<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/NCT03264625</url>
  </required_header>
  <id_info>
    <org_study_id>Vitamin D, RCT</org_study_id>
    <nct_id>NCT03264625</nct_id>
  </id_info>
  <brief_title>The Effects of Oral Vitamin D Supplementation on the Prevention of Peritoneal Dialysis-related Peritonitis</brief_title>
  <official_title>The Effects of Oral Vitamin D Supplementation on the Prevention of Peritoneal Dialysis-related Peritonitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University First Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University First Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pilot randomized, controlled trial of Vitamin D supplementation in patients on&#xD;
      peritoneal dialysis to determine the feasibility of a future full-scale RCT exploring if oral&#xD;
      administration of vitamin D3 could reduce the risk of subsequent Peritoneal dialysis-related&#xD;
      (PD-related) peritonitis.&#xD;
&#xD;
      Aims of the study:&#xD;
&#xD;
      Aim 1: To determine the feasibility of oral vitamin D supplementation among PD patients who&#xD;
      have recovered from a recent episode of peritonitis.&#xD;
&#xD;
      Aim 2: To examine the effect of vitamin D supplementation on the risk for peritonitis among&#xD;
      patients on peritoneal dialysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be screened for eligibility one month after the onset of PD-related&#xD;
      peritonitis, those who meet the inclusion criteria will be enrolled in this study.&#xD;
&#xD;
      All consenting participants will be randomized into the vitamin D treatment group or the&#xD;
      control group, general information and baseline biochemistry data would be collected.&#xD;
      Patients in the treatment group will be treated with oral Cholecalciferol (2000IU/day) apart&#xD;
      from routine treatment for PD. Those in the control group will receive routine treatment for&#xD;
      PD. Both groups will be followed for 12 months. During the observational period, any onset of&#xD;
      subsequent peritonitis will be recorded, serum 25(OH)D, biochemical indices will be measured&#xD;
      every 3 months. Follow up would take place frequently, any outcome events would be recorded.&#xD;
&#xD;
      Aims and hypotheses:&#xD;
&#xD;
      Aim 1: To determine the feasibility of oral vitamin D supplementation among PD patients who&#xD;
      have recovered from a recent episode of peritonitis.&#xD;
&#xD;
      Hypothesis1: A large、full-scale randomized controlled trail on the effects of oral vitamin D&#xD;
      on the risk for peritonitis among PD patients is feasible.&#xD;
&#xD;
      Aim 2: To examine the effect of vitamin D supplementation on the risk for peritonitis among&#xD;
      patients on peritoneal dialysis.&#xD;
&#xD;
      Hypothesis 2: Oral supplementation of vitamin D will reduce the risk of subsequent peritoneal&#xD;
      dialysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 30, 2017</start_date>
  <completion_date type="Actual">July 30, 2021</completion_date>
  <primary_completion_date type="Actual">May 28, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recruitment rate of the trial</measure>
    <time_frame>From date of randomization until 1 year after the randomization of last participant.</time_frame>
    <description>Recruitment rate of patients screened for the trial measured by percentage.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Retention rate of the trial</measure>
    <time_frame>From date of randomization until 1 year after the randomization of last participant</time_frame>
    <description>Retention rate of included patients in the trial measured by percentage.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence rate of the trial</measure>
    <time_frame>From date of randomization until 1 year after the randomization of last participant.</time_frame>
    <description>Percentage of participants adherent to the dosing regimen of vitamin D in the trial.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>From date of randomization until 1 year after the randomization of last participant.</time_frame>
    <description>Incidence of adverse events measured by number of events per patient-month</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in serum 25(OH)D level</measure>
    <time_frame>From date of randomization until 1 year after the randomization of last participant</time_frame>
    <description>Change in serum 25(OH)D level between baseline and 12 months measured by ng/ml.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in risk of a subsequent peritonitis measured by Hazard Ratio.</measure>
    <time_frame>From date of randomization until the date of subsequent peritonitis, assessed up to 1 year.</time_frame>
    <description>Risk of a subsequent peritoneal dialysis related peritonitis in the interventional group compared with the control group measured by Hazard Ratio.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Probability of participants who recovered after subsequent peritoneal dialysis related peritonitis.</measure>
    <time_frame>From date of randomization until the date of documented death, assessed up to 1 year.</time_frame>
