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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
204
Treatment with Vit D2.
Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol).
Beijing Friedship Hospital
Beijing, Beijing Municipality, China
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.
Time frame: 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.
Time frame: 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.
Time frame: 24 months
The Blood 25(OH)Vitamin D Level.
The levels of blood 25(OH)Vitamin D at the 24th month of following up.
Time frame: 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.
Time frame: 24 months
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