The Ketogenic Diet for Pediatric Acute Brain Injury
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02174016|
Recruitment Status : Recruiting
First Posted : June 25, 2014
Last Update Posted : February 15, 2018
This is a prospective pilot study evaluating the safety and feasibility of implementing the ketogenic diet in children admitted to the pediatric intensive care unit with acute brain injury such as stroke, traumatic brain injury, and intracerebral hemorrhage. Animal studies suggest that in the aftermath of injury the brain's ability to use glucose as a fuel is impaired. The ketogenic diet is a high fat, low carbohydrate diet which is already used in clinical practice for the treatment of medication resistant epilepsy and is intended to switch the body over to burning fat rather than carbohydrates for fuel. In lieu of their standard tube-feeds, 5-10 children admitted to the PICU with these diagnoses will receive low carbohydrate, high fat ketogenic feeds for 2 weeks. We hypothesize that ketones will be detectable through serum tests and MRI spectroscopy studies of the brain within several days of diet initiation, and that there will be a low incidence of side effects and adverse events,
Measures of interest will include the incidence of kidney stones, excessive acidosis and excessive hypoglycemia. The feasibility of implementing this protocol for a larger efficacy trial will be assessed through serial measurements of blood glucose, beta-hydroxybutyrate (a type of ketone body), and serum bicarbonate levels. In addition, levels of ketone bodies within the brain will be measured through MRI spectroscopy sequence which will be acquired at the same time as a follow-up MRI brain study ordered for clinical purposes.
|Condition or disease||Intervention/treatment||Phase|
|Acute Brain Injuries||Dietary Supplement: Ketogenic diet||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open label use of ketogenic diet in children with acute brain injury|
|Masking:||None (Open Label)|
|Official Title:||The Ketogenic Diet for Pediatric Acute Brain Injury|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2020|
Experimental: Ketogenic diet
All subjects will be started on ketogenic diet formula feeding after enrollment for 2 weeks.
Dietary Supplement: Ketogenic diet
- Increase in Beta-hydroxybutyrate level [ Time Frame: 2 weeks ]Serum beta hydroxybutyrate levels will be checked daily, in order to determine how many days it will take to achieve elevated levels.
- Number of episodes of low blood glucose levels [ Time Frame: 2 weeks ]
- Number of episodes of low serum bicarbonate levels [ Time Frame: 2 weeks ]Bicarbonate levels are expected to decrease because ketone bodies are acidic in nature, but episodes of excessively low bicarbonate levels will be assessed.
- Number of subjects with MRI brain spectroscopy peaks corresponding to ketone body compounds, [ Time Frame: 5 days ]
- Number of subjects who develop kidney stones [ Time Frame: 2 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174016
|Contact: Joyce H Matsumoto, MD||310-825-6196|
|Contact: Christopher C Giza, MD||310-825-6196|
|United States, California|
|Ronald Reagan UCLA Medical Center||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Joyce Matsumoto, MD 310-825-6196|
|Principal Investigator: Joyce H Matsumoto, MD|
|Principal Investigator: Christopher C Giza, MD|