Clinical Trials Directory

Trials / Completed

CompletedNCT04457518

Nutritional Status in Children With IBD

Nutritional Status in Children With Inflammatory Bowel Disease

Status
Completed
Phase
Study type
Observational
Enrollment
824 (actual)
Sponsor
Ankara University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Timeline

Start date
2020-06-25
Primary completion
2020-09-30
Completion
2020-10-30
First posted
2020-07-07
Last updated
2021-03-01

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT04457518. Inclusion in this directory is not an endorsement.