NCT04274179 · Johns Hopkins University
Ketogenic Diet for New-Onset Absence Epilepsy
What this study is about
The ketogenic diet is a medical therapy for epilepsy that is used nearly predominantly for refractory epilepsy (after 2-3 drugs have been tried and failed).
View original scientific description
The ketogenic diet is a medical therapy for epilepsy that is used nearly predominantly for refractory epilepsy (after 2-3 drugs have been tried and failed). However, there is both published evidence for first-line use (infantile spasms, Glut1 deficiency syndrome) and also anecdotal experience (families choosing to change the child's (or the family' own) diet rather than use anticonvulsant medications). Childhood absence epilepsy (refractory) has been published as being responsive to ketogenic diet therapy by the investigators' group previously. This is a small, prospective, 3 month trial to assess if using a modified Atkins diet is a feasible and effective option for new-onset childhood absence epilepsy. The investigators will compare to a group of children in which the parents have declined and chose to start anticonvulsant medications.
Interventions
OTHER
Modified Atkins Diet
Low carb (20g/day), high fat, moderate protein diet. Started as an outpatient in clinic.
DRUG
Absence epilepsy medications
At neurologist's discretion. \*OF NOTE\< THIS ARM IS COMPLETED
Primary outcome measures
Change in seizure frequency
Time frame: At 1 and 3 months post treatment
Parental report of seizure frequency.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Children ages 3-12 years at seizure onset with classic childhood absence epilepsy clinically.
- Normal intellect or mild disability
- EEG with confirmed 3/second spike-wave discharges, usually with hyperventilation
- Daily reported absence seizures.
- Generalized convulsions allowed
Exclusion criteria
- Previous treatment with any anticonvulsant drug
- Previous use of a ketogenic dietary therapy for epilepsy or any other condition
- Glut1 deficiency syndrome
- Metabolic disorder known that would preclude dietary therapy
- Dietary restrictions for which a high fat, low carbohydrate diet would be precluded.
- Prior history of epilepsy (febrile seizures allowed)
- Unwilling to consent to study procedures or return for visits
Where
- Baltimore, Maryland
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 7, 2026 · Source of record for eligibility and locations