Recruiting
Phase 3

Ketogenic Diet

Sponsor:

Johns Hopkins University

Code:

NCT04274179

Conditions

Absence Epilepsy

Ketogenic Dieting

Epilepsy, Absence

Eligibility Criteria

Sex: All

Age: 3 - 12

Healthy Volunteers: Not accepted

Interventions

Modified Atkins Diet

Absence epilepsy medications

Study Details

Brief summary:

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.

Conditions

Absence Epilepsy

Ketogenic Dieting

Epilepsy, Absence

Study ID

NCT04274179

Start date

Aug 10, 2020

Status verified date

May, 2026

Completion date

May 1, 2028

Anticipated

Primary completion date

May 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 12

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Diet therapy

Modified Atkins Diet - high fat, low carbohydrate, outpatient initiated approach. Parents will check urine ketones twice weekly and follow by email, phone and clinic. Labs at baseline and 3 months. Dietitian support.

active comparator: Drug therapy

Families will have the usual care for absence epilepsy at the discretion of the family's neurologist and the family choice. Typically ethosuximide bis in die (BID), however, if convulsions have occurred or other factors are involved, the child may be started on valproate or lamotrigine. The child will continue medications with dose adjustment and antiseizure drug levels checked as usual. \*\*OF NOTE, THIS ARM IS COMPLETED

Interventions

Modified Atkins Diet

Low carb (20g/day), high fat, moderate protein diet. Started as an outpatient in clinic.

Absence epilepsy medications

At neurologist's discretion. \*OF NOTE< THIS ARM IS COMPLETED

Primary outcome measure

  • Change in seizure frequency [ Time Frame: At 1 and 3 months post treatment ]

Central Contacts and Locations

Central contacts

Eric H Kossoff, MD

4109559100ekossoff@jhmi.edu

Locations

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Eric H Kossoff, MD

410-955-9100ekossoff@jhmi.edu

Principal Investigator:

Eric H Kossoff, MD

More Information

Sponsor

Johns Hopkins University

Last update posted

May 7, 2026

Last verified

May, 2026

Keywords

  • ketogenic
  • diet
  • absence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-23. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-05-07.