Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2026-02-03 @ 3:26 AM
Study NCT ID:
NCT01879995
Status:
COMPLETED
Last Update Posted:
2016-02-08
First Post:
2013-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phenylketonuria and Hyperphenylalaninemia Nutrition Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010661', 'term': 'Phenylketonurias'}], 'ancestors': [{'id': 'D020739', 'term': 'Brain Diseases, Metabolic, Inborn'}, {'id': 'D001928', 'term': 'Brain Diseases, Metabolic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000592', 'term': 'Amino Acid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-05', 'studyFirstSubmitDate': '2013-06-04', 'studyFirstSubmitQcDate': '2013-06-13', 'lastUpdatePostDateStruct': {'date': '2016-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Macronutrient and micronutrient intake, calculated from a nutrition protocol (four consecutive days)', 'timeFrame': 'assessed during 4 consecutive days max. within 1 month after a regular consultation in the outpatient clinic', 'description': 'Assessed nutrients:\n\nMacronutrients: protein, fat, carbohydrates in g/kg/d\n\nDaily phenylalanine and tyrosine intake Micronutrients and minerals: Calcium, magnesium, iron, zinc, selenium\n\nVitamins: D, B12, B6, C, folic acid'}], 'secondaryOutcomes': [{'measure': 'Phenylalanine level (umol/l)', 'timeFrame': 'assessed at the end of the four-day nutrition protocol (see primary outcome)', 'description': 'this outcome measure is not study-specific and is collected as part of established routine care (self-measurement by patient)'}, {'measure': 'Plasma amino acid profile', 'timeFrame': 'determined at a routine visit at the outpatient clinic, on average 1x per year', 'description': 'this outcome measure is not study-specific and is collected as part of established routine care.'}, {'measure': 'Concentrations of micronutrients, minerals and vitamins', 'timeFrame': 'determined at a routine visit at the outpatient clinic, on average 1x per year', 'description': 'assessed parameters: Ferritin, zinc, selenium, vitamin D, vitamin B12, folic acid.\n\nThese outcome measures are not study-specific and are collected as part of established routine care'}, {'measure': 'body weight (kg)', 'timeFrame': 'determined at a routine visit at the outpatient clinic, on average once every 6 - 12 months', 'description': 'assessed as part of routine clinical care'}]}, 'conditionsModule': {'conditions': ['Phenylketonuria (PKU) and Hyperphenylalaninemia']}, 'descriptionModule': {'briefSummary': "The mainstay of PKU treatment is a low-phenylalanine diet (i.e restriction of natural protein), and supplementation with a protein substitute (a mixture of amino acids free from phenylalanine, also containing micronutrients and vitamins) and special low-protein foods, to meet the patient's energy requirements. When diet and treatment is relaxed after childhood, adult and adolescent patients with phenylketonuria are at risk for malnutrition, depending on the compliance with treatment and the intake of amino acid supplements.\n\nIn this study, nutrition status of patients with PKU and hyperphenylalaninemia is systematically assessed under ongoing current treatment, in relation to Phe-tolerance, compliance with treatment, and psychosocial issues.\n\nStudy participants do not undergo any specific therapeutic or diagnostic intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with phenylketonuria or hyperphenylalaninemia, in treatment at the participating centres', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* PKU (Phenylketonuria) or hyperphenylalaninemia\n* male or female, minimum age 16y\n* signed informed consent\n\nExclusion criteria:\n\n\\- patient who can not comply with the study protocol (e.g. unable to fill in questionnaires by themselves or a representative)'}, 'identificationModule': {'nctId': 'NCT01879995', 'briefTitle': 'Phenylketonuria and Hyperphenylalaninemia Nutrition Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Nutrition Status of Adult and Adolescent Patients With Classical Phenylketonuria (PKU) and Hyperphenylalaninemia', 'orgStudyIdInfo': {'id': 'KEK-ZH-Nr. 2013-0120'}}, 'armsInterventionsModule': {'interventions': [{'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich, Division of Endocrinology, Diabetes and Clinical Nutrition', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': 'CH-8032', 'city': 'Zurich', 'country': 'Switzerland', 'facility': "University Children's Hospital", 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Michel Hochuli, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Zurich, Division of Endocrinology, Diabetes and Clinical Nutrition'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}