Ketogenic Diet Following Moderate to Severe Pediatric Traumatic Brain Injury

NCT04933448 | Completed DMC

• 1 other identifier: STUDY00009115
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Duration of Unconsciousness

  14 days

• Need for Surgeries

  14 days

• Duration of Acute Hospitalization

  14 days

• Duration of Post-traumatic Amnesia

  14 days

Study Arms (2)

Prospective Intervention Group

EXPERIMENTAL

Participants will receive standard of care for acute management of moderate to severe traumatic brain injury, together with a weight-based ketogenic diet added for up to fourteen days.

Other: Ketogenic Diet

Historical Control Group

NO INTERVENTION

Medical records of past TBI patients will be used as controls matched for age, gender, socioeconomic status (type of health care coverage including private insurance vs. government-funded coverage), lowest first 24 hour post-injury Glasgow Coma Score (GCS) (\<8 or 8-12), and pre-injury school program (regular or special education).

Interventions

Ketogenic Diet OTHER

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.

Also known as: Keto

Prospective Intervention Group

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gillette Children's Specialty Healthcare: lead
• State of Minnesota Spinal Cord Injury and Traumatic Brain Injury Research Grant Program: collaborator

Study Sites (2)

Children's Minnesota

Minneapolis, Minnesota, 55404, United States

Location

Gillette Children's Specialty Healthcare

Saint Paul, Minnesota, 55101, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Brain Injuries; 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 Officials

• Linda Krach, MD

  Department of Physical Medicine and Rehabilitation

  PRINCIPAL INVESTIGATOR

• Angela Sinner, DO

  Department of Physical Medicine and Rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: June 21, 2021
• Study Start: May 16, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)