The Ketogenic Diet for Pediatric Acute Brain Injury

Not Applicable

Suspended

• Conditions: Acute Brain Injuries
• Interventions: Dietary Supplement: Ketogenic diet

• Registration Number: NCT02174016
• Lead Sponsor: University of California, Los Angeles

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-06-23
• Study First Submitted QC: 2014-06-24
• Study First Posted: 2014-06-25
• Study Start: 2015-01
• Primary Completion: 2019-06
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-19
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 5

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ketogenic diet	Ketogenic diet	All subjects will be started on ketogenic diet formula feeding after enrollment for 2 weeks.

Primary Outcome Measures

Name	Time	Method
Increase in Beta-hydroxybutyrate level	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

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

Trial Locations

Locations (1)

Ronald Reagan UCLA Medical Center; 🇺🇸 Los Angeles, California, United States