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.|
|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Behavioral: atkins diet Behavioral: ability to follow low carbohydrate diet||Not Applicable|
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)|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
- seizure reduction
- cognitive improvement
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): NCT00188500
|Contact: Nina Politzer||416 603-5800 ext 2446|
|Toronto Western Hospital||Recruiting|
|Toronto, Ontario, Canada, M5T 2S8|
|Contact: Nina Politzer, BScN 416 603-5800 ext 2446 email@example.com|
|Principal Investigator: J. Martin delCampo, MD FRCP(C)|
|Principal Investigator:||J Martin delCampo||UHN|