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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04457518
Other study ID # 12.10.2011/11-7/2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 25, 2020
Est. completion date October 30, 2020

Study information

Verified date February 2021
Source Ankara University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 824
Est. completion date October 30, 2020
Est. primary completion date September 30, 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Ankara University Ankara

Sponsors (2)

Lead Sponsor Collaborator
Ankara University Turkish Society of Pediatric Gastroenterology, Hepatology and Nutrition

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary nutritional profiles of children with IBD evaluating nutritional profiles of children with IBD at the time of diagnosis by anthropometric parameters Day 1 of diagnosis
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