Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2026-02-20 @ 10:45 PM
Study NCT ID:
NCT03913156
Status:
COMPLETED
Last Update Posted:
2020-06-19
First Post:
2018-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feeding Patterns and Practices in Young Children With PKU During the First Two Years of Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-17', 'studyFirstSubmitDate': '2018-08-28', 'studyFirstSubmitQcDate': '2019-04-10', 'lastUpdatePostDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feeding patterns- product intake', 'timeFrame': 'up to 2 years', 'description': 'Actual intake of product and prescribed amount of product \\[# sachets\\] will be recorded as documented in diaries.'}, {'measure': 'Feeding patterns - intake other than study product', 'timeFrame': 'up to 2 years', 'description': 'Intakes of standard formulas / breast-milk and normal foods \\[mL\\] or \\[g/day\\] and \\[frequency\\] of breastfeeding, as documented in diaries.'}, {'measure': 'Feeding practices and difficulties by questionnaire; position', 'timeFrame': 'up to 2 years', 'description': 'Feeding practices entered by parents in diaries: the way the child has been fed will be assessed : categories \\[sitting position e.g on lap, in chair etc\\]'}, {'measure': 'Feeding practices and difficulties by questionnaire; self feeding', 'timeFrame': 'up to 2 years', 'description': 'Feeding practices entered by parents in diaries; the way the child has been fed will be assessed : \\[self-feeding; parent feeding\\]; \\[type of self feeding: bottle, finger; spoon, fork\\]'}, {'measure': 'Occurence of Adverse Events [ Safety and tolerability]', 'timeFrame': 'up to 2 years', 'description': 'Occurence of Adverse Events'}, {'measure': 'Gastro-Intestinal symptoms', 'timeFrame': 'up to 2 years', 'description': 'Occurence of GI symptoms \\[yes/no\\] for:\n\n* Mouth Ulcers\n* Tummy upset\n* Harder poos\n* Constipation\n* Softer poos\n* Vomiting\n* Colic\n* Other (free entry)'}, {'measure': 'Product Acceptability yes/no', 'timeFrame': 'up to 2 years', 'description': "Acceptability questions \\[yes/no\\] for:\n\n* Refuses more than takes\n* Refuses as much as takes\n* Takes more than refuses\n* Spits out product\n* Puts spoon away\n* Holds in mouth but won't swallow\n* Closes mouth on feeding\n* Cries at beginning of feed\n* Cries at end of feed\n* Deliberately spills feed\n* Turns head away\n* Other (free entry)"}, {'measure': 'Blood Phenylalanine control: Phe levels', 'timeFrame': 'up to 2 years', 'description': 'Phe levels \\[umol/L\\]'}, {'measure': 'Blood Tyrosine levels', 'timeFrame': 'up to 2 years', 'description': 'Tyrosine levels \\[umol/L\\]'}, {'measure': 'Intake of energy and nutritients: Study product', 'timeFrame': 'up to 2 years', 'description': 'Intakes of energy and nutrients from the study product \\[diet diary; #g product/day\\]'}, {'measure': 'Intake of energy and nutritients: Weaning', 'timeFrame': 'up to 2 years', 'description': 'Intakes of energy and nutrients from the weaning diet: descriptive information, intakes \\[g/day\\]'}, {'measure': 'Intake of energy and nutritients: Weaning', 'timeFrame': 'up to 2 years', 'description': 'Intakes of energy and nutrients from the weaning diet: descriptive information, intakes \\[# meals or snacks/day\\]'}, {'measure': 'Anthropometry: weight', 'timeFrame': 'up to 2 years', 'description': 'Weight \\[g\\]'}, {'measure': 'Anthropometry: length', 'timeFrame': 'up to 2 years', 'description': 'Length \\[cm\\]'}], 'secondaryOutcomes': [{'measure': 'Weaning per group (with our without protein substitute) - descriptive', 'timeFrame': 'up to 2 years', 'description': 'Compare the weaning , nutritional intakes \\[g/day\\] and metabolic control of infants taking the study product, with historical controls of the same age and weaning stage whose diet did not incorporate a semi-solid second stage protein substitute during the same time period \\[parent questionnaires\\]'}, {'measure': "Anxiety levels of parents - Beck's Anxiety inventory", 'timeFrame': 'up to 2 years', 'description': "The Beck's Anxiety Inventory, scores on domains \\[0 not at all - 3 severely\\]"}, {'measure': 'Coping mechanisms of parents by questionnaire', 'timeFrame': 'up to 2 years', 'description': 'Coping Health Inventory for Parents (scores on domains coping behaviour \\[3 extremely helpful -0 not helpful\\]'}, {'measure': 'Parent experience of Feeding via questionnaire', 'timeFrame': 'up to 2 years', 'description': "Feeding time Parent Questionnaire, experience of parents of their child's feeding time, scores on various domains \\[0-7\\]"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['PKU']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6471165/', 'label': 'Growth, protein, and energy intake in children with PKU taking a weaning protein substitute in the first 2 years of life: a case-control study; Nutrients 2019, 11(3), 552;'}, {'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6470524/', 'label': 'How Does Feeding Development and Progression onto Solid Foods in PKU Compare with Non-PKU Children During Weaning?; Nutrients 2019, 11(3), 529'}, {'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6950038/', 'label': 'Mealtime Anxiety and Coping Behaviour in Parents and Children During Weaning in PKU: A Case-Control Study; Nutrients. 