Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-03-03 @ 3:04 PM
Study NCT ID:
NCT02825758
Status:
COMPLETED
Last Update Posted:
2024-02-16
First Post:
2016-06-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of ZestiVits in Children and Adults on a Ketogenic or Restricted Therapeutic Diet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-15', 'studyFirstSubmitDate': '2016-06-24', 'studyFirstSubmitQcDate': '2016-07-01', 'lastUpdatePostDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Palatability via qualitative assessments from a subject questionnaire', 'timeFrame': '7 days', 'description': 'Qualitative outcome measures will be described in a narrative summarising the study outcomes'}, {'measure': 'Gastrointestinal tolerance via qualitative assessments from a subject questionnaire', 'timeFrame': '7 days', 'description': 'Qualitative outcome measures will be described in a narrative summarising the study outcomes'}, {'measure': 'Patient compliance via qualitative assessments from a subject questionnaire', 'timeFrame': '7 days', 'description': 'Qualitative outcome measures will be described in a narrative summarising the study outcomes'}, {'measure': 'Ease of use of product via qualitative assessments from a subject questionnaire', 'timeFrame': '7 days', 'description': 'Qualitative outcome measures will be described in a narrative summarising the study outcomes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Micronutrients', 'restricted', 'ketogenic', 'diet', 'acceptability'], 'conditions': ['Deficiency of Micronutrients']}, 'descriptionModule': {'briefSummary': 'A study to evaluate the acceptability of ZestiVits; a new vitamin, mineral and trace element supplement for children aged 11 years and over and adults on a ketogenic or restricted therapeutic diet with regard to product tolerance, palatability and compliance.', 'detailedDescription': 'To evaluate the gastrointestinal tolerance, palatability and compliance of ZestiVits in a seven-day period for 15 subjects aged 11 years and over following a ketogenic or restricted therapeutic diet.\n\n* Qualitative assessments from subject questionnaires that allow evaluation of the acceptability and ease of use of the study product.\n* Collection of daily data about the gastro-intestinal tolerance of the study product.\n\n * Collection of daily data about compliance with the study product i.e. actual versus prescribed intake.\n * Improve quality of life by increasing range of products available for use in a ketogenic or restricted therapeutic diet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '11 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of condition requiring a ketogenic or restrictive therapeutic diet\n2. On a ketogenic or restricted therapeutic diet with good compliance\n3. Aged 11 years and over\n4. Has a requirement for a micronutrient supplement\n5. Written informed consent by subject or parent/carer\n\nExclusion Criteria:\n\n1. Participants aged less than 11 years\n2. Use of additional micronutrient supplements during the study period unless clinically indicated and prescribed by the investigator (must be recorded in patient case record file)'}, 'identificationModule': {'nctId': 'NCT02825758', 'acronym': 'ZestiVits', 'briefTitle': 'Evaluation of ZestiVits in Children and Adults on a Ketogenic or Restricted Therapeutic Diet', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vitaflo International, Ltd'}, 'officialTitle': 'A Study to Evaluate the Acceptability of ZestiVits; a New Vitamin, Mineral and Trace Element Supplement for Those Aged 11 and Over on a Ketogenic or Restricted Diet With Regard to Product Tolerance, Palatability and Compliance', 'orgStudyIdInfo': {'id': 'MCT-Zest-14/01/2016-01'}, 'secondaryIdInfos': [{'id': '209722', 'type': 'OTHER', 'domain': 'IRAS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ZestiVits', 'description': 'Supplement for use in ketogenic and restricted therapeutic diets, from the age of 11.\n\nDaily use for 7 days. Daily intake level for each subject will be determined and prescribed by a dietitian.', 'interventionNames': ['Dietary Supplement: ZestiVits']}], 'interventions': [{'name': 'ZestiVits', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The study product is a low-carbohydrate, orange flavour, vitamin, mineral and trace element (micronutrient) supplement for use in ketogenic and restricted therapeutic diets, for children aged from 11 years of age and adults.\n\nThe recommended dosage of the study product for each subject will be determined and prescribed by a dietitian. This will be based on individual requirements for micronutrient supplementation.', 'armGroupLabels': ['ZestiVits']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BS2 8BJ', 'city': 'Bristol', 'state': 'Avon', 'country': 'United Kingdom', 'facility': 'Bristol Royal Hospital for Children', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'M6 8HD', 'city': 'Salford', 'state': 'Greater Manchester', 'country': 'United Kingdom', 'facility': 'Salford Royal NHS Foundation Trust', 'geoPoint': {'lat': 53.48771, 'lon': -2.29042}}, {'zip': 'LS1 3EX', 'city': 'Leeds', 'state': 'West Yorkshire', 'country': 'United Kingdom', 'facility': "Leeds Children's Hospital", 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}], 'overallOfficials': [{'name': 'Gisela Wilcox', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northern Care Alliance NHS Foundation Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vitaflo International, Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}