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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2015 by Xu Zhang, Taixing People's Hospital.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01561222
First Posted: March 22, 2012
Last Update Posted: June 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Xu Zhang, Taixing People's Hospital
March 19, 2012
March 22, 2012
June 8, 2015
July 2015
March 2016   (Final data collection date for primary outcome measure)
Osteoprotegin level [ Time Frame: one year ]
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 ]
    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 ]
    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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
 
Unknown status
300
Not Provided
March 2016   (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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01561222
zhangxu2012
Not Provided
Not Provided
Not Provided
Xu Zhang, Taixing People's Hospital
Taixing People's Hospital
Not Provided
Not Provided
Taixing People's Hospital
June 2015

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