<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/NCT03003312</url>
  </required_header>
  <id_info>
    <org_study_id>MRER(30)2016</org_study_id>
    <nct_id>NCT03003312</nct_id>
  </id_info>
  <brief_title>Prevalence of Pediatric Urolithiasis in Kashgar Area of Xinjiang in China</brief_title>
  <official_title>Prevalence of Pediatric Urolithiasis in Kashgar Area of Xinjiang in China: a Population and Ultrasonography Based Cross-sectional Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guohua Zeng</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital of Guangzhou Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objective:The aim of this study is to investigate the prevalence and associated factors of&#xD;
      pediatric urolithiasis in Kashgar area in China.&#xD;
&#xD;
      Methods: The investigators carry out a cross-sectional survey among children aged 0 to14&#xD;
      years across Kashgar area in China. The participants are selected by a two-stage and&#xD;
      clustered random sampling method. Participants are asked to undergo urinary tract&#xD;
      ultrasonographic examinations, provided blood and urine samples to analyze. Their parents or&#xD;
      guardians are asked to fill out the questionnaires. Children those who are found with any&#xD;
      abnormalities of their urinary system by ulrtasonography will undergo a low-dose computed&#xD;
      tomography (CT) to confirm the abnormalities. The end point of this study is to calculate the&#xD;
      prevalence rate, distribution and associated factors of pediatric urolithiasis in Kashi area.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Urolithiasis in children is a painful and costly disease that may also have&#xD;
      detrimental long-term effects on kidney function. Although urolithiasis is rarely found in&#xD;
      the pediatric population, several studies indicated that the incidence and inpatient&#xD;
      hospitalization rates were sharply increased. The incidence of nephrolithiasis for children&#xD;
      aged 18 years in South Carolina was 18.5 per 100,000 children in 2007, much higher than 7.9&#xD;
      per 100,000 in 1996. Data from Iceland revealed an incidence of 5.6 per 100,000 children aged&#xD;
      0 to 18 years on the basis of 26 new diagnoses of renal stone during a 6-year period among a&#xD;
      national population of approximately 78,000 children. The composition analysis of stone in&#xD;
      children revealed that the calcium stone was the most common one, accounted for 72% to 88%,&#xD;
      and the uric acid stone accounted for 2% to 3% while the infective stone (included ammonium&#xD;
      acid urate and magnesium ammonium phosphate) was rare.&#xD;
&#xD;
      Kashgar area lies in the southwest of Xinjiang province in China, with a climate of less&#xD;
      annual rainfall, long hours of sunshine, high temperature and dry air. The population of&#xD;
      Kashgar area is about 4 million and the Uighur residents account for about 90%.Pediatirc&#xD;
      urolithiasis is a very common disease in Kashgar area. From August 2014 to July 2016, there&#xD;
      were 708 pediatric patients with urolithiasis were treated in the department of urology in&#xD;
      the First People's Hospital of Kashgar area which is a central hospital. The stone analysis&#xD;
      of these pediatric patients by infrared spectroscopy indicated that ammonium acid urate&#xD;
      accounted for 66%, magnesium ammonium phosphate accounted for 2.5%, uric acid accounted for&#xD;
      11%, and calcium stone accounted for 19% (these data has not been published ).This was very&#xD;
      different from previous studies.&#xD;
&#xD;
      So we wonder urolithiasis maybe a very common disease among children in Kashgar area, even in&#xD;
      south Xinjiang province. And maybe there are some special reasons for pediatric urolithiasis&#xD;
      formation in this area.&#xD;
&#xD;
      Methods Study design and participants: A cross-sectional survey is carried out among children&#xD;
      aged 0 to 14 years in Kashgar area in China. Before designed the study, we have conducted a&#xD;
      pre-survey in a village which had 418 children by randomness clustered selected in Kashgar&#xD;
      area. And ten children were found with urinary stone by ultrasonography. So we estimate the&#xD;
      prevalence of pediatric urolithiasis (p) in this area is about 2.4% (10/418), with α of 0.05,&#xD;
      a margin of error of less than 0.5%, 3599 children would needed by the formula of sample size&#xD;
      caculation.Consider a relative sampling error of 10%, a predicted 20% refusal rate, and at&#xD;
      least 4751 target children will be needed in this study.&#xD;
&#xD;
      Randomization: A two-stage and clustered random sampling method is used to select a&#xD;
      representative sample of children across Kashgar area. The sampling process is initially&#xD;
      stratified the 12 regions of Kashgar area (Kashi, Taxian, Shule, Zhepu, Yuepu, Bachu,&#xD;
      Maigaiti, Yuecheng, Jiashi, Shufu, Shache, and Yingjisha) in descending order by Gross&#xD;
      Domestic Product (GDP) 2014. The first tier is selected two regions by simple random sampling&#xD;
      in the first six regions and the last six regions separately. Then the selected regions are&#xD;
      stratified by the degree of urbanization (urban area vs rural area), and one community in&#xD;
      urban area and one village in rural area is selected by randomization. At last four&#xD;
      communities in urban area and four villages in rural area are selected across Kashgar area.&#xD;
      Children those aged 0 to14 years in these selected communities and villages were all our&#xD;
      target population.&#xD;
&#xD;
      Data collection:&#xD;
&#xD;
      The data include urinary tract ultrasonography (UTU), a standard questionnaire, urine&#xD;
      examines and blood species. All of examinations are free of charge. All data are collected by&#xD;
      investigators of our research group in community clinics of participant's residential area.&#xD;
&#xD;
        1. Appointment: After obtaining the population information from the local government, we&#xD;
           will visit every family or household accompanied by staffs of the selected communities&#xD;
