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

Not Applicable

• Conditions: Chronic Kidney Disease; Vitamin D Deficiency
• Interventions: Drug: Vitamin D2

• Registration Number: NCT01672047
• Lead Sponsor: Peking University People's Hospital

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.

Study Timeline

• Study Start: 2012-04
• Status Verified: 2012-08
• Study First Submitted: 2012-08-21
• Study First Submitted QC: 2012-08-23
• Study First Posted: 2012-08-24
• Last Update Submitted: 2012-08-29
• Last Update Posted: 2012-08-30
• Primary Completion: 2014-04
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treament	Vitamin D2	Intervention Vitamin D2

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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。

Trial Locations

Locations (1)

The People's Hospital of Peking University; 🇨🇳 Beijing, Beijing, China