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Clinical Trials/NCT02174016
NCT02174016
Suspended
Not Applicable

The Ketogenic Diet for Pediatric Acute Brain Injury

University of California, Los Angeles1 site in 1 country5 target enrollmentJanuary 1, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Brain Injuries
Sponsor
University of California, Los Angeles
Enrollment
5
Locations
1
Primary Endpoint
Increase in Beta-hydroxybutyrate level
Status
Suspended
Last Updated
4 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2015
End Date
December 1, 2026
Last Updated
4 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joyce Matsumoto

Health Sciences Assistant Clinical Professor

University of California, Los Angeles

Eligibility Criteria

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

  • True milk allergy (anaphylaxis or severe rash)
  • Significant gastrointestinal injury precluding enteral feeding
  • Hepatic or renal insufficiency
  • History of nephrolithiasis
  • Severe acidosis (serum bicarbonate ≤ 17 mEq/L) resistant to correction
  • History of inborn error of metabolism
  • Preexisting epilepsy or developmental delay

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Number of episodes of low blood glucose levels(2 weeks)
  • Number of episodes of low serum bicarbonate levels(2 weeks)
  • Number of subjects with MRI brain spectroscopy peaks corresponding to ketone body compounds,(5 days)
  • Number of subjects who develop kidney stones(2 weeks)

Study Sites (1)

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