Efficacy of Vitamin D2 to Treat Chronic Kidney Disease Mineral and Bone Disorder

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Study of Vitamin D2 Virus 1,25(OH)2-Vitamin D3 in the Treatment of Chronic Kidney Disease Mineral and Bone Disease

Conditions
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Vitamin D Deficiency

Intervention / Treatment
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* Drug: Vitamin D2
* Drug: 1,25(OH)2 Vit D3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with age between 18-75 years. Patients with chronic kidney disease stage 3 to 5, and concurrent chronic kidney disease mineral and bone disorder. Exclusion Criteria: Renal artery stenosis, inherent renal malformation, solitary kidney, or malignancy in urinary system. New fracture in last 3 months. 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: 75 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>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. | Drug: Vitamin D2<br>* Treatment with Vit D2.<br>* Other names: Vitamin D2 soft capsules;|
| Active Comparator: 1,25(OH)2 Vitamin D3<br>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. | Drug: 1,25(OH)2 Vit D3<br>* Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol).<br>* Other names: Rocaltrol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 24 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 disorder, vitamin D2, parathyroid hormone