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临床试验/NCT02704026
NCT02704026已完成不适用

Nutritional Status and Body Composition in Children With Inflammatory Bowel Disease: A Prospective Cohort Study

Ankara University1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
1
主要终点
Paediatric Crohn's Disease Activity Index

研究概览

简要总结

Malnutrition and growth retardation are common in children with inflammatory bowel disease (IBD), especially in Crohn's Disease (CD). Malnutrition is associated with disease type, anatomical location, severity of disease and age of patient. Recently, it is reported that almost all children with CD and half with Ulcerative Colitis (UC) have reduced lean mass, however, body fat alteration are not well defined.

The aim of this prospective and observational study was to evaluate nutritional and growth status and body composition of children with IBD using anthropometric measurement and bioelectrical impedance during 1 year follow-up.

详细描述

Patients 6 to 18 years of age at the time of enrolment who have IBD at any stage of disease activity, on any or no treatment and age- and sex-matched healthy controls will be included. All participants will be followed for 1 year.

Written informed consent will be obtained from the parents or guardians of the participants at the time of enrolment. Prospective and retrospective data will be collected. Complete family and medical history, physical examination and laboratory findings will be recorded on standard case report form. Disease activity will be scored using the Paediatric Crohn's Disease Activity Index for children with CD and the Pediatric Ulcerative Colitis Activity index for those with UC. Endoscopic data will be reviewed and disease location will be classified according to Paris classification. Puberty will be assessed based on the development of secondary sexual characteristics. At the time of enrollment and after 1 year, anthropometric measurements including height, weight, triceps skin fold thickness, middle arm circumference and assessment of body composition by bioelectrical impedance will be performed for each child. Anthropometric data will be standardized by generation of z-scores for height and weight based on age and gender. Growth deficiency for height and weight measurements will be defined as a z-score\-2.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • A male or female of 6 to 18 years of age at the time of enrolment
  • For children with IBD; the diagnosis of IBD are based on the combination of clinical features and serological, endoscopic, colonoscopic, and histological findings
  • For controls : no evidence of inflammatory or chronic disease

排除标准

  • A male or female < 6 years or > 18 years old at the enrollment
  • For children with IBD : Presence of other chronic diseases
  • For healthy control: Any coexisting chronic disease known to affect growth, nutritional status, dietary intake, or development

结局指标

主要结局

Paediatric Crohn's Disease Activity Index

时间窗: 1 year

Paediatric Ulcerative colitis Activity Index

时间窗: 1 year

Triceps skin fold thickness

时间窗: 1 year

Middle arm circumference

时间窗: 1 year

Body mass index

时间窗: 1 year

kg/m

Body composition

时间窗: 1 year

fat (%), fat mass and fat-free mass

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 (M.D.)

Ankara University

研究点 (1)

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