Nutritional Status and Body Composition in Childhood Inflammatory Bowel Disease
1 other identifier
observational
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 17, 2016
CompletedFirst Posted
Study publicly available on registry
March 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedJanuary 8, 2018
January 1, 2018
1 year
February 17, 2016
January 4, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Body mass index
kg/m
1 year
Triceps skin fold thickness
1 year
Middle arm circumference
1 year
Body composition
fat (%), fat mass and fat-free mass
1 year
Paediatric Crohn's Disease Activity Index
1 year
Paediatric Ulcerative colitis Activity Index
1 year
Study Arms (2)
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
Control
Age- and sex-matched healthy controls
Interventions
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
Eligibility Criteria
Patients with IBD at any stage of disease activity, on any or no treatment and age- and sex-matched healthy controls
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ankara University School of Medicine
Ankara, 06100, Turkey (Türkiye)
Related Publications (5)
Kugathasan S, Nebel J, Skelton JA, Markowitz J, Keljo D, Rosh J, LeLeiko N, Mack D, Griffiths A, Bousvaros A, Evans J, Mezoff A, Moyer S, Oliva-Hemker M, Otley A, Pfefferkorn M, Crandall W, Wyllie R, Hyams J; Wisconsin Pediatric Inflammatory Bowel Disease Alliance; Pediatric Inflammatory Bowel Disease Collaborative Research Group. Body mass index in children with newly diagnosed inflammatory bowel disease: observations from two multicenter North American inception cohorts. J Pediatr. 2007 Nov;151(5):523-7. doi: 10.1016/j.jpeds.2007.04.004. Epub 2007 Aug 24.
PMID: 17961699BACKGROUNDMarkowitz J, Grancher K, Rosa J, Aiges H, Daum F. Growth failure in pediatric inflammatory bowel disease. J Pediatr Gastroenterol Nutr. 1993 May;16(4):373-80. doi: 10.1097/00005176-199305000-00005.
PMID: 8315544BACKGROUNDBurnham JM, Shults J, Semeao E, Foster BJ, Zemel BS, Stallings VA, Leonard MB. Body-composition alterations consistent with cachexia in children and young adults with Crohn disease. Am J Clin Nutr. 2005 Aug;82(2):413-20. doi: 10.1093/ajcn.82.2.413.
PMID: 16087987BACKGROUNDSylvester FA, Leopold S, Lincoln M, Hyams JS, Griffiths AM, Lerer T. A two-year longitudinal study of persistent lean tissue deficits in children with Crohn's disease. Clin Gastroenterol Hepatol. 2009 Apr;7(4):452-5. doi: 10.1016/j.cgh.2008.12.017. Epub 2008 Dec 27.
PMID: 19249399BACKGROUNDThangarajah D, Hyde MJ, Konteti VK, Santhakumaran S, Frost G, Fell JM. Systematic review: Body composition in children with inflammatory bowel disease. Aliment Pharmacol Ther. 2015 Jul;42(2):142-57. doi: 10.1111/apt.13218. Epub 2015 Jun 4.
PMID: 26043941BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Zarife Kuloglu
Ankara University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor (M.D.)
Study Record Dates
First Submitted
February 17, 2016
First Posted
March 9, 2016
Study Start
July 1, 2015
Primary Completion
July 1, 2016
Study Completion
January 1, 2017
Last Updated
January 8, 2018
Record last verified: 2018-01