Trials / Completed
CompletedNCT02704026
Nutritional Status and Body Composition in Childhood Inflammatory Bowel Disease
Nutritional Status and Body Composition in Children With Inflammatory Bowel Disease: A Prospective Cohort Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 72 (actual)
- Sponsor
- Ankara University · Academic / Other
- Sex
- All
- Age
- 6 Years – 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2015-07-01
- Primary completion
- 2016-07-01
- Completion
- 2017-01-01
- First posted
- 2016-03-09
- Last updated
- 2018-01-08
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT02704026. Inclusion in this directory is not an endorsement.