           or villages, to obtain pediatric information of each family, explain the aim of the&#xD;
           study, and invite the parents to take their kids to participate in the study which is&#xD;
           held at the community of village clinic. Also we will give a notice that include the aim&#xD;
           of the study, contents, date, and matter need attention of this survey to the parents.&#xD;
&#xD;
        2. Inform consent form: When the parents and children coming to the clinic, the&#xD;
           investigators will explain the details of consent form to the parents again. If the&#xD;
           parents are fully understand the aim of the study and agree to let their kids to&#xD;
           participant in this study, they will be asked to sign their name and the date on the&#xD;
           consent form. Also, the investigators will be required to sign the name and date on the&#xD;
           same page.&#xD;
&#xD;
        3. Anthropometric indexes: Height (cm) and weight (kg) is measured using weighting-scale.&#xD;
           Circumference of head, chest, arm and forearm is measured by a same tape. Subcutaneous&#xD;
           fat thickness of triceps, biceps, scapular region, and abdominal wall is measured by a&#xD;
           subcutaneous fat meter. All values are recorded on the first page of the questionnaire.&#xD;
&#xD;
        4. Blood specimen collecting and analysis: All children are invited to collect vein blood&#xD;
           to analysis. The standard blood analysis protocol includes complete blood count (CBC),&#xD;
           serum creatinine, urea, and uric acid. Blood samples for CBC analysis are collected&#xD;
           using tubes with EDTA-K2 as preservative and are frozen at 4℃.Blood samples for serum&#xD;
           chemistries analysis are collected using tubes without any preservative. All blood&#xD;
           samples are delivered to the First People's Hospital of Kashgar area for analysis by&#xD;
           automated analyzers. All blood samples are analyzed in 12 hours after collection. Also,&#xD;
           we will preserve a blood sample of each child in a -80℃refrigerator for further analysis&#xD;
           of etiology which include genetics.&#xD;
&#xD;
        5. Questionnaire: All parents are invited to fill out a pre-designed and standardized&#xD;
           questionnaire by face to face interview of our Uygur staffs. Information on demographic&#xD;
           data, feeding patterns, lifestyle, information of parents and family, possible symptoms&#xD;
           of urinary stone, co-morbidities of kids, history of medicine, family history are&#xD;
           recorded. Completeness and accuracy of questionnaires are checked up on site by special&#xD;
           quality controller.&#xD;
&#xD;
        6. UTU: UTU is conducted by using same model of ultrasound machines with a 3.0-5.0 MHz&#xD;
           frequency probe throughout this study. We will provide enough water to drink and all&#xD;
           participants are required to have moderate bladder filling. Initially, participants lay&#xD;
           in a prone position for scanning of bilateral kidneys and upper ureters. Then&#xD;
           participants will turn to a supine position to have lower ureters and bladder scanned.&#xD;
           The position is adjusted if necessary to achieve successful scanning. Details of the&#xD;
           abnormalities are record including stone size, number, location, depth of hydronephrosis&#xD;
           (mm). The longest axis of the stone in millimeter (mm) is used for the stone size. And&#xD;
           also all the children which are found with urinary abnormalities are asked to undergo a&#xD;
           Non-enhanced helical CT scans with two-mm slices in the First People's Hospital of&#xD;
           Kashgar area.&#xD;
&#xD;
        7. Urine samples of children are collected after finishing UTU. All urine samples are&#xD;
           analyzed by semi-automatic analyzers with dry chemical method on site.&#xD;
&#xD;
        8. Dietary record of case-control study: When one child is found with urinary stone, we&#xD;
           will ask his/her parents to make a dietary record for three consecutive days by weight&#xD;
           method. And also we will select four healthy children which have the same age and gender&#xD;
           and ask their parents to make a dietary record with the same method. We will provide a&#xD;
           weigh for each family. The table of dietary record is printed in Uygur.&#xD;
&#xD;
        9. Quality control: The investigators involved in this study have completed a training&#xD;
           program on the methodology and data acquisition procedures. Each of them have a&#xD;
           procedure manual that detailed the administration of the questionnaires, operation of&#xD;
           the UTU, measurements of the anthropometric indexes, along with collecting and handling&#xD;
           the blood specimens. The same doctor and machine of ultrasound is used during the whole&#xD;
           study. All collected data will be registered and treated with the Epidata software&#xD;
           (version 3.1).&#xD;
&#xD;
       10. End points evaluation: Prevalence is separately calculated for all participants and for&#xD;
           their subgroups according to age, sex, urban or rural residence, BMI and family history&#xD;
           of urinary stones, which is expressed as an unadjusted rate with 95% confidence&#xD;
           intervals (CIs). Difference between the categorical variables is compared using the&#xD;
           chi-square test. The association between urinary stone and relevant covariates is&#xD;
           calculated using binary logistic regression models.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2016</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Anticipated">June 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of urolithasis among children in Kashgar area in Xinjiang, China.</measure>
    <time_frame>From July 2016 to June 2017</time_frame>
    <description>We are conducting a cross-sectional and ultrosound based survey among children aged 0 to 14 years across Kashgar area in China to evaluate the prevalence and associated factors of urolithiasis.This survey has been started in July 2016.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The weight of children aged 0 to 14 years in Kashgar area in Xinjiang, China.</measure>
