RCT of the Efficacy of the Ketogenic Diet in the Treatment of Epilepsy

Institute of Child Health

Status and phase: Completed; Phase 4

Conditions: Epilepsy

Treatments: Dietary Supplement: Ketogenic diet

Study type: Interventional

Funder types: Other

Identifiers

NCT00564915

98NR04

Details and patient eligibility

About

A study of the efficacy and tolerability of two different ketogenic diets in children with drug resistant epilepsy; children resistant to at least two drugs randomised to reveive diet after baseline or after further 3m control period; in addition randomised to either MCT or classical ketogenic diet.

Enrollment: 145 patients

Sex: All

Ages: 2 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Diagnosis of epilepsy for at least 2 years, resistant to at least two AEDs, at least 7 seizures/week

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)