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Efficacy of Modified Ketogenic Diet (Atkins) in Management of Epilepsy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2004 by University Health Network, Toronto.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00188500
First Posted: September 16, 2005
Last Update Posted: December 29, 2005
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.
Information provided by:
University Health Network, Toronto
  Purpose
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 Intervention
Epilepsy Behavioral: atkins diet Behavioral: ability to follow low carbohydrate diet

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • seizure reduction

Secondary Outcome Measures:
  • cognitive improvement

Study Start Date: August 2005
Estimated Study Completion Date: September 2005
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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

Exclusion Criteria:

  • Low BMI
  Contacts and Locations
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): NCT00188500


Contacts
Contact: Nina Politzer 416 603-5800 ext 2446

Locations
Canada, Ontario
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Nina Politzer, BScN    416 603-5800 ext 2446    politzer@uhnres.utoronto.ca   
Principal Investigator: J. Martin delCampo, MD FRCP(C)         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: J Martin delCampo UHN
  More Information

ClinicalTrials.gov Identifier: NCT00188500     History of Changes
Other Study ID Numbers: 05-0027-AE
First Submitted: September 12, 2005
First Posted: September 16, 2005
Last Update Posted: December 29, 2005
Last Verified: March 2004

Keywords provided by University Health Network, Toronto:
epilepsy
atkins diet

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