ClinicalTrials.gov
ClinicalTrials.gov Menu

Nutritional Status and Body Composition in Childhood Inflammatory Bowel Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02704026
Recruitment Status : Completed
First Posted : March 9, 2016
Last Update Posted : January 8, 2018
Sponsor:
Information provided by (Responsible Party):
Zarife Kuloglu, Ankara University

Brief Summary:

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.


Condition or disease Intervention/treatment
Inflammatory Bowel Disease Other: Assesment of nutritional status and body composition

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
Actual Enrollment : 72 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nutritional Status and Body Composition in Children With Inflammatory Bowel Disease: A Prospective Cohort Study
Actual Study Start Date : July 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : January 2017

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




Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02704026


Locations
Turkey
Ankara University School of Medicine
Ankara, Turkey, 06100
Sponsors and Collaborators
Ankara University
Investigators
Study Director: Zarife Kuloglu Ankara University School of Medicine

Publications:
Responsible Party: Zarife Kuloglu, Professor (M.D.), Ankara University
ClinicalTrials.gov Identifier: NCT02704026     History of Changes
Other Study ID Numbers: 15H0230004
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: January 2018

Keywords provided by Zarife Kuloglu, Ankara University:
Body composition
Nutritional status

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis