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临床试验/NCT04457518
NCT04457518已完成不适用

Nutritional Status in Children With Inflammatory Bowel Disease

Ankara University1 个研究点 分布在 1 个国家目标入组 824 人开始时间: 2020年6月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
824
试验地点
1
主要终点
nutritional profiles of children with IBD

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age: ≤ 18 years
  • Diagnosis of IBD with clinical, laboratory, endoscopic and histopathologic findings
  • No other chronical diseases known affect nutritional status
  • No missing data in major variables including symptom duration, weight, height, disease activity, disease location and phenotype at the time of diagnosis

排除标准

  • Age: >18 years old
  • Another chronical disease known affect nutritional status
  • Missing data in major variables including symptom duration, weight, height, disease activity, disease location and phenotype at the time of diagnosis

结局指标

主要结局

nutritional profiles of children with IBD

时间窗: Day 1 of diagnosis

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zarife Kuloglu

Professor, MD.

Ankara University

研究点 (1)

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