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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK099199 | U.S. NIH Grant/Contract | View source | |
| P30DK089507 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single pharmacokinetics arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| d6-25-hydroxyvitamin D3 | Drug | intravenous administration of stable isotope-labeled D6-25(OH)D3 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| AUC of D6-25(OH)D3 | AUC is calculated using the linear trapezoidal method. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
| Serum Concentration of Calcium |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian de Boer, MD, MS | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | CF Group | Participants with cystic fibrosis |
| FG001 | Healthy Controls | Participants without cystic fibrosis |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CF Group | Participants with cystic fibrosis |
| BG001 | Healthy Controls | Participants without cystic fibrosis |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | mL/day | 8 weeks |
|
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CF Group | Participants with cystic fibrosis | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain or sensation in arm during infusion | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ian de Boer | University of Washington | 206-616-5403 | IDeBoer@Nephrology.washington.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 30, 2015 | Sep 18, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| 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. | 8 weeks |
Change in the serum concentration of calcium from baseline to 7 days after 25(OH)D3 |
| 7 days |
| Serum Concentration of Creatinine | Change in the serum concentration of creatinine from baseline to 7 days after 25(OH)D3 | 7 days |
| Serum Concentration of AST | Change in the serum concentration of AST from baseline to 7 days after 25(OH)D3 | 7 days |
| Serum Concentration of ALT | Change in the serum concentration of ALT from baseline to 7 days after 25(OH)D3 | 7 days |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | AUC of D6-25(OH)D3 | AUC is calculated using the linear trapezoidal method. | Posted | Mean | Standard Deviation | ng x day/mL | 8 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | day | 8 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Liters | 8 weeks |
|
|
|
| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | ratio | 8 weeks |
|
|
|
| Other Pre-specified | Serum Concentration of Calcium | Change in the serum concentration of calcium from baseline to 7 days after 25(OH)D3 | Posted | Mean | Standard Deviation | mg/dL | 7 days |
|
|
|
| Other Pre-specified | Serum Concentration of Creatinine | Change in the serum concentration of creatinine from baseline to 7 days after 25(OH)D3 | Posted | Mean | Standard Deviation | mg/dL | 7 days |
|
|
|
| Other Pre-specified | Serum Concentration of AST | Change in the serum concentration of AST from baseline to 7 days after 25(OH)D3 | Posted | Mean | Standard Deviation | Units/L | 7 days |
|
|
|
| Other Pre-specified | Serum Concentration of ALT | Change in the serum concentration of ALT from baseline to 7 days after 25(OH)D3 | Posted | Mean | Standard Deviation | Units/L | 7 days |
|
|
|
| 5 |
| 0 |
| 5 |
| 2 |
| 5 |
| EG001 | Healthy Controls | Participants without cystic fibrosis | 0 | 5 | 0 | 5 | 1 | 5 |
| Bruising after blood draw | Blood and lymphatic system disorders | Systematic Assessment |
|
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| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |