Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2026-01-05 @ 2:47 AM
Study NCT ID:
NCT05937061
Status:
COMPLETED
Last Update Posted:
2023-07-10
First Post:
2023-04-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Persistent Food Allergy on Nutritional Status of Children With Food Allergy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005512', 'term': 'Food Hypersensitivity'}], 'ancestors': [{'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015502', 'term': 'Absorptiometry, Photon'}], 'ancestors': [{'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003720', 'term': 'Densitometry'}, {'id': 'D010783', 'term': 'Photometry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples for analysis'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-29', 'studyFirstSubmitDate': '2023-04-05', 'studyFirstSubmitQcDate': '2023-06-29', 'lastUpdatePostDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Influence of food allergy on growth', 'timeFrame': '6 years', 'description': 'Patients body weight (kg), height (cm) and use WHO growth curves to asses their growth and nutritional status and compare the to control group. Comparison of their measurements against the measurements at the time od diagnosis to asses the influence on growth.'}, {'measure': 'Influence of food allergy on food intake and nutrient intake', 'timeFrame': '29 months', 'description': 'Patients caregivers will deliver 3 - day food diary and dietitan will analyse it (energy intake - kcals/KJ, intake of proteins kg/kg of body weight/day, intake of calcium and iron in mg/day and %of fat, %of carbohydrates and % of proteins in their nutrition. It will all be compared to the control group..'}, {'measure': 'Influence of food allergy on blood sampling analysis', 'timeFrame': '29 months', 'description': 'Blood sample analysis will be performed and results of intervention groups compared versus control group'}, {'measure': 'Influence of milk allergy on bone mineral density', 'timeFrame': '29 months', 'description': 'Data of bone mineral density will be gathered from our patients database and analysed'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Food Allergy']}, 'referencesModule': {'references': [{'pmid': '24933388', 'type': 'BACKGROUND', 'citation': "Berni Canani R, Leone L, D'Auria E, Riva E, Nocerino R, Ruotolo S, Terrin G, Cosenza L, Di Costanzo M, Passariello A, Coruzzo A, Agostoni C, Giovannini M, Troncone R. The effects of dietary counseling on children with food allergy: a prospective, multicenter intervention study. J Acad Nutr Diet. 2014 Sep;114(9):1432-9. doi: 10.1016/j.jand.2014.03.018. Epub 2014 Jun 3."}, {'pmid': '26441150', 'type': 'BACKGROUND', 'citation': 'Beck C, Koplin J, Dharmage S, Wake M, Gurrin L, McWilliam V, Tang M, Sun C, Foskey R, Allen KJ; HealthNuts Investigators. Persistent Food Allergy and Food Allergy Coexistent with Eczema Is Associated with Reduced Growth in the First 4 Years of Life. J Allergy Clin Immunol Pract. 2016 Mar-Apr;4(2):248-56.e3. doi: 10.1016/j.jaip.2015.08.009. Epub 2015 Oct 2.'}, {'pmid': '27418957', 'type': 'BACKGROUND', 'citation': 'Meyer R, De Koker C, Dziubak R, Godwin H, Dominguez-Ortega G, Chebar Lozinsky A, Skrapac AK, Gholmie Y, Reeve K, Shah N. The impact of the elimination diet on growth and nutrient intake in children with food protein induced gastrointestinal allergies. Clin Transl Allergy. 2016 Jul 14;6:25. doi: 10.1186/s13601-016-0115-x. eCollection 2016.'}, {'pmid': '27244780', 'type': 'BACKGROUND', 'citation': "Mailhot G, Perrone V, Alos N, Dubois J, Delvin E, Paradis L, Des Roches A. Cow's Milk Allergy and Bone Mineral Density in Prepubertal Children. Pediatrics. 2016 May;137(5):e20151742. doi: 10.1542/peds.2015-1742."}, {'pmid': '25312758', 'type': 'BACKGROUND', 'citation': 'Robbins KA, Wood RA, Keet CA. Milk allergy is associated with decreased growth in US children. J Allergy Clin Immunol. 2014 Dec;134(6):1466-1468.e6. doi: 10.1016/j.jaci.2014.08.037. Epub 2014 Oct 11. No abstract available.'}, {'pmid': '24353835', 'type': 'BACKGROUND', 'citation': 'Kim J, Kwon J, Noh G, Lee SS. The effects of elimination diet on nutritional status in subjects with atopic dermatitis. Nutr Res Pract. 2013 Dec;7(6):488-94. doi: 10.4162/nrp.2013.7.6.488. Epub 2013 Nov 29.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this single center retrospective cohort study with observational longitudinal follow up is to compare food - allergic children (egg, milk and peanut allergy) with children in control group (children without any food allergy).\n\nThe main question\\[s\\] it aims to answer are:\n\n* If children with food allergy groups will have lower food intake od micronutrients?\n* If growth in children with food allergy is worse as in control group?\n* If they are more malnourished and in the food allergies group is more stunting than in the control group?\n* If children with milk allergy have lower intake of calcium in their diet and lower mineral bone density?\n\nParticipants will be asked to do 3 day food diary and to have blood analysed (hemograme, complete blood count, serum iron status, serum protein).