- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02174016
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90095
- Ronald Reagan UCLA Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ketogenic diet
All subjects will be started on ketogenic diet formula feeding after enrollment for 2 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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2 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of episodes of low blood glucose levels
Time Frame: 2 weeks
|
2 weeks
|
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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.
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2 weeks
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Number of subjects with MRI brain spectroscopy peaks corresponding to ketone body compounds,
Time Frame: 5 days
|
5 days
|
|
Number of subjects who develop kidney stones
Time Frame: 2 weeks
|
2 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-001156A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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