    <time_frame>From July 2016 to June 2017</time_frame>
    <description>We evaluate the development status of children in Kashgar according these anthropometric indexes: weight (kilogram) .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The development status of children aged 0 to 14 years in Kashgar area in Xinjiang, China.</measure>
    <time_frame>From July 2016 to June 2017</time_frame>
    <description>2、We evaluate the development status of children in Kashgar according these anthropometric indexes: height (centimeter)，circumference of head (centimeter), chest (centimeter), arm (centimeter), and forearm (centimeter).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The development status of children aged 0 to 14 years in Kashgar area.</measure>
    <time_frame>From July 2016 to June 2017</time_frame>
    <description>We evaluate the development status of children in Kashgar according these anthropometric indexes: subcutaneous fat thickness of triceps (millimeter), biceps (millimeter), scapular region (millimeter), and abdominal wall (millimeter).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Associated factors of urolithasis among children in Kashgar area in Xinjiang, China.</measure>
    <time_frame>From July 2016 to June 2017</time_frame>
    <description>We are conducting a cross-sectional and ultrosound based survey among children aged 0 to 14 years across Kashgar area in China to evaluate the prevalence and associated factors of urolithiasis.This survey has been started in July 2016.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The nutrition status between children with urolithiassis and healthy kids.</measure>
    <time_frame>From July 2016 to June 2017</time_frame>
    <description>We also carry out a case-control study of comparing dietary nutrition between children with urolithiasis and healthy kids of 1:4. During the cross-sectional study, when one child is found with urinary stone, we will ask his/her parents to make a dietary record for three consecutive days by weight method. And also we will select four healthy children which have the same age and gender and ask their parents to make a dietary record with the same method.</description>
  </other_outcome>
  <enrollment type="Anticipated">4751</enrollment>
  <condition>Urolithiasis</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      A blood sample of each child will be preserved in a -80℃refrigerator for further analysis of&#xD;
      etiology of urolithiasis which include genetics.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Children aged 0 to 14 years live in Kashgar area in China.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children aged 0 to 14 years and live in Kashgar area in China.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children aged 15 to 17 years live in Kashgar area in China.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guohua Zeng, PH.D and M.D</last_name>
    <role>Study Chair</role>
    <affiliation>The First Affiliated Hospital of Guangzhou Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Guohua Zeng, PH.D and M.D</last_name>
    <phone>+86 13802916676</phone>
    <email>gzgyzgh@vip.sina.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zanlin Mai, M.D.</last_name>
    <phone>+86 34296202</phone>
    <email>maizanlin1001@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Guangzhou Medical University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510120</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guohua Zeng, Ph.D.</last_name>
      <phone>+86 13802916676</phone>
      <email>gzgyzgh@vip.sina.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First People's Hospital of Kashgar Area</name>
      <address>
        <city>Kashgar</city>
        <state>Xinjiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Arkon Tursun, M.D.</last_name>
      <phone>+86 13899148588</phone>
      <email>Arkin64@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Penido MG, Tavares Mde S. Pediatric primary urolithiasis: Symptoms, medical management and prevention strategies. World J Nephrol. 2015 Sep 6;4(4):444-54. doi: 10.5527/wjn.v4.i4.444.</citation>
    <PMID>26380196</PMID>
  </results_reference>
  <results_reference>
    <citation>Clayton DB, Pope JC. The increasing pediatric stone disease problem. Ther Adv Urol. 2011 Feb;3(1):3-12. doi: 10.1177/1756287211400491.</citation>
    <PMID>21789094</PMID>
  </results_reference>
  <results_reference>
    <citation>Wang HH, Wiener JS, Lipkin ME, Scales CD Jr, Ross SS, Routh JC. Estimating the nationwide, hospital based economic impact of pediatric urolithiasis. J Urol. 2015 May;193(5 Suppl):1855-9. doi: 10.1016/j.juro.2014.09.116. Epub 2014 Oct 8.</citation>
    <PMID>25305358</PMID>
  </results_reference>
  <results_reference>
    <citation>Dwyer ME, Krambeck AE, Bergstralh EJ, Milliner DS, Lieske JC, Rule AD. Temporal trends in incidence of kidney stones among children: a 25-year population based study. J Urol. 2012 Jul;188(1):247-52. doi: 10.1016/j.juro.2012.03.021. Epub 2012 May 15.</citation>
    <PMID>22595060</PMID>
  </results_reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>October 27, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>December 21, 2016</last_update_submitted>
  <last_update_submitted_qc>December 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>The First Affiliated Hospital of Guangzhou Medical University</investigator_affiliation>
    <investigator_full_name>Guohua Zeng</investigator_full_name>
    <investigator_title>Vice-president</investigator_title>
  </responsible_party>
  <keyword>Urolithiasis</keyword>
  <keyword>Uyghur</keyword>
  <keyword>Prevalence</keyword>
  <keyword>Associated factors</keyword>
  <keyword>Children</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urolithiasis</mesh_term>
    <mesh_term>Urinary Calculi</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03003312
org study id: MRER(30)2016
nct id: NCT03003312
lead sponsor: 
has dmc: No
Objective:The aim of this study is to investigate the prevalence and associated factors of
      pediatric urolithiasis in Kashgar area in China.

