<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01672047</url>
  </required_header>
  <id_info>
    <org_study_id>PURCP201103</org_study_id>
    <nct_id>NCT01672047</nct_id>
  </id_info>
  <brief_title>Effect of Vitamin D Supplementation on Coronary Calcification and Parathyroid Hormone in CKD Patients</brief_title>
  <acronym>EVIDENCE</acronym>
  <official_title>Effect of Vitamin D Supplementation on Coronary Calcification and Parathyroid Hormone in CKD Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University People's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypothesize that the chronic kidney disease patients who suffer from&#xD;
      vitamin D deficiency will be benefit from given Vitamin D2 because coronary artery&#xD;
      calcification and hyperparathyroidism will be improved.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We will call for 350 CKD patients (250 CKD3-5stage and 100 CKD5D stage)who suffer from&#xD;
      vitamin D deficiency.They will be divided into 2 groups. One group will be given vitamin D&#xD;
      and the other will not. They will take coronary artery CT test every year(in 2 years).We will&#xD;
      compare the coronary calcification progression between the 2 groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2012</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">April 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the improvement of coronary artery calcification</measure>
    <time_frame>2 years</time_frame>
    <description>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。</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the improvement of proteinuria</measure>
    <time_frame>2 years</time_frame>
    <description>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。</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">350</enrollment>
  <condition>Chronic Kidney Disease</condition>
  <condition>Vitamin D Deficiency</condition>
  <arm_group>
    <arm_group_label>Treament</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention Vitamin D2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Not take Vitamin D2</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vitamin D2</intervention_name>
    <description>25（OH）D level &lt;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， &gt;116.75nmol/L stopped.</description>
    <arm_group_label>Treament</arm_group_label>
    <other_name>Vitmain D2 capsule</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  chronic kidney disease patients (3-5D)&#xD;
&#xD;
          -  serum 25（OH）D &lt; 40nmol/L(16ng/ml)，serum calcium &lt; 2.55mmol/L（10.2mg/dL）；&#xD;
&#xD;
          -  willing to sign&#xD;
&#xD;
          -  could obey the follow up design&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  allergy to vitamin D&#xD;
&#xD;
          -  heart failure (NYHA more than 2 grade)&#xD;
&#xD;
          -  pregnant&#xD;
&#xD;
          -  malignant tumor&#xD;
&#xD;
          -  critical hepatic disease&#xD;
&#xD;
          -  taking Vitamin D or analogue in 3 recent months&#xD;
&#xD;
          -  taking other clinical trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mei Wang, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University People's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The People's Hospital of Peking University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100044</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sui Zhun, MD</last_name>
      <phone>86-010-88325507</phone>
      <email>suizhun@bjmu.edu.cn</email>
    </contact>
    <contact_backup>
      <last_name>Wang Mei, MD</last_name>
      <phone>86-010-88325513</phone>
      <email>wangmei@163.com</email>
    </contact_backup>
    <investigator>
      <last_name>Wang Mei, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 24, 2012</study_first_posted>
  <last_update_submitted>August 29, 2012</last_update_submitted>
  <last_update_submitted_qc>August 29, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 30, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University People's Hospital</investigator_affiliation>
    <investigator_full_name>Wang Mei</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>The 25(OH) vitamin D level</keyword>
  <keyword>The 1.25(OH) vitamin D level</keyword>
  <keyword>The intact PTH level</keyword>
  <keyword>The calcification score of coronary artery</keyword>
  <keyword>The microalbuminuria level</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Vitamin D Deficiency</mesh_term>
    <mesh_term>Calcinosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</mesh_term>
    <mesh_term>Ergocalciferols</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01672047
org study id: PURCP201103
nct id: NCT01672047
lead sponsor: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: the improvement of coronary artery calcification
time frame: 2 years
description: 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。
measure: the improvement of proteinuria
time frame: 2 years
description: 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。
arm group label: Treament
arm group type: Experimental
description: Intervention Vitamin D2
arm group label: Control
arm group type: No Intervention
description: Not take Vitamin D2
intervention type: Drug
intervention name: Vitamin D2
description: 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.
arm group label: Treament
other name: Vitmain D2 capsule
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Mei Wang, MD, PhD
role: Principal Investigator
affiliation: Peking University People's Hospital
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University People's Hospital
investigator full name: Wang Mei
investigator title: Professor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Vitamin D Deficiency
mesh term: Calcinosis
mesh term: Vitamin D
mesh term: Ergocalciferols