Inflammatory Bowel DiseaseNCT02704026
Nutritional Status and Body Composition in Childhood Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Disease, run by Ankara University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- Assesment of nutritional status and body composition
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2015to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients with IBD at any stage of disease activity, on any or no treatment and age- and sex-matched healthy controls
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University School of Medicine
Ankara, 06100
About this study
Official title: Nutritional Status and Body Composition in Children With Inflammatory Bowel Disease: A Prospective Cohort Study
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.
Read the 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
- Inflammatory Bowel Disease
- Being tested
- Assesment of nutritional status and body composition
- Keywords
- Body composition, Nutritional status
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assesment of nutritional status and body compositionOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Assesment of nutritional status and body composition | |
| Control | Age- and sex-matched healthy controls Receives: Other: Assesment of nutritional status and body composition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index
kg/m
Measured: 1 year
Triceps skin fold thickness
Measured: 1 year
Middle arm circumference
Measured: 1 year
Body composition
fat (%), fat mass and fat-free mass
Measured: 1 year
Paediatric Crohn's Disease Activity Index
Measured: 1 year
Paediatric Ulcerative colitis Activity Index
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startJul 2015
- Primary completionJul 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zarife Kuloglu, Ankara University
- Investigators
- Zarife Kuloglu, Study director, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704026
- Sponsor's protocol ID
- 15H0230004
- Status last verified
- Jan 2018
- First submitted
- 17 Feb 2016
- Last updated
- 8 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17961699Markowitz 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.
PubMed 8315544Burnham 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.
PubMed 16087987Sylvester 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.
PubMed 19249399Thangarajah 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.
PubMed 26043941
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Status and Body Composition in Children With Inflammatory Bowel Disease: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02704026
- Acronym / sponsor ID
- 15H0230004
- Conditions
- Inflammatory Bowel Disease
- Keywords
- Body composition, Nutritional status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 9 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inflammatory Bowel Disease | – | Other: Assesment of nutritional status and body compositionPatients 6-18 of age at the time of enrolment who have IBD at any stage of disease activity, on any or no treatment |
| Control | – | Other: Assesment of nutritional status and body compositionAge- and sex-matched healthy controls |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients with IBD at any stage of disease activity, on any or no treatment and age- and sex-matched healthy controls
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- A male or female < 6 years or > 18 years old at the enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assesment of nutritional status and body compositionAt the time of enrollment and after 1 year, anthropometric measurements and assessment of body composition by bioelectrical impedance will be performed for each child | Other | Control, Inflammatory Bowel Disease |
Primary outcome
Body mass index
Time frame: 1 year
kg/m
Triceps skin fold thickness
Time frame: 1 year
Middle arm circumference
Time frame: 1 year
Body composition
Time frame: 1 year
fat (%), fat mass and fat-free mass
Paediatric Crohn's Disease Activity Index
Time frame: 1 year
Paediatric Ulcerative colitis Activity Index
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2018.
- Background: PubMed 17961699Kugathasan 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.
- Background: PubMed 8315544Markowitz 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.
- Background: PubMed 16087987Burnham 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.
- Background: PubMed 19249399Sylvester 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.
- Background: PubMed 26043941Thangarajah 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zarife Kuloglu study director
Ankara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index (time frame: 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02704026, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2018.