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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2014

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

  • 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.

Arms, Groups and Cohorts

  • Experimental: Treament
    • Intervention Vitamin D2
  • No Intervention: Control
    • Not take Vitamin D2

Clinical Trial Outcome Measures

Primary Measures

  • the improvement of coronary artery calcification
    • Time Frame: 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 Measures

  • the improvement of proteinuria
    • Time Frame: 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。

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Peking University People’s Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Wang Mei, Professor – Peking University People’s Hospital
  • Overall Official(s)
    • Mei Wang, MD, PhD, Principal Investigator, Peking University People’s Hospital

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