Nutritional Status in Children With IBD

NCT ID: NCT04457518

Last Updated: 2021-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

824 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-25

Study Completion Date

2020-10-30

Brief Summary

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Malnutrition and growth retardation are major extraintestinal presentations of inflammatory bowel disease (IBD) in childhood and are especially prevalent among those with Crohn's disease. We aimed to evaluate nutritional status of children with IBD at the time of diagnosis.

Detailed Description

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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.

Conditions

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Inflammatory Bowel Diseases Child

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age: ≤ 18 years
2. Diagnosis of IBD with clinical, laboratory, endoscopic and histopathologic findings
3. No other chronical diseases known affect nutritional status
4. No missing data in major variables including symptom duration, weight, height, disease activity, disease location and phenotype at the time of diagnosis

Exclusion Criteria

1. Age: \>18 years old
2. Another chronical disease known affect nutritional status
3. Missing data in major variables including symptom duration, weight, height, disease activity, disease location and phenotype at the time of diagnosis
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Turkish Society of Pediatric Gastroenterology, Hepatology and Nutrition

OTHER

Sponsor Role collaborator

Ankara University

OTHER

Sponsor Role lead

Responsible Party

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Zarife Kuloglu

Professor, MD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zarife Kuloglu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ankara University

Locations

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Ankara University

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Kuloglu Z, Cetin F, Urganci N, Onal Z, Sari S, Yuksekkaya H, Caltepe G, Kutluk G, Dumlupinar E; Turkish Inflammatory Bowel Disease Study Group. Nutritional characteristic of children with inflammatory bowel disease in the nationwide inflammatory bowel disease registry from the Mediterranean region. Eur J Clin Nutr. 2022 Sep;76(9):1289-1296. doi: 10.1038/s41430-022-01094-6. Epub 2022 Feb 16.

Reference Type DERIVED
PMID: 35173290 (View on PubMed)

Related Links

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https://www.who.int/publications/i/item/9789241550123

Assessing and managing children at primary health-care facilities to prevent overweight and obesity in the context of the double burden of malnutrition

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4958701/

Nutritional concerns in pediatric inflammatory bowel disease

https://pubmed.ncbi.nlm.nih.gov/29570147/

Nutrition in Paediatric Inflammatory Bowel Disease: A Position Paper on Behalf of The Porto IBD Group of ESPGHAN

Other Identifiers

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12.10.2011/11-7/2

Identifier Type: -

Identifier Source: org_study_id

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