Effect of Vitamin D Supplement on Osteoprotegin Expression and Disease Progression in Patients With Chronic Kidney Disease Stage 1 and 2

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2012 by Taixing People's Hospital
Sponsor:
Information provided by (Responsible Party):
Xu Zhang, Taixing People's Hospital
ClinicalTrials.gov Identifier:
NCT01561222
First received: March 19, 2012
Last updated: March 21, 2012
Last verified: March 2012

March 19, 2012
March 21, 2012
July 2012
December 2014   (final data collection date for primary outcome measure)
Osteoprotegin level [ Time Frame: one year ] [ Designated as safety issue: No ]
To assess the effect of vitamin D supplementation on osteoprotegin level in CKD patients
Same as current
Complete list of historical versions of study NCT01561222 on ClinicalTrials.gov Archive Site
  • Bone mineral density [ Time Frame: one year ] [ Designated as safety issue: No ]
    To assess the effect of vitamin D supplementation on bone mineral density in patients with CKD stage 1 and 2
  • vascular calcification score [ Time Frame: one year ] [ Designated as safety issue: No ]
    To assess the effect of vitamin D supplementation on vascular calcification score through performing lateral abdominal radiography or CT-based techniques in patients with CKD stage 1 and 2
Same as current
Not Provided
Not Provided
 
Effect of Vitamin D Supplement on Osteoprotegin Expression and Disease Progression in Patients With Chronic Kidney Disease Stage 1 and 2
Not Provided

Vitamin D Supplement in patients with CKD stage 1 and 2 may change osteoprotegin expression so as to produce beneficial effects of cardiovascular、bone metabolism and CKD progression.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Chronic Kidney Disease Stage 1
  • Chronic Kidney Disease Stage 2
  • Drug: Calcitriol
    0.25 ug per day for one year
    Other Name: Rocaltrol
  • Drug: placebo
    one pill per day
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
  • Experimental: Calcitriol
    Intervention: Drug: Calcitriol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
300
Not Provided
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of CKD stage 1 and 2
  • Age >18 years
  • Ability to provide informed consent

Exclusion Criteria:

  • On vitamin D in past 4 weeks
  • Plans to relocate out of Taixing City in the next one year
  • Serum phosphate >5.5 mg/dl in past 3 months
  • Serum calcium >10.0 mg/dl in past 3 months
  • Cancer
  • Transplanted organ
  • Rapidly deteriorating kidney function with the expectation for initiation of dialysis in less than 6 months
Both
18 Years to 80 Years
No
Contact: Xu Zhang, Bachelor 008-613-905-266-789 dr.zhangxu@tom.com
Contact: Cai-xia Zhao, Master 008-615-896-079-628 zhaocaixia2010@yahoo.cn
China
 
NCT01561222
zhangxu2012
Not Provided
Xu Zhang, Taixing People's Hospital
Taixing People's Hospital
Not Provided
Not Provided
Taixing People's Hospital
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP