Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-26 @ 3:52 AM
Study NCT ID:
NCT04457518
Status:
COMPLETED
Last Update Posted:
2021-03-01
First Post:
2020-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nutritional Status in Children With IBD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2022-03-22', 'releaseDate': '2022-01-21'}], 'estimatedResultsFirstSubmitDate': '2022-01-21'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 824}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-25', 'studyFirstSubmitDate': '2020-06-26', 'studyFirstSubmitQcDate': '2020-07-02', 'lastUpdatePostDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'nutritional profiles of children with IBD', 'timeFrame': 'Day 1 of diagnosis', 'description': 'evaluating nutritional profiles of children with IBD at the time of diagnosis by anthropometric parameters'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['İnflammatory bowel disease', 'children', 'nutritional status'], 'conditions': ['Inflammatory Bowel Diseases', 'Child']}, 'referencesModule': {'references': [{'pmid': '35173290', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://www.who.int/publications/i/item/9789241550123', 'label': 'Assessing and managing children at primary health-care facilities to prevent overweight and obesity in the context of the double burden of malnutrition'}, {'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4958701/', 'label': 'Nutritional concerns in pediatric inflammatory bowel disease'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/29570147/', 'label': 'Nutrition in Paediatric Inflammatory Bowel Disease: A Position Paper on Behalf of The Porto IBD Group of ESPGHAN'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Secondary and Tertiary Care Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: ≤ 18 years\n2. Diagnosis of IBD with clinical, laboratory, endoscopic and histopathologic findings\n3. No other chronical diseases known affect nutritional status\n4. No missing data in major variables including symptom duration, weight, height, disease activity, disease location and phenotype at the time of diagnosis\n\nExclusion Criteria:\n\n1. Age: \\>18 years old\n2. Another chronical disease known affect nutritional status\n3. Missing data in major variables including symptom duration, weight, height, disease activity, disease location and phenotype at the time of diagnosis'}, 'identificationModule': {'nctId': 'NCT04457518', 'briefTitle': 'Nutritional Status in Children With IBD', 'organization': {'class': 'OTHER', 'fullName': 'Ankara University'}, 'officialTitle': 'Nutritional Status in Children With Inflammatory Bowel Disease', 'orgStudyIdInfo': {'id': '12.10.2011/11-7/2'}}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Zarife Kuloglu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Turkish Society of Pediatric Gastroenterology, Hepatology and Nutrition', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, MD.', 'investigatorFullName': 'Zarife Kuloglu', 'investigatorAffiliation': 'Ankara University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-01-21', 'type': 'RELEASE'}, {'date': '2022-03-22', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Zarife Kuloglu, Professor, MD., Ankara University'}}}}