 5 minutes, 4 hours, and at 1, 4, 7, 14, 21, 28, 42, and 56 days post administration.
Time frame: 8 weeks
AUC of D6-25(OH)D3
AUC is calculated using the linear trapezoidal method. Concentration was measured at 5 minutes, 4 hours, and at 1, 4, 7, 14, 21, 28, 42, and 56 days post administration.
Time frame: 8 weeks
Terminal Half-life of D6-25(OH)D3
Terminal half-life is equal to ln2/k, where k is the slope of the terminal regression line estimated using ≥3 plasma concentrations. Concentration was measured at 5 minutes, 4 hours, and at 1, 4, 7, 14, 21, 28, 42, and 56 days post administration.
Time frame: 8 weeks
Volume of Distribution of D6-25(OH)D3
Volume of distribution in the central compartment is calculated as dose/C0, where dose is the administered dose of 25(OH)D3 and C0 is the initial (estimated) concentration of drug in plasma. Concentration was measured at 5 minutes, 4 hours, and at 1, 4, 7, 14, 21, 28, 42, and 56 days post administration.
Time frame: 8 weeks
Metabolic Formation Clearance of D6-25(OH)D3 Metabolites.
Metabolic formation clearance is calculated as the daughter metabolite plasma AUC divided by the AUC of D6-25(OH)D3 (metabolite/parent AUC ratio). AUC is calculated using the linear trapezoidal method. Concentration was measured at 5 minutes, 4 hours, and at 1, 4, 7, 14, 21, 28, 42, and 56 days post administration.
Time frame: 8 weeks
Change in the Serum Concentration of Calcium
Change in the serum concentration of calcium from baseline to 7 days after 25(OH)D3 administration
Time frame: 7 days
Change in the Serum Concentration of Creatinine
Change in the serum concentration of creatinine from baseline to 7 days after 25(OH)D3 administration
Time frame: Baseline, 7 days
Change in the Serum Concentration of AST
Change in the serum concentration of AST from baseline to 7 days after 25(OH)D3 administration
Time frame: Baseline, 7 days
Change in the Serum Concentration of ALT
Change in the serum concentration of ALT from baseline to 7 days after 25(OH)D3 administration
Time frame: Baseline, 7 days
| Milestone | Healthy Controls | CKD Group | Kidney Failure Group |
|---|---|---|---|
| Started | 43 | 25 | 20 |
| Completed | 43 | 24 | 20 |
| Not completed | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 |
Metabolic clearance is calculated as the administered dose of 25(OH)D3 divided by the area under the plasma concentration-time curve (AUC). AUC is calculated using the linear trapezoidal method. Concentration was measured at 5 minutes, 4 hours, and at 1, 4, 7, 14, 21, 28, 42, and 56 days post administration.
| milliliter per day (ml/d) | Healthy Controls | CKD Group | Kidney Failure Group |
|---|---|---|---|
| Metabolic Clearance of D6-25(OH)D3 | 360 ± 108 | 313 ± 86 | 263 ± 163 |
AUC is calculated using the linear trapezoidal method. Concentration was measured at 5 minutes, 4 hours, and at 1, 4, 7, 14, 21, 28, 42, and 56 days post administration.
| nanograms x day/mL (ngxd/mL) | Healthy Controls | CKD Group | Kidney Failure Group |
|---|---|---|---|
| AUC of D6-25(OH)D3 | 59.8 ± 10.2 | 68.7 ± 10.2 | 76.6 ± 12.0 |
Terminal half-life is equal to ln2/k, where k is the slope of the terminal regression line estimated using ≥3 plasma concentrations. Concentration was measured at 5 minutes, 4 hours, and at 1, 4, 7, 14, 21, 28, 42, and 56 days post administration.
| days (d) | Healthy Controls | CKD Group | Kidney Failure Group |
|---|---|---|---|
| Terminal Half-life of D6-25(OH)D3 | 21.9 ± 5.7 | 25.5 ± 6.5 | 35.6 ± 8.1 |
Volume of distribution in the central compartment is calculated as dose/C0, where dose is the administered dose of 25(OH)D3 and C0 is the initial (estimated) concentration of drug in plasma. Concentration was measured at 5 minutes, 4 hours, and at 1, 4, 7, 14, 21, 28, 42, and 56 days post administration.
