Efficacy of Modified Ketogenic Diet (Atkins) in Management 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. Identifier: NCT00188500
Recruitment Status : Unknown
Verified March 2004 by University Health Network, Toronto.
Recruitment status was:  Recruiting
First Posted : September 16, 2005
Last Update Posted : December 29, 2005
Information provided by:
University Health Network, Toronto

Brief Summary:
The purpose of this study is to determine whether patients with uncontrolled epilepsy can follow a low carbohydrate diet long-term and if so, how will that diet affect their seizures

Condition or disease Intervention/treatment Phase
Epilepsy Behavioral: atkins diet Behavioral: ability to follow low carbohydrate diet Not Applicable

Detailed Description:

In the management of drug-resistant epilepsy, many strategies have been examined. The Ketogenic Diet, high in fats and low in all other nutrients was observed to be of benefit. However, due to its complexedness and unpalatability, this diet is rarely used in the adult population. A recent small study showed seizure reduction with the Atkins Diet.

In this study, patients will be randomized into one of 2 groups- group 1 receiving limited dietary instruction for the Atkins Diet and group 2- receiving detailed dietary instruction. A seizure severity-matched control group will also take part. We will follow these patients over a period of 2 years looking at seizure frequency, weight, sustainability of the diet, effect on anti-epilepsy medication dosage, effect in cognition, quality of life and financial impact of the diet.

Patients will come to clinic to see the dietitian at specific intervals. cognitive testing will also be done at the beginning of the study and every 6 months thereafter. Patients will keep food charts, ketosis charts and seizure diaries.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy, Tolerability and Long-Term Adherence of a Modified Ketogenic Diet (Atkins) in the Management of Pharmacoresistant Epilepsy
Study Start Date : August 2005
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Primary Outcome Measures :
  1. seizure reduction

Secondary Outcome Measures :
  1. cognitive improvement

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:medically refractory partial epilepsy financial ability to pay for higher priced food

Exclusion Criteria:

  • Low BMI

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 identifier (NCT number): NCT00188500

Contact: Nina Politzer 416 603-5800 ext 2446

Canada, Ontario
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Nina Politzer, BScN    416 603-5800 ext 2446   
Principal Investigator: J. Martin delCampo, MD FRCP(C)         
Sponsors and Collaborators
University Health Network, Toronto
Principal Investigator: J Martin delCampo UHN Identifier: NCT00188500     History of Changes
Other Study ID Numbers: 05-0027-AE
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: December 29, 2005
Last Verified: March 2004

Keywords provided by University Health Network, Toronto:
atkins diet

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