      Methods: The investigators carry out a cross-sectional survey among children aged 0 to14
      years across Kashgar area in China. The participants are selected by a two-stage and
      clustered random sampling method. Participants are asked to undergo urinary tract
      ultrasonographic examinations, provided blood and urine samples to analyze. Their parents or
      guardians are asked to fill out the questionnaires. Children those who are found with any
      abnormalities of their urinary system by ulrtasonography will undergo a low-dose computed
      tomography (CT) to confirm the abnormalities. The end point of this study is to calculate the
      prevalence rate, distribution and associated factors of pediatric urolithiasis in Kashi area.
Background: Urolithiasis in children is a painful and costly disease that may also have
      detrimental long-term effects on kidney function. Although urolithiasis is rarely found in
      the pediatric population, several studies indicated that the incidence and inpatient
      hospitalization rates were sharply increased. The incidence of nephrolithiasis for children
      aged 18 years in South Carolina was 18.5 per 100,000 children in 2007, much higher than 7.9
      per 100,000 in 1996. Data from Iceland revealed an incidence of 5.6 per 100,000 children aged
      0 to 18 years on the basis of 26 new diagnoses of renal stone during a 6-year period among a
      national population of approximately 78,000 children. The composition analysis of stone in
      children revealed that the calcium stone was the most common one, accounted for 72% to 88%,
      and the uric acid stone accounted for 2% to 3% while the infective stone (included ammonium
      acid urate and magnesium ammonium phosphate) was rare.

      Kashgar area lies in the southwest of Xinjiang province in China, with a climate of less
      annual rainfall, long hours of sunshine, high temperature and dry air. The population of
      Kashgar area is about 4 million and the Uighur residents account for about 90%.Pediatirc
      urolithiasis is a very common disease in Kashgar area. From August 2014 to July 2016, there
      were 708 pediatric patients with urolithiasis were treated in the department of urology in
      the First People's Hospital of Kashgar area which is a central hospital. The stone analysis
      of these pediatric patients by infrared spectroscopy indicated that ammonium acid urate
      accounted for 66%, magnesium ammonium phosphate accounted for 2.5%, uric acid accounted for
      11%, and calcium stone accounted for 19% (these data has not been published ).This was very
      different from previous studies.

      So we wonder urolithiasis maybe a very common disease among children in Kashgar area, even in
      south Xinjiang province. And maybe there are some special reasons for pediatric urolithiasis
      formation in this area.

      Methods Study design and participants: A cross-sectional survey is carried out among children
      aged 0 to 14 years in Kashgar area in China. Before designed the study, we have conducted a
      pre-survey in a village which had 418 children by randomness clustered selected in Kashgar
      area. And ten children were found with urinary stone by ultrasonography. So we estimate the
      prevalence of pediatric urolithiasis (p) in this area is about 2.4% (10/418), with α of 0.05,
      a margin of error of less than 0.5%, 3599 children would needed by the formula of sample size
      caculation.Consider a relative sampling error of 10%, a predicted 20% refusal rate, and at
      least 4751 target children will be needed in this study.

      Randomization: A two-stage and clustered random sampling method is used to select a
      representative sample of children across Kashgar area. The sampling process is initially
      stratified the 12 regions of Kashgar area (Kashi, Taxian, Shule, Zhepu, Yuepu, Bachu,
      Maigaiti, Yuecheng, Jiashi, Shufu, Shache, and Yingjisha) in descending order by Gross
      Domestic Product (GDP) 2014. The first tier is selected two regions by simple random sampling
      in the first six regions and the last six regions separately. Then the selected regions are
      stratified by the degree of urbanization (urban area vs rural area), and one community in
      urban area and one village in rural area is selected by randomization. At last four
      communities in urban area and four villages in rural area are selected across Kashgar area.
      Children those aged 0 to14 years in these selected communities and villages were all our
      target population.

      Data collection:

      The data include urinary tract ultrasonography (UTU), a standard questionnaire, urine
      examines and blood species. All of examinations are free of charge. All data are collected by
      investigators of our research group in community clinics of participant's residential area.

