- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04457518
Nutritional Status in Children With IBD
Nutritional Status in Children With Inflammatory Bowel Disease
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Ankara, Turquie
- Ankara University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
nutritional profiles of children with IBD
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Zarife Kuloglu, M.D., Ankara University
Publications et liens utiles
Liens utiles
- 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
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 12.10.2011/11-7/2
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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