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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	4 December 2023
Main ID:	NCT02745457
Date of registration:	13/04/2016
Prospective Registration:	No
Primary sponsor:	Schneider Children's Medical Center, Israel
Public title:	Body Composition in Children With Inflammatory Bowel Disease
Scientific title:	The Natural Course and the Effect of Treatment on Body Composition in Children With Inflammatory Bowel Disease
Date of first enrolment:	April 2016
Target sample size:	72
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/ct2/show/NCT02745457
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Israel

Contacts

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of IBD

- Age: 6 - 17 years ( inclusive)

- Informed consent

Exclusion Criteria:

- Pregnancy

- Non IBD associated chronic diseases

- Morbid obesity

Age minimum: 6 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Crohn's Disease

Intervention(s)

Primary Outcome(s)

To evaluate the change in body composition accorging to treatment treatment is children with IBD over the course of 2 years [Time Frame: 24 months]

Secondary Outcome(s)

To evaluate the correlation of body composition with BMI [Time Frame: 24 months]

To evaluate the correlation of body composition with disease activity [Time Frame: 24 months]

To evaluate the correlation of body composition to skin fold and mid arm circumference measurements in children with IBD [Time Frame: 24 months]

To assess the accuracy of ADP in comparison to DEXA based measurement of body composition in children with IBD [Time Frame: 24 months]

To evaluate the correlation of body composition with physical activity [Time Frame: 24 months]

Secondary ID(s)

BodPod IBD

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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