The Ketogenic Diet for Pediatric Acute Brain Injury

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by University of California, Los Angeles
Sponsor:
Collaborator:
UCLA Children's Discovery and Innovation Institute
Information provided by (Responsible Party):
Joyce Matsumoto, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT02174016
First received: June 23, 2014
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Acute Brain Injuries
Dietary Supplement: Ketogenic diet
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: The Ketogenic Diet for Pediatric Acute Brain Injury

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 5
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ketogenic diet
All subjects will be started on ketogenic diet formula feeding after enrollment for 2 weeks.
Dietary Supplement: Ketogenic diet

  Eligibility

Ages Eligible for Study:   1 Year to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02174016

Contacts
Contact: Joyce H Matsumoto, MD 310-825-6196
Contact: Christopher C Giza, MD 310-825-6196

Locations
United States, California
Ronald Reagan UCLA Medical Center Not yet 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         
Sponsors and Collaborators
University of California, Los Angeles
UCLA Children's Discovery and Innovation Institute
  More Information

No publications provided

Responsible Party: Joyce Matsumoto, Health Sciences Assistant Clinical Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02174016     History of Changes
Other Study ID Numbers: 13-001156A
Study First Received: June 23, 2014
Last Updated: June 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Intensive Care Units
Pediatric

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 20, 2014