Back to resultsRCT of the Efficacy of the Ketogenic Diet in the Treatment of Epilepsy
Primary Purpose
Epilepsy
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Ketogenic diet
Sponsored by
About this trial
This is an interventional diagnostic trial for Epilepsy focused on measuring Epilepsy
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of epilepsy for at least 2 years, resistant to at least two AEDs, at least 7 seizures/week
Sites / Locations
- Institute of Child Health, The Wolfson Centre
Outcomes
Primary Outcome Measures
Change in seizure frequency
Secondary Outcome Measures
Tolerability and assessment of ketosis and growth
Full Information
NCT ID
NCT00564915
First Posted
November 28, 2007
Last Updated
November 28, 2007
Sponsor
Institute of Child Health
1. Study Identification
Unique Protocol Identification Number
NCT00564915
Brief Title
RCT of the Efficacy of the Ketogenic Diet in the Treatment of Epilepsy
Official Title
RCT of the Efficacy of the Ketogenic Diet in the Treatment of Epilepsy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Institute of Child Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
145 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketogenic diet
Intervention Description
Ketogenic diet
Primary Outcome Measure Information:
Title
Change in seizure frequency
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Tolerability and assessment of ketosis and growth
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of epilepsy for at least 2 years, resistant to at least two AEDs, at least 7 seizures/week
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Cross, Professor
Organizational Affiliation
UCL Institute of Child Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Child Health, The Wolfson Centre
City
London
ZIP/Postal Code
WC1N 1EH
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
18456557
Citation
Neal EG, Chaffe H, Schwartz RH, Lawson MS, Edwards N, Fitzsimmons G, Whitney A, Cross JH. The ketogenic diet for the treatment of childhood epilepsy: a randomised controlled trial. Lancet Neurol. 2008 Jun;7(6):500-6. doi: 10.1016/S1474-4422(08)70092-9. Epub 2008 May 2.
Results Reference
derived
Learn more about this trial
RCT of the Efficacy of the Ketogenic Diet in the Treatment of Epilepsy
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