\n\nIf there is a comparison group: Researchers will compare milk, egg and peanut allergy group to the control group (peers without food allergy) to see if the food allergy affects growth, macronutrient, micronutrient intake.', 'detailedDescription': "Study design A single center retrospective cohort study with observational longitudinal follow up will be performed. The study will include three intervention groups (milk, egg and peanut allergy) and a control group (children with no food allergy). Patients will be 2 to 12 years old. The patients will be recruited at our University Medical Center Ljubljana, Pediatric hospital Ljubljana, outpatient care of our Department for Allergology, Rheumatology and Clinical Immunology. This study will be conducted according to the guidelines in Declaration of Helsinki and approved by Ethics Committee of Slovenia. Written informed consent will be obtained from all the subject's caregivers. The investigators will follow patients from confirmation of food allergy on and will collect data about their weight (kg) and height (cm) from our information system or patients' doctor (or caregiver). The investigators will collect data prospectively for 3 months from outpatient registry of our clinic. At the day of appointment patients will bring 3-day nutrition diary which was later analyzed by dietitian. The parents will attend an appointment by the dietitian where they will be informed about food diary analysis result and given the advice to enhance nutrition if necessary."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with food-allergy were between 2 and 12 years old. All children in intervention group had IgE-mediated food allergy (skin prick test and/or specific IgE combined with an allergy focused history) to milk, egg or peanut.\n\nIn control group there were children between 2 and 12 years old, with no food allergy (patients with bee venom or drug allergy).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* IgE-mediated food allergy (skin prick test and/or specific IgE combined with an allergy focused history)\n\nExclusion Criteria:\n\n* other chronic diseases (except atopic dermatitis, asthma, anaphylactic reaction, angioedema),\n* vegetarian or vegan nutrition.'}, 'identificationModule': {'nctId': 'NCT05937061', 'briefTitle': 'Influence of Persistent Food Allergy on Nutritional Status of Children With Food Allergy', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Centre Ljubljana'}, 'officialTitle': 'Influence of Persistent Food Allergy on Nutritional Status of Children With Food Allergy', 'orgStudyIdInfo': {'id': '20200133'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Milk allergy', 'description': 'Children with milk allergy.', 'interventionNames': ['Biological: Blood sample analysis', 'Radiation: Bone mineral density measurement (DXA)', 'Other: Influence of food allergy on growth (intervention groups)']}, {'label': 'Egg Allergy', 'description': 'Children with egg allergy', 'interventionNames': ['Biological: Blood sample analysis', 'Other: Anthropometrics measurement - at inclusion to the study (all groups).', 'Other: Influence of food allergy on growth (intervention groups)']}, {'label': 'Peanut allergy', 'description': 'Children with peanut allergy', 'interventionNames': ['Biological: Blood sample analysis', 'Other: Anthropometrics measurement - at inclusion to the study (all groups).', 'Other: Influence of food allergy on growth (intervention groups)']}, {'label': 'Control group', 'description': 'Patients withhout food allergy (bee venom or drug allergy).', 'interventionNames': ['Biological: Blood sample analysis', 'Other: Anthropometrics measurement - at inclusion to the study (all groups).']}], 'interventions': [{'name': 'Blood sample analysis', 'type': 'BIOLOGICAL', 'description': 'Analysis of complete blood count, hemogram, serum proteins, serum iron status (iron, transferin, ferritin). Group comparison - intervention vs. control.', 'armGroupLabels': ['Control group', 'Egg Allergy', 'Milk allergy', 'Peanut allergy']}, {'name': 'Anthropometrics measurement - at inclusion to the study (all groups).', 'type': 'OTHER', 'description': 'Measurement of body height (cm), weight (kg) and calculating BMI (kg/m2). Group comparison - intervention vs. control.', 'armGroupLabels': ['Control group', 'Egg Allergy', 'Peanut allergy']}, {'name': 'Bone mineral density measurement (DXA)', 'type': 'RADIATION', 'description': 'Analysis of bone mineral density with DXA in patients with milk allegy. Analysis ordered by medical doctor.', 'armGroupLabels': ['Milk allergy']}, {'name': 'Influence of food allergy on growth (intervention groups)', 'type': 'OTHER', 'description': 'Gathering the data about of body height (cm), weight (kg) BMI (kg/m2) at the diagnosis of food allergy and comparison versus data at the enrollment in the study to asses growth.', 'armGroupLabels': ['Egg Allergy', 'Milk allergy', 'Peanut allergy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'Universitiy Medical center Ljubljana, division for Pediatrics', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'overallOfficials': [{'name': 'Tadej Avcin, prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Head of Department of Clinical Immunology, Rheumatology and Allergology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Centre Ljubljana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}