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

August 29, 2012 updated by: Wang Mei, Peking University People's Hospital
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100044
        • Recruiting
        • The People's Hospital of Peking University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wang Mei, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treament
Intervention Vitamin D2
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.
Other Names:
  • Vitmain D2 capsule
No Intervention: Control
Not take Vitamin D2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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。
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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。
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Investigators

  • Principal Investigator: Mei Wang, MD, PhD, Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Anticipated)

April 1, 2014

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

August 21, 2012

First Submitted That Met QC Criteria

August 23, 2012

First Posted (Estimate)

August 24, 2012

Study Record Updates

Last Update Posted (Estimate)

August 30, 2012

Last Update Submitted That Met QC Criteria

August 29, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PURCP201103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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