Efficacy of Vitamin D2 to Treat Chronic Kidney Disease Mineral and Bone Disorder
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|ClinicalTrials.gov Identifier: NCT01633853|
Recruitment Status : Completed
First Posted : July 4, 2012
Results First Posted : February 15, 2016
Last Update Posted : February 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Vitamin D Deficiency||Drug: Vitamin D2 Drug: 1,25(OH)2 Vit D3||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||204 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Vitamin D2 Virus 1,25(OH)2-Vitamin D3 in the Treatment of Chronic Kidney Disease Mineral and Bone Disease|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
Experimental: Vitamin D2 Treatment
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
Treatment with Vit D2.
Other Name: Vitamin D2 soft capsules
Active Comparator: 1,25(OH)2 Vitamin D3
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
Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol).
Other Name: Rocaltrol
- The Blood Levels of Calcium at the 24th Month of Following up. [ Time Frame: 24 months ]The blood levels of calcium at the 24th month of following up will be detected.
- The Blood Levels of Phosphorus at the 24th Month of Following up. [ Time Frame: 24 months ]The blood levels of phosphorus at the 24th month of following up will be detected.
- The Blood Levels of Intact Parathyroid Hormone at the 24th Month of Following up. [ Time Frame: 24 months ]The blood levels of intact parathyroid hormone (iPTH) at the 24th month of following up will be detected.
- The Blood 25(OH)Vitamin D Level. [ Time Frame: 24 months ]The levels of blood 25(OH)Vitamin D at the 24th month of following up.
- The Incidence Rate of Secondary Hyperparathyroidism. [ Time Frame: 24 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01633853
|Beijing Friedship Hospital|
|Beijing, Beijing, China, 100050|
|Principal Investigator:||Dongliang Zhang, Doctor||Nephrology Department of Beijing Friendship Hospital|