Nutritional Status in Children With IBD

Inflammatory Bowel Diseases Clinical Trial

Official title:

Nutritional Status in Children With Inflammatory Bowel Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04457518
• Other study ID #: 12.10.2011/11-7/2
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Child
• Inflammatory Bowel Diseases
• Intestinal Diseases

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

External Links

•   Assessing and managing children at primary health-care facilities to prevent overweight and obesity in the context of the double burden of malnutrition
•   Nutrition in Paediatric Inflammatory Bowel Disease: A Position Paper on Behalf of The Porto IBD Group of ESPGHAN
•   Nutritional concerns in pediatric inflammatory bowel disease
•   Training Course on Child Growth Assessment WHO Child Growth Standards