Nutritional Status in Children With IBD

Sponsor
Ankara University (Other)
Overall Status
Completed
CT.gov ID
NCT04457518
Collaborator
Turkish Society of Pediatric Gastroenterology, Hepatology and Nutrition (Other)
824
1
4.2
197.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    824 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Other
    Official Title:
    Nutritional Status in Children With Inflammatory Bowel Disease
    Actual Study Start Date :
    Jun 25, 2020
    Actual Primary Completion Date :
    Sep 30, 2020
    Actual Study Completion Date :
    Oct 30, 2020

    Outcome Measures

    Primary Outcome Measures

    1. nutritional profiles of children with IBD [Day 1 of diagnosis]

      evaluating nutritional profiles of children with IBD at the time of diagnosis by anthropometric parameters

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Age: ≤ 18 years

    2. Diagnosis of IBD with clinical, laboratory, endoscopic and histopathologic findings

    3. No other chronical diseases known affect nutritional status

    4. No missing data in major variables including symptom duration, weight, height, disease activity, disease location and phenotype at the time of diagnosis

    Exclusion Criteria:
    1. Age: >18 years old

    2. Another chronical disease known affect nutritional status

    3. Missing data in major variables including symptom duration, weight, height, disease activity, disease location and phenotype at the time of diagnosis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ankara University Ankara Turkey

    Sponsors and Collaborators

    • Ankara University
    • Turkish Society of Pediatric Gastroenterology, Hepatology and Nutrition

    Investigators

    • Principal Investigator: Zarife Kuloglu, M.D., Ankara University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Zarife Kuloglu, Professor, MD., Ankara University
    ClinicalTrials.gov Identifier:
    NCT04457518
    Other Study ID Numbers:
    • 12.10.2011/11-7/2
    First Posted:
    Jul 7, 2020
    Last Update Posted:
    Mar 1, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Zarife Kuloglu, Professor, MD., Ankara University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 1, 2021