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The Ketogenic Diet for Pediatric Acute Brain Injury

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ClinicalTrials.gov Identifier: NCT02174016
Recruitment Status : Unknown
Verified November 2015 by Joyce Matsumoto, University of California, Los Angeles.
Recruitment status was:  Recruiting
First Posted : June 25, 2014
Last Update Posted : December 2, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment Phase
Acute Brain Injuries Dietary Supplement: Ketogenic diet Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: The Ketogenic Diet for Pediatric Acute Brain Injury
Study Start Date : January 2015
Estimated Primary Completion Date : December 2016
Arms and Interventions

Arm Intervention/treatment
Experimental: Ketogenic diet
All subjects will be started on ketogenic diet formula feeding after enrollment for 2 weeks.
Dietary Supplement: Ketogenic diet


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Number of episodes of low blood glucose levels [ Time Frame: 2 weeks ]
  2. 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.

  3. Number of subjects with MRI brain spectroscopy peaks corresponding to ketone body compounds, [ Time Frame: 5 days ]
  4. Number of subjects who develop kidney stones [ Time Frame: 2 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


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 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
More Information

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
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015

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

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