| Liters (L) | Healthy Controls | CKD Group | Kidney Failure Group |
|---|---|---|---|
| Volume of Distribution of D6-25(OH)D3 | 11.0 ± 2.9 | 11.1 ± 2.8 | 12.5 ± 4.0 |
Metabolic formation clearance is calculated as the daughter metabolite plasma AUC divided by the AUC of D6-25(OH)D3 (metabolite/parent AUC ratio). AUC is calculated using the linear trapezoidal method. Concentration was measured at 5 minutes, 4 hours, and at 1, 4, 7, 14, 21, 28, 42, and 56 days post administration.
| ratio | Healthy Controls | CKD Group | Kidney Failure Group |
|---|---|---|---|
| Metabolic Formation Clearance of D6-25(OH)D3 Metabolites. | 0.12 ± 0.04 | 0.08 ± 0.03 | 0.03 ± 0.03 |
Change in the serum concentration of calcium from baseline to 7 days after 25(OH)D3 administration
| milligrams/deciliter (mg/dl) | Healthy Controls | CKD Group | Kidney Failure Group |
|---|---|---|---|
| Change in the Serum Concentration of Calcium | 0.42 ± 1.75 | 0.16 ± 0.26 | -0.27 ± 0.48 |
Change in the serum concentration of creatinine from baseline to 7 days after 25(OH)D3 administration
| milligrams/deciliter (mg/dl) | Healthy Controls | CKD Group | Kidney Failure Group |
|---|---|---|---|
| Change in the Serum Concentration of Creatinine | 0.04 ± 0.09 | -0.05 ± 0.27 | 2.81 ± 2.26 |
Change in the serum concentration of AST from baseline to 7 days after 25(OH)D3 administration
| units/Liter (u/L) | Healthy Controls | CKD Group | Kidney Failure Group |
|---|---|---|---|
| Change in the Serum Concentration of AST | 0.40 ± 3.43 | 0.57 ± 5.98 | 0.10 ± 5.22 |
Change in the serum concentration of ALT from baseline to 7 days after 25(OH)D3 administration
| units/Liter (u/L) | Healthy Controls | CKD Group | Kidney Failure Group |
|---|---|---|---|
| Change in the Serum Concentration of ALT | 0.16 ± 3.71 | 1.52 ± 6.92 | 0.45 ± 3.66 |
Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Participants | 0/87 (0%) | 1/87 (1.1%) | 16/87 (18.4%) |
| Event | All Participants |
|---|---|
| Deep vein thrombosisBlood and lymphatic system disorders | 1/87 |
| Event | All Participants |
|---|---|
| Pain or sensation in arm during infusionGeneral disorders | 16/87 |
| Age, Continuous(years) | Healthy Controls | CKD Group | Kidney Failure Group | Total |
|---|---|---|---|---|
| Mean | 64 ± 10 | 67 ± 11 | 58 ± 9 | 64 ± 11 |
| Sex: Female, Male(Participants) | Healthy Controls | CKD Group | Kidney Failure Group | Total |
|---|---|---|---|---|
| Female | 24 | 8 | 4 | 36 |
| Male | 19 | 16 | 16 | 51 |
| Race (NIH/OMB)(Participants) | Healthy Controls | CKD Group | Kidney Failure Group | Total |
|---|---|---|---|---|
| Race — American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Race — Asian | 0 | 0 | 0 | 0 |
| Race — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Race — Black or African American | 12 | 8 | 6 | 26 |
| Race — White | 31 | 16 | 14 | 61 |
| Race — More than one race | 0 | 0 | 0 | 0 |
| Race — Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Vitamin-D3 Supplement Use(participants) | Healthy Controls | CKD Group | Kidney Failure Group | Total |
|---|---|---|---|---|
| Number | 6 | 1 | 1 | 8 |
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University of Washington