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| ID | Type | Description | Link |
|---|---|---|---|
| K23DK081673 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The investigators aim to study potential racial differences in renal phosphorus handling by provocatively testing urinary phosphorus excretion using parathyroid hormone infusions in healthy white volunteers compared to healthy black volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PTH infusion | Experimental | (1-34) PTH infusion at a rate of 0.055 ug/kg/hour for six hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1-34 parathyroid infusion | Drug | 1-34 parathyroid infusion at 0.055 mcg/kg/hr for 6 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Phosphorus Excretion | Fractional excretion of phosphorus (the fraction of phosphorus filtered by the kidney which is excreted in the urine) | six hours |
| Measure | Description | Time Frame |
|---|---|---|
| Fibroblast Growth Factor 23 | The change in fibroblast growth factor 23 concentrations from baseline to six hours | six hours |
| Serum Phosphorus | change in serum phosphorus from baseline to six hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Orlando M Gutierrez, MD, MMSc | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22246283 | Result | Gutierrez OM, Smith KT, Barchi-Chung A, Patel NM, Isakova T, Wolf M. (1-34) Parathyroid hormone infusion acutely lowers fibroblast growth factor 23 concentrations in adult volunteers. Clin J Am Soc Nephrol. 2012 Jan;7(1):139-45. doi: 10.2215/CJN.06240611. |
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| ID | Title | Description |
|---|---|---|
| FG000 | PTH Infusion | (1-34) PTH infusion at a rate of 0.055 ug/kg/hour for six hours 1-34 parathyroid infusion: 1-34 parathyroid infusion at 0.055 mcg/kg/hr for 6 hours |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PTH Infusion | (1-34) PTH infusion at a rate of 0.055 ug/kg/hour for six hours 1-34 parathyroid infusion: 1-34 parathyroid infusion at 0.055 mcg/kg/hr for 6 hours |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Urinary Phosphorus Excretion | Fractional excretion of phosphorus (the fraction of phosphorus filtered by the kidney which is excreted in the urine) | Posted | Mean | Standard Deviation | percentage of fractional excretion | six hours |
|
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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 | PTH Infusion | (1-34) PTH infusion at a rate of 0.055 ug/kg/hour for six hours 1-34 parathyroid infusion: 1-34 parathyroid infusion at 0.055 mcg/kg/hr for 6 hours |
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It is possible that the length of the intervention needed to be longer to detect racial differences in phosphorus excretion.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Orlando Gutierrez | University of Alabama at Birmingham | 205-996-2736 | ogutierrez@uabmc.edu |
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| six hours |
| Serum Calcium | change in serum calcium from baseline to six hours | six hours |
| Parathyroid Hormone | change in parathyroid hormone from baseline to six hours | six hours |
| Fractional Excretion of Calcium | change in urinary fractional excretion of calcium from baseline to six hours | six hours |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
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| Secondary | Fibroblast Growth Factor 23 | The change in fibroblast growth factor 23 concentrations from baseline to six hours | adult volunteers | Posted | Mean | Standard Deviation | relative units (RU)/ml | six hours |
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| Secondary | Serum Phosphorus | change in serum phosphorus from baseline to six hours | adult volunteers | Posted | Mean | Standard Deviation | mg/dL | six hours |
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| Secondary | Serum Calcium | change in serum calcium from baseline to six hours | adult volunteers | Posted | Mean | Standard Deviation | mg/dL | six hours |
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| Secondary | Parathyroid Hormone | change in parathyroid hormone from baseline to six hours | adult volunteers | Posted | Mean | Standard Deviation | pg/ml | six hours |
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| Secondary | Fractional Excretion of Calcium | change in urinary fractional excretion of calcium from baseline to six hours | adult volunteers | Posted | Mean | Standard Deviation | percentage of fractional excretion | six hours |
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| 26 |
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| 26 |
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