Chronic Kidney Disease Stage 1, Chronic Kidney Disease Stage 2
Conditions
Keywords
calcitrol, Bone mineral density, Osteoprotegin, Vascular calcification
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.
Interventions
DRUGCalcitriol
0.25 ug per day for one year
DRUGplacebo
one pill per day
Sponsors
Taixing People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Osteoprotegin level | one year | To assess the effect of vitamin D supplementation on osteoprotegin level in CKD patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bone mineral density | 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 | 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 |
Countries
China
Contacts
Primary ContactXu Zhang, Bachelor
Backup ContactCai-xia Zhao, Master
Outcome results
None listed