Optimizing Treatment Programs for Chronic Kidney Disease-mineral and Bone Disorder and Malnutrition

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Study of Vitamin D2 Virus 1,25(OH)2-Vitamin D3 and Normal Protein Diet Virus Low Protein Diet in the Treatment of CKD-MBD and Malnutrition for Progressive CKD Patients

Conditions
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Vitamin D Deficiency, Malnutrition

Intervention / Treatment
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* Drug: 1,25(OH)2 Vitamin D3
* Drug: Vitamin D2
* Dietary Supplement: low protein diet
* Dietary Supplement: normal protein diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with age between 18-80 years. Patients with chronic kidney disease stage 3 to 5, and concurrent chronic kidney disease mineral and bone disorder and malnutrition Exclusion Criteria: Renal artery stenosis, inherent renal malformation, solitary kidney, or malignancy in urinary system. Active system immunity diseases. History of liver failure History of intestinal malabsorption or chronic diarrhea Treatment with phenobarbital, phenytoin, rifampicin, sucralfate, steroids, digoxin, or other medications that could affect vitamin D metabolism Primary hyperparathyroidism Treatment with cinacalcet or other calcimimetic within the past 6 months Anticipated dialysis within 6 months after randomization Have an unstable medical condition, defined as having been hospitalized within 30 days before screening, the expectation of recurrent hospital admissions or life expectancy of less than 6 months in the judgment of the investigator Subject is currently enrolled in, or fewer than 30 days have passed since subject has completed another investigational device or drug study(s); or subject is receiving another investigational agent(s). Current treatment with vitamin D 50,000 IU Using glucocorticoid or immunosuppressive agents. Acute renal dysfunction. The expected live time is less than 2 years. Pregnant or lactating woman. Suffered from acute myocardial infraction, acute congestive heart failure, or stroke in last 6 months. Patients whose concurrent illnesses, disability, or geographical residence would hamper attendance at required study visit.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D2 Treatment<br> | Drug: Vitamin D2<br>* 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.<br>* Other names: Vit D2;|
| Active Comparator: 1,25(OH)2 Vitamin D3<br> | Drug: 1,25(OH)2 Vitamin D3<br>* 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.<br>* Other names: Active Vit D3;|
| Experimental: low protein diet<br> | Dietary Supplement: low protein diet<br>* 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.<br>|
| Active Comparator: normal protein diet<br> | Dietary Supplement: normal protein diet<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic kidney disease, mineral and bone disease, Malnutrition, Vitamin D, low protein diet