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

Phase 4

Completed

• Conditions: Epilepsy

• Registration Number: NCT00564915
• Lead Sponsor: Institute of Child Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-12
• Study Completion: 2006-07
• Status Verified: 2007-11
• Study First Submitted: 2007-11-28
• Study First Submitted QC: 2007-11-28
• Last Update Submitted: 2007-11-28
• Study First Posted: 2007-11-29
• Last Update Posted: 2007-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in seizure frequency	3 months

Secondary Outcome Measures

Name	Time	Method
Tolerability and assessment of ketosis and growth	3 months

Trial Locations

Locations (1)

Institute of Child Health, The Wolfson Centre; 🇬🇧 London, United Kingdom