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
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Disease Stage 1
Chronic Kidney Disease Stage 2
Drug: Calcitriol
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Taixing People's Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 300
Study Start Date: July 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo Drug: placebo
one pill per day
Experimental: Calcitriol Drug: Calcitriol
0.25 ug per day for one year
Other Name: Rocaltrol

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01561222

Contacts
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

Locations
China, Jiangsu
Taixing People's Hospital Not yet recruiting
Taixing, Jiangsu, China, 225400
Contact: Xu Zhang, bachelor    008-613-905-266-789    dr.zhangxu@tom.com   
Sponsors and Collaborators
Taixing People's Hospital
  More Information

No publications provided

Responsible Party: Xu Zhang, Zhang Xu, Taixing People's Hospital
ClinicalTrials.gov Identifier: NCT01561222     History of Changes
Other Study ID Numbers: zhangxu2012
Study First Received: March 19, 2012
Last Updated: March 21, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Taixing People's Hospital:
calcitrol
Bone mineral density
Osteoprotegin
Vascular calcification

Additional relevant MeSH terms:
Kidney Diseases
Disease Progression
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Disease Attributes
Pathologic Processes
Renal Insufficiency
Calcitriol
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014