Nutritional Status and Body Composition in Childhood Inflammatory Bowel Disease

Inflammatory Bowel Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02704026
• Other study ID #: 15H0230004
• Status: Completed
• Phase: N/A
• First received: February 17, 2016
• Last updated: January 4, 2018
• Start date: July 2015
• Est. completion date: January 2017

Study information

• Verified date: January 2018
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: January 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

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

Locations

Country	Name	City	State
Turkey	Ankara University School of Medicine	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View 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. Epub 2007 Aug 24. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

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