Ignite Creation Date:
2025-12-17 @ 2:47 PM
Ignite Modification Date:
2025-12-23 @ 10:23 PM
Study NCT ID:
NCT05038995
Status:
UNKNOWN
Last Update Posted:
2021-09-09
First Post:
2021-08-19
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Early Cow's Milk Elimination Diet on the Growth Pattern
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016269', 'term': 'Milk Hypersensitivity'}], 'ancestors': [{'id': 'D005512', 'term': 'Food Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-09-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-03', 'studyFirstSubmitDate': '2021-08-19', 'studyFirstSubmitQcDate': '2021-09-03', 'lastUpdatePostDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body weight in kilograms-T0', 'timeFrame': 'One month prior to the diagnosis of CMA', 'description': 'Body weight (kg)'}, {'measure': 'Body weight in kilograms-T1', 'timeFrame': 'On the 3-month of CME diet', 'description': 'Body weight (kg)'}, {'measure': 'Body weight in kilograms-T2', 'timeFrame': 'Three months after the end of the CME diet', 'description': 'Body weight (kg)'}, {'measure': 'Body weight in kilograms-T3', 'timeFrame': 'The last examination date of the patient after 3rd month control after CME diet', 'description': 'Body weight (kg)'}, {'measure': 'Height in centimeters-T0', 'timeFrame': 'One month prior to the diagnosis of CMA', 'description': 'Height (cm)'}, {'measure': 'Height in centimeters-T1', 'timeFrame': 'On the 3-month of CME diet', 'description': 'Height (cm)'}, {'measure': 'Height in centimeters-T2', 'timeFrame': 'Three months after the end of the CME diet', 'description': 'Height (cm)'}, {'measure': 'Height in centimeters-T3', 'timeFrame': 'The last examination date of the patient after 3rd month control after CME diet', 'description': 'Height (cm)'}, {'measure': 'Head circumference in centimeters-T0', 'timeFrame': 'One month prior to the diagnosis of CMA', 'description': 'Head circumference (cm)'}, {'measure': 'Head circumference in centimeters-T1', 'timeFrame': 'On the 3-month of CME diet', 'description': 'Head circumference (cm)'}, {'measure': 'Head circumference in centimeters-T2', 'timeFrame': 'Three months after the end of the CME diet', 'description': 'Head circumference (cm)'}, {'measure': 'Head circumference in centimeters-T3', 'timeFrame': 'The last examination date of the patient after 3rd month control after CME diet', 'description': 'Head circumference (cm)'}], 'secondaryOutcomes': [{'measure': 'Dietary intake', 'timeFrame': 'The last examination date of the patient after 3rd month control after CME diet', 'description': 'Three day dietary record'}, {'measure': 'Blood measurements-Hemoglobin', 'timeFrame': 'The last examination date of the patient after 3rd month control after CME diet', 'description': 'Hemoglobin g/dl'}, {'measure': 'Blood measurements-Sodium', 'timeFrame': 'The last examination date of the patient after 3rd month control after CME diet', 'description': 'sodium mg/ml'}, {'measure': 'Blood measurements-Potassium', 'timeFrame': 'The last examination date of the patient after 3rd month control after CME diet', 'description': 'Potassium'}, {'measure': 'Blood measurements-Albumin', 'timeFrame': 'The last examination date of the patient after 3rd month control after CME diet', 'description': 'Albumin'}, {'measure': 'Blood measurements-Protein', 'timeFrame': 'The last examination date of the patient after 3rd month control after CME diet', 'description': 'Protein'}, {'measure': 'Blood measurements-Calcium', 'timeFrame': 'The last examination date of the patient after 3rd month control after CME diet', 'description': 'Calcium'}, {'measure': 'Blood measurements-Vitamin B12', 'timeFrame': 'The last examination date of the patient after 3rd month control after CME diet', 'description': 'Vitamin B12'}, {'measure': 'Blood measurements-selenium', 'timeFrame': 'The last examination date of the patient after 3rd month control after CME diet', 'description': 'Selenium'}, {'measure': 'Blood measurements-zinc', 'timeFrame': 'The last examination date of the patient after 3rd month control after CME diet', 'description': 'Zinc'}, {'measure': 'Blood measurements-25-OH vitamin D', 'timeFrame': 'The last examination date of the patient after 3rd month control after CME diet', 'description': '25-OH vitamin D'}, {'measure': 'Blood measurements-iron', 'timeFrame': 'The last examination date of the patient after 3rd month control after CME diet', 'description': 'Iron'}, {'measure': 'Blood measurements-Folate', 'timeFrame': 'The last examination date of the patient after 3rd month control after CME diet', 'description': 'Folate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cow milk allergy', 'Elimination diet', 'Anthropometry', 'Growth status'], 'conditions': ['Cow Milk Allergy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/30412327/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to survey the growth of children who were on elimination diet due to cow milk allergy in Turkey. 