Effect of Vitamin D Supplementation on Coronary Calcification and Parathyroid Hormone in CKD Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Vitamin D Supplementation on Coronary Calcification and Parathyroid Hormone in CKD Patients

Conditions
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Chronic Kidney Disease, Vitamin D Deficiency

Intervention / Treatment
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* Drug: Vitamin D2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treament<br>Intervention Vitamin D2 | Drug: Vitamin D2<br>* 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.<br>* Other names: Vitmain D2 capsule;|
| No Intervention: Control<br>Not take Vitamin D2 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the improvement of coronary artery calcification | 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。 | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the improvement of proteinuria | 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。 | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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