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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK035423-19 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Children's Hospital Los Angeles | OTHER |
| Loma Linda University | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The study outlined is designed to measure and to determine whether the combined use of vitamin D2 (ergocalciferoI) and 1-alpha-hydroxyvitamin D2 (doxercalciferol)) or doxercalciferol alone will correct the mineralization defect in pediatric patients with established secondary hyperparathyroidism (2°HPT) undergoing regular peritoneal dialysis. Serum phosphorus levels will be controlled with a calcium¬-free-metal free phosphate binder; (obtained at baseline and after 8 months of treatment) sevelamer. Indices of bone mineralization obtained at baseline and after 8 months of treatment will be measured by quantitative histomorphometry in iliac crest bone biopsies after double tetracycline labeling. Immunohistochemistry will be done in specimens of bone biopsies from iliac crest to examine the expression for selected markers of bone turnover and mineralization such as FGF-23, DMP1, MEPE and OPG. Serum PTH levels will be measured with the 1st and 2nd generation immunometric assay (PTH-IMAs) and fibroblast growth factor-23 (FGF-23) will be determined by one assay with specific detection antibodies that are against epitopes within the C-terminus of FGF-23 and another assay that uses antibodies against epitopes within the N- and C-terminal portions of the molecule respectively. The value of non-invasive assessment of bone mass by quantitative computed tomography (QCT) and its relationship with vascular disease determined by ultrasound (US) of intimal carotid thickness (CIMT) will be correlated with bone histomorphometry and the different biochemical determinations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with vitamin D2 | Active Comparator | Vitamin D2 50,000u titrated to serum 25(OH)D values given orally once a month in addition to standard of care: Doxercalciferol escalating doses beginning at 2.5 mcg given orally thrice weekly. Sevelamer Carbonate 800 mg (1600- 4800 mg) given orally with each meal |
|
| Standard of Care | No Intervention | Standard of Care: Doxercalciferol escalating doses beginning at 2.5 mcg given orally thrice weekly. Sevelamer Carbonate 800 mg (1600- 4800 mg) given orally with each meal |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D2 | Drug | These patients will receive standard of care vitamin D 1,25 therapy with intervention of vitamin D2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of bone mineralization defect demonstrated by bone histomorphometry | Iliac crest bone biopsy pre and post treatment with vitamin D2 | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic improvement of skeletal abnormalities associated with renal osteodystrophy | We will compare skeletal lesions identified through radiographic studies with bone histomorphometry pre and post treatment with vitamin D2 | 8 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isidro Salusky, MD | Contact | 310.206.6987 | isalusky@mednet.ucla.edu |
| Name | Affiliation | Role |
|---|---|---|
| Isidro Salusky, MD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University | Recruiting | Loma Linda | California | 92354 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 7, 2018 | |
| Reset | Mar 8, 2018 | |
| Release | Aug 25, 2021 | |
| Reset | Sep 21, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 7, 2018 | Mar 8, 2018 | |||
| Aug 25, 2021 |
| ID | Term |
|---|---|
| D004872 | Ergocalciferols |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Childrens Hospital Los Angeles | Recruiting | Los Angeles | California | 90027 | United States |
|
| Sep 21, 2021 |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |