Ignite Creation Date:
2025-12-24 @ 4:38 PM
Ignite Modification Date:
2025-12-28 @ 4:17 AM
Study NCT ID:
NCT01278966
Status:
COMPLETED
Last Update Posted:
2011-01-19
First Post:
2010-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modified Atkins Diet in Children and Adolescents With Drug-resistant Epilepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055423', 'term': 'Diet, Ketogenic'}], 'ancestors': [{'id': 'D050528', 'term': 'Diet, Carbohydrate-Restricted'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-17', 'studyFirstSubmitDate': '2010-12-29', 'studyFirstSubmitQcDate': '2011-01-17', 'lastUpdatePostDateStruct': {'date': '2011-01-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seizure frequency', 'timeFrame': '6 months', 'description': 'Seizure frequency is assessed after 1 month, 3 months and 6 months.'}], 'secondaryOutcomes': [{'measure': 'Ambulatory EEG', 'timeFrame': 'After 6 months', 'description': '24-hours EEG before diet treatment and after 6 months on the diet.'}, {'measure': 'Body Weight', 'timeFrame': '6 months', 'description': 'Body weight was measured before diet treatment, after 1 month, 3 months and 6 months.'}, {'measure': 'Quality of life', 'timeFrame': '6 months', 'description': 'Questionnaire assessing quality of life and life on a strict diet, assessed after one, three and six months.'}, {'measure': 'Ketosis', 'timeFrame': '6 months', 'description': 'Ketosis in blood and urine measured during the whole study period'}, {'measure': 'Dietary records', 'timeFrame': '10 weeks', 'description': '3-days dietary records were obtained after two and ten weeks on the diet.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Epilepsy', 'Diet', 'the Modified Atkins Diet', 'Ketogenic diet'], 'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the effect of the Modified Atkins Diet in children and adolescents with drug-resistant epilepsy regarding seizure control, and to create a protocol for the use of the Modified Atkins Diet as a treatment for epilepsy in Norway.', 'detailedDescription': 'The study is a prospective trial on the Modified Atkins Diet for children and adolescents with drug-resistant epilepsy. The Modified Atkins Diet is a less restrictive diet than the classical ketogenic diet, which is usually offered to this group of patients. Twenty patients between 2 and 18 years are included in the study, and the study period is 6 months. The study will be conducted at the National Centre for Child Epilepsy in Norway.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age: 2-18 years\n* At least 3 epileptic seizures per week\n* Tried at least two anti-epileptic drugs without satisfactory seizure control\n* Willing to try diet treatment for 6 months\n\nExclusion Criteria:\n\n* Too difficult for the family to adhere to a strict diet\n* Not able to fill in a seizure calendar\n* Local authorities will not approve the treatment\n* VNS stimulator the last 12 months or changes made to VNS stimulator during the last three months\n* Other disease where a diet high in fat is contra indicated\n* Diet treatment is not possible because of poor intake of food or fluids\n* Cortisol or other medication that influence energy metabolism or epileptic drug metabolism last month\n* Patient has the last month used alternative medicine which may influence the diet\n* Patient has tried the ketogenic fiet og Modified Atkins diet the last three years\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT01278966', 'briefTitle': 'Modified Atkins Diet in Children and Adolescents With Drug-resistant Epilepsy', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Modified Atkins Diet in Children and Adolescents With Drug-resistant Epilepsy - a Prospective Pilot Trial', 'orgStudyIdInfo': {'id': 'S-09180a (REK)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The Modified Atkins Diet', 'description': 'Treatment with the Modified Atkins Diet for 6 months', 'interventionNames': ['Other: The Modified Atkins Diet']}], 'interventions': [{'name': 'The Modified Atkins Diet', 'type': 'OTHER', 'otherNames': ['Ketogenic diet'], 'description': 'The Modified Atkins Diet; 10 g carbohydrate per day and a high fat intake', 'armGroupLabels': ['The Modified Atkins Diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1306', 'city': 'Pb. 53', 'state': 'Bærum Postterminal', 'country': 'Norway', 'facility': 'The National Centre for Child Epilepsy'}], 'overallOfficials': [{'name': 'Morten Lossius, Phd', 'role': 'STUDY_CHAIR', 'affiliation': 'Oslo University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Kathrine Haavardsholm', 'oldOrganization': 'Oslo University Hospital, Division of Surgery and Clinical Neuroscience, National Centre for Child Epilepsy'}}}}