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| ID | Type | Description | Link |
|---|---|---|---|
| D131100004713001 | Other Grant/Funding Number | Beijing Municipal Science and Technology Commission |
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| Name | Class |
|---|---|
| Beijing Municipal Science & Technology Commission | OTHER |
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Multi-center, prospective, randomized, controlled study to verify the clinical effectiveness of K / DOQI guidelines. The efficiency and safety of Vitamin D2 and low protein diet treatment for prevention and treatment of CKD-MBD and malnutrition in CKD3-5 (ND) patients.
This study will enroll chronic kidney disease patients, stage 3 to 5ND, who have chronic kidney disease mineral and bone disease (CKD-MBD) and malnutrition as defined by Kidney Disease Improvement Global Outcome (KDIGO) Guidelines. Patients in five centers will be randomized. A total of 600 patients will be enrolled, 150 patients receiving Vitamin D2 treatment virus 150 patients receiving calcitriol treatment, and another 150 patients receiving low protein diet virus 150 patients receiving normal protein diet. Outcomes will be assessed as proportion of patients achieving target blood levels on calcium, phosphorus, parathyroid hormone, 25 hydroxyvitamin D, albumin and hemoglobin. Other outcomes will also be assessed, which include secondary hyperparathyroidism (sHPT), vascular calcification, cardiovascular diseases, nutritional status and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D2 Treatment | Experimental |
| |
| 1,25(OH)2 Vitamin D3 | Active Comparator |
| |
| low protein diet | Experimental |
| |
| normal protein diet | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1,25(OH)2 Vitamin D3 | Drug | Oral 1,25(OH)2 Vitamin D3 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The changes on the blood levels of calcium, phosphorus, and intact parathyroid (iPTH) hormone during 36 months | The blood levels of calcium, phosphorus,and intact parathyroid (iPTH) will be detected every three months. The values during follow-up will be compared to the baseline. | 36 months |
| The changes on the clinical indicators of nutritional status | The blood levels of albumin, prealbumin, transferrin and hemoglobin will be detected every three months. The values during follow-up will be compared to the baseline. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| The changes of the blood 25(OH)Vitamin D level | 36 months | |
| The changes of the quality of life | Assess the quality of life for patients in accordance with KDQOL-SF scale every 6 month. The values during follow-up will be compared to the baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wenhu Liu, Doctor | Nephrology Department of Beijing Friendship Hospita | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing XuanWu Hospital | Beijing | Beijing Municipality | 100000 | China | ||
| People's Liberation Army Air Force General Hospital |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| D044342 | Malnutrition |
| D051436 | Renal Insufficiency, Chronic |
| D002114 | Calcinosis |
| D001847 | Bone Diseases |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004872 | Ergocalciferols |
| D018753 | Diet, Protein-Restricted |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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|
| Vitamin D2 | Drug | 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. |
|
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| low protein diet | Dietary Supplement | Using nutritious software to make meals recipes and give dietary guidance for patients to reach the DPI goal of 0.6g-0.8g/kg/d. |
|
| normal protein diet | Dietary Supplement | Using nutritious software to make meals recipes and give dietary guidance for patients to reach the DPI goal of more than 0.8g/kg/d. |
|
| 36 months |
| Beijing |
| Beijing Municipality |
| 100000 |
| China |
| People's Liberation Army General Hospital | Beijing | Beijing Municipality | 100000 | China |
| Sino-Japanese Friendship Hospital | Beijing | Beijing Municipality | 100000 | China |
| Beijing Friedship Hospital | Beijing | Beijing Municipality | 100050 | China |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009140 | Musculoskeletal Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |