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Completed

NCT Number: NCT02704026

Nutritional Status and Body Composition in Childhood Inflammatory Bowel Disease

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.

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Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara University School of Medicine

Ankara, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Assesment of nutritional status and body composition

Other

At the time of enrollment and after 1 year, anthropometric measurements and assessment of body composition by bioelectrical impedance will be performed for each child

Primary outcomes

  1. Body mass index

    Time frame: 1 year

    kg/m

  2. Triceps skin fold thickness

    Time frame: 1 year

  3. Middle arm circumference

    Time frame: 1 year

  4. Body composition

    Time frame: 1 year

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

  5. Paediatric Crohn's Disease Activity Index

    Time frame: 1 year

  6. Paediatric Ulcerative colitis Activity Index

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Mar 9, 2016
Registry last updated
Jan 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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