<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/NCT03285854</url>
  </required_header>
  <id_info>
    <org_study_id>15HM36</org_study_id>
    <nct_id>NCT03285854</nct_id>
  </id_info>
  <brief_title>Calcium Balance Studies in Children With CKD and on Dialysis</brief_title>
  <acronym>Cal-Bal</acronym>
  <official_title>Assessing Calcium Balance in Children With Chronic Kidney Disease to Optimise Treatment Strategies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Great Ormond Street Hospital for Children NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Kiel</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Athens General Children's Hospital &quot;Pan. &amp; Aglaia Kyriakou&quot;</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cukurova University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Great Ormond Street Hospital for Children NHS Foundation Trust</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 novel, non-invasive method of assessing Ca balance by natural Ca isotope&#xD;
      fractionation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Detailed description and study protocol will be available to individuals on request.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2022</completion_date>
  <primary_completion_date type="Actual">December 30, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Calcium isotope fractionation in blood, urine and stool in healthy children and those with CKD</measure>
    <time_frame>24 months</time_frame>
    <description>available on request</description>
  </primary_outcome>
  <primary_outcome>
    <measure>number of children with fractures, and clinical and biochemical correlates of fractures</measure>
    <time_frame>12 months</time_frame>
    <description>available on request</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bone scans - whole body &amp; lumbar spine DEXA, bone mineral density on tibial peripheral quantitative CT scan</measure>
    <time_frame>24 months</time_frame>
    <description>available on request</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">120</enrollment>
  <condition>Chronic Kidney Disease Mineral and Bone Disorder</condition>
  <arm_group>
    <arm_group_label>Children with CKD stage 3-5 and dialysis</arm_group_label>
    <description>Children of all ages with an eGFR &lt;60ml/min/1.73m2, including those on dialysis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy age and gender matched children</arm_group_label>
    <description>All children &lt;18 years&#xD;
Normal renal function (eGFR 90-120ml/min/1.73m2 [calculated by Schwartz formula] in children &gt;1 year and serum creatinine &lt;35μMol/L in children &lt;1 year)&#xD;
Weight, height and BMI within 2 SD of normal using WHO growth charts In order to make this study as 'real-life' as possible, free-living UK children on their usual diet and dietary supplementation (including Ca and Vit D), if any, will be included, but analysis will account for medication doses and blood levels.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Collection of blood, urine and stool samples</intervention_name>
    <description>Collection of blood, urine and stool samples, diet diary and bone scans</description>
    <arm_group_label>Children with CKD stage 3-5 and dialysis</arm_group_label>
    <arm_group_label>Healthy age and gender matched children</arm_group_label>
    <other_name>DEXA - lumbar spine and hips</other_name>
    <other_name>tibial peripheral quantitative CT</other_name>
    <other_name>Dietary record</other_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood, urine, stool and dialysis fluid samples will be collected&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All children with chronic kidney disease stage 3-5 and on dialysis and age matched controls&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        I - For healthy children&#xD;
&#xD;
        Inclusion criteria&#xD;
&#xD;
          -  All children &lt;18 years&#xD;
&#xD;
          -  Normal renal function (eGFR 90-120ml/min/1.73m2 [calculated by Schwartz formula] in&#xD;
             children &gt;1 year and serum creatinine &lt;35μMol/L in children &lt;1 year)&#xD;
&#xD;
          -  Weight, height and BMI within 2 SD of normal using WHO growth charts In order to make&#xD;
             this study as 'real-life' as possible, free-living UK children on their usual diet and&#xD;
             dietary supplementation (including Ca and Vit D), if any, will be included, but&#xD;
             analysis will account for medication doses and blood levels.&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Pre-existing bone disease - inherited or acquired&#xD;
&#xD;
          -  Fractures in the preceding 6 months&#xD;
&#xD;
          -  Glucocorticoid therapy in the preceding year, or a lifetime cumulative steroid&#xD;
             exposure ≥6 months&#xD;
&#xD;
          -  Bisphosphonate therapy at any time in the past&#xD;
&#xD;
          -  Any acute illness in the preceding 2 weeks (when the child is unable to maintain their&#xD;
             usual diet or has bed rest)&#xD;
&#xD;
        II - For CKD and dialysis children&#xD;
&#xD;
        Inclusion criteria&#xD;
&#xD;
          -  Children of all ages with an eGFR &lt;60ml/min/1.73m2, including those on dialysis.&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  As listed above for healthy children.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rukshana C Shroff, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Great Ormond Street Hospital for Children NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Great Ormond Street Hospital for Children NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>WC1N 3JH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>March 15, 2022</last_update_submitted>
  <last_update_submitted_qc>March 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CKD</keyword>
  <keyword>Dialysis</keyword>
  <keyword>calcium</keyword>
  <keyword>mineral and bone disorder (MBD)</keyword>
  <keyword>calcification</keyword>
  <keyword>DXA</keyword>
  <keyword>peripheral quantitative CT scan (pqCT)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bone Diseases</mesh_term>
    <mesh_term>Chronic Kidney Disease-Mineral and Bone Disorder</mesh_term>
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>IPD sharing will be considered at the end of the study.</ipd_description>
  </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/NCT03285854
org study id: 15HM36
nct id: NCT03285854
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a novel, non-invasive method of assessing Ca balance by natural Ca isotope
      fractionation.
Detailed description and study protocol will be available to individuals on request.
observational model: Case-Control
time perspective: Prospective
measure: Calcium isotope fractionation in blood, urine and stool in healthy children and those with CKD
time frame: 24 months
description: available on request
measure: number of children with fractures, and clinical and biochemical correlates of fractures
time frame: 12 months
description: available on request
measure: Bone scans - whole body & lumbar spine DEXA, bone mineral density on tibial peripheral quantitative CT scan
time frame: 24 months
description: available on request
arm group label: Children with CKD stage 3-5 and dialysis
description: Children of all ages with an eGFR <60ml/min/1.73m2, including those on dialysis
arm group label: Healthy age and gender matched children
description: All children <18 years
Normal renal function (eGFR 90-120ml/min/1.73m2 [calculated by Schwartz formula] in children >1 year and serum creatinine <35μMol/L in children <1 year)
Weight, height and BMI within 2 SD of normal using WHO growth charts In order to make this study as 'real-life' as possible, free-living UK children on their usual diet and dietary supplementation (including Ca and Vit D), if any, will be included, but analysis will account for medication doses and blood levels.
intervention type: Diagnostic Test
intervention name: Collection of blood, urine and stool samples
description: Collection of blood, urine and stool samples, diet diary and bone scans
arm group label: Children with CKD stage 3-5 and dialysis
arm group label: Healthy age and gender matched children
other name: DEXA - lumbar spine and hips
other name: tibial peripheral quantitative CT
other name: Dietary record
blood, urine, stool and dialysis fluid samples will be collected
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rukshana C Shroff, MD PhD
role: Principal Investigator
affiliation: Great Ormond Street Hospital for Children NHS Foundation Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Bone Diseases
mesh term: Chronic Kidney Disease-Mineral and Bone Disorder
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
sharing ipd: Undecided
ipd description: IPD sharing will be considered at the end of the study.