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

Chronic Kidney Disease Stage 2 Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01561222
• Other study ID #: zhangxu2012
• Status: Not yet recruiting
• Phase: Phase 4
• First received: March 19, 2012
• Last updated: June 5, 2015
• Start date: July 2015

Study information

• Verified date: June 2015
• Source: Taixing People's Hospital
• Contact: Xu Zhang, Bachelor
• Phone: 008-613-905-266-789
• Email: dr.zhangxu[@]tom.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Chronic Kidney Disease Stage 1
• Chronic Kidney Disease Stage 2
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Calcitriol
0.25 ug per day for one year
• placebo
one pill per day

Locations

Country	Name	City	State
China	Taixing People's Hospital	Taixing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Taixing People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Osteoprotegin level	To assess the effect of vitamin D supplementation on osteoprotegin level in CKD patients	one year	No
Secondary	Bone mineral density	To assess the effect of vitamin D supplementation on bone mineral density in patients with CKD stage 1 and 2	one year	No
Secondary	vascular calcification score	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	one year	No