Clinical trial NCT02704026: Nutritional Status and Body Composition in Childhood Inflammatory Bowel Disease
Official title: Nutritional Status and Body Composition in Children With Inflammatory Bowel Disease: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Disease
Keywords: Body composition
Nutritional status
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2016-03-09
Enrollment: 72
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility 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

Primary outcomes:
measure: Body mass index
timeFrame: 1 year
measure: Triceps skin fold thickness
timeFrame: 1 year
measure: Middle arm circumference
timeFrame: 1 year
measure: Body composition
timeFrame: 1 year
measure: Paediatric Crohn's Disease Activity Index
timeFrame: 1 year
measure: Paediatric Ulcerative colitis Activity Index
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University School of Medicine
Study officials:
affiliation: Ankara University
name: Zarife Kuloglu
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.