<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/NCT04457518</url>
  </required_header>
  <id_info>
    <org_study_id>12.10.2011/11-7/2</org_study_id>
    <nct_id>NCT04457518</nct_id>
  </id_info>
  <brief_title>Nutritional Status in Children With IBD</brief_title>
  <official_title>Nutritional Status in Children With Inflammatory Bowel Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ankara University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Turkish Society of Pediatric Gastroenterology, Hepatology and Nutrition</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ankara University</source>
  <oversight_info>
    <has_dmc>No</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>
      Malnutrition and growth retardation are major extraintestinal presentations of inflammatory&#xD;
      bowel disease (IBD) in childhood and are especially prevalent among those with Crohn's&#xD;
      disease. We aimed to evaluate nutritional status of children with IBD at the time of&#xD;
      diagnosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Data for this study will be derived from the web-based National Registry for Pediatric IBD.&#xD;
      The children (age: ≤ 18 years) who diagnosed with IBD according to international criteria&#xD;
      will be eligible for enrollment. Data on demographic, clinical and laboratory characteristics&#xD;
      at the time of diagnosis were extracted from the registry. All cases in the registry will be&#xD;
      screened for eligibility criteria by principal investigator (senior gastroenterologist). The&#xD;
      patients with other chronic disease known affect nutritional status will be excluded. The&#xD;
      cases who had the missing major outcome variables including symptom duration, weight, height,&#xD;
      disease activity, disease location and phenotype at the time of diagnosis will be excluded&#xD;
      from the analysis, if they had all of these outcome variables, they were included.&#xD;
&#xD;
      The nutritional status of participants will be evaluated based on anthropometric parameters.&#xD;
      The weight status will be assessed by weight-for-length in children &lt;2 years of age, and&#xD;
      BMI-for-age in children 2 years of age and older. Height status will be evaluated by&#xD;
      length/height-for-age in all cases. Age-and-sex specific percentile and the corresponding z&#xD;
      score for all anthropometric parameters will be calculated in the WHOAnthro for under five&#xD;
      years and WHOAnthroplus (WHO, Geneva, Switzerland) for those aged 5-18 years by using WHO&#xD;
      standards and references. Z-scores between +2.0 and -2.0 for all parameters will be&#xD;
      considered normal. Wasted/thinness and overweight will be defined by weight-for-length/BMI z&#xD;
      score &lt; -2.0, and &gt; +2.0, respectively. Stunting (short stature) and tallness will be defined&#xD;
      as length/height-for-age z score &lt; -2.0 and &gt; +2.0, respectively. Children will be stratified&#xD;
      into two age groups for analysis: &lt; 10 years of age and older. A p value of &lt;0.05 was&#xD;
      considered statistically significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 25, 2020</start_date>
  <completion_date type="Actual">October 30, 2020</completion_date>
  <primary_completion_date type="Actual">September 30, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>nutritional profiles of children with IBD</measure>
    <time_frame>Day 1 of diagnosis</time_frame>
    <description>evaluating nutritional profiles of children with IBD at the time of diagnosis by anthropometric parameters</description>
  </primary_outcome>
  <enrollment type="Actual">824</enrollment>
  <condition>Inflammatory Bowel Diseases</condition>
  <condition>Child</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Secondary and Tertiary Care Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age: ≤ 18 years&#xD;
&#xD;
          2. Diagnosis of IBD with clinical, laboratory, endoscopic and histopathologic findings&#xD;
&#xD;
          3. No other chronical diseases known affect nutritional status&#xD;
&#xD;
          4. No missing data in major variables including symptom duration, weight, height, disease&#xD;
             activity, disease location and phenotype at the time of diagnosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age: &gt;18 years old&#xD;
&#xD;
          2. Another chronical disease known affect nutritional status&#xD;
&#xD;
          3. Missing data in major variables including symptom duration, weight, height, disease&#xD;
             activity, disease location and phenotype at the time of diagnosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zarife Kuloglu, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ankara University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ankara University</name>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <link>
