Nutritional Status and Body Composition in Childhood Inflammatory Bowel Disease
NCT ID: NCT02704026
Last Updated: 2018-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
72 participants
OBSERVATIONAL
2015-07-31
2017-01-31
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Years
18 Years
ALL
Yes
Sponsors
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Ankara University
OTHER
Responsible Party
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Zarife Kuloglu
Professor (M.D.)
Principal Investigators
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Zarife Kuloglu
Role: STUDY_DIRECTOR
Ankara University
Locations
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Ankara University School of Medicine
Ankara, , Turkey (Türkiye)
Countries
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References
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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.
Markowitz 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.
Burnham 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.
Sylvester 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.
Thangarajah 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.
Other Identifiers
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15H0230004
Identifier Type: -
Identifier Source: org_study_id
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