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The Ketogenic Diet for Pediatric Acute Brain Injury

NCT ID: NCT02174016

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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Acute Brain Injuries

Keywords

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Intensive Care Units Pediatric

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open label use of ketogenic diet in children with acute brain injury
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Ketogenic diet

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

Group Type EXPERIMENTAL

Ketogenic diet

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Ketogenic diet

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Joyce Matsumoto

Health Sciences Assistant Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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13-001156A

Identifier Type: -

Identifier Source: org_study_id