Acute Brain InjuriesNCT02174016
The Ketogenic Diet for Pediatric Acute Brain Injury
A study testing Ketogenic diet in people with Acute Brain Injuries, run by University of California, Los Angeles at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Acute Brain Injuries
- What is being tested?
- Ketogenic diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Dec 2026
- 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 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
About this study
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
- Being tested
- Ketogenic diet
- Keywords
- Intensive Care Units, Pediatric
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic dietDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic diet | Experimental | All subjects will be started on ketogenic diet formula feeding after enrollment for 2 weeks. Receives: Dietary Supplement: Ketogenic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (4)
Number of episodes of low blood glucose levels
Measured: 2 weeks
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.
Measured: 2 weeks
Number of subjects with MRI brain spectroscopy peaks corresponding to ketone body compounds,
Measured: 5 days
Number of subjects who develop kidney stones
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startJan 2015
- Primary completionJun 2019
- Study completionDec 2026 (estimated)
Why it stopped: Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Brain InjuriesStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label use of ketogenic diet in children with acute brain injury
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joyce Matsumoto, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174016
- Sponsor's protocol ID
- 13-001156A
- Status last verified
- Dec 2025
- First submitted
- 23 Jun 2014
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ketogenic Diet for Pediatric Acute Brain Injury
- ClinicalTrials.gov ID
- NCT02174016
- Acronym / sponsor ID
- 13-001156A
- Conditions
- Acute Brain Injuries
- Keywords
- Intensive Care Units, Pediatric
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Funding
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2019 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Jun 2014 (estimated)
- 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label use of ketogenic diet in children with acute brain injury
| Arm | Type | Receives |
|---|---|---|
| Ketogenic diet | Experimental | Dietary Supplement: Ketogenic dietAll subjects will be started on ketogenic diet formula feeding after enrollment for 2 weeks. |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- 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
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 diet | Dietary supplement | Ketogenic diet |
Primary outcome
Increase in Beta-hydroxybutyrate level
Time frame: 2 weeks
Serum beta hydroxybutyrate levels will be checked daily, in order to determine how many days it will take to achieve elevated levels.
4 secondary outcomes
Number of episodes of low blood glucose levels
Time frame: 2 weeks
Number of episodes of low serum bicarbonate levels
Time frame: 2 weeks
Number of subjects with MRI brain spectroscopy peaks corresponding to ketone body compounds,
Time frame: 5 days
Number of subjects who develop kidney stones
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Acute Brain Injuries, run by University of California, Los Angeles at 1 site 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 0 inclusion and 7 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: paused, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Increase in Beta-hydroxybutyrate level (time frame: 2 weeks). 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 19 Dec 2025.