Clinical trial NCT04457518: Nutritional Status in Children With IBD
Official title: Nutritional Status in Children With Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Child
Keywords: İnflammatory bowel disease
children
nutritional status
Lead sponsor: Ankara University
Sponsor class: OTHER
Collaborators: name: Turkish Society of Pediatric Gastroenterology, Hepatology and Nutrition
First posted: 2020-07-07
Enrollment: 824
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Secondary and Tertiary Care Hospital

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: nutritional profiles of children with IBD
timeFrame: Day 1 of diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University
Study officials:
affiliation: Ankara University
name: Zarife Kuloglu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kuloglu Z, Cetin F, Urganci N, Onal Z, Sari S, Yuksekkaya H, Caltepe G, Kutluk G, Dumlupinar E; Turkish Inflammatory Bowel Disease Study Group. Nutritional characteristic of children with inflammatory bowel disease in the nationwide inflammatory bowel disease registry from the Mediterranean region. Eur J Clin Nutr. 2022 Sep;76(9):1289-1296. doi: 10.1038/s41430-022-01094-6. Epub 2022 Feb 16.