        1. Appointment: After obtaining the population information from the local government, we
           will visit every family or household accompanied by staffs of the selected communities
           or villages, to obtain pediatric information of each family, explain the aim of the
           study, and invite the parents to take their kids to participate in the study which is
           held at the community of village clinic. Also we will give a notice that include the aim
           of the study, contents, date, and matter need attention of this survey to the parents.

        2. Inform consent form: When the parents and children coming to the clinic, the
           investigators will explain the details of consent form to the parents again. If the
           parents are fully understand the aim of the study and agree to let their kids to
           participant in this study, they will be asked to sign their name and the date on the
           consent form. Also, the investigators will be required to sign the name and date on the
           same page.

        3. Anthropometric indexes: Height (cm) and weight (kg) is measured using weighting-scale.
           Circumference of head, chest, arm and forearm is measured by a same tape. Subcutaneous
           fat thickness of triceps, biceps, scapular region, and abdominal wall is measured by a
           subcutaneous fat meter. All values are recorded on the first page of the questionnaire.

        4. Blood specimen collecting and analysis: All children are invited to collect vein blood
           to analysis. The standard blood analysis protocol includes complete blood count (CBC),
           serum creatinine, urea, and uric acid. Blood samples for CBC analysis are collected
           using tubes with EDTA-K2 as preservative and are frozen at 4℃.Blood samples for serum
           chemistries analysis are collected using tubes without any preservative. All blood
           samples are delivered to the First People's Hospital of Kashgar area for analysis by
           automated analyzers. All blood samples are analyzed in 12 hours after collection. Also,
           we will preserve a blood sample of each child in a -80℃refrigerator for further analysis
           of etiology which include genetics.

        5. Questionnaire: All parents are invited to fill out a pre-designed and standardized
           questionnaire by face to face interview of our Uygur staffs. Information on demographic
           data, feeding patterns, lifestyle, information of parents and family, possible symptoms
           of urinary stone, co-morbidities of kids, history of medicine, family history are
           recorded. Completeness and accuracy of questionnaires are checked up on site by special
           quality controller.

        6. UTU: UTU is conducted by using same model of ultrasound machines with a 3.0-5.0 MHz
           frequency probe throughout this study. We will provide enough water to drink and all
           participants are required to have moderate bladder filling. Initially, participants lay
           in a prone position for scanning of bilateral kidneys and upper ureters. Then
           participants will turn to a supine position to have lower ureters and bladder scanned.
           The position is adjusted if necessary to achieve successful scanning. Details of the
           abnormalities are record including stone size, number, location, depth of hydronephrosis
           (mm). The longest axis of the stone in millimeter (mm) is used for the stone size. And
           also all the children which are found with urinary abnormalities are asked to undergo a
           Non-enhanced helical CT scans with two-mm slices in the First People's Hospital of
           Kashgar area.

        7. Urine samples of children are collected after finishing UTU. All urine samples are
           analyzed by semi-automatic analyzers with dry chemical method on site.

        8. Dietary record of case-control study: When one child is found with urinary stone, we
           will ask his/her parents to make a dietary record for three consecutive days by weight
           method. And also we will select four healthy children which have the same age and gender
           and ask their parents to make a dietary record with the same method. We will provide a
           weigh for each family. The table of dietary record is printed in Uygur.

        9. Quality control: The investigators involved in this study have completed a training
           program on the methodology and data acquisition procedures. Each of them have a
           procedure manual that detailed the administration of the questionnaires, operation of
           the UTU, measurements of the anthropometric indexes, along with collecting and handling
           the blood specimens. The same doctor and machine of ultrasound is used during the whole
           study. All collected data will be registered and treated with the Epidata software
           (version 3.1).