0-5 year aged children diagnosed with cow\'s milk allergy (CMA) and healthy age-sex-matched children as the control group was planned for inclusion. Participants will be included in the study by consecutive sampling. The anthropometry measurements (height-for-age \\[HFA\\], weight-for-age \\[WFA\\], and weight-for-height \\[WtHt\\]) will be evaluated according to the Z-score using the WHO ANTHRO \\[Z-score = Patient\'s value - Average value / Standard Deviation (SD)\\]. The Z-score (SDS) in the average child by age was "0".', 'detailedDescription': '0-5 year aged children diagnosed with cow\'s milk allergy (CMA) and healthy age-sex-matched children as the control group was planned for inclusion. The study will constitute of two groups; group 1; the children who received cow\'s milk elimination (CME) diet and group 2; the healthy controls. Group 1 will constitute of children aged 0-5 years who received a CME diet due to CMA (Ig E-mediated and/or non-Ig E-mediated and/or mixed type)\\], confirmed by an oral food challenge test (OFC) and had reintroduced cow\'s milk for at least ≥ three months ago. Participants will be included in the study by consecutive sampling. The anthropometric measurements (height-for-age \\[HFA\\], weight-for-age \\[WFA\\], and weight-for-height \\[WtHt\\]) will be evaluated according to the Z-score using the WHO ANTHRO \\[Z-score = Patient\'s value - Average value / Standard Deviation (SD)\\]. The Z-score (SDS) in the average child by age was "0".'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '1 Month', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric Allergy Department Outpatient Clinic and Healthy Child Outpatient Clinic', 'healthyVolunteers': True, 'eligibilityCriteria': "Study Group Inclusion Criteria:\n\n* had a diagnosis of CMA by OFC, except children with known anaphylaxis\n* those on a CME diet or a specialized infant formula for at least three months\n* had reintroduced cow's milk for at least three months ago.\n* Children who excluded other foods in addition to cows' milk in the first four years of life for ≥ three months and who currently introduced these foods for at least ≥ three months were also enrolled in the CME group.\n\nHealthy group inclusion criteria:\n\n* did not have CMA and other allergic diseases\n* who had never been on a diet throughout their lives.\n\nExclusion Criteria:\n\n* Known acute (e.g., influenza) or chronic (e.g., diabetes, immune deficiencies ) diseases,\n* history of systemic steroid use \\> 0.5 mg/kg for more than one week in their life,\n* recurrent infections within the last three months,\n* food restriction other than food allergy (e.g., vegan, vegetarian),\n* moderate to severe asthma, and other medical or surgical conditions which might affect nutrition and growth."}, 'identificationModule': {'nctId': 'NCT05038995', 'briefTitle': "The Effect of Early Cow's Milk Elimination Diet on the Growth Pattern", 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi'}, 'officialTitle': "The Effect of Early Cow's Milk Elimination Diet on the Growth Pattern and Nutritional Status of Preschool Children", 'orgStudyIdInfo': {'id': 'NzlKbr2021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cow milk elimination group', 'description': "The CME children will be eligible for the study if they (1) had a diagnosis of CMA by OFC, except children with known anaphylaxis (2) those on a CME diet or a specialized infant formula for at least three months (3) had reintroduced cow's milk for at least three months ago. Children who excluded other foods in addition to cows' milk in the first four years of life for ≥ three months and who currently introduced these foods for at least ≥ three months will be also enrolled in the CME group."}, {'label': 'Healthy group', 'description': 'Healthy children will ve eligible for the study if they (1) did not have CMA and other allergic diseases (2) who had never been on a diet throughout their lives.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Nazli Ercan, MD', 'role': 'CONTACT', 'email': 'drnazliercan@gmail.com', 'phone': '+905319957255'}], 'facility': 'University of Health Sciences, Gulhane Education and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Nazlı Ercan, MD', 'role': 'CONTACT', 'email': 'drnazliercan@gmail.com', 'phone': '+905319957255'}], 'overallOfficials': [{'name': 'Nazli Ercan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Health Sciences Turkey, Gulhane Education and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Nazlı ERCAN', 'investigatorAffiliation': 'Saglik Bilimleri Universitesi'}}}}