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

Peking University

Status: Unknown

Conditions: Chronic Kidney Disease; Vitamin D Deficiency

Treatments: Drug: Vitamin D2

Study type: Interventional

Funder types: Other

Identifiers

NCT01672047

PURCP201103

Details and patient eligibility

About

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.

Full 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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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350 participants in 2 patient groups

Treament

Experimental group

Description:

Intervention Vitamin D2

Treatment:

Drug: Vitamin D2

Control

No Intervention group

Description:

Not take Vitamin D2