Chronic Kidney Disease, Vitamin D Deficiency
Conditions
Keywords
The 25(OH) vitamin D level, The 1.25(OH) vitamin D level, The intact PTH level, The calcification score of coronary artery, The microalbuminuria level
Brief summary
The investigators hypothesize that the chronic kidney disease patients who suffer from vitamin D deficiency will be benefit from given Vitamin D2 because coronary artery calcification and hyperparathyroidism will be improved.
Detailed description
We will call for 350 CKD patients (250 CKD3-5stage and 100 CKD5D stage)who suffer from vitamin D deficiency.They will be divided into 2 groups. One group will be given vitamin D and the other will not. They will take coronary artery CT test every year(in 2 years).We will compare the coronary calcification progression between the 2 groups.
Interventions
DRUGVitamin D2
25（OH）D level \<12 nmol/L 50000IU/weekX12week， 12-39 nmol/L 50000IU/weekX4week then，50000IU/month， 40-75 nmol/L 50000IU/month， 75-116.75nmol/L 25000IU/month， \>116.75nmol/L stopped.
Sponsors
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* chronic kidney disease patients (3-5D) * serum 25（OH）D \< 40nmol/L(16ng/ml)，serum calcium \< 2.55mmol/L（10.2mg/dL）； * willing to sign * could obey the follow up design
Exclusion criteria
* allergy to vitamin D * heart failure (NYHA more than 2 grade) * pregnant * malignant tumor * critical hepatic disease * taking Vitamin D or analogue in 3 recent months * taking other clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the improvement of coronary artery calcification | 2 years | We use CT to detect the coronary artery calcification score in the chronic kidney disease patients for 3 times (baseline, 12 month and 24 month). We will compare the 2 arms （treatment or not）to know if there is any difference。 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the improvement of proteinuria | 2 years | We detect the microalbuminuria in the chronic kidney disease patients for 5 times (baseline, 6 month,12 month 18month and 24 month). We will compare the 2 arms （treatment or not）to know if there is any difference。 |
Countries
China
Outcome results
None listed