Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT03982602
Status:
COMPLETED
Last Update Posted:
2024-05-03
First Post:
2019-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ketogenic Diet for Traumatic Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, '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': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-02', 'studyFirstSubmitDate': '2019-06-03', 'studyFirstSubmitQcDate': '2019-06-07', 'lastUpdatePostDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of Ketogenic Diet on Intracranial Pressure', 'timeFrame': 'Baseline, till patient on KD (maximim 1 month)', 'description': 'Intracranial Pressure will be measured hourly and it will be trended daily.'}, {'measure': 'Development of Ketosis in blood', 'timeFrame': 'Baseline, till patient on KD ( maximum 1month)', 'description': 'Serum beta-hydroxybutyrate will be done alternate day to assess the level of ketosis in blood.'}, {'measure': 'Excretion of Ketones in Urine', 'timeFrame': 'Baseline, till patient on KD (maximum 1 month)', 'description': 'Urine Ketones will be measured alternate day to assess the level of ketosis'}], 'secondaryOutcomes': [{'measure': 'Evaluate change in the neurological exam', 'timeFrame': 'Baseline, before discharge from ICU', 'description': 'Neurological exam will be documented with Glasgow Coma Scale.'}, {'measure': 'Evaluate subjects with gastro-intestinal adverse effects', 'timeFrame': 'Baseline, till patient on KD (Maximum 1month)', 'description': 'Adverse effects like Diarrhea, vomiting, abdominal distension (ileus), abdominal tenderness will be monitored.'}, {'measure': 'Evaluate subjects for muscle wasting', 'timeFrame': 'Baseline, till patient on Kd (Maximum 1month)', 'description': 'Urinary Nitrogen and urinary creatinine will be measured alternate day to look for muscle wasting.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Traumatic Brain Injury', 'Ketogenic Dieting']}, 'referencesModule': {'references': [{'pmid': '35063224', 'type': 'DERIVED', 'citation': 'Arora N, Litofsky NS, Golzy M, Aneja R, Staudenmyer D, Qualls K, Patil S. Phase I single center trial of ketogenic diet for adults with traumatic brain injury. Clin Nutr ESPEN. 2022 Feb;47:339-345. doi: 10.1016/j.clnesp.2021.11.015. Epub 2021 Nov 16.'}]}, 'descriptionModule': {'briefSummary': 'Traumatic Brain Injury is a major health concern in United States. There is a un-met need to develop new therapeutic options for faster neuron recovery without causing significant side effects. The role of ketones in neuronal recovery has been studied and has been found to be useful in decreasing size of contusion. The present study aims to study the safety and feasibility profile of ketogenic diet.', 'detailedDescription': 'Traumatic Brain Injury (TBI) is a major health concern for United States contributing nearly one-third of injury-related deaths in United States. The Centers for Disease Control and Prevention (CDC) estimates that 1.7 million people in the United States sustain a TBI each year. It is responsible for significant disabilities and the total cost of productivity loss was estimated to be $76.5 billion in the United States in 2004.\n\nSeveral animal models have demonstrated the effectiveness of ketones in brain injury to decrease the size of contusion, improving cortical ATP levels, reduced brain edema and cellular apoptosis. Ketones have been shown to be effective in neuromodulation in animal models. Evaluation of carbohydrate free diet has been done in traumatic brain injury patients and it was noted to not cause fluctuations in blood glucose. There is a need for safety and feasibility study of ketogenic diet in traumatic brain injury patients and to understand the effectiveness in neuromodulation in humans. The present study focuses on identifying the safety and feasibility of KD in traumatic brain injury patients.\n\nThis pilot project data will be utilized to design future randomized clinical trials. Based on the safety data, further trials will be conducted to evaluate the effectiveness of KD in traumatic brain injury patients and its effectiveness in controlling elevated intracranial pressure. It will open the avenue for consideration of new treatment option for intracranial pressure management and functional recovery. From a nutrition perspective, Ketogenic diet might become the standard of care for this patient population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Severe Traumatic Brain Injury\n2. GCS\\<= 8 with severe head injury\n3. Age more than 18years\n\nExclusion Criteria:\n\n1. Diabetic Ketoacidosis\n2. Unstable metabolic condition (persistent hyponatremia, hypernatremia, hypoglycemia, hypocalcemia, acidosis)\n3. Cardiorespiratory or hemodynamic instability\n4. Coagulopathy\n5. Pancreatitis\n6. Liver Failure\n7. Severe hyperlipidemia\n8. Inability to tolerate enteral feeds including ileus\n9. Known Fatty acid oxidation disorder or pyruvate carboxylase deficiency\n10. Any terminally ill patient with poor brain stem reflexes and mortality within 24h of admission.\n11. Pregnant Females'}, 'identificationModule': {'nctId': 'NCT03982602', 'acronym': 'KETI', 'briefTitle': 'Ketogenic Diet for Traumatic Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri-Columbia'}, 'officialTitle': 'Safety and Feasibility of Ketogenic Diet for Traumatic Brain Injury Study Protocol', 'orgStudyIdInfo': {'id': '2014675'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subjects on Ketogenic diet', 'description': 'Treatment with KD will consist of 4:1 \\[fat\\]: \\[protein + carbohydrate\\] weight ratio. KD will be started as soon as the patient is ready for alimentation (while they are in neurocritical care unit). The rate of feeds will be calculated by trained dietician on service. Ketogenic diet will be continued during the entire length of ICU stay. Supplementation with vitamins, calcium and phosphorus will be done.', 'interventionNames': ['Other: Ketogenic diet']}], 'interventions': [{'name': 'Ketogenic diet', 'type': 'OTHER', 'otherNames': ['Ketovie'], 'description': 'Subjects will be provided with the Ketogenic diet in the form of tube feeds once the decision is made to start the patient on diet.', 'armGroupLabels': ['Subjects on Ketogenic diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65212', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri Hospital', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Missouri-Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Niraj Arora', 'investigatorAffiliation': 'University of Missouri-Columbia'}}}}