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

This study has been completed.
Sponsor:
Information provided by:
Institute of Child Health
ClinicalTrials.gov Identifier:
NCT00564915
First received: November 28, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Epilepsy
 Dietary Supplement: Ketogenic diet
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: RCT of the Efficacy of the Ketogenic Diet in the Treatment of Epilepsy

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

Further study details as provided by Institute of Child Health:

Primary Outcome Measures:
  • Change in seizure frequency [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability and assessment of ketosis and growth [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 145
Study Start Date: December 2001
Study Completion Date: July 2006
Intervention Details:
    Dietary Supplement: Ketogenic diet
    Ketogenic diet
  Eligibility

Ages Eligible for Study:   2 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of epilepsy for at least 2 years, resistant to at least two AEDs, at least 7 seizures/week
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00564915

Locations
United Kingdom
Institute of Child Health, The Wolfson Centre
London, United Kingdom, WC1N 1EH
Sponsors and Collaborators
Institute of Child Health
Investigators
Principal Investigator: Helen Cross, Professor UCL Institute of Child Health
  More Information

No publications provided

Responsible Party: Tracy Assari, Institute of Child Health
ClinicalTrials.gov Identifier: NCT00564915     History of Changes
Other Study ID Numbers: 98NR04
Study First Received: November 28, 2007
Last Updated: November 28, 2007
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Institute of Child Health:
Epilepsy

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013