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To examine the effects of two types of active vitamin D (calcitriol and doxercalciferol) and two phosphate binders (sevelamer and calcium carbonate) on the bone disease and blood tests of children with kidney failure
Pediatric patients treated with CCPD who displayed biochemical and bone biopsy proven secondary hyperparathyroidism were randomly assigned to one of 2 vitamin D analogues (calcitriol or doxercalciferol) and one of two phosphate binders (sevelamer or calcium carbonate) in a two by two factorial designed prospective trial. Serum biochemical measurements were obtained at baseline and monthly throughout the 8 months of the trial. Bone biopsy was obtaine at baseline and repeated at study completion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Doxercalciferol + Calcium Carbonate |
|
| 2 | Experimental | Doxercalciferol + Sevelamer |
|
| 3 | Experimental | Calcitriol + Calcium Carbonate |
|
| 4 | Experimental | Calcitriol + Sevelamer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1 alpha D2 | Drug | Vitamin D sterol |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone Formation Rate | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Bone histomorphometric parameters other than bone formation rate, biochemical parameters (phosphorus, calcium, PTH, alkaline phosphatase, FGF-23, vitamin D dose) | 8 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isidro B Salusky, MD | University of California, Los Angeles | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40576086 | Derived | Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4. |
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| ID | Term |
|---|---|
| D006962 | Hyperparathyroidism, Secondary |
| D012080 | Chronic Kidney Disease-Mineral and Bone Disorder |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D012279 | Rickets |
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| ID | Term |
|---|---|
| C042533 | 1 alpha-hydroxyergocalciferol |
| D002117 | Calcitriol |
| D000069603 | Sevelamer |
| D002119 | Calcium Carbonate |
| ID | Term |
|---|---|
| D004100 | Dihydroxycholecalciferols |
| D006887 | Hydroxycholecalciferols |
| D002762 | Cholecalciferol |
| D002782 | Cholestenes |
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| 1,25 dihydroxy vitamin D3 | Drug | Active vitamin D sterol |
|
|
| Sevelamer HCl | Drug | Phosphate binder |
|
|
| Calcium Carbonate | Drug | Phosphate binder |
|
|
| D001851 |
| Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D002128 | Calcium Metabolism Disorders |
| D014808 | Vitamin D Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002776 |
| Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D008903 | Minerals |