Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-03-02 @ 11:13 PM
Study NCT ID:
NCT02229318
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2014-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Taste and Acceptance Study of FruitiVits in Children Aged 4-8 Years Following a Ketogenic Diet.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Bergqvist@Email.CHoP.Edu', 'phone': '+1 215 590 1719', 'title': 'Dr Christina Bergqvist, M.D., Study Principal Investigator', 'organization': "The Children's Hospital of Philadelphia"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '7 days per patient', 'description': 'A symptom diary was completed for each patient specifically asking about the following:\n\nNausea and/or vomiting Diarrhea and/or constipation Gas, flatulence and/or regurgitation Abdominal bloating and/or distention Abdominal discomfort and/or pain', 'eventGroups': [{'id': 'EG000', 'title': 'FruitiVits', 'description': 'Daily administration of FruitiVits dietary supplement', 'otherNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Acceptability of FruitiVits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FruitiVits', 'description': 'Daily administration of FruitiVits dietary supplement'}], 'classes': [{'title': 'Appearance score 1-3', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Smell score 1-3', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Taste score 1-3', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Texture score 1-3', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 8 of trial', 'description': 'The study product was rated on a scale of 1-5:\n\n1. (liked very much)\n2. (liked moderately)\n3. (neither liked nor disliked)\n4. (disliked moderately)\n5. (disliked very much).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Children aged 4 to 8 years.'}, {'type': 'SECONDARY', 'title': 'Ease of Preparation of FruitiVits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FruitiVits', 'description': 'Administration of FruitiVits dietary supplement'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 8 of trial', 'description': 'Ease of preparation of FruitiVits was rated on a scale of 1-5:\n\n1. (very easy)\n2. (moderately easy)\n3. (neither easy nor difficult)\n4. (moderately difficult)\n5. (very difficult).\n\nThose who considered it not difficult to prepare and scored 1-3 on the scale: 11/11 patients', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Children aged 4 to 8 years.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FruitiVits', 'description': 'Daily administration of FruitiVits dietary supplement'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'September 6th 2014 11 enrolled', 'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'September 15th 2014 11 completed', 'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Children between the ages of 4 and 8 years, attending the Ketogenic Diet Center at The Children's Hospital of Philadelphia were invited by email to attend a study family day held on a Saturday afternoon in September 2014. The first 12 families to respond were contacted via telephone and invited to enroll in the study.", 'preAssignmentDetails': '12 families invited to participate, one subject failed to attend the recruitment family day and did not enroll in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'FruitiVits', 'description': 'Daily administration of FruitiVits dietary supplement'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'groupId': 'BG000', 'lowerLimit': '4.3', 'upperLimit': '8.9'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-15', 'studyFirstSubmitDate': '2014-08-26', 'resultsFirstSubmitDate': '2015-09-07', 'studyFirstSubmitQcDate': '2014-08-28', 'lastUpdatePostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-08-15', 'studyFirstPostDateStruct': {'date': '2014-09-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability of FruitiVits', 'timeFrame': 'Day 8 of trial', 'description': 'The study product was rated on a scale of 1-5:\n\n1. (liked very much)\n2. (liked moderately)\n3. (neither liked nor disliked)\n4. (disliked moderately)\n5. (disliked very much).'}], 'secondaryOutcomes': [{'measure': 'Ease of Preparation of FruitiVits', 'timeFrame': 'Day 8 of trial', 'description': 'Ease of preparation of FruitiVits was rated on a scale of 1-5:\n\n1. (very easy)\n2. (moderately easy)\n3. (neither easy nor difficult)\n4. (moderately difficult)\n5. (very difficult).\n\nThose who considered it not difficult to prepare and scored 1-3 on the scale: 11/11 patients'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Seizure Disorders']}, 'descriptionModule': {'briefSummary': 'Subjects will be asked to substitute their usual vitamin and mineral supplement/s with FruitiVits for seven consecutive days.', 'detailedDescription': 'The study will involve 12 subjects between 4 and 8 years of age, who routinely use comprehensive micronutrient supplementation as part of their dietary management.\n\nPrimary Hypothesis:\n\nFruitiVits is an acceptable source of vitamin, mineral and trace elements for patients on a Ketogenic diet.\n\nSecondary Hypothesis:\n\nFruitiVits will be well accepted and tolerated when given orally to children on a Ketogenic diet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of condition requiring a Ketogenic diet\n2. Currently on a Ketogenic diet\n3. Aged 4 - 8 years\n4. Routinely taking a complete micronutrient supplement\n5. Oral feeding\n\nExclusion Criteria:\n\n1\\) Children aged less than 4 years or older than 9 years of age'}, 'identificationModule': {'nctId': 'NCT02229318', 'acronym': 'FruitiVits', 'briefTitle': 'A Taste and Acceptance Study of FruitiVits in Children Aged 4-8 Years Following a Ketogenic Diet.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vitaflo International, Ltd'}, 'officialTitle': 'A Taste and Acceptance Study of FruitiVits, for Use in the Dietary Management of Young Children Requiring Very Restrictive Diets Such as the Ketogenic Diet.', 'orgStudyIdInfo': {'id': 'NA-FRV-012014-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FruitiVits', 'description': 'Daily administration of FruitiVits dietary supplement', 'interventionNames': ['Dietary Supplement: FruitiVits']}], 'interventions': [{'name': 'FruitiVits', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Daily administration of FruitiVits dietary supplement', 'armGroupLabels': ['FruitiVits']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "The Children's Hospital of Philadelphia, Division of Neurology", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Christina Bergqvist, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Philadelphia"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vitaflo International, Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}