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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

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ClinicalTrials.gov Identifier: NCT01561222
Recruitment Status : Unknown
Verified June 2015 by Xu Zhang, Taixing People's Hospital.
Recruitment status was:  Not yet recruiting
First Posted : March 22, 2012
Last Update Posted : June 8, 2015
Sponsor:
Information provided by (Responsible Party):
Xu Zhang, Taixing People's Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Kidney Disease Stage 1 Chronic Kidney Disease Stage 2 Drug: Calcitriol Drug: placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Study Start Date : July 2015
Estimated Primary Completion Date : March 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Calcitriol

Arm Intervention/treatment
Placebo Comparator: placebo Drug: placebo
one pill per day

Experimental: Calcitriol Drug: Calcitriol
0.25 ug per day for one year
Other Name: Rocaltrol




Primary Outcome Measures :
  1. Osteoprotegin level [ Time Frame: one year ]
    To assess the effect of vitamin D supplementation on osteoprotegin level in CKD patients


Secondary Outcome Measures :
  1. 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

  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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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): 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

Responsible Party: Xu Zhang, Zhang Xu, Taixing People's Hospital
ClinicalTrials.gov Identifier: NCT01561222     History of Changes
Other Study ID Numbers: zhangxu2012
First Posted: March 22, 2012    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: June 2015

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

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Calcitriol
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents