Traumatic Brain InjuryNCT04933448
Ketogenic Diet Following Moderate to Severe Pediatric Traumatic Brain Injury
A study testing Ketogenic Diet in people with Traumatic Brain Injury, run by Gillette Children's Specialty Healthcare at 2 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Ketogenic Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 May 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Minnesota
Minneapolis, Minnesota, 55404
Gillette Children's Specialty Healthcare
Saint Paul, Minnesota, 55101
About this study
Official title: Ketogenic Diet Following Moderate to Severe Pediatric Traumatic Brain Injury: A Pilot Study
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.
Read the detailed 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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Ketogenic Diet
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic DietOther
Also called Keto
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Secondary outcomes (4)
Duration of Unconsciousness
Outcome is reported as the length of time (in hours) a participant is unconscious following their injury.
Measured: 14 days
Need for Surgeries
Outcome is reported as the number of surgeries required in each group following injury.
Measured: 14 days
Duration of Acute Hospitalization
Outcome is reported as the length (in days) of acute hospitalization following injury.
Measured: 14 days
Duration of Post-traumatic Amnesia
Outcome is reported as the length of time (in days) that a participant experiences amnesia following their injury.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start16 May 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gillette Children's Specialty Healthcare
- Sponsor type
- University, hospital or other
- Collaborators
- State of Minnesota Spinal Cord Injury and Traumatic Brain Injury Research Grant Program
- Responsible party
- Sponsor
- Investigators
- Linda Krach, MD, Principal investigator, Department of Physical Medicine and RehabilitationAngela Sinner, DO, Principal investigator, Department of Physical Medicine and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933448
- Sponsor's protocol ID
- STUDY00009115
- Status last verified
- Feb 2026
- First submitted
- 17 Jun 2021
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: pilot, feasibility study only.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketogenic Diet Following Moderate to Severe Pediatric Traumatic Brain Injury: A Pilot Study
- ClinicalTrials.gov ID
- NCT04933448
- Acronym / sponsor ID
- STUDY00009115
- Conditions
- Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Gillette Children's Specialty HealthcareUniversity, hospital or other
- Collaborators
- State of Minnesota Spinal Cord Injury and Traumatic Brain Injury Research Grant Program
- Study start
- 16 May 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 21 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective Intervention Group | Experimental | Other: Ketogenic DietParticipants 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. |
| 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). |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketogenic DietAlso: KetoThe 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. | Other | Prospective Intervention Group |
Primary outcome
Ability to complete a course of the ketogenic diet (KD)
Time frame: 14 days
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.
4 secondary outcomes
Duration of Unconsciousness
Time frame: 14 days
Need for Surgeries
Time frame: 14 days
Duration of Acute Hospitalization
Time frame: 14 days
Duration of Post-traumatic Amnesia
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No. pilot, feasibility study only.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Krach, MD principal investigator
Department of Physical Medicine and Rehabilitation
Angela Sinner, DO principal investigator
Department of Physical Medicine and Rehabilitation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic Diet in people with Traumatic Brain Injury, run by Gillette Children's Specialty Healthcare at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to complete a course of the ketogenic diet (KD) (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.