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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00564915
• Other study ID #: 98NR04
• Status: Completed
• Phase: Phase 4
• First received: November 28, 2007
• Last updated: November 28, 2007
• Start date: December 2001
• Est. completion date: July 2006

Study information

• Verified date: November 2007
• Source: Institute of Child Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 16 Years

Eligibility

Inclusion Criteria:

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Epilepsy

Intervention

Dietary Supplement:
• Ketogenic diet
Ketogenic diet

Locations

Country	Name	City	State
United Kingdom	Institute of Child Health, The Wolfson Centre	London

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Child Health

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in seizure frequency		3 months	No
Secondary	Tolerability and assessment of ketosis and growth		3 months	No