RECRUITING

Ketogenic Diet for New-Onset Absence Epilepsy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

A Prospective, Case-control Evaluation of Ketogenic Dietary Therapy for New-onset Childhood Absence Epilepsy

Quick Facts

Study Start:2020-08-10
Study Completion:2026-05-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04274179

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Years to 12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Children ages 3-12 years at seizure onset with classic childhood absence epilepsy clinically.
  2. * Normal intellect or mild disability
  3. * EEG with confirmed 3/second spike-wave discharges, usually with hyperventilation
  4. * Daily reported absence seizures.
  5. * Generalized convulsions allowed
  1. * Previous treatment with any anticonvulsant drug
  2. * Previous use of a ketogenic dietary therapy for epilepsy or any other condition
  3. * Glut1 deficiency syndrome
  4. * Metabolic disorder known that would preclude dietary therapy
  5. * Dietary restrictions for which a high fat, low carbohydrate diet would be precluded.
  6. * Prior history of epilepsy (febrile seizures allowed)
  7. * Unwilling to consent to study procedures or return for visits

Contacts and Locations

Study Contact

Eric H Kossoff, MD
CONTACT
4109559100
ekossoff@jhmi.edu

Principal Investigator

Eric H Kossoff, MD
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Eric H Kossoff, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-10
Study Completion Date2026-05-01

Study Record Updates

Study Start Date2020-08-10
Study Completion Date2026-05-01

Terms related to this study

Keywords Provided by Researchers

  • ketogenic
  • diet
  • absence

Additional Relevant MeSH Terms

  • Absence Epilepsy
  • Ketogenic Dieting
  • Epilepsy, Absence