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

Chronic Kidney Disease Clinical Trial

— EVIDENCE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01672047
• Other study ID #: PURCP201103
• Status: Recruiting
• Phase: N/A
• First received: August 21, 2012
• Last updated: August 29, 2012
• Start date: April 2012
• Est. completion date: December 2015

Study information

• Verified date: August 2012
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: December 2015
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Calcinosis
• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic
• Vitamin D Deficiency

Intervention

Drug:
• Vitamin 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.

Locations

Country	Name	City	State
China	The People's Hospital of Peking University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No