The Ketogenic Diet for Pediatric Acute Brain Injury

Acute Brain Injuries Clinical Trial

Official title:

The Ketogenic Diet for Pediatric Acute Brain Injury

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02174016
• Other study ID #: 13-001156A
• Status: Suspended
• Phase: N/A
• Start date: January 2015
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 5
• Est. completion date: December 2024
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Brain Injuries
• Brain Injuries
• Wounds and Injuries

Intervention

Dietary Supplement:
• Ketogenic diet

Locations

Country	Name	City	State
United States	Ronald Reagan UCLA Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of episodes of low blood glucose levels		2 weeks
Secondary	Number of episodes of low serum bicarbonate levels	Bicarbonate levels are expected to decrease because ketone bodies are acidic in nature, but episodes of excessively low bicarbonate levels will be assessed.	2 weeks
Secondary	Number of subjects with MRI brain spectroscopy peaks corresponding to ketone body compounds,		5 days
Secondary	Number of subjects who develop kidney stones		2 weeks