NCT01633853

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: Dongliang Zhang, MD · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Vitamin D Deficiency

Interventions

Type	Name	Description
DRUG	Vitamin D2	Treatment with Vit D2.
DRUG	1,25(OH)2 Vit D3	Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol).

Timeline

• Start date: 2012-07-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2012-07-04
• Last updated: 2016-02-15
• Results posted: 2016-02-15

Locations

1 site across 1 country: China