    <url>https://www.who.int/publications/i/item/9789241550123</url>
    <description>Assessing and managing children at primary health-care facilities to prevent overweight and obesity in the context of the double burden of malnutrition</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4958701/</url>
    <description>Nutritional concerns in pediatric inflammatory bowel disease</description>
  </link>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/29570147/</url>
    <description>Nutrition in Paediatric Inflammatory Bowel Disease: A Position Paper on Behalf of The Porto IBD Group of ESPGHAN</description>
  </link>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>February 25, 2021</last_update_submitted>
  <last_update_submitted_qc>February 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ankara University</investigator_affiliation>
    <investigator_full_name>Zarife Kuloglu</investigator_full_name>
    <investigator_title>Professor, MD.</investigator_title>
  </responsible_party>
  <keyword>İnflammatory bowel disease</keyword>
  <keyword>children</keyword>
  <keyword>nutritional status</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>January 21, 2022</submitted>
    <returned>March 22, 2022</returned>
  </pending_results>
  <!-- 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/NCT04457518
org study id: 12.10.2011/11-7/2
nct id: NCT04457518
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Malnutrition and growth retardation are major extraintestinal presentations of inflammatory
      bowel disease (IBD) in childhood and are especially prevalent among those with Crohn's
      disease. We aimed to evaluate nutritional status of children with IBD at the time of
      diagnosis.
Data for this study will be derived from the web-based National Registry for Pediatric IBD.
      The children (age: ≤ 18 years) who diagnosed with IBD according to international criteria
      will be eligible for enrollment. Data on demographic, clinical and laboratory characteristics
      at the time of diagnosis were extracted from the registry. All cases in the registry will be
      screened for eligibility criteria by principal investigator (senior gastroenterologist). The
      patients with other chronic disease known affect nutritional status will be excluded. The
      cases who had the missing major outcome variables including symptom duration, weight, height,
      disease activity, disease location and phenotype at the time of diagnosis will be excluded
      from the analysis, if they had all of these outcome variables, they were included.

      The nutritional status of participants will be evaluated based on anthropometric parameters.
      The weight status will be assessed by weight-for-length in children <2 years of age, and
      BMI-for-age in children 2 years of age and older. Height status will be evaluated by
      length/height-for-age in all cases. Age-and-sex specific percentile and the corresponding z
      score for all anthropometric parameters will be calculated in the WHOAnthro for under five
      years and WHOAnthroplus (WHO, Geneva, Switzerland) for those aged 5-18 years by using WHO
      standards and references. Z-scores between +2.0 and -2.0 for all parameters will be
      considered normal. Wasted/thinness and overweight will be defined by weight-for-length/BMI z
      score < -2.0, and > +2.0, respectively. Stunting (short stature) and tallness will be defined
      as length/height-for-age z score < -2.0 and > +2.0, respectively. Children will be stratified
      into two age groups for analysis: < 10 years of age and older. A p value of <0.05 was
      considered statistically significant.
observational model: Case-Only
time perspective: Other
measure: nutritional profiles of children with IBD
time frame: Day 1 of diagnosis
description: evaluating nutritional profiles of children with IBD at the time of diagnosis by anthropometric parameters
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
last name: Zarife Kuloglu, M.D.
role: Principal Investigator
affiliation: Ankara University
facility: 
country: Turkey
url: https://www.who.int/publications/i/item/9789241550123
description: Assessing and managing children at primary health-care facilities to prevent overweight and obesity in the context of the double burden of malnutrition
url: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4958701/
description: Nutritional concerns in pediatric inflammatory bowel disease
url: https://pubmed.ncbi.nlm.nih.gov/29570147/
description: Nutrition in Paediatric Inflammatory Bowel Disease: A Position Paper on Behalf of The Porto IBD Group of ESPGHAN
responsible party type: Principal Investigator
investigator affiliation: Ankara University
investigator full name: Zarife Kuloglu
investigator title: Professor, MD.
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases
sharing ipd: Undecided
submitted: January 21, 2022
returned: March 22, 2022