Nutritional Status and Body Composition in Childhood Inflammatory Bowel Disease

January 4, 2018 updated by: Zarife Kuloglu, Ankara University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Ankara University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with IBD at any stage of disease activity, on any or no treatment and age- and sex-matched healthy controls

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Inflammatory Bowel Disease
Patients 6-18 of age at the time of enrolment who have IBD at any stage of disease activity, on any or no treatment
Other: Assesment of nutritional status and body composition
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
Control
Age- and sex-matched healthy controls
Other: Assesment of nutritional status and body composition
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body mass index
Time Frame: 1 year
kg/m
1 year
Triceps skin fold thickness
Time Frame: 1 year
1 year
Middle arm circumference
Time Frame: 1 year
1 year
Body composition
Time Frame: 1 year
fat (%), fat mass and fat-free mass
1 year
Paediatric Crohn's Disease Activity Index
Time Frame: 1 year
1 year
Paediatric Ulcerative colitis Activity Index
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Investigators

  • Study Director: Zarife Kuloglu, Ankara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

February 17, 2016

First Submitted That Met QC Criteria

March 4, 2016

First Posted (Estimate)

March 9, 2016

Study Record Updates

Last Update Posted (Actual)

January 8, 2018

Last Update Submitted That Met QC Criteria

January 4, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15H0230004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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