       10. End points evaluation: Prevalence is separately calculated for all participants and for
           their subgroups according to age, sex, urban or rural residence, BMI and family history
           of urinary stones, which is expressed as an unadjusted rate with 95% confidence
           intervals (CIs). Difference between the categorical variables is compared using the
           chi-square test. The association between urinary stone and relevant covariates is
           calculated using binary logistic regression models.
observational model: Cohort
time perspective: Prospective
measure: Prevalence of urolithasis among children in Kashgar area in Xinjiang, China.
time frame: From July 2016 to June 2017
description: We are conducting a cross-sectional and ultrosound based survey among children aged 0 to 14 years across Kashgar area in China to evaluate the prevalence and associated factors of urolithiasis.This survey has been started in July 2016.
measure: The weight of children aged 0 to 14 years in Kashgar area in Xinjiang, China.
time frame: From July 2016 to June 2017
description: We evaluate the development status of children in Kashgar according these anthropometric indexes: weight (kilogram) .
measure: The development status of children aged 0 to 14 years in Kashgar area in Xinjiang, China.
time frame: From July 2016 to June 2017
description: 2、We evaluate the development status of children in Kashgar according these anthropometric indexes: height (centimeter)，circumference of head (centimeter), chest (centimeter), arm (centimeter), and forearm (centimeter).
measure: The development status of children aged 0 to 14 years in Kashgar area.
time frame: From July 2016 to June 2017
description: We evaluate the development status of children in Kashgar according these anthropometric indexes: subcutaneous fat thickness of triceps (millimeter), biceps (millimeter), scapular region (millimeter), and abdominal wall (millimeter).
measure: Associated factors of urolithasis among children in Kashgar area in Xinjiang, China.
time frame: From July 2016 to June 2017
description: We are conducting a cross-sectional and ultrosound based survey among children aged 0 to 14 years across Kashgar area in China to evaluate the prevalence and associated factors of urolithiasis.This survey has been started in July 2016.
measure: The nutrition status between children with urolithiassis and healthy kids.
time frame: From July 2016 to June 2017
description: We also carry out a case-control study of comparing dietary nutrition between children with urolithiasis and healthy kids of 1:4. During the cross-sectional study, when one child is found with urinary stone, we will ask his/her parents to make a dietary record for three consecutive days by weight method. And also we will select four healthy children which have the same age and gender and ask their parents to make a dietary record with the same method.
A blood sample of each child will be preserved in a -80℃refrigerator for further analysis of
      etiology of urolithiasis which include genetics.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Day
maximum age: 14 Years
healthy volunteers: No
last name: Guohua Zeng, PH.D and M.D
role: Study Chair
affiliation: The First Affiliated Hospital of Guangzhou Medical University
last name: Guohua Zeng, PH.D and M.D
phone: +86 13802916676
email: gzgyzgh@vip.sina.com
last name: Zanlin Mai, M.D.
phone: +86 34296202
email: maizanlin1001@163.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: China
citation: Penido MG, Tavares Mde S. Pediatric primary urolithiasis: Symptoms, medical management and prevention strategies. World J Nephrol. 2015 Sep 6;4(4):444-54. doi: 10.5527/wjn.v4.i4.444.
PMID: 26380196
citation: Clayton DB, Pope JC. The increasing pediatric stone disease problem. Ther Adv Urol. 2011 Feb;3(1):3-12. doi: 10.1177/1756287211400491.
PMID: 21789094
citation: Wang HH, Wiener JS, Lipkin ME, Scales CD Jr, Ross SS, Routh JC. Estimating the nationwide, hospital based economic impact of pediatric urolithiasis. J Urol. 2015 May;193(5 Suppl):1855-9. doi: 10.1016/j.juro.2014.09.116. Epub 2014 Oct 8.
PMID: 25305358
citation: Dwyer ME, Krambeck AE, Bergstralh EJ, Milliner DS, Lieske JC, Rule AD. Temporal trends in incidence of kidney stones among children: a 25-year population based study. J Urol. 2012 Jul;188(1):247-52. doi: 10.1016/j.juro.2012.03.021. Epub 2012 May 15.
PMID: 22595060
responsible party type: Sponsor-Investigator
investigator affiliation: The First Affiliated Hospital of Guangzhou Medical University
investigator full name: Guohua Zeng
investigator title: Vice-president
mesh term: Urolithiasis
mesh term: Urinary Calculi
sharing ipd: Undecided