The Ketogenic Diet for Pediatric Acute Brain Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by University of California, Los Angeles
Sponsor:
Information provided by (Responsible Party):
Joyce Matsumoto, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT02174016
First received: June 23, 2014
Last updated: November 30, 2015
Last verified: November 2015

June 23, 2014
November 30, 2015
January 2015
December 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02174016 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
The Ketogenic Diet for Pediatric Acute Brain Injury
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.

Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Acute Brain Injuries
Dietary Supplement: Ketogenic diet
Experimental: Ketogenic diet
All subjects will be started on ketogenic diet formula feeding after enrollment for 2 weeks.
Intervention: Dietary Supplement: Ketogenic diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5
Not Provided
December 2016   (final data collection date for primary outcome measure)

Inclusion Criteria: children age -17 years admitted to the pediatric intensive care unit with acute brain injury such as acute stroke, severe traumatic brain injury, and intracerebral hemorrhage

Exclusion Criteria:

  1. True milk allergy (anaphylaxis or severe rash)
  2. Significant gastrointestinal injury precluding enteral feeding
  3. Hepatic or renal insufficiency
  4. History of nephrolithiasis
  5. Severe acidosis (serum bicarbonate ≤ 17 mEq/L) resistant to correction
  6. History of inborn error of metabolism
  7. Preexisting epilepsy or developmental delay
Both
1 Year to 17 Years   (Child)
No
Contact: Joyce H Matsumoto, MD 310-825-6196
Contact: Christopher C Giza, MD 310-825-6196
United States
 
NCT02174016
13-001156A
No
Not Provided
Not Provided
Joyce Matsumoto, University of California, Los Angeles
University of California, Los Angeles
Not Provided
Not Provided
University of California, Los Angeles
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP