Ketogenic Diet Following Moderate to Severe Pediatric Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:

Ketogenic Diet Following Moderate to Severe Pediatric Traumatic Brain Injury: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04933448
• Other study ID #: STUDY00009115
• Status: Recruiting
• Phase: N/A
• Start date: May 16, 2022
• Est. completion date: September 2025

Study information

• Verified date: September 2023
• Source: Gillette Children's Specialty Healthcare
• Contact: Linda Krach, MD
• Phone: (651)-229-3873
• Email: LKrach[@]gillettechildrens.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the feasibility and safety of using the ketogenic diet (KD) in children who sustained moderate to severe traumatic brain injury (TBI). The secondary objective is a preliminary evaluation of the outcomes of children who have had the standard of care plus the KD, compared to those with standard of care alone. Outcome measures for the secondary objective will include: need for ventriculoperitoneal shunt, duration of unconsciousness, need for any type of craniotomy, duration of post-traumatic amnesia, acute hospitalization length of stay, and cognitive and motor function at 12 months after injury. If this study demonstrates feasibility and safety, the information related to outcomes will be used to inform the planning of a future, larger, randomized study of the efficacy of the KD in children and adolescents with TBI. Specifically, this information will be used to assist with sample size calculations for this future study.

Description:

The KD is an alternative feeding regimen that has been in use since 1921. It is a high fat, low carbohydrate and moderate protein diet. There are various forms of the KD. The classic KD consists of long-chain triglycerides with a fat-to-combined-protein-and-carbohydrate ratio that can vary. At our institution, it is standard of care to initiate a ketogenic diet at a ratio of 2:1, and to increase the ratio to 3:1 or 4:1 as needed to achieve ketosis. Clinically, the KD has been proven to be an effective therapy in children and adolescents with refractory epilepsy, as well as for those with type II diabetes. In addition, an international consensus was published in 2009 that recommended the use of the KD to treat epilepsy refractory as an alternative to at least two antiepileptic medications. Before initiating the KD for epilepsy management, labs such as urine and blood ketones, blood glucose and a basic metabolic panel including magnesium are commonly recommended. Risks for long-term use of the KD include but are not limited to the following: hypercholesterolemia, mineral deficiencies, acidosis, constipation, weight loss and nephrolithiasis. However, short-term use should significantly limit the occurrence of these potential complications.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21
• Est. completion date: September 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

Inclusion Criteria:

• Age limits met at the time of injury and admission

• Participants with moderate to severe traumatic brain injury defined as a Glasgow Coma Scale Score of 3-12 (lowest score in the first 24 hours after injury). Individuals requiring craniotomy and/or evacuation of intracranial hemorrhage may be included.

Exclusion Criteria:

• Currently on an oral diet at time of screening or currently on IV-only and in opinion of Pediatric Intensive Care Unit intensivist will be transitioning to an oral diet, not tube-feeding

• Anoxia/ischemia as a significant portion of injury, including near-drowning

• Non-accidental traumatic brain injury (i.e., assault, abuse)

• Penetrating injury including gunshot wounds

• Pregnancy

• Any condition that in the opinion of the Pediatric Intensive Care Unit or neurosurgery medical staff warrants exclusion from the study

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Other:
• Ketogenic Diet
The ketogenic diet (KD) is an alternative feeding regimen that has been in use since 1921. It is a high-fat, low carbohydrate, and moderate protein diet. There are various forms of the KD. The classic KD consists of long-chain triglycerides with a fat-to-combined-protein-and-carbohydrate ratio that can vary. At the investigating institution, it is standard of care to initiate a ketogenic diet at a ratio of 2:1, and to increase the ratio to 3:1 or 4:1 as needed to achieve ketosis.

Locations

Country	Name	City	State
United States	Children's Minnesota	Minneapolis	Minnesota
United States	Gillette Children's Specialty Healthcare	Minneapolis	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Gillette Children's Specialty Healthcare	Children's Minnesota, State of Minnesota Spinal Cord Injury and Traumatic Brain Injury Research Grant Program

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability to complete a course of the ketogenic diet (KD)	Safety and feasibility will be determined by the ability to complete a 14-day course of the KD after TBI without needing to terminate the diet due to intolerance resulting from gastrointestinal side effects (for example, nausea and vomiting, diarrhea, or acidosis), or due to abnormal findings on laboratory tests. Outcome is reported as the number of participants who complete the 14-day keto diet treatment.	14 days
Secondary	Duration of Unconsciousness	Outcome is reported as the length of time (in hours) a participant is unconscious following their injury.	14 days
Secondary	Need for Surgeries	Outcome is reported as the number of surgeries required in each group following injury.	14 days
Secondary	Duration of Acute Hospitalization	Outcome is reported as the length (in days) of acute hospitalization following injury.	14 days
Secondary	Duration of Post-traumatic Amnesia	Outcome is reported as the length of time (in days) that a participant experiences amnesia following their injury.	14 days