The Ketogenic Diet for Pediatric Acute Brain Injury
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||The Ketogenic Diet for Pediatric Acute Brain Injury|
- Increase in Beta-hydroxybutyrate level [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]
- Number of episodes of low serum bicarbonate levels [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]
- Number of subjects who develop kidney stones [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2015|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: Ketogenic diet
All subjects will be started on ketogenic diet formula feeding after enrollment for 2 weeks.
|Dietary Supplement: Ketogenic diet|
Please refer to this study by its ClinicalTrials.gov identifier: 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|