    <description>Probability of participants who recovered after peritoneal dialysis-related peritonitis measured by percentage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risk of participants who died because of subsequent peritoneal dialysis related peritonitis.</measure>
    <time_frame>From date of randomization until the date of documented death, assessed up to 1 year.</time_frame>
    <description>Risk of participants who died because of peritoneal dialysis-related peritonitis measured by percentage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risk of participants who are transitioned to hemodialysis because of subsequent peritoneal dialysis related peritonitis.</measure>
    <time_frame>From date of randomization until the date of documented transition to hemodialysis because of peritoneal dialysis related peritonitis, assessed up to 1 year.</time_frame>
    <description>Risk of patients who are transferred to hemodialysis because of peritoneal dialysis related peritonitis measured by percentage.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Peritoneal Dialysis-associated Peritonitis</condition>
  <condition>Vitamin D Deficiency</condition>
  <arm_group>
    <arm_group_label>Treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive oral Cholecalciferol (2000IU qd) apart from routine therapy for PD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients randomized to the placebo group will receive routine therapy for PD.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cholecalciferol (2000iu qd)</intervention_name>
    <description>Patients will receive oral Cholecalciferol (2000IU qd) apart from routine therapy for PD</description>
    <arm_group_label>Treatment group</arm_group_label>
    <other_name>Natural Vitamin D3</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Routine therapy for PD</intervention_name>
    <description>Patients randomized to the placebo group will receive routine therapy for PD.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Medically stable and receiving peritoneal dialysis (PD) for&gt;1 months&#xD;
&#xD;
          2. Age at least 18 years.&#xD;
&#xD;
          3. Serum 25(OH)D&lt;75nmol/l (30ng/ml)&#xD;
&#xD;
          4. Adequate dialysis on evaluation, weekly Kt/V ≥ 1.5 and no clinical uremic symptoms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Receive Vitamin D2/D3 or drugs known to alter serum 25-hydroxyvitamin D (25(OH)D)&#xD;
             levels during the previous 12 months;&#xD;
&#xD;
          2. History of allergic reaction to Cholecalciferol;&#xD;
&#xD;
          3. Current or past malignant disease, active hepatitis or hepatic failure, acute systemic&#xD;
             infection, active autoimmune diseases, severe digestive malabsorption or eating&#xD;
             disorder, HIV/AIDS;&#xD;
&#xD;
          4. A high probability (assessed by the recruiting physician) of receiving a kidney&#xD;
             transplant or transferring to hemodialysis (HD) or drop-out due to socioeconomic&#xD;
             causes within 6 months;&#xD;
&#xD;
          5. Pregnant or breastfeeding;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jie Dong</last_name>
    <role>Study Director</role>
    <affiliation>Peking Universiy First Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking University First Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Pi HC, Ren YP, Wang Q, Xu R, Dong J. Serum 25-Hydroxyvitamin D Level Could Predict the Risk for Peritoneal Dialysis-Associated Peritonitis. Perit Dial Int. 2015 Dec;35(7):729-35. doi: 10.3747/pdi.2014.00177. Epub 2015 Jul 29.</citation>
    <PMID>26224791</PMID>
  </reference>
  <reference>
    <citation>Armas LA, Andukuri R, Barger-Lux J, Heaney RP, Lund R. 25-Hydroxyvitamin D response to cholecalciferol supplementation in hemodialysis. Clin J Am Soc Nephrol. 2012 Sep;7(9):1428-34. doi: 10.2215/CJN.12761211. Epub 2012 Jul 12.</citation>
    <PMID>22798536</PMID>
  </reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>October 10, 2016</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>August 12, 2021</last_update_submitted>
  <last_update_submitted_qc>August 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University First Hospital</investigator_affiliation>
    <investigator_full_name>Dong Jie</investigator_full_name>
    <investigator_title>Director of PD center</investigator_title>
  </responsible_party>
  <keyword>Cholecalciferol</keyword>
  <keyword>Peritoneal dialysis</keyword>
  <keyword>Peritonitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peritonitis</mesh_term>
    <mesh_term>Vitamin D Deficiency</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>Cholecalciferol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 1, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/25/NCT03264625/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03264625
org study id: Vitamin D, RCT
nct id: NCT03264625
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a pilot randomized, controlled trial of Vitamin D supplementation in patients on
      peritoneal dialysis to determine the feasibility of a future full-scale RCT exploring if oral
      administration of vitamin D3 could reduce the risk of subsequent Peritoneal dialysis-related
      (PD-related) peritonitis.

      Aims of the study:

      Aim 1: To determine the feasibility of oral vitamin D supplementation among PD patients who
      have recovered from a recent episode of peritonitis.

      Aim 2: To examine the effect of vitamin D supplementation on the risk for peritonitis among
      patients on peritoneal dialysis.
Patients will be screened for eligibility one month after the onset of PD-related
      peritonitis, those who meet the inclusion criteria will be enrolled in this study.

      All consenting participants will be randomized into the vitamin D treatment group or the
      control group, general information and baseline biochemistry data would be collected.
      Patients in the treatment group will be treated with oral Cholecalciferol (2000IU/day) apart
      from routine treatment for PD. Those in the control group will receive routine treatment for
      PD. Both groups will be followed for 12 months. During the observational period, any onset of
      subsequent peritonitis will be recorded, serum 25(OH)D, biochemical indices will be measured
      every 3 months. Follow up would take place frequently, any outcome events would be recorded.

      Aims and hypotheses:

      Aim 1: To determine the feasibility of oral vitamin D supplementation among PD patients who
      have recovered from a recent episode of peritonitis.

      Hypothesis1: A large、full-scale randomized controlled trail on the effects of oral vitamin D
      on the risk for peritonitis among PD patients is feasible.

      Aim 2: To examine the effect of vitamin D supplementation on the risk for peritonitis among
      patients on peritoneal dialysis.

      Hypothesis 2: Oral supplementation of vitamin D will reduce the risk of subsequent peritoneal
      dialysis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Recruitment rate of the trial
time frame: From date of randomization until 1 year after the randomization of last participant.
description: Recruitment rate of patients screened for the trial measured by percentage.
measure: Retention rate of the trial
time frame: From date of randomization until 1 year after the randomization of last participant
description: Retention rate of included patients in the trial measured by percentage.
measure: Adherence rate of the trial
time frame: From date of randomization until 1 year after the randomization of last participant.
description: Percentage of participants adherent to the dosing regimen of vitamin D in the trial.
measure: Incidence of adverse events
time frame: From date of randomization until 1 year after the randomization of last participant.
description: Incidence of adverse events measured by number of events per patient-month
measure: Change in serum 25(OH)D level
time frame: From date of randomization until 1 year after the randomization of last participant
description: Change in serum 25(OH)D level between baseline and 12 months measured by ng/ml.
measure: Difference in risk of a subsequent peritonitis measured by Hazard Ratio.
time frame: From date of randomization until the date of subsequent peritonitis, assessed up to 1 year.
description: Risk of a subsequent peritoneal dialysis related peritonitis in the interventional group compared with the control group measured by Hazard Ratio.
measure: Probability of participants who recovered after subsequent peritoneal dialysis related peritonitis.
time frame: From date of randomization until the date of documented death, assessed up to 1 year.
description: Probability of participants who recovered after peritoneal dialysis-related peritonitis measured by percentage.
measure: Risk of participants who died because of subsequent peritoneal dialysis related peritonitis.
time frame: From date of randomization until the date of documented death, assessed up to 1 year.
description: Risk of participants who died because of peritoneal dialysis-related peritonitis measured by percentage.
measure: Risk of participants who are transitioned to hemodialysis because of subsequent peritoneal dialysis related peritonitis.
time frame: From date of randomization until the date of documented transition to hemodialysis because of peritoneal dialysis related peritonitis, assessed up to 1 year.
description: Risk of patients who are transferred to hemodialysis because of peritoneal dialysis related peritonitis measured by percentage.
arm group label: Treatment group
arm group type: Experimental
description: Patients will receive oral Cholecalciferol (2000IU qd) apart from routine therapy for PD
arm group label: Control group
arm group type: Placebo Comparator
description: Patients randomized to the placebo group will receive routine therapy for PD.
intervention type: Drug
intervention name: Cholecalciferol (2000iu qd)
description: Patients will receive oral Cholecalciferol (2000IU qd) apart from routine therapy for PD
arm group label: Treatment group
other name: Natural Vitamin D3
intervention type: Other
intervention name: Routine therapy for PD
description: Patients randomized to the placebo group will receive routine therapy for PD.
arm group label: Control group
arm group label: Treatment group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jie Dong
role: Study Director
affiliation: Peking Universiy First Hospital
facility: 
country: China
citation: Pi HC, Ren YP, Wang Q, Xu R, Dong J. Serum 25-Hydroxyvitamin D Level Could Predict the Risk for Peritoneal Dialysis-Associated Peritonitis. Perit Dial Int. 2015 Dec;35(7):729-35. doi: 10.3747/pdi.2014.00177. Epub 2015 Jul 29.
PMID: 26224791
citation: Armas LA, Andukuri R, Barger-Lux J, Heaney RP, Lund R. 25-Hydroxyvitamin D response to cholecalciferol supplementation in hemodialysis. Clin J Am Soc Nephrol. 2012 Sep;7(9):1428-34. doi: 10.2215/CJN.12761211. Epub 2012 Jul 12.
PMID: 22798536
responsible party type: Principal Investigator
investigator affiliation: Peking University First Hospital
investigator full name: Dong Jie
investigator title: Director of PD center
mesh term: Peritonitis
mesh term: Vitamin D Deficiency
mesh term: Vitamin D
mesh term: Cholecalciferol
sharing ipd: No
provided document: 