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| ID | Type | Description | Link |
|---|---|---|---|
| Z121107001012138 | Other Grant/Funding Number | Beijing Municipal Science and Technology Commission | |
| 2011-2002-02 | Other Grant/Funding Number | The capital health research and development of special |
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| Name | Class |
|---|---|
| Beijing Municipal Science & Technology Commission | OTHER |
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It is hypothesised that the efficacy and safety of Vitamin D2 soft capsule to treat the Chronic Kidney Disease Mineral and Bone Disease (CKD-MBD) are equal to 1,25(OH)2 Vitamin D3 (Rocaltrol) in the patients with CKD stage 3-5.
This study will enroll chronic kidney disease patients, stage 3 to 5, who have chronic kidney disease mineral and bone disease (CKD-MBD)as defined by Kidney Disease Improvement Global Outcome (KDIGO) Guidelines. Patients in one center will be randomized to receive oral Vitamin D2 soft capsule or Rocaltrol. A total of 200 patients will be enrolled, 100 in the Vitamin D2 group and 100 in the 1,25(OH)2 Vitamin D3 group. Outcomes will be assessed as proportion of patients achieving target blood levels on calcium, phosphorus, parathyroid hormone, and 25 hydroxyvitamin D. Other outcomes will also be assessed, which include secondary hyperparathyroidism (sHPT), vascular calcification, and cardiovascular diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D2 Treatment | Experimental | Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level. |
|
| 1,25(OH)2 Vitamin D3 | Active Comparator | Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D2 | Drug | Treatment with Vit D2. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The Blood Levels of Calcium at the 24th Month of Following up. | The blood levels of calcium at the 24th month of following up will be detected. | 24 months |
| The Blood Levels of Phosphorus at the 24th Month of Following up. | The blood levels of phosphorus at the 24th month of following up will be detected. | 24 months |
| The Blood Levels of Intact Parathyroid Hormone at the 24th Month of Following up. | The blood levels of intact parathyroid hormone (iPTH) at the 24th month of following up will be detected. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| The Blood 25(OH)Vitamin D Level. | The levels of blood 25(OH)Vitamin D at the 24th month of following up. | 24 months |
| The Incidence Rate of Secondary Hyperparathyroidism. | Patients with the blood iPTH level higher than 300 pg/ml will be regard as sHPT. The incidence of sHPT during following up were recorded and compared between two groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dongliang Zhang, Doctor | Nephrology Department of Beijing Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friedship Hospital | Beijing | Beijing Municipality | 100050 | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin D2 | Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level. Vitamin D2: Treatment with Vit D2. |
| FG001 | 1,25(OH)2 Vitamin D3 | Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone. 1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin D2 | Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level. Vitamin D2: Treatment with Vit D2. |
| BG001 | 1,25(OH)2 Vitamin D3 |
| 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 | The Blood Levels of Calcium at the 24th Month of Following up. | The blood levels of calcium at the 24th month of following up will be detected. | Posted | Mean | Standard Deviation | mmol/L | 24 months |
|
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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 | Vitamin D2 | Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level. Vitamin D2: Treatment with Vit D2. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AMI | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Renal replacement therapy | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Zhang Dongliang | Peking University Internetional Hospital | +86-10-69006561 | zhangdongliang@pkuih.edu.cn |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| D012080 | Chronic Kidney Disease-Mineral and Bone Disorder |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D004872 | Ergocalciferols |
| D002117 | Calcitriol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| 1,25(OH)2 Vit D3 | Drug | Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol). |
|
|
| 24 months |
Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone. 1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Ca-baseline | Mean | Standard Deviation | mmol/L |
|
| P-baseline | Mean | Standard Deviation | mmol/L |
|
| iPTH-baseline | Mean | Standard Deviation | ng/ml |
|
| 25(OH)Vit D | Mean | Standard Deviation | ng/ml |
|
|
|
|
| Secondary | The Blood 25(OH)Vitamin D Level. | The levels of blood 25(OH)Vitamin D at the 24th month of following up. | Posted | Mean | Standard Deviation | ng/ml | 24 months |
|
|
|
|
| Secondary | The Incidence Rate of Secondary Hyperparathyroidism. | Patients with the blood iPTH level higher than 300 pg/ml will be regard as sHPT. The incidence of sHPT during following up were recorded and compared between two groups. | Posted | Number | participants | 24 months |
|
|
|
|
| Primary | The Blood Levels of Phosphorus at the 24th Month of Following up. | The blood levels of phosphorus at the 24th month of following up will be detected. | Posted | Mean | Standard Deviation | mmol/L | 24 months |
|
|
|
|
| Primary | The Blood Levels of Intact Parathyroid Hormone at the 24th Month of Following up. | The blood levels of intact parathyroid hormone (iPTH) at the 24th month of following up will be detected. | Posted | Mean | Standard Deviation | pg/ml | 24 months |
|
|
|
|
| 13 |
| 104 |
| 10 |
| 104 |
| EG001 | 1,25(OH)2 Vitamin D3 | Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone. 1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol). | 10 | 100 | 8 | 100 |
| congestive heart failure | Cardiac disorders | Systematic Assessment |
|
| Stroke | Nervous system disorders | Systematic Assessment |
|
| In patient | General disorders | Systematic Assessment |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| D012279 | Rickets |
| 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 |
| D002128 | Calcium Metabolism Disorders |
| D006962 | Hyperparathyroidism, Secondary |
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D004100 | Dihydroxycholecalciferols |
| D006887 | Hydroxycholecalciferols |
| D002762 | Cholecalciferol |
| t-test, 2 sided |
| <0.001 |
| 2-Sided |
| No |
| Superiority or Other |
| The levels of blood 25(OH) Vitamin D at the 24th month of following up were compared between two groups. | t-test, 2 sided | <0.001 | P<0.001, t=-14.982. | 2-Sided | No | Superiority or Other |
| t-test, 2 sided |
| <0.001 |
| 2-Sided |
| No |
| Superiority or Other |
| The levels of blood phosphorus at the 24th month of following up were compared between two groups. | t-test, 2 sided | 0.694 | t=0.394 | 2-Sided | No | Superiority or Other |
| t-test, 2 sided |
| 0.106 |
| 2-Sided |
| No |
| Superiority or Other |
| The levels of blood iPTH at the 24th month of following up were compared between two groups. | t-test, 2 sided | 0.463 | t=-0.736 | 2-Sided | No | Superiority or Other |