- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04457518
Nutritional Status in Children With IBD
Nutritional Status in Children With Inflammatory Bowel Disease
Study Overview
Status
Conditions
Detailed Description
Data for this study will be derived from the web-based National Registry for Pediatric IBD. The children (age: ≤ 18 years) who diagnosed with IBD according to international criteria will be eligible for enrollment. Data on demographic, clinical and laboratory characteristics at the time of diagnosis were extracted from the registry. All cases in the registry will be screened for eligibility criteria by principal investigator (senior gastroenterologist). The patients with other chronic disease known affect nutritional status will be excluded. The cases who had the missing major outcome variables including symptom duration, weight, height, disease activity, disease location and phenotype at the time of diagnosis will be excluded from the analysis, if they had all of these outcome variables, they were included.
The nutritional status of participants will be evaluated based on anthropometric parameters. The weight status will be assessed by weight-for-length in children <2 years of age, and BMI-for-age in children 2 years of age and older. Height status will be evaluated by length/height-for-age in all cases. Age-and-sex specific percentile and the corresponding z score for all anthropometric parameters will be calculated in the WHOAnthro for under five years and WHOAnthroplus (WHO, Geneva, Switzerland) for those aged 5-18 years by using WHO standards and references. Z-scores between +2.0 and -2.0 for all parameters will be considered normal. Wasted/thinness and overweight will be defined by weight-for-length/BMI z score < -2.0, and > +2.0, respectively. Stunting (short stature) and tallness will be defined as length/height-for-age z score < -2.0 and > +2.0, respectively. Children will be stratified into two age groups for analysis: < 10 years of age and older. A p value of <0.05 was considered statistically significant.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ankara, Turkey
- Ankara University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age: ≤ 18 years
- Diagnosis of IBD with clinical, laboratory, endoscopic and histopathologic findings
- No other chronical diseases known affect nutritional status
- No missing data in major variables including symptom duration, weight, height, disease activity, disease location and phenotype at the time of diagnosis
Exclusion Criteria:
- Age: >18 years old
- Another chronical disease known affect nutritional status
- Missing data in major variables including symptom duration, weight, height, disease activity, disease location and phenotype at the time of diagnosis
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
nutritional profiles of children with IBD
Time Frame: Day 1 of diagnosis
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evaluating nutritional profiles of children with IBD at the time of diagnosis by anthropometric parameters
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Day 1 of diagnosis
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zarife Kuloglu, M.D., Ankara University
Publications and helpful links
Helpful Links
- Assessing and managing children at primary health-care facilities to prevent overweight and obesity in the context of the double burden of malnutrition
- Nutritional concerns in pediatric inflammatory bowel disease
- Nutrition in Paediatric Inflammatory Bowel Disease: A Position Paper on Behalf of The Porto IBD Group of ESPGHAN
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12.10.2011/11-7/2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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