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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00564915
Recruitment Status : Completed
First Posted : November 29, 2007
Last Update Posted : November 29, 2007
Sponsor:
Information provided by:
Institute of Child Health

Study Description
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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.

Condition or disease Intervention/treatment Phase
Epilepsy Dietary Supplement: Ketogenic diet Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: RCT of the Efficacy of the Ketogenic Diet in the Treatment of Epilepsy
Study Start Date : December 2001
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arms and Interventions
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Intervention Details:
  • Dietary Supplement: Ketogenic diet
    Ketogenic diet

Outcome Measures
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Primary Outcome Measures :
  1. Change in seizure frequency [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Tolerability and assessment of ketosis and growth [ Time Frame: 3 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00564915


Locations
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United Kingdom
Institute of Child Health, The Wolfson Centre
London, United Kingdom, WC1N 1EH
Sponsors and Collaborators
Institute of Child Health
Investigators
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Principal Investigator: Helen Cross, Professor UCL Institute of Child Health
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Tracy Assari, Institute of Child Health
ClinicalTrials.gov Identifier: NCT00564915    
Other Study ID Numbers: 98NR04
First Posted: November 29, 2007    Key Record Dates
Last Update Posted: November 29, 2007
Last Verified: November 2007
Keywords provided by Institute of Child Health:
Epilepsy
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases