<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/NCT01735461</url>
  </required_header>
  <id_info>
    <org_study_id>H11-02525</org_study_id>
    <nct_id>NCT01735461</nct_id>
  </id_info>
  <brief_title>Calcium Supplements Strategy for Kidney Stones Prevention in Crohn's Patients</brief_title>
  <official_title>Oral Calcium Supplementation, a Strategy to Reduce Kidney Stones in Crohn's Patients Living With a Small Bowel Resection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hospitalization for kidney stones in the Inflammatory Bowel Disease (IBD) population is&#xD;
      common, particularly among Crohn's patients who had a small bowel resection. This patient&#xD;
      population experiences a lifetime occurrence of kidney stone formation as high as 25%&#xD;
      accompanied with a high rate of recurrence (the typical rate of stone formation is ~10% in&#xD;
      the non IBD population). Giving oral calcium is used to bind oxalate in the intestine in an&#xD;
      attempt to reduce the amount of oxalate that is absorbed into the body and to reduce urinary&#xD;
      oxalate levels. However, there are no defined guidelines for the optimum dosing of calcium.&#xD;
      This study's primary objective is to scientifically define an appropriate range of calcium&#xD;
      supplementation that reduce the level of oxalate found in the urine of patients living with&#xD;
      inflammatory bowel disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this study is to establish optimal oral calcium supplementation in&#xD;
      Crohn's patients who have had an ileal bowel resection. This population is at high risk for&#xD;
      calcium oxalate kidney stones, a direct consequence of extensive gut malabsorption and&#xD;
      enteric hyperoxaluria. The benefit of providing oral calcium in this patient population (as a&#xD;
      means to reduce intestinal oxalate absorption) is known, however, there are no appropriate&#xD;
      targets for calcium dosing, which is presently performed empirically or not at all. Our goal&#xD;
      is to establish simple, safe and practical guidelines for calcium supplementation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Molar ratio of urinary calcium:oxalate in relation to the supersaturation product of calcium oxalate</measure>
    <time_frame>7 days</time_frame>
    <description>Molar ratio of urinary calcium:oxalate in relation to the supersaturation product of calcium oxalate will be calculated from the 24-hour urine test.&#xD;
The patient will take dietary calcium for 7 days and then we will evaluate their urine chemistry. Additionally, 24-hour urine collections are considered the standard for urinalysis in comparison to spot urine chemistry. The initial data, prior to calcium supplementation, will serve as the control, providing the patient's baseline risk for kidney stone formation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Optimal level of Ca supplementation for prevention of stones in Crohn's patients</measure>
    <time_frame>7 days</time_frame>
    <description>Practical guidelines for physicians managing Crohn's patients will be developed based on the optimal Ca supplement dosages and determine the optimal level of calcium supplementation in each patient, based on urinary parameters from 24-hour urine.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Kidney Calculi</condition>
  <condition>Crohn's Disease</condition>
  <arm_group>
    <arm_group_label>Dietary supplement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Calcium Carbonate</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Calcium Carbonate</intervention_name>
    <description>There is a regimen for dietary supplement intake that will be provided to study participants.</description>
    <arm_group_label>Dietary supplement</arm_group_label>
    <other_name>CaCO3</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. a pathologically confirmed diagnosis of Crohn's disease&#xD;
&#xD;
          2. prior ileal resection with an intact colon (surgery&gt;6 months preceding involvement in&#xD;
             study)&#xD;
&#xD;
          3. hyperoxaluria (defined as&gt; 48 mg (&gt;0.5 mmol) per 24 hour urine samples.&#xD;
&#xD;
               -  Patients will not be excluded if they are known kidney stone formers.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. current pregnancy&#xD;
&#xD;
          2. patient's without baseline hyperoxaluria (defined as &gt;48 mg or 0.5mmol per 24 hour&#xD;
             urine samples)&#xD;
&#xD;
          3. patients in renal failure assessed by a GFR &lt; 60&#xD;
&#xD;
          4. inability to provide informed consent&#xD;
&#xD;
          5. active cancer&#xD;
&#xD;
          6. hyperparathyroidism&#xD;
&#xD;
          7. hyperphosphatemia&#xD;
&#xD;
          8. &lt;19 years of age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ben Chew, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Olga Arsovska</last_name>
    <phone>6048754111</phone>
    <phone_ext>62421</phone_ext>
    <email>olga.arsovska@ubc.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>Vancouver General Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z1M9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Ben Chew, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ryan Paterson, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>November 22, 2012</study_first_submitted>
  <study_first_submitted_qc>November 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <last_update_submitted>May 16, 2022</last_update_submitted>
  <last_update_submitted_qc>May 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Ben Chew, MD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
    <mesh_term>Kidney Calculi</mesh_term>
    <mesh_term>Nephrolithiasis</mesh_term>
    <mesh_term>Calculi</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium Carbonate</mesh_term>
    <mesh_term>Calcium</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT01735461
org study id: H11-02525
nct id: NCT01735461
lead sponsor: 
collaborator: 
has dmc: Yes
Hospitalization for kidney stones in the Inflammatory Bowel Disease (IBD) population is
      common, particularly among Crohn's patients who had a small bowel resection. This patient
      population experiences a lifetime occurrence of kidney stone formation as high as 25%
      accompanied with a high rate of recurrence (the typical rate of stone formation is ~10% in
      the non IBD population). Giving oral calcium is used to bind oxalate in the intestine in an
      attempt to reduce the amount of oxalate that is absorbed into the body and to reduce urinary
      oxalate levels. However, there are no defined guidelines for the optimum dosing of calcium.
      This study's primary objective is to scientifically define an appropriate range of calcium
      supplementation that reduce the level of oxalate found in the urine of patients living with
      inflammatory bowel disease.
The primary objective of this study is to establish optimal oral calcium supplementation in
      Crohn's patients who have had an ileal bowel resection. This population is at high risk for
      calcium oxalate kidney stones, a direct consequence of extensive gut malabsorption and
      enteric hyperoxaluria. The benefit of providing oral calcium in this patient population (as a
      means to reduce intestinal oxalate absorption) is known, however, there are no appropriate
      targets for calcium dosing, which is presently performed empirically or not at all. Our goal
      is to establish simple, safe and practical guidelines for calcium supplementation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Molar ratio of urinary calcium:oxalate in relation to the supersaturation product of calcium oxalate
time frame: 7 days
description: Molar ratio of urinary calcium:oxalate in relation to the supersaturation product of calcium oxalate will be calculated from the 24-hour urine test.
The patient will take dietary calcium for 7 days and then we will evaluate their urine chemistry. Additionally, 24-hour urine collections are considered the standard for urinalysis in comparison to spot urine chemistry. The initial data, prior to calcium supplementation, will serve as the control, providing the patient's baseline risk for kidney stone formation.
measure: Optimal level of Ca supplementation for prevention of stones in Crohn's patients
time frame: 7 days
description: Practical guidelines for physicians managing Crohn's patients will be developed based on the optimal Ca supplement dosages and determine the optimal level of calcium supplementation in each patient, based on urinary parameters from 24-hour urine.
arm group label: Dietary supplement
arm group type: Experimental
description: Calcium Carbonate
intervention type: Dietary Supplement
intervention name: Calcium Carbonate
description: There is a regimen for dietary supplement intake that will be provided to study participants.
arm group label: Dietary supplement
other name: CaCO3
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Ben Chew, MD
role: Principal Investigator
affiliation: University of British Columbia
last name: Olga Arsovska
phone: 6048754111
phone ext: 62421
email: olga.arsovska@ubc.ca
facility: 
status: Recruiting
investigator: 
investigator: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Ben Chew, MD
investigator title: Associate Professor
mesh term: Crohn Disease
mesh term: Kidney Calculi
mesh term: Nephrolithiasis
mesh term: Calculi
mesh term: Calcium Carbonate
mesh term: Calcium
sharing ipd: No