The Ketogenic Diet for Pediatric Acute Brain Injury

NCT02174016 | Suspended

• 1 other identifier: 13-001156A
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Brain Injuries

Keywords

Intensive Care Units; Pediatric

Outcome Measures

Primary Outcomes (1)

• Increase in Beta-hydroxybutyrate level

  Serum beta hydroxybutyrate levels will be checked daily, in order to determine how many days it will take to achieve elevated levels.

  2 weeks

Secondary Outcomes (4)

• Number of episodes of low blood glucose levels

  2 weeks

• Number of episodes of low serum bicarbonate levels

  2 weeks

• Number of subjects with MRI brain spectroscopy peaks corresponding to ketone body compounds,

  5 days

• Number of subjects who develop kidney stones

  2 weeks

Study Arms (1)

Ketogenic diet

EXPERIMENTAL

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

Dietary Supplement: Ketogenic diet

Interventions

Ketogenic diet DIETARY_SUPPLEMENT

Ketogenic diet

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Brain Injuries

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Health Sciences Assistant Clinical Professor

Model Details: Open label use of ketogenic diet in children with acute brain injury

Study Record Dates

• First Submitted: June 23, 2014
• First Posted: June 25, 2014
• Study Start: January 1, 2015
• Primary Completion: June 1, 2019
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

US (1)