2019 Dec; 11(12): 2857'}]}, 'descriptionModule': {'briefSummary': 'In this study the feeding patterns and practices at the introduction of a second stage phe-free protein substitute will be assessed in young children with PKU. This will be compared with the normal weaning process in healthy non-PKU age-matched children. In addition, tolerability and acceptability of the study product will be evaluated in a smaller group of subjects who have already been transferred onto a second stage protein substitute. The study is performed in 3 centers in the United Kingdom.', 'detailedDescription': 'Part 1:\n\nFor subjects with PKU, the study product will be incorporated in the diet as the second stage protein substitute until the subjects are 2 years of age.\n\nThe healthy non-PKU age-matched subjects will not have the study product incorporated in their diet in order to be able to compare the weaning experience and nutritional intake of PKU subjects with non-PKU subjects. The healthy subjects will also be part of the study until the subjects are 2 years of age.\n\nPart 2:\n\nAll PKU subjects will take the study product for 7 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of PKU identified on screening during the newborn period and requiring a phenylalanine free protein substitute\n* Subjects who are about to commence weaning and require a concentrated phe-free protein substitute to meet their total protein requirements and are aged between 4 and 10 months (Part 1)\n* Subjects aged under 5 years who have already been fully transferred onto a concentrated phe-free protein substitute and are willing to try the study product for 7 days (Part 2)\n* Written informed consent obtained from subject or parents / caregiver\n* May or may not have commenced weaning solids (i.e. using normal foods)\n\nExclusion Criteria:\n\n* Presence of serious concurrent illness\n* Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements\n* Any child who has not commenced a second stage protein substitute and is over the age of 10 months\n* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study\n* Any children having taken antibiotics over the previous 2 weeks leading up to the study"}, 'identificationModule': {'nctId': 'NCT03913156', 'acronym': 'PKU-weaning', 'briefTitle': 'Feeding Patterns and Practices in Young Children With PKU During the First Two Years of Life', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nutricia Research'}, 'officialTitle': 'Feeding Patterns and Practices in Young Children With PKU During the First Two Years of Life: Acceptability and Efficacy of a New Protein Substitute', 'orgStudyIdInfo': {'id': 'B2970'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Part 1', 'description': 'Part 1 of the study will recruit subjects who are about to be introduced to a concentrated phe-free protein substitute (i.e. second stage protein substitute) for the first time.', 'interventionNames': ['Other: B2970 Metabolic Texture Modified Protein Substitute']}, {'type': 'OTHER', 'label': 'Part 2', 'description': 'Part 2 of the study will recruit subjects who have already been introduced to a concentrated phe-free protein substitute (i.e. have already transferred from phe-free infant formula onto a second stage protein substitute). This group will be included to evaluate the acceptability of the study product in patients who have already moved onto a second stage protein substitute.', 'interventionNames': ['Other: B2970 Metabolic Texture Modified Protein Substitute']}], 'interventions': [{'name': 'B2970 Metabolic Texture Modified Protein Substitute', 'type': 'OTHER', 'otherNames': ['PKU gel'], 'description': "The study product is a powdered phe-free protein substitute supplemented with long chain polyunsaturated fatty acids (LCP's), containing essential and non-essential amino acids, carbohydrate, fat, vitamins, minerals and trace elements and has been designed for use in the management of proven PKU in children aged 6 months to 5 years.", 'armGroupLabels': ['Part 1', 'Part 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B4 6NH', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': "Birmingham Children's Hospital", 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'BD5 0NA', 'city': 'Bradford', 'country': 'United Kingdom', 'facility': "Bradford Teaching Hospitals NHS Foundation Trust, St Luke's Hospital", 'geoPoint': {'lat': 53.79391, 'lon': -1.75206}}, {'zip': 'G12 OXH', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'JB Russell House, Gartnavel Royal Hospital', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'overallOfficials': [{'name': 'Anita MacDonald', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Birmingham Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nutricia Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}