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Ketogenic Diet for New-Onset Absence Epilepsy

ConditionsAbsence EpilepsyKetogenic DietingEpilepsy, Absence
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age3-12
SponsorJohns Hopkins University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Modified Atkins Diet

    Other intervention

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

  • Absence epilepsy medications

    Drug

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Diet therapyExperimental treatment 1 intervention
Group B: Drug therapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in seizure frequency

Parental report of seizure frequency.

Time frame
At 1 and 3 months post treatment

Secondary outcomes

1

Tolerability of diet therapy as assessed by restrictiveness of the diet therapy

Diet therapy restrictiveness will be assessed with an open ended questionnaire that asks "how hard has it been for the child?". Completely subjective with no scale or scoring.

Time frame
At 3 months
2

Tolerability of diet therapy as assessed by restrictiveness of the diet therapy

Diet therapy restrictiveness will be assessed with an open ended questionnaire that asks "how hard has it been for the child?". Completely subjective with no scale or scoring.

Time frame
At 6 months
3

Duration of diet therapy

Duration of diet therapy in months.

Time frame
Up to 3 months post treatment
4

Tolerability of diet therapy as assessed by change in urinary ketones

Urinary ketones in mg/dl will be measured (80-160mg/dl is considered large ketosis).

Time frame
At 1 and 3 months post treatment

Other outcomes

Sponsors and contacts

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Johns Hopkins University

Lead sponsor

Source ClinicalTrials.gov
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